Job Description

Associate Director, Process Chemistry & API Development Associate Director, Process Chemistry & API Development 2 weeks ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Location: California (East Bay) On-site commitment: 4 days a week HireMinds is partnered with a biotech company focused on peptide and small molecule drug development, within reach of bringing commercial products to market. We are seeking your expertise in Process Chemistry and API process development to support peptide and small molecule 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 these CDMOs. You will provide an on-site and hands-on presence in collaboration with the R&D, Analytical, Manufacturing, and Clinical teams to deliver API parts of projects in this on-site work culture environment. Your Responsibilities: Analyze medicinal chemistry procedures to identify routes for efficient and scalable manufacturing of peptides and amino acids using both solid- and solution-phase peptide synthesis; communicate results clearly to internal and external 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. Ability to commute and work on-site 4 days a week and participate in an on-site culture in a growing biotech team. Compensation: Salary: $175,000 to $190,000 Bonus: 10-15% Stock considerations, health, dental, and 401k plan Seniority level ~ Seniority level Director Employment type ~ Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Staffing and Recruiting Referrals increase your chances of interviewing at Capital Markets Placement by 2x Get notified about new Director of Chemistry jobs in California, United States . San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Director, Analytical Sciences, Drug Product Executive Director/Vice President, Medicinal Chemistry Sr. Director/Exec. Director of Cheminformatics for Early Molecule Discovery Associate Director/Director of CMC Chemistry Senior Director, Analytical Development & QC Director / Senior Director, Chemistry - Peptide & Radiotherapy Senior Director, Sample Management, Discovery Chemistry Operations Director, Chemical Development & Drug Substance Manufacturing Redwood City, CA $210,000.00-$230,000.00 3 months ago Director, Computational Chemistry Methods San Diego Metropolitan Area $265,000.00-$310,000.00 6 days ago Director, Computational Chemistry Methods Vista, CA $149,360.00-$205,370.00 2 weeks ago Newark, CA $175,000.00-$190,000.00 2 weeks ago Associate Vice President, Medicinal Chemistry Director, Small Molecule Process Development Associate Director, CMC Analytical Chemistry Associate Director, Analytical Chemistry Sr. Scientific Director, Biochemical Process Development Were unlocking community knowledge in a new way. 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Full time, Contract work, For contractors,

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