Director, CMC Project Management
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.
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.
- 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.
- 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. 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