Director, Analytical Development & Quality Control
About The Position
The Director of Analytical Development & Quality Control will provide strategic and operational leadership for analytical development, characterization, method validation, transfer, and quality control activities supporting a growing pipeline of small molecule and antibody-drug conjugate (ADC) programs, with an emphasis on drug product, and antibody/ADC-focused analytical activities. This individual will be responsible for operating in a 100% outsourced environment to establish and manage phase-appropriate analytical strategies from preclinical through commercialization, overseeing external analytical operations, and ensuring compliance with global regulatory expectations and GMP requirements for assigned programs. As a key member of the Technical Operations team, the Director will collaborate cross-functionally with Drug Substance, Drug Product, ADC production, Regulatory Affairs, Quality Assurance, and external CDMOs/CROs/consultants to advance programs efficiently through development milestones while building scalable analytical and quality control capabilities for a rapidly growing organization.
Requirements
- Ph.D./MS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemical Engineering, or related scientific discipline preferred.
- 12+ years (Ph.D.)15+ years (MS) of progressive pharmaceutical or biotechnology analytical development experience with experience in both OSD drug product analytical development and in biologics/ADC analytical development.
- Demonstrated experience supporting both small molecule drug product and biologic/ADC development programs.
- Proven track record advancing products from early development through late-stage clinical development and/or commercialization.
- Demonstrated success working with CDMOs and global development partners.
- Strong working knowledge of: Analytical method development and validation; Stability programs and specification setting; Quality control laboratory operations; GMP analytical testing; Oral solid dose characterization and phase-appropriate method development, including discriminatory dissolution method development; ADC analytical characterization; Biologics testing methodologies; ICH Q1, Q2, Q3, Q6, Q7, Q8, Q9, Q10, and Q14 guidance; Regulatory submissions and health authority interactions.
- Strategic thinker with strong business and scientific acumen.
- Excellent project management and organizational skills.
- Strong communication and influence skills across scientific, quality, regulatory, and program teams
- Ability to travel (20%) to CDMO domestic and international sites.
- Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project) and JMP (or similar statistical tools).
- High level of personal integrity, commitment to excellence and to our patients.
Nice To Haves
- Experience in developing and commercializing drugs for oncology is preferred.
Responsibilities
- Develop and execute phase-appropriate analytical strategies supporting small molecule and ADC development, with an emphasis on Drug Product and ADC method development for assigned programs.
- Lead analytical characterization efforts for assigned programs, including: Phase-appropriate small molecule oral solid dose drug product method development and testing (tablets, capsules, gelcaps); Phase-appropriate method development supporting antibody manufacture, ADC conjugation, and parenteral drug product manufacture.
- Provide technical oversight for development, qualification, validation, and lifecycle management of analytical methods.
- Ensure analytical methods support process development, formulation development, manufacturing, release testing, and regulatory submissions.
- Serve as the company's analytical subject matter expert for ADC development.
- Support characterization of monoclonal antibodies, cytotoxic payloads, linkers, conjugates, and related impurities.
- Guide implementation and interpretation of advanced analytical techniques such as: HPLC, UPLC, LC-MS, HRMS, SEC, CE-SDS, icIEF, HIC, ELISA, and bioassays.
- Collaborate with external CDMOs and internal process development teams to define CQAs and control strategies for ADC products.
- Establish and lead QC strategies across clinical manufacturing operations for assigned programs.
- Oversee external GMP testing activities including raw materials, IPCs, release testing and stability programs.
- Ensure timely release and disposition support for clinical materials.
- Manage investigations involving OOS, OOT, deviations, and laboratory events.
- Author and review analytical sections of regulatory submissions including: INDs, IMPDs, BLAs, NDAs, and CTAs.
- Ensure analytical approaches align with ICH, FDA, EMA, and other global regulatory expectations.
- Support establishment of specifications and analytical control strategies throughout the product lifecycle.
- May participate in regulatory agency interactions and inspections.
- Ensure compliance with cGMP, GLP, GCP, and data integrity requirements.
- Partner closely with Quality Assurance to maintain inspection readiness.
- Support audits of contract testing laboratories and manufacturing partners.
- Manage relationships with contract laboratories and CDMOs.
- Oversee method transfers, validation activities, and technical governance of external laboratories.
- Establish performance metrics and ensure delivery against development and manufacturing timelines.
- Evaluate and implement new analytical technologies and outsourced capabilities as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
