Strategic Sr. Director, Biologics Manufacturing & CMC

AmpersandPeople, Inc.; South San Francisco (CA); On-site; USD 300,000 - 550,000; Full time

Job summary

AmpersandPeople, Inc. in South San Francisco is seeking an experienced Sr. Director / VP, Manufacturing and CMC to drive CMC strategy and operations for biologics.

You will lead external CDMO partnerships, oversee early-stage development, and ensure readiness for IND/CTA submissions, while managing budgets and timelines in a lean startup environment. This role requires deep technical leadership, hands-on execution, and the ability to translate complex progress and risks to executive leadership

Qualifications

• 12+ years in biotech with early-stage CMC operations experience.
• Proven ability to lead externalCDMO/CRO partnerships.
• Experience authoring Module 3/CMC sections for IND/CTA submissions.
• Strong leadership and effective communication in fast-paced startups.

Responsibilities

• Oversee external CDMO/CRO execution for CLD, DSP/USP, and formulation development.
• Lead tech transfer, scale-up, and GMP/non-GMP manufacturing for DS/DP.
• Direct phase-appropriate analytical methods and stability testing.
• Prepare and review Module 3/CMC regulatory filings for approvals.
• Provide hands-on oversight of protocols, COAs, CAPAs, and change controls.

Skills

External CDMO/CRO management

Regulatory writing

Leadership by example

Cross-functional communication

Budget & project management

Education

Biotechnology/related sciences (B.S./M.S./PhD)

Job description

AmpersandPeople, Inc. in South San Francisco is seeking an experienced Sr. Director / VP, Manufacturing and CMC to drive CMC strategy and operations for biologics.

You will lead external CDMO partnerships, oversee early-stage development, and ensure readiness for IND/CTA submissions, while managing budgets and timelines in a lean startup environment. This role requires deep technical leadership, hands-on execution, and the ability to translate complex progress and risks to executive leadership