Associate Director, Drug Safety and Pharmacovigilance

Associate Director, Drug Safety and Pharmacovigilance Location: Alameda, CA Status: Full-Time

POSITION SUMMARY

Celcuity (SAB) is a precision Immunology bio-therapeutics company focused on the development of disruptive therapies for the treatment of autoimmune, allergic, and inflammatory disorders. SAB is seeking an experienced, creative, and motivated leader in analytical development & QC field to join our growing team. In this role, the successful candidate must have in-depth scientific knowledge and hands-on experience on analytical method development and validation for biologic product testing and characterization. Demonstrated experience managing analytical and QC activities at CDMOs/CROs for various antibody-derived protein modalities is a must.

QUALIFICATIONS

Proven track record of successfully supporting preclinical and clinical stage product pipeline for antibody-derived protein modalities. Demonstrated analytical development experience in both drug substance and drug product, including establishment of specifications and analytical method development and validation, analytical control strategies for starting materials, intermediates, and final products. In-depth scientific knowledge on modern analytical techniques, including HPLC, CE, LC-MS, ELISA, qPCR and spectrophotometer etc. Solid understanding of the fundamentals of ICH and other industry guidelines supporting method development, qualification, and transfer, with a proven ability to assimilate data and growing product knowledge into the broader aspects of CMC development and lifecycle management. Proven track record on technical document writing and generation of the relevant regulatory sections of IND/IMPD/CTA etc. Demonstrated strong project and cross-functional team leadership, as well as ability to build high-performing team. Excellent written and verbal communication, project planning, collaboration and organizational skills. Team oriented, highly motivated, execution focused with strong work ethic, ability to demonstrate effectiveness and growth in a fast-paced and dynamic team environment.

RESPONSIBILITIES

Provide technical leadership for all CMC analytical activities, including phase-appropriate specification setting, test method development and qualification, analytical control strategies and QC testing at selected CDMOs/CROs for starting materials, intermediates, drug substance and drug product. Lead the analytical method development, characterization, investigation and assay validation activities at the CDMO/CRO to support batch release, stability and characterization of the drug substance and drug product with respect to the USP/FDA/ICH guidelines and quality compliance requirements. Serve as a technical liaison between analytical development, research, process development, manufacturing and QA functions of internal and CDMO/CRO organizations to provide analytical support. Provide key strategic compliance and analytical development input to projects and cross-functional teams, including process development, manufacturing implementation, IND/IMPD/CTA preparation, and discussions with regulators. Prepare, review and/or approve technical documents (protocols, reports, SOPs, test methods, Risks and Impact Assessment, CoTs/CoAs, OOS or deviation investigation reports etc.). Author relevant regulatory sections of IND/IMPD/CTA etc. Partner closely with CMC and QA to (i) write or review test methods, SOPs, analytical data summaries (CoT/CoA), protocols, and technical reports, (ii) critically review, trend, and interpret analytical testing results, and (iii) support investigation of nonconformances (OOS/OOT results, deviations, etc.) Play a critical role in CDMO and other vendor identification, evaluation, qualification and management. A key member in MSA/QA/Scope of Work proposal review and negotiation process. Serve as a project core team member and communicate analytical strategy, risk management and status to key stakeholders cross-functionally and assist in driving decision-making. Identify and monitor key performance metrics to optimize quality and productivity of the laboratory.

REQUIREMENTS

Ph.D. or MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related fields with 15+ years of experience in the pharmaceutical/biotech industry with a proven track record of technical expertise and organizational leadership in supporting early and late phase development and manufacturing for biological product, preferably in a biotech setting. Celcuity is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets #J-18808-Ljbffr Celcuity Inc.