DNAjobs.com is proud to feature the following jobs posted April 10 - 17 (listed in chronological order). 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
Bioinformatics Senior Technical Specialist - Asia Pacific
(Hong Kong) Essential Functions: Oversees Asia Pacific region. Develop strong relationships with customers in order to assess their needs, develop and present sales proposals, market systems solutions and achieve assigned sales plan for targeted products. Educate and train customers, field sales force individually and in groups, in order to increase effective product use and customer satisfaction. Promote targeted new technologies directly through seminars, and customer visits with and independent of Account managers. Actively participate in the formulation and implementation of account(s) strategy, including the role of the BC in team selling new technologies. In conjunction with Account Managers, identify thought leaders at top accounts for future alpha and beta tests of new technology, feedback regarding existing/new technologies, and access to new ideas and technology. Establish and coordinate technology use groups, roundtables, conferences and other sponsored events to share experience and applications of key technologies or areas of interest. Proactively identify and communicate emerging technologies and in-licensing opportunities to Marketing and Business Development. Develop and maintain advanced expertise about key applications, products and technologies to ensure credibility source of state of the art.
(US-New York-Buffalo) Principle Scientists needed in the areas of: Metabolic,Lipid Chemistry, Protein Chemistry,Human Post Natal Stem Cells, Stem Cells(3),Molecular Virology Responsible for initiating, directing and executing scientific research and/or development strategies through the research staff or individual studies. Acts as the technical lead on new product development teams and may be the technical expert on multiple projects. Thinks creatively and provides technical justification for novel concepts and approaches. Independently plan, direct and execute laboratory research. Independently adapt or modify experimental methods to achieve technical objectives. Critically analyze data and interpret results. Maintain complete and thorough documentation. Anticipate potential problems and design preventative solutions. Determine strategic approach to experimental design. Provide guidance to other Research Associates in their daily experiments and troubleshooting. Act as the technical lead and collaborate with other departments (le: Technical Service and/or Operations) to coordinate product development and improvement. Serve as internal technical expert and outside consultant. May act as spokesperson on corporate research and development and advise top management.
(India) As a world class research organization, we pride ourselves on the employees that work to fulfill our mission. We offer a wide array of opportunities for those seeking a rewarding and challenging career in genomics, informatics and clinical research. Positions Available: Clinical Research Associates (MBBS, MD, Mpharm or Clinical research experience) Pathologists (MD Pathology with Histopathology/Molecular Pathology experience) Research Associates (Genomics/Molecular Biology, PhD, MSc with 2+ years experience) Medical Social Worker/Counsellers (MSW, counseling experience a plus) Medical Laboratory Technicians (Masters degree with sample handling experience) Electronic Health Record Specialists (Graduate degree with MRD experience) Data Entry Operators (Graduate degree with medical data entry experience).
(US-California) Our client, a major pharmaceutical company in Alameda, CA is looking for a Clinical Research Associate - B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE. Member of the clinical team responsible for conducting Phase I - IV studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRF's), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRF's from study sites, processing CRF's including data cleanup and classification of data, and completion of study summary. BS preferred. Clinical Affairs 2-3 years experience as a CRA for a device manufacturer. Willing to engage hands on, patient contact. Bloodborne pathogen training and Hep B vaccination required. Knowledge of GCP and FDA requirements for investigational device studies.
(US-Illinois) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. REQUIRES 3-5 YEARS EXPERIENCE Manage Phases I - IV domestic and international clinical research studies. Responsibilities include protocol design and development, case report form development, contract negotiation, site recruitment, support program management for project reviews, budget and timeline development, establish relationships with outside vendors, medical consultants and partners, provide IND and NDA summary reports, interface with interdisciplinary teams, monitor project timelines, develop project management tools, and provide project presentations. Advanced degree, and/or PhD education level required Individual will work with a small team of clinical research professionals, dedicated to Women's Health (Edometriosis) Clinical Development.
(Germany) Within our Injection Team you will actively participate in the development of novel techniques in transgenesis. Primary responsibilities will involve generation of gene-targeted mice via injection into diploid and tetraploid blastocysts, production of transgenic mice by pronuclear injection, micro-surgical procedures, cryoconservation of embryos and sperm, Project tracking via database, and organisational management of the transgenic facility. Your qualifications should include proficiency in transgenic services with barrier housed animals and organisational and team skills. Artemis Pharmaceuticals GmbH offers a highly stimulating work place and an attractive financial package.
(US-North Carolina-Raleigh/Durham-RTP) Direct, manage and participate in the development, qualification and validation of analytical and bioanalytical methods used for product characterization, process development and QC in-process and release tests for viral vaccine clinical supplies. Develop methods to assist in process development activities. Manage vaccine substance and product stability testing in support of clinical lot production. Assure that testing is performed according to current regulatory guidelines. This position will coordinate activities across relevant functional areas and may handle other non-technical administrative duties on a limited basis. Responsibilities Tutor, train, and advise colleagues in areas related to analytical sciences. Assure activities are conducted in accordance with corporate procedures, SOPs, GLPs and GMPs Serve as a technical representative and/or technical lead on projects and coordinate project activities with other functions. Estimate resource requirements in order to determine cost estimates for projects included in proposals. Maintain a high level of scientific excellence by regularly attending national and regional technical meetings and presenting technical work whenever the opportunity arises.
(US-New York-Buffalo) This individual will lead a team of scientists and technicians focused on development of novel products for cell culture-based research and biotechnology applications. Coordinate objectives with Business Area Management and other functions and be responsible for all aspects of product development. This position is responsible for new product development from ideation and concept identification to business case approval. The director is expected to evaluate industry market trends and work with product managers and senior Business Segment staff, Program and Project leaders and other staff team members to identify key new product opportunities, to research those opportunities, and to prepare and gain approval on business cases for those opportunities. The position requires a high level of leadership and influence, collaboration, strong analytical skills, a facility with product financials, and an ability to persuasively present product and technology strategy and plans. This position is responsible to help develop infrastructure, leadership, staffing plans, training and other initiatives supporting excellence and innovation.
(US-Massachusetts-Boston) This position provides guidance/leadership to cross-functional product teams for the generation of FDA submission information and will prepare and file drug submissions. The Speecialist ensures product SUPAC compliance, interacts with the FDA regarding current and future requirements and develops and implements regulatory strategies. QUALIFICATIONS: Bachelor's degree in a scientific field. 3+ years FDA regulatory drug submission experience. Strong knowledge/experience with the following submissions: IND, A/NDA, CBE-0/CBE-30, Annual Drug Reports, export certificates, Drug Master Files. Prefer a candidate who also has Canadian submission experience. Proven project management experience/skills. Excellent oral/written communication skills Only local candidates will be considered for this position as there is no relocation assistance being offered. Competitive salary and company benefit package. A similar position with our client's medical device division is also open. If interested in discussing, you may e-mail your resume as instructed.
(US-Pennsylvania-Philadelphia) Validation & Compliance expertise required to review documents associated with Contractor and Company Validations and Qualifications: i.e., Process Validations, Equipment Qualifications (including Utilities, Facilities and Systems) & Cleaning Validations. Supports Contractors launching or receiving tech transfers of Oral Solids or Oral Liquid/Suspension Dosage forms. Must have Compliance /Quality Assurance for Validations & Qualifications Background.
(India) Manager-QA (Biotechnology) Desired profile of the candidate: M.Pharm with 7 to 12 years of experience in Pharma or biotech industry. Comprehensive knowledge of current international and national regulatory requirements and guidelines. Able to handle international audits like US-FDA, MCC, TGA etc. independently. Understanding of computer system validation(GAMP) Job description: Supervision, planning, development, implementation and compliance of Quality Policies and Quality Systems. To provide information from / to R&D, Production, QC, Clinical and Marketing Departments and to make “Quality “ as the prime focus for all personnel. Identify Communicate acceptability of data to regulatory agencies, production departments and QC/QA and to make recommendations to improve quality functions and records. Designing and reviewing various documents such as SOPs, specifications, Validation (DQ/IQ/OQ/PQ) as per cGMP norms. GMP training. Compensation: Remuneration will not be a constraint for the right candidate Location of posting: Ahmedabad Comment: Send your resume in word format to hrd_biotech@intaspharma.com mentioning the Job Title in the subject line of your e-mail.
(India) Executive - Manufacturing (Formulation) Desired profile of the candidate: M.Pharm. with 2-5 yrs of experience in manufacturing of small volume parenterals formulations. Preferably FDA approved (Parenterals) person. Job description: Production planning & actual production of injectables. Packing of finished products. Validation & trial batches of new lines, alternate locations or new products. Fully responsible for GMP compliance in parenterals manufacturing area. More emphasis on scale-up of trails, new product trials, variety of product types etc. Documentation and GMP related aspects. Compensation: Remuneration will not be a constraint for the right candidate. Location of posting: Ahmedabad Comment: Send your resume in word format to hrd_biotech@intaspharma.com mentioning the Job Title in the subject line of your e-mail.
(US-Illinois) Our client, a major pharmaceutical company in Lake Forest, IL is looking for a Clinical Research Associate Sr. - A with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE. Member of the clinical team responsible for conducting Phase I - IV studies according to Federal Regulations and ICH guidelines and study protocol, including planning study conduct, writing study protocols, designing CRF's, CRO selection, CRO training and management, selections and training of study investigators, planning and running study meetings, and overseeing the evaluation, selection and training of new study investigators. Responsible for the initial budget and contract negotiations with study sites or CRO's. Responsible for writing and supervision of contributors of clinical reports and NDA documents, including integrated Summaries of Safety and Efficacy (ISS and ISE), as appropriate. Prefer previous experience with pediatric studies or pediatric population; Prior experience with all phases (1-4) is preferred; Prior experience in conducting studies ex-US is helpful. Some traveling may be required.
(Bangalore, India) Qualifications:Post-graduate degree in any of Molecular Genetics, Molecular Biology or Medicine (MBBS or MD), Ph. D in any of Medicine, Molecular Genetics, Molecular Biophysics or Molecular Biology. Thesis work must possess a very strong application of computational techniques. Thesis areas could be any of the following: Structure-Based Drug Design, Medical Informatics, Pharmacogenomics, Clinical Genomics, Proteomics, Computational Techniques in Biology, or Laboratory Information Management Systems. Roles & Responsibilities: Build thought-leadership in the domain by collaborating with the Life Sciences group. Build up-to-date understanding of the domain. Transfer as-required domain-related knowledge to the team, through seminars, discussions and reviews-for the purpose of IP (Intellectual Property) generation. Represent the company in Industry events and forums. Help build domain-specific middleware by creating and reviewing functional specifications. Participate in standards committees and internal discussions for the evolution of standards and guidelines for the industry.
(India) Position -Head Biology We seek a PhD level scientist with postdoctoral experience and a minimum of 5 years of industrial experience for a leadership position in Biology Group for a research center at Bangalore. The successful candidate will have broad interdisciplinary knowledge in biochemistry, cell biology, pharmacology, metabolism, and physiology that are appropriate for drug discovery research. Demonstrated track record of accomplishments through scholarly publications and/or patents will be essential. Abilities to lead and motivate scientists and to manage resources will be essential. Solid work ethic and meticulous organizational skills are vital.
(US-Texas-El Paso) Are you experienced in medical device manufacturing? If so, we want to talk to you. Our client is a leading medical device manufacturer that concentrates on proprietary OEM products and private label fluid disposables. To be considered for the Compliance Manager opportunity you must hold a degree in Engineering and possess ten years medical device experience. Other requirements include experience with quality systems compliance, FDA regulations, quality systems auditing, sterilization process, process validations, product transfers, quality improvement programs, statistical background and project management. It would be highly beneficial if you are proficient in English and Spanish.
(US-Utah-Salt Lake City) Our client is a cutting-edge pharmaceutical company in the southwest focusing on the discovery and development of target compounds related to major human diseases including cancer and AIDS. As the Vice President of Research and Development, you will lead an experienced team of researchers from target identification to drug discovery. Requirements for consideration include a Ph.D with 12-16 years of experience in the drug discovery industry. You should have extensive experience moving a program from target identification to small molecule discovery. Familiarity with molecular biology, biochemistry, and cell biology are essential for success. Additionally, you should be willing to work in different disease areas and have experience with projects involving clinical candidates for clinical trials. Organization offers exceptional compensation, benefit, and relocation package.
(US-California-San Diego) $100,000 - $120,000. Our client develops biopharmaceutical products that are used for the prevention and treatment of serious life-threatening diseases such as cancer. These products are based on patented gene delivery technologies. Responsibilities: Principle tactical liaison with the regulatory agencies, internal functional departments and product development teams for domestic filings. Provide leadership for subordinate regulatory functions involving IND filing and clinical /preclinical topics. Assist the Executive Director of RA/QA with management responsibilities in accordance with the organization’s policies and applicable laws. Responsible for interviewing, hiring, training, and developing employees; planning, assigning and directing work; appraising performance, rewarding and disciplining employees; addressing complaints and resolving problems. Supervise subordinate regulatory functions and provide regulatory guidance to cross- functional departments. Read, review, interpret and keep current with drug product regulations and publications. Provide input for regulatory requirements and strategy on product development in interdepartmental meetings to ensure timely submission and approval. Support departmental budgets and coordinate the evaluation of reporting functions. Primary regulatory contact for assigned products and projects.
(US-Texas-Houston) This position requires proven experience in successfully managing high-throughput operations on a 24-hour basis. A background in chemistry, biochemistry, or biotechnology is essential. Successful candidate will have superior interpersonal skills to professionally manage production personnel including supervisors. This position requires the ability to translate department goals to shift and technician goals on daily basis. The regular hours associated with this position are mainly 1st shift, but will require some availibility during off-shifts.
