Associate Director, Process Chemistry & API Development

Associate Director, Process Chemistry & API Development

Location : California (East Bay)

On-site commitment : 4 days a week

HireMinds is partnered with a biotech company focused on peptide drug development, with a vision of bringing commercial products to market.

We're looking for your expertise in Process Chemistry and API process development to support peptide drug development with our client.

To be successful in this role you will be responsible for peptide process research, large-scale laboratory production, and related technology transfer to CDMOs, as well as managing successful partnerships with partner CDMOs.

Your Responsibilities :

Analyze medicinal chemistry procedures to identify routes for efficient and scalable manufacturing of peptides and amino acids using both solid-phase and solution-phase peptide synthesis;

communicate results clearly to teams.

• Develop and execute manufacturing and supply strategies for raw materials, regulatory starting materials, and drug substances that meet global regulatory expectations.
• Collaborate with multiple CDMOs to source amino acids and peptide fragments for large-scale API manufacturing; effectively manage outsourced process R&D and production activities.
• Lead the evaluation and selection of new third-party contractors and suppliers globally for process development and manufacturing activities.
• Work closely with analytical scientists to monitor and understand the impact of process changes on yield and impurity profiles during the development of peptide APIs.
• Interface between analytical and toxicology departments to identify and qualify impurities.
• Contribute to quality and CMC-related regulatory correspondence.
• Stay current with the latest scientific literature related to peptide and process R&D.
• Effectively document laboratory and scale-up activities.
• Act as a creative and innovative problem-solver with a hands-on approach to resolving issues when needed.

You’ll Bring :

• PhD in organic / peptide chemistry with 7+ years, or MS in organic / peptide synthesis with 10+ years, industry pharmaceutical, biotech, or contract lab process chemistry experience.
• Experience with process performance qualification and early commercial manufacturing is preferred.
• Knowledge of QbD principles including DoE methodology applied to process development.
• Strong understanding of FDA / ICH / cGMP guidance.
• Proven ability to effectively lead projects with internal and external resources.
• Experience with regulatory CMC filings (IND, NDA, IMPD, PAS) across all phases of pre-clinical and clinical development in both the U.

S. and global markets. Familiarity with FDA and EMA regulations, and ability to work within regulatory agency requirements.

• Strategic thinker and problem-solver capable of identifying risks and developing mitigation strategies.
• Strong teamwork abilities related to negotiation and influencing skills.
• Ability to adhere to strict project timelines and budgets, and advise teams and management on project impacts and changes.

Compensation :

Salary : $175,000 to $190,000

Bonus : 10-15%

Stock considerations, health, dental, and 401k plan