This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
Job description
Associate Director, Analytical Development
Associate Director, Analytical Development
3 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Continue with Google Continue with Google
Continue with Google Continue with Google
Continue with Google Continue with Google
Continue with Google Continue with Google
Continue with Google Continue with Google
Continue with Google Continue with Google
Direct message the job poster from AL Solutions
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 level
Director
Employment type
Employment type
Full-time
Job function
Job function
Manufacturing, Research, and Science
Industries
Staffing 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 -
Senior Director, Global Commercial Training and Development
Associate Director of Development: San Diego
San Diego, CA
$235,000.00
-
$285,000.00
16 hours ago
Senior Director of Development, Jacobs School of Engineering
Director, 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 & Engagement
Principal, Maritime Business Development
San Diego, CA
$132,680.00
-
$197,481.00
20 hours ago
Lead Development Director, Language Services
Director of Learning and Organizational Development
Associate Director, People Success Partner
Program 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
Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.