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Job type: Permanent

Discipline: Biochemistry

Location: United States

Director - Permanent - San Fransico

Own and accelerate CMC strategy for innovative protein therapeutics at the highest level.

Proclinical is seeking a Director, CMC Biologics to lead and execute Chemistry, Manufacturing, and Controls (CMC) strategies for protein therapeutic programs. This role focuses on advancing programs from late preclinical stages through all phases of clinical development.

Primary Responsibilities:

The successful candidate will oversee external partnerships, ensure regulatory compliance, and collaborate cross-functionally to achieve clinical milestones efficiently. Additionally, you will manage a team of consultants and build an internal team to support biologics CMC activities. This is a high-impact position requiring technical expertise in biologics development, manufacturing, and regulatory processes, with the ability to thrive in a fast-paced biotech environment.

Skills & Requirements:

Advanced degree (PhD, MS, or BS) in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field.
Strong experience in biologics CMC development, including late-stage clinical development and regulatory filings.
Expertise in protein therapeutic development, manufacturing, and managing CDMOs in a virtual biotech model.
In-depth knowledge of FDA and ICH CMC requirements for biologics.
Proven track record in planning and executing biologics CMC development, GMP manufacturing, and regulatory submissions.
Experience with monoclonal antibodies and fusion proteins.
Strategic thinker with strong project management, organizational, and communication skills.
Ability to operate effectively in a lean, fast-paced environment with a high level of accountability.

The Director's responsibilities will be:

Develop and implement integrated CMC strategies aligned with clinical development plans and timelines.
Lead CMC activities from late preclinical stages through regulatory filings for all clinical phases.
Define and execute phase-appropriate control strategies and proactively address CMC risks.
Oversee formulation, process, and analytical development, including upstream/downstream processes and drug product formulations.
Manage CDMO selection and oversight for biologic development, manufacturing, and tech transfer.
Ensure cGMP compliance, adherence to timelines, budgets, and quality standards.
Author and review CMC sections for regulatory filings and support agency interactions.
Collaborate cross-functionally with Quality, Regulatory, Clinical, Nonclinical Development, Commercial, and Finance teams to align CMC strategies with program goals.
Develop and manage CMC budgets and integrate timelines into overall program plans.

Compensation:

$225 000.00 - $260 000.00 Per Annum

If you are having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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