Director, Analytical Development
About The Position
The Director, Analytical Development is accountable for the strategic, scientific, and organizational leadership of the Analytical Development department overseeing functional groups. The incumbent will have strong scientific acumen for defining extended characterization approaches through product development and regulatory filing. This role oversees and leads the development, optimization, validation, and transfer of analytical methods for biologics drug substance, drug product, and raw materials (non-compendial) from early phase to post-approval. The role oversees the daily laboratory operations, as well as directs scientists and people leaders, on experimental design, execution, and results (presentation and reports). Additionally, the incumbent will lead and manage analytical efforts with Contract Research Organizations (CROs), Contract Testing Laboratories (CTLs), and Contract Development Manufacturing Organizations (CDMOs). The incumbent must also be able to establish and manage stability studies of critical reagents and engineering/non-GMP batches. This role works closely and collaborates with leaders across Scientific Innovation (R&D and Process Development departments), MSAT, Quality Control, Quality Assurance, and Regulatory Affairs teams, as well as external partner(s), to represent analytical operations in the cross-functional CMC matrix.
Requirements
- B.S. degree in biological sciences or related field with 8+ years of progressive experience in the biotechnology or pharmaceutical industry or M.S. degree in biological sciences or related field with 6+ years of progressive experience in the biotechnology or pharmaceutical industry
- Experience managing/mentoring team(s) of scientists and/or people leaders.
- Extensive experience performing basic analytical assay techniques: absorbance assays, SDS-PAGE, chromatography, CE-SDS, icIEF, immunoassay, western blot, and/or cell-based potency assay.
- Extensive experience in common characterization techniques such as AUC, LC/MS, NMR, MFI, DLS, and CD.
- Extensive experience developing/authoring protocols, methods, and SOPs.
- Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution.
- Strong written and verbal communication skills.
- Working knowledge of statistics; JMP, R, Python, and/or other statistical tools.
- Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
- Self-motivated, proactive, and driven individual with an interest in experimental design and development.
- GxP knowledge.
Nice To Haves
- PhD in relevant scientific discipline such as biochemistry, chemistry, pharmaceutical sciences, or related field strongly preferred.
- 3+ years of progressive experience in the biotechnology or pharmaceutical industry
- Expert level experience for LC-MS/MS is highly desired.
- Experience or working knowledge in neurotoxin as therapeutics.
- Experience in managing change control, deviation, laboratory investigation, and/or other quality records.
- Experience in extended characterization (such as AUC, SEC-MALS, DLS, Peptide Mapping, Disulfide Mapping, Amino Acid Modification/PTM Analysis, and intact mass analysis) is highly desirable.
Responsibilities
- Lead the analytical teams in the development, validation/transfer, and implementation of robust analytical methods for in-process and final drug substance/drug product testing.
- Employ DoE approaches to understand the product in development and its formulation.
- Leads and designs extended characterization testing strategies for regulatory interactions and filing.
- Write and/or review method development summary reports, test methods, validation/transfer protocols, validation/transfer reports, comparability and compatibility study reports, and regulatory submissions.
- Demonstrate expertise and hands-on technical leadership in analytical techniques for the characterization of biologics.
- Lead assay development and troubleshooting activities through DoE based approaches.
- Collaborate with upstream, downstream, and formulation teams to deliver manufacturing processes that meet speed, yield, and product quality requirements. Perform critical data review and provide direction for troubleshooting and investigation.
- Serve as an analytical development SME working closely with external partner(s), QC, QA and Regulatory to present analytical data and conclusions in a concise manner.
Benefits
- Competitive Compensation including base salary and annual performance bonus.
- Flexible PTO, holidays, and parental leave.
- Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
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What This Job Offers
Job Type
Full-time
Career Level
Director
