Associate Director, Analytical Strategy & External Testing Oversight

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:
   P
  rovide 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).

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Why Join UsJoin 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 StatementGenerate: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.