Head of CMC (Sr. Director / VP)

About the Company

Alphina Therapeutics is a preclinical stage biotech company redefining precision oncology for ADCs with a novel payload. We are seeking a hands-on leader with expertise in ADC CMC to lead our CMC function.

About the Role

The Head of CMC will lead and be responsible for all CMC activities at Alphina, including developing the end-to-end CMC strategy, overseeing execution at the CDMO, and ensuring alignment with preclinical and clinical plans. This role involves building the technical and operational foundation to establish phase-appropriate, fit-for-purpose CMC processes and methods suitable for supporting regulatory filings and clinical development. As a senior leader in a fast-paced startup, this person will operate both strategically and hands-on, driving timelines, quality, and cross-functional integration. Occasional domestic and international travel is required.

Responsibilities

• CMC Strategy & Leadership
  • Develop and execute the end-to-end CMC strategy for Alphina’s ADCs, including linker-payload, mAb, ADC DS, and ADC DP, as well as Quality and Supply chain.
  • Lead risk assessments, scenario planning, and technical decision-making across conjugation chemistry, linker-payload supply, antibody production, and ADC DS/DP manufacturing.
  • Build an integrated CMC development plan aligned with nonclinical (IND-enabling GLP toxicology studies) and clinical milestones, including regulatory filings and Phase 1/Phase 2 trial initiation.
  • Own CMC budgets, timelines, and resource planning, and communicate progress, risks, and mitigation strategies to the executive leadership and the Board of Directors.
• CDMO Oversight & Technical Execution
  • Serve as the primary technical and operational point of contact for the CDMOs across linker/payload, mAb, ADC DS, and DP development and manufacturing.
  • Provide technical oversight for all CMC process development activities including cell line, cell culture, purification, linker-payload synthesis, conjugation, formulation, and fill/finish development.
  • Guide analytical development and phase-appropriate method qualification, including potency assays, DAR characterization, purity/impurity profiles, stability, release testing, and specification setting.
  • Oversee technology transfer, GMP batch execution, deviation management, and change control.
  • Ensure CDMO deliverables meet GMP, ICH, and regulatory guidelines for ADCs while holding partners accountable for program timelines and budget.

Qualifications

• Ph.D. or equivalent in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field with 10+ years of relevant CMC experience; or B.S./M.S. with 12+ years of relevant CMC experience.
• Broad ADC experience and technical expertise across linker-payload chemistry, mAb production, ADC DS/DP development, and analytical development.
• Solid understanding of ADC conjugation chemistry, linker-payload chemistry, biologics DS/DP development, and analytical characterization techniques.
• Demonstrated leadership of CMC strategy from preclinical through early phase clinical trials.
• Proven experience successfully managing CDMOs and CROs, including technical and quality oversight, and demonstrated ability to resolve technical and operational issues.
• Working knowledge of GMP, ICH, and regulatory requirements applicable to ADCs.
• Direct experience in authoring or reviewing CMC sections for regulatory submissions, including participation in health authority interactions.
• Proven ability to operate in a lean, fast-paced startup environment, balancing strategic oversight with hands-on execution.
• Excellent communication, cross-functional leadership, and problem-solving skills.

Skills

• Decisive and results-driven leader with an ability to actively engage in problem-solving and drive issues to resolution with a sense of urgency.
• Strong strategic agility, including the analytical skills to evaluate several options across multiple dimensions and drive to a recommendation.
• Team builder who leads by example and encourages collaboration across functional areas and all levels to achieve key corporate objectives.
• Excellent communication skills with a demonstrated ability to present to a broad range of audiences, including colleagues, the Board of Directors, and investors.
• Interest and excitement to ‘roll up your sleeves’ in a fast-paced biotech environment.

Benefits

• Medical, dental, and vision coverage
• Retirement savings plan
• Life insurance