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 reliability of QC data and ensure all test methods, protocols, and technical reports comply with current pharmacopeial and regulatory requirements. Adhere to ALCOA principles of data integrity for self and ensure compliance of other team members. 

• Quality Investigations and Audits: Ensure that laboratory incidents including OOS, deviations, and OOT/OOE results are thoroughly investigated, root causes identified, and CAPAs implemented. Support internal and external change controls and quality audits as required. 

• Strategy and Risk mitigation: Ensure timely completion of QC activities as per project timelines. Update work plans periodically to accommodate changes in scope or priorities, identify technical risks, resolution of issues and collaborate with the greater team on risk mitigation strategy. 

• Collaboration: Effectively interact with multi-disciplinary teams that include Analytical Development, Process Development, Drug Product Development, Regulatory, Quality Assurance, Supply Chain among others. Network globally to share best quality practices, rationale, and control strategies to ensure harmonization and alignment between sites. 

• Engagement: Be willing to take initiative, be motivated to lead and influence, have a strong technical background, have excellent communication and interpersonal skills, have the ability to multi-task, and process a strong desire to learn and contribute. 

The Ideal Candidate will have:

• PhD in a scientific field of study  in disciplines of Chemistry, Biochemistry, Biology, Pharmaceutical Science,  or a related field and 8  years of related experience; or Master’s degree in a scientific field of study and 12 years of related experience; or Bachelor’s degree in a scientific field of study and 14 years of related experience. 

• Direct and diverse experience with analytical methods (e.g., chromatographic, electrophoretic, spectroscopic, microbiological, compendial, ELISA, potency, etc.), and specifications for biologic drug substance/drug product release, stability and characterization across various modalities such as monoclonal antibodies, bi-specific antibodies, ADCs, fusion proteins, and combination products is required. 

• Experience in conducting and managing stability studies per ICH Guidelines is required. 

• Experience working with contract research organizations/contract development and manufacturing organizations (CROs/CDMOs) is required. 

• Experience with the development, validation, and management of cell-based potency assays is highly desirable. 

• Working experience and knowledge in a wide variety of Quality Control statistical methodologies and software (e.g., Excel, JMP) is highly desirable. 

• Strong analytical and quantitative problem-solving skills with ability to balance short term needs with long term business evolution. 

• Proficient in project management, excellent organizational skills and the ability to work on multiple projects with tight deadlines. 

• Experience with complex regulatory, quality or technical issues for pharmaceutical manufacturing. 

• Experience developing, reviewing and submitting regulatory filings for biologics and combination products (e.g., IND, IMPD, BLA, MAA), including response preparation for Health Authorities is desired. 

• Ability to support CMC and program teams as subject matter expert, including technical due diligence and CRO/CDMO assessment and management. 

• Skilled in authoring, reviewing, and approving technical protocols, reports, and GMP/quality documentation. 

• Excellent communication skills and a proven track record of Influencing/building/promoting a culture of Quality and Excellence. 

• Ability to travel (on occasion). 

 #LI-AE1

Why Join Us
Join a mission-driven company revolutionizing medicine with Generative Biology™. This is a high-impact opportunity to influence both program execution and the evolution of CMC QC practices in a next-generation biotech environment.

Equal Opportunity Employer Statement
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.