Analytical Development Manager
Location: Norwood , Massachusetts
Job Category: Biotechnology
We’re looking for a highly skilled Manager of Analytical Development to support early to late phase development as part of the Technical Development organization. The selected Manager will provide technical management of CRO/CMO, conduct data mining/trending and statistical analysis generated with analytical methods for lipid raw materials (primarily), mRNA drug substance and lipid nanoparticle drug products. The Manager, AD will have a scientific mindset with the ability to undertake very detail-oriented work to support external contract organizations and internal work. Additional responsibilities include creating and developing analytical strategies and collaborating with cross-functional teams in Analytical Development, Process Development, Production, Clinical Ops., Reg. Affairs and Quality. This is a non-laboratory management-oriented scientific position in the Analytical group.
Here’s What You’ll Do:
- Undertake technical management for analytical testing to support multitude of activities in early to late phase development
- Undertake technical management for analytical testing at external CRO/CMO
- Create, track and manage technical deliverables and activities for project milestones
- Build strong knowledge of synthetic chemistry for small molecules to support lipid projects
- Scientifically evaluate needs of lipid project and create deliverables
- Undertake very detail-oriented work to mine data, trend them, statistically evaluate them for assay performance and integrity of results
- Contribute to strategy, review and management of qualification/validation protocols and reports utilizing ICH/Regulatory guidances from external CRO/CMOs
- Work with various SMEs within the Analytical team to identify need for new method development, create deliverables, troubleshoot assays, track and manage them etc.
- Provide summary presentations and detailed reports to internal and external stake holders.
- Provide subject matter expertise to support major lipid projects.
- Generate high quality documentation to support regulatory filings be it brief or comprehensive technical protocols and reports, IND modules.
Here’s What You’ll Bring to the Table:
- BS with 8-10 years or MS with 5-8 years of relevant industry experience in analytical chemistry.
- BS/MS in Chemistry, Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.
- Knowledge of chromatographic separation, biophysical characterization, and spectrophotometric techniques, equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, ChemStation, Empower).
- Knowledge of lipids, small molecules, nanoparticle drug products, liposomal products, nucleic acid chemistry and biology and standard methods of analysis of these molecules is a plus.
- Hands on industry experience with analytical development for small molecules, lipids, nanoparticles, RNA and DNA therapeutics
- Knowledge in small molecule synthesis is a plus and preferred
- Knowledge of statistical analysis is a plus
- Experience is early to mid-phase development: Experience in late phase development is a plus
- Knowledge of GMP and ICH guidance documents
- Knowledge of late phase validation and/or early phase qualification of methods
- Experience authoring technical development reports, IND or other is a plus
- Highly self-motivated, driven, can-do, make it happen attitude with ability to own and drive major projects
- Strong collaborator with cross-functional teams and external partners
- Continuous learning, open-minded, curious, highly organized, thorough, relentless, diligent, detail-oriented