Senior Scientist, Analytical Validations & Tech Transfer
The qualified candidate will be a senior level scientist in an analytical organization (Analytical R&D) seeking to lead the industry in technologies applied to advance biotechnologically-derived products to the market through innovation and delivery of cutting edge analytical testing. The qualified candidate will be part of an organization that focuses on method validation and transfer of analytical methods and technologies specifically in support of commercialization of gene therapies.
The group is responsible for the validation and late-stage analytical lifecycle management of quality controlled methods as they are established in commercial manufacturing sites. Qualified candidates will deliver results in a fast paced matrix-oriented setting. The candidate is expected to be a leader in defining validation strategies for fast paced gene therapy products to support method validations and transfers to global commercial laboratories. Consequently the candidate is expected to effortlessly work across different analytical functions, projects, and geographies.
The successful candidate will be involved to ensure the proper and timely execution of all aspects of the validation and analytical transfer activities to support process qualification and commercial launch.
Colleagues in this group are expected to lead or be involved in cross-functional analytical technology transfer teams across many sites in the United States and Europe. These teams are responsible for the planning, coordination, execution, and communication of analytical responsibilities.
Qualified candidates will serve as an analytical and biochemistry resource for the department and project teams, proactively keeping colleagues at the commercial launch sites aware of historical product knowledge and experience such as specifications, stability, reference materials, and any method development documentation.
Individuals in this group will be the primary authors, reviewers, and approvers of regulated documents such at method validation reports, protocols, transfers, and regulatory submissions (BLAs, MAAs,) and support any queries or questions from the regulatory agencies.
Colleagues in this group are expected to be updated with current scientific trends, strategies, and technical aspects from conferences, local meetings, and the literature. Furthermore, the candidate will be responsible for the development of novel approaches and methods with the latest analytical technologies for more informative and efficient product characterization in alignment with commercial manufacturing organizations.
M.S. or Ph.D. in biology, biochemistry, immunology, molecular biology, analytical chemistry, or related field required.
M.S. with 3-5 years of experience or Ph.D. with 0-3 years of experience with interdisciplinary drug development teams and industrial experience developing analytical strategies and methods in support of product and process development and to assess the quality and characteristics of Biotherapeutics required.
Experience with technologies focused on analysis of biomolecules and conjugates such as HPLC, qPCR and ELISA. Experience working in a regulated environment (e.g. GLP, cGMP).
Demonstrated technical writing skills and effective communication are a high priority.
Experience with method validations and method transfers to commercial manufacturing receiving labs.
Proven record of strong technical skills and scientific expertise in analytical method development and troubleshooting. Proven record of delivering results in a fast paced environment and effective communication to project teams and external partners (e.g. regulatory authorities).
Candidate should have in-depth scientific knowledge and experience in the development and validation of analytical methods, covering a wide array of techniques such as HPLC, qPCR and ELISA.
Coursework and/or experience in statistical analysis, physical biochemistry, and quantitative analysis.
Direct experience working with FDA or other regulatory authorities for programs in late-stage clinical development or approved products.
Knowledge and experience in Critical Quality Attributes (CQA) principles and practices and product specifications and specification setting.
Desire to train and develop colleagues, comfortable delegating.
Change agile, functional in a fast-paced team environment where multi-tasking required.
Enthusiastic about communicating to a broad range of stakeholders (from novices to experts) and seeking agreement in complex situations.
Curiosity about seeking and applying current relevant scientific literature.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional work-related travel will be needed.
EEO & Employment Eligibility
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Eligible for Relocation Package: yes
Eligible for Employee Referral Bonus: yes
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