Associate Director, Analytical Strategy & External Testing Oversight

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role: 

We are seeking to expand our Technical Development Team within Technical Operations by recruiting a highly experienced and collaborative Associate Director, Analytical Strategy and External Testing Oversight who will be responsible for providing external testing oversight and supporting QC operations for all biologics products in early- to late-stage clinical development up to product commercialization. Reporting to the VP of Technical Operations and working closely with CMC Analytical Development and other members of the Technical Development team, the successful candidate will be accountable for end-to-end technical QC oversight across multiple external global CDMO/CTL partners.  

This position includes establishing relevant analytical quality standards for current or novel biotherapeutic candidates, ensuring internal and cross-functional alignment with industry and regulatory expectations, and identifying analytical quality risks and mitigations throughout development of the assigned programs. 

This position also provides a unique opportunity to develop AI-based, next generation biotherapeutics while enabling a high degree of independence in their daily work. The position also provides opportunities for cross-functional collaboration and learning, contribution to project direction and scope, and potential involvement in shaping technical and regulatory documents in a well-funded and dynamic biotech startup company. 

Here's how you will contribute:

• Scope of the Position: Work across the biological products/programs to ensure all current Good Manufacturing Practices (cGMP) Quality Control initiatives and objectives are achieved.  

• Method Development, Validation, and Transfer:  Support the development, validation, and transfer of analytical methods used for QC release testing of drug substances, drug products and product stability. 

• Critical Review of QC Data:  Manage, review, and organize release/stability, method validation/transfer data from long term and predictive stability programs in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines and generate interim/final stability trending reports using scientific rationale and statistical methods. 

• External Contract Organization Management: Support external CDMO/CTL partners with method validation, QC testing, and reference standard management activities and collaborate in the development of analytical control strategies and specifications. 

• Quality Control Operational Support: Review and/or author technical documents including test procedures, specifications, validation and stability protocols, CoAs, technical reports, and shelf-life/storage statements. 

• Regulatory Submissions: Provide co-authorship of relevant IND/IMPD sections and collaborate toward responses to briefing books and Health Authority requests for information. 

• Quality Systems and Data Integrity: Implement and maintain quality systems to ensure the integrity and reliab