AL Solutions
Associate Director, Analytical Development
AL Solutions, San Diego, California, United States, 92154
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Principal Recruiter | Biologics, CMC and Small Molecules | CDMO & Biopharma
Position:
Associate Director, Analytical Development George Higginson is currently searching for an experienced
Associate Director, Analytical Development , with experience across all aspects of
Biologics and/or Chemistry development ,
analytical and GMP Manufacturing , for a Biologics specialist
CDMO . The incumbent is responsible for managing a team of x3 scientists that will develop and optimize
analytical and bioassay methods
to support upstream/downstream process development, in-process monitoring, and drug substance/product testing. Main Responsibilities: Optimizes processes to balance client requests with scope of work in a fast-paced environment. Leads development of analytical methods for drug testing and process monitoring. Designs pre-qualification strategies aligned with product specs and regulations. Provides guidance on capability, comparability, and formulation studies. Oversees method pre-qualification and transfer to quality control. Reviews analytical methods, validation reports, and stability protocols. Troubleshoots assays and improves analytical methods. Manages client relationships and technical discussions. Contributes to strategic planning and effective scientific communication. Sets goals for employees and department. Ensures compliance with regulations and company policies. Maintains expertise in drug development and regulatory requirements. Requirements: Ph.D. in Science/Engineering or M.Sc. with additional experience. 5+ years (7+ with M.Sc.) in Development and/or cGMP manufacturing. Expertise in Biologics/Chemistry development, analytics, and GMP manufacturing. Experience with bioassays is essential. Experience with ADCs/Antibodies would be advantageous. Strong leadership, communication, and client relationship skills. Proven track record in drug discovery, development, and CMC/GMP processes. Experience in strategic planning for pre-BLA, process validation, and product launch. Financial and business acumen with CDMO experience in biomanufacturing. Skilled in method development, optimization, and validation for large molecules. Proficient in analytical technologies (HPLC, MS, CE-SDS, ELISA, and more). This is a fantastic opportunity to be a key part of a cutting-edge CDMO, helping to shape the future of the organization while ensuring the process development, in-process monitoring, drug substance and drug product testing, is done to the highest of levels. Apply today
to take the next step in your leadership journey! Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionManufacturing, Research, and Science IndustriesStaffing and Recruiting, Pharmaceutical Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at AL Solutions by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Director of Development jobs in
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All candidates should make sure to read the following job description and information carefully before applying. $235,000.00 - $285,000.00 16 hours ago Senior Director of Development, Jacobs School of EngineeringDirector, Business Development - 1898 & Co. San Diego, CA $220,000.00 - $420,000.00 17 hours ago Director, Project Management ($128,600.00 - $183,900.00)Senior Director, Talent Development & EngagementPrincipal, Maritime Business Development San Diego, CA $132,680.00 - $197,481.00 20 hours ago Lead Development Director, Language ServicesDirector of Learning and Organizational DevelopmentAssociate Director, People Success PartnerProgram Director - Eating Disorder, Residential Del Mar, CA $95,000 - $110,000 2 weeks ago Director, Business Development - 1898 & Co. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Position:
Associate Director, Analytical Development George Higginson is currently searching for an experienced
Associate Director, Analytical Development , with experience across all aspects of
Biologics and/or Chemistry development ,
analytical and GMP Manufacturing , for a Biologics specialist
CDMO . The incumbent is responsible for managing a team of x3 scientists that will develop and optimize
analytical and bioassay methods
to support upstream/downstream process development, in-process monitoring, and drug substance/product testing. Main Responsibilities: Optimizes processes to balance client requests with scope of work in a fast-paced environment. Leads development of analytical methods for drug testing and process monitoring. Designs pre-qualification strategies aligned with product specs and regulations. Provides guidance on capability, comparability, and formulation studies. Oversees method pre-qualification and transfer to quality control. Reviews analytical methods, validation reports, and stability protocols. Troubleshoots assays and improves analytical methods. Manages client relationships and technical discussions. Contributes to strategic planning and effective scientific communication. Sets goals for employees and department. Ensures compliance with regulations and company policies. Maintains expertise in drug development and regulatory requirements. Requirements: Ph.D. in Science/Engineering or M.Sc. with additional experience. 5+ years (7+ with M.Sc.) in Development and/or cGMP manufacturing. Expertise in Biologics/Chemistry development, analytics, and GMP manufacturing. Experience with bioassays is essential. Experience with ADCs/Antibodies would be advantageous. Strong leadership, communication, and client relationship skills. Proven track record in drug discovery, development, and CMC/GMP processes. Experience in strategic planning for pre-BLA, process validation, and product launch. Financial and business acumen with CDMO experience in biomanufacturing. Skilled in method development, optimization, and validation for large molecules. Proficient in analytical technologies (HPLC, MS, CE-SDS, ELISA, and more). This is a fantastic opportunity to be a key part of a cutting-edge CDMO, helping to shape the future of the organization while ensuring the process development, in-process monitoring, drug substance and drug product testing, is done to the highest of levels. Apply today
to take the next step in your leadership journey! Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionManufacturing, Research, and Science IndustriesStaffing and Recruiting, Pharmaceutical Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at AL Solutions by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Director of Development jobs in
San Diego, CA . Assistant Director of Development, Athletics (Administrator I)Regional Director of Philanthropy (Major Gifts)Senior Dir. of Development, Jacobs Engineering - 132395Senior Director, Global Commercial Training and DevelopmentAssociate Director of Development: San Diego San Diego, CA
All candidates should make sure to read the following job description and information carefully before applying. $235,000.00 - $285,000.00 16 hours ago Senior Director of Development, Jacobs School of EngineeringDirector, Business Development - 1898 & Co. San Diego, CA $220,000.00 - $420,000.00 17 hours ago Director, Project Management ($128,600.00 - $183,900.00)Senior Director, Talent Development & EngagementPrincipal, Maritime Business Development San Diego, CA $132,680.00 - $197,481.00 20 hours ago Lead Development Director, Language ServicesDirector of Learning and Organizational DevelopmentAssociate Director, People Success PartnerProgram Director - Eating Disorder, Residential Del Mar, CA $95,000 - $110,000 2 weeks ago Director, Business Development - 1898 & Co. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr