Principal Scientist, Analytical Development

Role Summary:

The position will support and oversee analytical method development, method transfer and qualification, and overall management of CMC activities related to internal and external analytical testing and stability of antibody drug conjugates and intermediates. The Principal Scientist will lead analytical development for several preclinical programs, and direct method qualification for use in GMP production of clinical materials (Phase 1-3) with guidance from analytical leadership. This includes identification, selection, and setup of a central testing lab (CTL), and coordinating external activities related to analytical method development at the CTL and at various manufacturing organizations (CDMOs). This role works closely with key stakeholders within Technical Operations as well as across the company including Platform Research, Regulatory, and Project Management.

This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week.

Primary Responsibilities Include:

• Oversight of all analytical aspects for bioconjugate drug substance and drug product as well as support for PMO and ASO oligonucleotides and small molecule intermediates including analytical method development, product quality characterization, technology and method transfer, analytical method qualification, in-process and release testing, and stability programs.
• Assist with developing the analytical strategy for complex biologics/bioconjugates guided by ICH frameworks.
• Identify and direct external cGMP laboratories conducting raw materials, intermediate and DS/DP product testing.
• Work with partner organizations and internal quality as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, OOS/OOT investigations, and CAPAs are initiated, addressed, and closed within target timeframes.
• Develop, review and approve method transfer/validation protocols and validation approaches.
• Author and review change controls, risk assessments and product specifications.
• Manage external CMOs and CTLs for the transfer and validation of analytical methods, product characterization testing and product release/stability testing.
• Advise and plan extended characterization of intermediates and drug substance to expand product understanding and impurity characterization.
• Support establishment of critical quality attributes, specifications, and overall control strategy.
• Partner with QA to provide oversight of cGMP-related activities and documents (change controls, deviations, CAPAs, procedures, batch release support, stability protocols and programs etc.)
• Support Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate.
• Support the development of regulatory CMC documentation including INDs, IMPDs and BLA as well as RTQs.
• Support internal analytical wet lab work as needed and the development and expansion of the internal AD/CMC lab.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline.
• Minimum of 8 years of experience in Analytical Chemistry preferably in a clinical-stage biotechnology company.
• Knowledge and hands-on experience with a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, and mass spectroscopy.
• Strong experience with bioconjugates/ADCs a plus.
• Self-directed individual who is able to work effectively with limited direction in a complex, fast-paced environment.
• Excellent interpersonal, organizational, negotiation, and communication skills; a team member that can work collaboratively with colleagues across functions.

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