Associate Director of Analytical Development
5 days ago
We are seeking an experienced and highly motivated Associate Director of Analytical Development to manage and drive analytical development and quality control activities across our small molecule drug discovery and development programs.
This individual will fill a critical role as the subject matter expert (SME) and functional lead, contributing to the strategic direction, technical management, and operational execution for CMC development and manufacturing activities.
This position is instrumental in collaborating with and managing a network of consultants and Contract Development and Manufacturing Organization (CDMO) partners to enable our efforts to discover and develop small molecule therapeutics.
Key Responsibilities- Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry, form and formulation development, and GMP manufacture.
- Represent CMC and participate in cross-functional project teams and manage multiple priorities in a fast-paced, dynamic environment, ensuring on-time supply of drug to support non-GLP toxicology studies, IND-enabling activities, and clinical trials across a portfolio of programs.
- Collaborate closely in cross-functional teams, including but not limited to Medicinal Chemistry, DMPK, Toxicology, Quality, Project Management, Development Sciences, and Clinical Pharmacology to achieve project goals.
- Contribute to the development of CMC strategies to meet program and project development targets, ensuring timely and efficient delivery of high-quality products, and facilitating regulatory approvals.
- Support the development of the quality system to ensure product quality and data integrity, including authoring and reviewing standard operating procedures, guidelines, and work instructions.
- Author and review analytical methods, protocols, reports, batch records, change controls, corrective and preventative actions, deviations, and investigation, including OOS and OOT events.
- Contribute to the CMC control strategies, including development, review, and justification of specifications for raw materials, intermediates, drug substance, and drug product in alignment with industry standards and regulatory expectations.
- Develop analytical test methods and manage method validation and transfer as necessary to support CDMO GMP manufacturing, release, and stability of drug substance and drug product.
- Establish and manage a reference standard program, including oversight of qualification and maintenance of reference standards at CDMOs.
- Write and review CMC sections of regulatory documents and submissions (IMPD, IB, IND, NDA, etc.) and the supporting technical documents, and remain current on Health Authority guidance and expectations.
- Support the evaluation, selection, and management of CDMOs to perform process and method development, and GMP manufacture, release testing, and stability studies.
A BS, MS, or PhD degree in analytical chemistry or related field with a minimum of 12 years, 10 years, or 6 years, respectively, of relevant industry experience with demonstrated increasing responsibilities within analytical development.
Exhibited track record of success in delivering timely execution of CMC activities ranging from non-GLP and IND-enabling material supplies, through GMP clinical trial supplies.
Demonstrated expertise with analytical method development, phase-appropriate method qualification/validation, release and stability testing, and specification development and justification.
Experience with analytical techniques for small molecules and oral solid dose products, including IR, UPLC/HPLC, KF, GC, dissolution, and microbial limit tests.
Strong understanding of Quality systems, including SOPs, protocols, and reports, release and stability data review, OOT and OOS management, Good Documentation Practices, LIMS, and cGMP data traceability, Deviations, and Change Management.
Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.
Proven ability to manage and collaborate with external partners, including consultants and CDMOs.
Excellent interpersonal and communication skills (written and oral) with the ability to effectively and concisely present data to peers, management, and external groups.
Exhibited strong organizational and critical thinking skills with an attention to detail enabling sound, technically driven decision making.
Able to travel domestically and internationally up to 20% of the time.
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