(Job Code: 52-21BA)

About Ambrx:

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into proteins, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, targeted immuno-oncology therapies, immunomodulatory smart cytokines, and long-acting therapeutic peptides for metabolic and cardiovascular disease.

We are seeking a highly motivated Director of CMC Project Management to be a key member of a fast-paced and dynamic organization.

Overall Responsibilities:

The Director of CMC Project Management will manage and support CMC development plans for multiple programs from IND to BLA, to ensure successful execution of program goals. He/she will cover multiple functional areas, including Process Development, Analytical and Formulation Development, CDMO management, Technology Transfer, Clinical Manufacturing, Quality, Validation, and Global Regulatory Filing of CMC Sections. He/she will also be responsible for internal communications, including status reports, risk management, and escalation of issues to cross-functional stakeholders and senior management.

Specific Responsibilities:

  • Establish and manage CMC development plans that align with company and program goals, including scenario planning to support decision-making and budgeting process.
  • Serve as primary CMC project management contact with contract development and manufacturing organizations (CDMOs), ensure clear and effective communications, and manage the relationships and activities.
  • Ensure functional leads have clearly defined project scopes, deliverables, and timelines, assist proactively to align with clinical development plans and facilitate team discussions to meet objectives.
  • Follow-up on issues and actions, ensure external and internal deliverables are met.
  • Identify gaps and risks, develop mitigation plans; enlist key people to resolve obstacles.
  • Drive the CMC document preparation and organization process for regulatory filings.
  • Coordinate subteam activities as required and ensure activity owners are completing assigned project tasks.
  • Maintain primary responsibility for CMC team meetings, including scheduling, preparation of agendas and minutes, action items, generate Gantt charts/Smart Sheets and actively track deliverables.
  • Ensure CMC related documents are well organized on SharePoint.
  • Prepare regular and ad hoc updates for senior management.

Qualifications:

  • BS or BA in a scientific discipline required; an advanced degree or PMP certification preferred.
  • 15+ years of experience in pharmaceutical/biotechnology industry with first-hand understanding of biopharmaceutical development process.
  • 8+ years of experience leading multi-disciplinary development teams in the execution of operational plans.
  • Solid understanding of technology transfer, clinical manufacturing, process development, analytical development, quality control, validation, and CMC regulatory documentation.
  • Technical experience in Process Development, Analytical and Formulation Development, or Manufacturing mAbs and complex Protein-conjugate therapeutics preferred.
  • Late-stage drug development and BLA experience preferred.
  • Knowledge of Quality systems and Regulatory guidance in an FDA regulated industry.
  • Experience with CDMO management.
  • Proven ability to manage cross-functional project teams and handle multiple projects at a time.
  • Excellent organizational and communication skills.
  • Strong interpersonal and leadership skills, excellence in building and managing relationships, ability to understand all perspectives, find common ground, and effectively bridge significant differences.
  • Detail-oriented while also maintaining the ability to see the big picture.
  • Demonstrated problem solving skills.

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to careers@ambrx.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. EOE