The following career opportunities were posted this week at DNAjobs.com. For each position, I have listed a short description and a link for more information.
As always, I wish you tremendous success in your searching!
Jason
Associate Medical Director
(US-New Jersey) For our client, a public pharma, the Associate Medical Director is accountable for key aspects of the successful design, execution, and reporting of clinical trials. This person reports to, supports and as needed substitutes for the Medical Director. S/he in conjunction with other medical personnel supports the clinical aspects of development. The ideal candidate for this position will act as principal medical person from the design perspective for clinical trial phases (I-IV) for products under development. The AMD is responsible for the safety assessment department for clinical trials phases (I-IV) for products under development, and will also monitor the adherence to protocols. This person will interact with and resolve clinical development and medical issues with the FDA and all other regulatory agencies. The AMD will Act as Principal medical person from the report writing perspective for clinical trials phases (I-IV) for products under development for those parts of reports related to medical aspects of trials.
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Vaccine Development Professionals
(US-North Carolina) Remember Why Your Career Matters to the Rest of the World. Wyeth Vaccines is committed to producing vaccines that attack life threatening illnesses and diseases. As we develop groundbreaking vaccines to make the quality of life better for millions, we’re pleased to think of how our work affects the lives of individuals. Heroes of Chemistry, 2003 Honoree Recipients discovery of Prevnar® (pneumococcal 7-valent conjugate vaccine diphtheria CRM197protein) to prevent Streptococcus pneumoniae infection. As proud recipients of the 2003 Heroes of Chemistry award, we pledge to continue our commitment of making the world a better place to live. With the expansion of our Sanford, NC group and a new laboratory facility in Research Triangle Park, we continue to grow at a rapid pace. This is an exciting time at our company and an exceptional opportunity to join our growing team of VACCINE DEVELOPMENT professionals. Bacterial Fermentation Development; Purification Chemistry; Bacterial Assay Method Validation; Bacterial Formulation -and- Vaccine R&D Quality Operations.
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Chief Medical Officer
(US-Massachusetts-Boston) Make a big impact on a small but growing genetics company in the Boston area. Our client has an immediate opening for a new Chief Medical Officer who will be a member of the senior management team contributing to company business and R&D strategies in areas of pharmacogenomics and nutrigenomics. This position will be a key driver in the company’s recent successful industry leading nutrigenomics partnership. The CMO will also have overall responsibility for all clinical studies and staff; oversee product development teams; responsible for company interactions with FDA; recruit, hire and manage in-house project managers and clinical staff. REQUIREMENTS: Medical Degree and Board Certified prefer Internal Medicine, ardiovascular or Osteoporosis. 8-10 years senior level management in Medical Affairs with a pharmaceutical, biotechnology or contract research company. Proven team building and management skills. Previous knowledge of and experience interacting with the FDA, FDA guidelines and requirements.
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Pharmacist
(US-Illinois) Our client, a major pharmaceutical company in Deerfield, IL is looking for a Pharmacist with the following qualifications: Reviews prescriptions issued by Physician, or other authorized prescriber to assure accuracy and determine formulas and ingredients needed. Compounds medications, using standard formulas and processes such as weighing, measuring, and mixing ingredients. Directs pharmacy workers engaged in mixing, packaging, and labeling pharmaceuticals. Answers questions and provides information to pharmacy customers on drug interactions, side effects, dosage and storage of pharmaceuticals. Maintains established procedures concerning quality assurance, security of controlled substances, and disposal of hazardous waste drugs. Enters data such as patient name, prescribed medication and cost, to maintain pharmacy files, charge system, and inventory. Assays medications to determine identity, purity, and strength.
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Analytical Scientist
(US) Client is a Midwest Manufacturer of parenteral pharmaceuticals. Client recently purchased a new manufacturing facility that will have the capability to produce sterile solutions and suspensions as well as lyophilized vials. POSITION: Analytical Scientist, reporting to the Director of Process Technology FUNCTIONS: Developing new analytical methods for new dosage forms (approx. 25% of job) Validating new methods (approx. 15% of job) Troubleshooting existing methods (approx. 20% of job) Serving as the analytical science and pharmaceutical analysis resource REQUIRES: A M.S. or Ph.D. in Chemistry or Analytical Chemistry, or closely related field. Expertise demonstrated by publication in analysis of pharmaceutical dosage forms by HPLC or similar techniques. Requires six (6) years experience in a laboratory environment with at least three (3) of those years in an industrial position involving pharmaceutical analysis related to client’s strategic focus, preferably at a mainstream pharmaceutical company.
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Clinical Medical Reviewer / Safety Reviewer - B
(US-Illinois) Our client, a major pharmaceutical company in Lake County, IL is looking for a Clinical Medical Reviewer/Safety Reviewer B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.
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Recruiter
(US-Connecticut) Due to continued growth, small recruiting firm with established Fortune 400 clientele is seeking an experienced recruiter to join our team. The recruiter position provides an excellent opportunity for a highly motivated individual who thrives in a fast-paced environment and is based in the State of Connecticut. Experience working out of a home office is desired. A minimum of 2 years experience recruiting in the Pharmaceutical industry is mandatory. Position is telephone intensive and involves sourcing, screening and placing qualified candidates. Training is provided in many areas from discussing opportunities with perspective candidates to interviewing techniques and hiring practices. We provide all the recruiting tools you need to be successful. Computer experience working with Word, Excel and Access is desired, along with good writing skills. Great opportunity for an individual who would like to dictate their income.
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Manager, Technical and Client Services
(US) Our client maintains a repository of human biological samples and offers purified RNA, DNA, protein samples, tissue microarrays and disease specific protein expression databases. POSITION: Manager, Technical and Client Services; Location-Northeast This is a key management position necessitated by growth. Reports to the President. Responsible for ongoing communication and correspondence with the company’s clients, including pharmaceutical research units and academic research laboratories. Responsible for development, implementation and maintenance of client management systems, relating to inquiry tracking and management. Also, commensurate with experience, opportunities to manage a laboratory operation. Opportunities to publish. REQUIREMENTS: PhD or PA preferred, MS acceptable with experience. Relevant degrees and experience in disciplines such as pathology, histopathology, molecular biology, cellular biology.
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Medical Director-Clinical Development
(US) Currently we have several companies searching for just the right person to lead their clinical development team. Areas of interest are numerous but could include Oncology, Neurology (drugs or devices), Cardiovascular (drugs or interventional) and Infectious Disease are some of the areas. A prototype job description is as follows: Job Description: The purpose of this position is to design, direct, and function as a Study Director of clinical studies (Phase II and phase III) as a part of the global clinical development plans in Neurology for worldwide registration and to provide Neurologic clinical input/support. As such, you will be ..... Responsible for all medical & scientific aspects of the study from design phase, through implementation, and finalization, including scientific and medical input into the final review and sign-off of all pertinent clinical trial documentation. Responsible for assuring that study conduct is in compliance with all applicable national, and internationally accepted regulations.
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Formulation Scientist
(US) Develop and characterize formulations to support small molecule drug discovery and development programs. The position requires hands on laboratory work. RESPONSIBILITIES: Establish a formulation development and testing lab. Develop prototypes of formulations (solid and liquid dosage forms for injection and oral dosing). Characterize new drug substances and formulations with respect to relevant thermal, solid state, solubility, and stability properties. Hands on operation and maintenance of analytical instruments. Effectively transfer research formulations developed in the lab to the manufacturing facilities. Assist with defining QC specifications / audits / generation of documents for regulatory agencies. The successful candidate will be responsible for planning and the prioritization of multiple projects in a cGMP environment, must have excellent managerial, organizational, communication skills and will be required to function on multi-disciplinary teams. He/She will also be responsible for drafting SOP’s, validation protocols, technical reports and conduct validation activities in conjunction with QC personnel.
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Director Protein Formulation
(US) Reporting to the Vice President, the qualified candidate will lead and manage the BioFormulations Development Group. This group is responsible for developing recombinant protein formulations suitable for commercial product use. This group interfaces with multiple Research and Development teams and also supports physical chemical characterization of candidate molecules, as well as early formulations, used during initial preclinical studies. Additionally, the group’s responsibilities entail profiling the physical chemical properties of lead formulation candidates and identifying potential development challenges in terms of stability as well as bioavailability and delivery. This group plays a lead role in the formulation selection process working in close collaboration with the Science, Clinical Research, Manufacturing Support, Quality and Regulatory teams. This individual will be responsible for supervising multiple levels of research associates and scientists, managing the day-to-day operations of the group, representing BioFormulations Development on both Research and Development project teams and will be a critical member of the management team.
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Investigator / Analytical / Bioanalytical
(US) This position will be responsible for early phase clinical product development, optimization, validation and transfer of complex analytical assays to Quality in order to support therapeutic proteins using a variety of methods including protein and carbohydrate techniques. RESPONSIBILITIES: The successful candidate will be responsible for planning and the prioritization of multiple projects in a cGMP environment, must have excellent managerial, organizational, communication skills and will be required to function on multi-disciplinary teams. The qualified candidate will also be responsible for drafting SOP’s, validation protocols, technical reports and conduct validation activities in conjunction with QC personnel. EXPERIENCE: A Ph.D in Biochemistry, Chemistry or a related field with 1-5 years industrial experience and solid background in the state-of-the-art mass spectrometric techniques, including Ion-Trap, MALDI-TOF and other MS/MS techniques used to determine detailed structural characterization including post-translational modifications (carbohydrate analyses) of therapeutic proteins.
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Medicinal Chemists-Research Associates (Multiple openings)
(US) A productive synthetic chemist, well-versed in modern synthetic methods and spectroscopy techniques, who will work closely with scientists in medicinal chemistry to plan and execute syntheses of compounds required in lead identification and lead optimization programs. The successful candidate will devise and execute synthetic routes to agreed target compounds; as well as monitor and evaluate new synthetic technologies (e.g. parallel synthesis and purification techniques). Record work in laboratory notebooks and present progress at chemistry group and project team meetings. Maintain current knowledge of synthetic methodology through literature reading and meeting attendance. Requirements: 5 years of synthesis experience, preferably in a biotechnology or pharmaceutical industry setting. Demonstrated experience executing multi-step organic syntheses and familiarity with application of modern spectroscopic and separations techniques are requisites.
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Pharmacogeneticist
(US) Design of pharmacogenetics studies to address questions related to drug metabolism, treatment efficacy or toxicity arising in the course of clinical trials. The design will be done in close collaboration with the clinical trial teams and may use a candidate gene or a whole genome scan approach. Conduct association studies to investigate the correlation between single nucleotide polymorphisms (SNPs) and clinical parameters. Statistical tools used may include multivariate analysis, survival analysis, ANOVA, ANCOVA, Linkage Disequilibrium, Hardy Weinberg Equilibrium and haplotype analysis. The goal is to find genetic factors associated with drug response. The analysis will be conducted in close collaboration with the clinical trial statisticians. Implement new statistical methods to address genome-wide association studies addressing the multi-genic nature of complex traits. Write reports to be included in the project file Present results to development teams and management Mentor and train new hires Interact with external specialists.
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Senior Director Medicinal Chemistry
(US-Massachusetts) The successful candidate will be a key member of a multidisciplinary team and be directly responsible for the success of the Medicinal Chemistry group. You will have a track record of interacting at the most senior levels of the Company you are currently employed by (SAB, CSO, etc.); of recruiting "top notch" Scientists to be on your team and of leading and directing successful drug discovery and development program. Requirements: 15-20 years of experience plus a strong track record of accomplishment will help you qualify for this GREAT opportunity!
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Associate Director Protein Engineering
(US) To lead a scientific team involved in the development of 2nd generation protein-based products, RESPONSIBILITIES: Associate Director will be responsible for leading a team of 10-12 Scientists who are responsible for the development of second generation therapeutic proteins using a variety of methods including protein and carbohydrate modification, and conjugation techniques. This key position will interface between research and product development. In addition, it will involve the planning and the prioritization of multiple projects. EXPERIENCE: The successful candidate will have excellent managerial, organizational, and communication skills. In addition, the candidate will have extensive experience leading multi-disciplinary teams with a background in protein engineering and have a proven track record in the production of products with improved biological properties. A Ph.D in biochemistry, cell, or molecular biology and 10 plus years is required.
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Computational Chemist
(US-Massachusetts) RESPONSIBILITIES: 1)Implement QSAR-ADME/Toxicology studies to support compound selection and virtual screening. 2)Correlate data to generate predictions for screening and lead optimization(initially using MDL QSAR package and Tripos software). 3) Perform docking and pharmacophore modeling to support virtual screening and compound selection in support of proprietary hit series identification primarily uses Tripos, Glide and InsightII software). 4) Maintain cheminformatics related hardware and software(this will include installation and upgrade of server and client side software, user training and immediate customer support). 5)Maintain data registration process, training and helping scientists to register biological assay and in vivo data into RS3 and ActivityBase databases. 6) Provide support for Compound Control and Screening as co-administrator of ActivityBase and support/programming as needed.
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Manager Preclinical Development
(US) RESPONSIBILITIES: Responsible for managing project support services for all programs across preclinical research. Direct the development and implementation of tools, procedures and metrics to track projects to ensure timely completion of studies and department initiatives. Works with preclinical therapeutic area directors/managers to standardize and streamline steps common to all preclinical projects. Assist to assign resources along business unit priorities based on iterative assessment of preclinical workload compared with current project priorities. Participates in or advises in the negotiation of contract and contract changes, internally as well as in partner relationships. Coordinates the preparation and tracking of animal study plans and synopses through internal processes and communicates the status of all projects to preclinical management on a periodic basis. Establishes milestones and monitors adherence to master plans and schedules identifies program problems and obtains solutions, such as allocation of resources or changing internal or external contractual specifications.
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Toxicology / Preclinical Scientist
(US-Massachusetts) The candidate who fills this position will be involved in registration-enabeling preclinical studies to support lead candidate development for both biologic and small molecule development programs. RESPONSIBILITIES: Design and oversight of preclinical pharmacology and toxicology studies. In addition, the candidate will be responsible for analysis of the resultant data and the reporting of study results at both internal and external forums, as necessary. The qualified candidate will also participate in the preparation of regulatory documents for both domestic and non-domestic regulatory agencies. EXPERIENCE: Ph.D in Pharmacology, Toxicology or related plus a minimum of 2 years in industry designing / conducting various aspects of preclinical safety evaluations of drug molecules; basic knowledge of drug development principles; must possess speaking and writing skills that will enable him/her to provide clear ideas, arguments, and rationale for study designs and analyses; must also be capable of engaging in scientific dialog among large groups scientists, senior management and regulatory authorities.
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Group Leader - Cancer Biology
(US) Join a team of leading researchers at one of the world's premier biotechnology Companies. Currently, this Company is expanding thier research program in Signal Transduction-Based Drug Discovery in Molecular Oncology and Cancer Biology. There is now a need for an experienced, highly talented Group Leader to take responsibility for establishing a retroviral RNAi-based mouse model engineering platform and leading a team of scientific personnel researching Signal Treansduction-based drug discovery in molecular oncology and cancer biology. RESPONSIBILITIES and QUALIFICATIONS: The incumbent will be involved in the hiring and identification of additional persons for this group involved in RNAi-based target validation. The successful individual will have extensive experience in the generation, phenotypic, and molecular analyses of genetically engineered mice, and ideally with the generation and use of retro/ lentiviral vectors and/or with siRNA.
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Senior Sales Analyst
(US) RESPONSIBILITIES: Plan and execute sales data analysis for the division, including running reports at both the district and territory levels as needed. Identify sales opportunities via integration of secondary sales data. Maintain and manage the Sales Information System (SIS) Database that is currently under construction. Collect, audit and merge inbound sales data from distributors into SIS Database. Manage field force alignment changes in the SIS system. Assist in the design of, set up and management of the incentive calculation system with partner vendor. Manage incentive payments and forecast incentive payment trends Individual will report into the Senior Director of Sales; dotted line report into the Corporate Controller QUALIFICATIONS/EXPERIENCE: Mastery of Excel and other computer based analytic tools, ie Microsoft Access, etc. Experience working with complex databases.
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Trade Relations - Specialty - Pharmacy
(US) MISSION STATEMENT: In reporting to the Trade Director, responsible for fostering and maintaining relationships with focus on the Specialty Pharmacy markets. Includes Specialty Pharmacy distribution strategy, development of contracts, and external partnering. SPECIFIC RESPONSIBILITIES: Implement new Channel distribution strategy to shorten chain and ship higher volume to SPPs that increase service level to end customers. Develop partnerships with preferred/qualified players in Specialty Pharmacy. Functionally manage major specialty pharmacy accounts. Execute plans on recalls, product launches, and other commercial initiatives involving specialty pharmacies and direct accounts. Manage various contracts with key external accounts as necessary and required to ensure clear, stable and profitable relationships with the Trade partners. Ensure that contracts and agreements are correctly implemented including monitoring of inventory levels, the active application of the returns policy, and the correct execution of any special sales agreements.
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Field Sales Representative
(US-Illinois-Chicago) The main focus shall be to increase sales bookings and market share in their specific territoty utilizing all four of our producst lines: thermal cyclers, real-time quantitative systems, plastics, and enzymes. Seeking a highly motivated individual to join our sales team working with DNA analysis equipment. MUST have extensive molecular biology experience, preferably a Ph.D. in a life science. Position will initially be based in our Schaumburg office, but ultimately will require relocation to cover Denver, St. Louis, North Carolina territory. Although prior experience in sales is desired -- it is not necessary. Depending upon experience, duties will include various sales activities, including telephone and personal sales calls, demonstrations at labs and at conferences, follow-ups with scientists and established customers. Must be willing to travel, and must have US work authorization without need of a sponsor.
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Field Sales Representative
(US-Colorado-Denver) The main focus shall be to increase sales bookings and market share in their specific territoty (Denver) utilizing all four of our producst lines: thermal cyclers, real-time quantitative systems, plastics, and enzymes. Seeking a highly motivated individual to join our sales team working with DNA analysis equipment. MUST have extensive molecular biology experience, preferably a Ph.D. in a life science. Although prior experience in sales is desired -- it is not necessary. Depending upon experience, duties will include various sales activities, including telephone and personal sales calls, demonstrations at labs and at conferences, follow-ups with scientists and established customers. Must be willing to travel, and must have US work authorization without need of a sponsor.
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Sr. Quality Control Microbiologist
(US-Massachusetts) Responsible for all microbiological and some analytical testing of production materials under GMP conditions. Responsible for process and equipment validation (autoclave and depyrogenation oven) in cooperation with Engineering and R&D (New Product Sterility and LAL validation). Works on complex problems requiring in-depth analysis and evaluations of factors, and on assignments that are required to be performed according to defined procedures and practices. Exercises considerable judgment and intiative within broadly defined practices and policies in selecting methods and techniques. SPECIFIC RESPONSIBILITIES: "Development and validation of new or improved microbiological methods. " Bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples."
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Director of Bioengineering
(US-Massachusetts-Boston) The Director of Bioengineering will manage a group of scientists in the development of cell culture processes in bioreactors that will ultimately be transferred to manufacturing for the production of therapeutic proteins. This key leadership role will direct the development of growth and production conditions, evaluate improved cell culture media formulations, evaluate production strategies for inoculum development and for harvesting conditioned media and will oversee the transfer of operations to the manufacturing group. The Bioengineering group, under the Directors supervision, will establish new technologies/processes using bench scale bioreactors as initial proof of concept stage. The processes will be scaled-up leading to the production of material suitable for toxicology, pharmacology and early clinical studies.
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Field Sales Representative
(US-North Carolina-Raleigh/Durham) MJ Research, Inc. (MJR) is a leading biotechnology company specializing in the instrument and reagent technology needed for modern biological research. The company has grown from a small attic-based operation to a multinational corporation that is recognized worldwide as the industry leader in its field of technology. The company has facilities in Waltham & Watertown, MA; South San Francisco, CA; Reno, NV; Sauk City, WI; vaerlose, Denmark; Seoul, South Korea; and Beijing, China. Affiliated companies also have offices in Toronto, Canada and Tokyo Japan.
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V.P. Medical Director
(US-Massachusetts) Your responsibilities will be numerous in this hands on position. Two (2) positions exist! You will report to, and work closely with the Sr. Vice President of Medical Affairs to plan, direct and oversee clinical studies intended for FDA and foreign regulatory submission. Other duties include: providing clinical expertise and leadership to the company, design, coordinate and finalize clinical research protocols, consent forms, protocol amendments, and CRFs for assigned project(s), establish and maintain relationships with FDA medical staff, consult with Investigators on exceptions to eligibility or deviations from protocols, be responsible for ensuring the successful and timely recruitment of clinical research study participants, review, finalize, and update Investigator Brochures, finalize drug supply forecasts and study drug distribution plans.
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Regulatory Affairs Manager
(US-Massachusetts) Reporting to the Associate Director of Regulatory Affairs, the Manager will be responsible for determining Regulatory strategy for specific projects relating to the development of new formulations, new delivery systems and new indications for commercial products as well as post-marketing commitments and Phase 4 studies. The Manager will also serve as the RA representative on relevant project teams and as the primary regulatory contact with regulatory authorities in the US and Canada. Specific duties include but are not limited to: -Represent RA on all relevant project teams -Responsible for the development and implementation of RA strategy for assigned projects and programs -Responsible as the primary contact for all communications with the regulatory agencies relevant to assigned projects or programs. -Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
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Director of Drug Safety
(US-Massachusetts) The Director is responsible for all activities related to the monitoring and reporting of the safety profile of marketed products on an ongoing basis. This includes the management of potential risks associated with these products, ensuring compliance with FDA regulations on expedited and periodic reporting of Adverse Events, developing and adhering to Corporate Standard Operating Procedures (SOP). Ensures the accurate, comprehensive and reliable collection, documentation and follow-up of any reported post-marketing adverse experience according to guidance from the FDA. Ensures the timely reporting of expedite and periodic reports to the FDA according to FDA regulations. Prepares and approves the specific local SOPs intended to achieve the above duty, their update, their dissemination within the local organization and the training of relevant personnel. Prepares and approves the specific local SOPs intended to ensure the total compliance of the Product Safety department.
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Vice President - Regulatory Affairs
(US-Massachusetts) To develop, support and manage regulatory strategies. To review and approve data packages for product candidates to ensure completeness, accuracy and validity of data in support of regulatory applications. RESPONSIBILITIES: Anticipate consequences and assess impact of new or revised worldwide regulations and guidelines on the company’s strategies. Review and approve key segments of regulatory submissions. Represent the company and effectively participate with senior level representatives of regulatory agencies worldwide. Effectively interact with senior company management to influence direction of the Regulatory Affairs group and associated company efforts. Communicate to senior management regulatory strategic & tactical plans to achieve company goals. Act as recognized leader in the drug development process with comprehensive and business knowledge in a variety of product areas.
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Manager Drug Safety
(US-Massachusetts) Manage the processes and reporting of adverse events (AE) of marketed products and products under development while assuring compliance with regulatory requirements and internal SOP’S. Responsibilities also include the management and oversight of Drug Safety Associates and their roles for adverse event report processing, Periodic Reports, registry functions, case report documentation triage of individual case reports. Participate in the update and reconciliation adverse event case reports in the ARISg safety database system as required. QUALIFICATIONS/EXPERIENCE: Minimum of a Bachelor of Science degree in life sciences and a minimum of 4-7 years experience in drug safety. Detailed knowledge of FDA & legal regulations and practices, and database management. Ability to effectively communicate with employees, consumers, and health professionals of varying levels of medical knowledge required.
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Sr. Quality Assurance Specialist
(US-Massachusetts) The qualified candidate will assist in the routine performance of Quality Systems to assure compliance with in-house specifications, standards and cGxPs, with an emphasis on auditing, documentation, data review and training. Responsibilities include the production of batch record/test report review, SOP review and approval, review and maintenance of investigations and change control requests. This position will require 5-10% travel both internationally and within the US. Qualifications: The successful candidate will have a BS or equivalent and 5+ years of relevant QA or industry experience. Demonstrated knowledge of GMP operations will be required. Experience in both internal and external compliance audits is required. Strong written and verbal communication skills, as well as strong organizational skills are required in order to assure that turnaround times are met in support of further manufacturing.
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Director of Clinical Affairs
(US-Massachusetts) The Director of Clinical Affairs will be responsible for all aspects of clinical trial management. These responsibilities include the management of contract research organizations (CROs), design and writing of protocols and clinical trial reports, preparation and monitoring of budgets and trial timelines, and recommendation on resource requirements. The Director will represent Clinical Affairs on Program Teams and provide strategic input on new development-stage products. This person will lead the cross-functional Clinical subteam for development of cellular and protein therapy products. RESPONSIBILITIES: Act as principal director of Phase I, II, and III clinical trials. Manage CRO, data management firm, central laboratory and other vendors. Interface with investigative sites, including investigators, pharmacists, and study coordinators. Proactively identify and resolve issues.
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Purification Manufacturing Supervisor
(US-California) Provide general oversight for Purification Operations within a biologics manufacturing facility. Establish effective working relationships with customer/support departments to achieve facility goals and resolve production issues. Conduct exception investigations and write justification reports to support product disposition. Ensure adherence to Safety and Quality Regulations. Audit area, host audits, prepare and implement responses.Manage and enthusiastically develop a staff of approximately 25 - 30 through two Supervisors. Assist Manager in the performance of technical reviews, preparation / planning / tracking of projects. Provide back-up coverage for Supervisors / Manager. QUALIFICATIONS: At least three years of Supervisory experience and strong personnel management potential. Eight years of experience in regulated Biotech/Biopharm industry.
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Clinical Program Manager
(US-Massachusetts) The (Sr) Clinical Program Manager works within the Department of Clinical Operations to manage clinical studies that are designed to establish the safety and effectiveness of Company's products. This person initially will focus on early clinical development, but will have the ability to bring one or more of these products to Phase III development, as necessary. Skills required include study planning and training, study initiation, study management, and completion of final clinical study reports. Liaison with potential clinical investigators and management of Contract Research Organizations and other clinical resources is a significant aspect of this position. Responsibilities: Develop clinical development plans and study timelines. Participate in the development of clinical protocols, Investigator Brochures, consent forms, training material, and other clinical documents, as required by the project.
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Director of Engineering
(US-Massachusetts) This position is responsible for directing the R&D Engineering group responsible for supporting a R&D site. The primary function of this group is to provide safe, functional cost effective buildings and equipment in a timely and professional manner. Responsibilities include facilities design, capital planning, project/construction management, technical studies, master planning, identification and remediation for ongoing facility/process issues. The performance of this group directly affects the ability of the business to meet strategic objectives by planning for and providing facilities in a timely and compliant manner while maximizing shareholder value. MINIMUM QUALIFICATIONS: Demonstrated leadership, team building and staff development skills. Strong Financial acumen and ability to forecast and manage budgets. BS in Engineering / prefer MS.
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Clinical Project Manager
(US-Massachusetts) Responsible for managing the development, initiation, conduct, monitoring and completion of clinical studies. SPECIFIC RESPONSIBILITIES: 1. Provide operational perspective to planning of clinical studies. 2. Generate timelines for initiation to completion and reporting of clinical studies. 3. Coordinate generation and assembly of all documentation associated with clinical studies. 4. Participate in site selection and qualification. 5. Negotiate investigator and CRO budgets in collaboration with Finance Department. 6. Coordinate all GCP activities from site selection through data completion and regulatory site audits with CROs. 7. Conduct site audits and perform periodic site visits. 8. Plan, monitor and report patient accrual and implement corrective actions as necessary to meet accrual targets. 9. Coordinate production, labeling and delivery of clinical supplies with Operations Department, external labeling company, and investigational sites.
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Senior Clinical Research Associate
(US-Massachusetts) Working independently, under minimal supervision, the Senior Clinical Research Associate will be responsible for all operational aspects of implementation and conduct of clinical studies including study planning, implementation, monitoring and completion activities. A travel commitment will be required. The key responsibilities of this position will be to contribute to the development of clinical programs including protocols, study procedure handbooks, and case report forms; to insure compliance of study activities with FDA regulations, Guidelines and principles of Good Clinical Practice. Along with the Medical Monitor, you will be responsible for study site selection; patient accrual, documentation of protocol violations; tracking study progress via standard reports; and management of adverse event reporting.
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Clinical Project Manager
(US-Massachusetts-Boston) Our client, a leading R&D Biopharmaceutical company in the area of rare diseases, has an immediate need for a Clinical Project Manager with expertise in clinical trial management. The position will report to the Director of Medical & Clinical Operations and will lead the clinical trial team. RESPONSIBILITIES: Manage/direct the clinical trial team. Preparation of budgets and projections. Project coordination, communication with R&D, regulatory affairs and pre- clinical teams. Preparation of reports and regulatory review REQUIREMENTS: B.S. in health sciences. Must have at least 3 years experience in clinical trials project management and a good understanding of clinical trial procedures. Must possess excellent interpersonal and communications skills, and must be able to work with multidisciplinary teams.
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Senior Biostatistician
(US-Massachusetts) The Senior Biostatistician will support clinical trial activities in accordance with industry standards for research, and relevant regulations and guidance documents. It is expected that the Senior Biostatistician will be able to work independently. RESPONSIBILITIES: A large portion of effort will be directed to oversight of biostatistical services provided by clinical CROs. An understanding of industry standards for data management procedures used to collect, compile, and present clinical data is required. Responsibilities will include activities that support the planning, analysis, review, and interpretation of clinical data sets from research projects and protocols conducted by the clinical research group. Activities will include, but are not limited to, working with study team members on pre-study planning, protocol development (in particular, the statistical section of the protocol including sample size/power calculations), Statistical Analysis Plan preparation/review, oversight of the biostatistical activities of contractors and contract research organizations (CRO), data quality reviews, and review of tables/listings/figures and clinical study reports.
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Manager, Regulatory Labeling and Promotion
(US-Massachusetts) The Manager, Regulatory Labeling and Promotion, is responsible for the management of regulatory activities in the support of external commercial communications, labeling development, and labeling maintenance. This person represents regulatory in cross-functional teams that review and/or approve promotional materials, sales training materials, press materials, and other external communications. This person represents regulatory in cross-functional teams that develop draft labeling for regulatory authority review and approval and maintains labeling after approval. and will be a liaison with regulatory authorities and other functional teams in matters relating to labeling and promotions. EXPERIENCE/EDUCATION: MS/PharmD preferred. Good knowledge of labeling and advertising regulations, guidance, and agency regulatory action history is required. Minimum experience 2 years in regulatory promotional review or labeling required.
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Regulatory Affairs Associate
(US-Massachusetts) Provide Regulatory guidance, strategic advice and contribute to a Regulatory project team planning on CMC issues. Handles all aspects of CMC-related activities for assigned biological development project. RESPONSIBILITIES: Review and assessment of all CMC documents for consistency Accuracy and conformance with all regulatory requirements; Identification of content, responsibility and timing of CMC documents for regulatory submissions; Coordinating and monitoring the progress of all CMC regulatory submissions; Providing regulatory guidance for CMC issues, processes and templates by working closely with Manufacturing and Quality through all phases of drug development; defining current regulatory requirements for technical submission (INDs, CTXs, BLAs, and DMFs); Directly interacting with regulatory authorities(internal) and Manufacturing and Quality (external) on CMC issues requiring agency feedback; and participating in pre-approval inspection activities.
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Research Scientist
(India) We are one of the of the leading manpower pharmaceutical consultants based in India working for top pharma companies like Dr. Reddy Laboratories, Dabur Research Foundation, Wockhardt Research Centre, Torrent Research Centre, Reliance Life Science, Vitalife Labs (Part of Apollo Tyres), Jubliant Organosys, Cipla, Matrix Laboratories, Winmedicare, Panacea Biotech, Nagarjuna Fertilizers and Chemicals Limited, etc., to name a few. At present outset we are looking for Research Scientists (Junior and Senior) for one of our clients based in Hyderabad. The Group is a Rs. 20,000 million global conglomerate well entrenched in the areas of Agri Business, Petroleum, Power, Life Sciences and New Initiatives. They have started their new R&D division which works on New Drug Discovery (NDD), for which they are looking for Junior and Senior Scientists (about a group of 100 scientist) from 0 years to 7 years of experience candidates with Ph.D / Post Doctors in the following fields: Molecular Biology / Biochemistry / Proteomics / Genomics / Bioinformatics / Cheminformatics / Chemical Engineering / Biochemical Engineering.
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