Associate Director, Analytical Development, Clinical Quality Control

Role Overview

• Manage quality activities for biologics programs in clinical development, ensuring compliance with ICH and GMP guidelines.
• Method validation and method transfers to and from CDMOs.
• Lead and or participate in specification setting activities for early and late-stage biologics programs.
• Manage method life cycle.
• Author, review, and approve method transfer protocols and reports.
• Author, review, and approve method validation protocols and reports.
• Author, revise, and approve governing SOPs, protocols, reports and memos.
• Manage Quality System records for QC activities.
• Support GMP audits and inspections.
• Act as the team leader to ensure alignment and effective communication among cross-functional areas.
• Design and improve processes to ensure compliance with global regulatory requirements.
• Support the budget planning and resource allocation to support laboratory operations and staffing.

Requirements

• A B.S. degree is required; an advanced degree (e.g., M.S./Ph.D.) in a related field is preferred.
• At least 10-12 years of experience in the biopharmaceutical industry, including prior leadership experience in quality control functions.
• Experience with a track record of method validation, method transfer, and hands-on management of day-to-day testing operations for outsourced biologics therapeutics.
• Knowledge of statistics and statistical tools (GraphPad Prism, JMP) to assist in trending and or specification setting
• Knowledge of Quality processes such as change control, CAPAs, and deviations
• Experience and knowledge with Root Cause Analysis tools for OOS investigations is a plus.
• Experience conducting QC OOS investigations and write-ups in conjunction with CDMOs.
• Experience with Veeva, LIMS and Smartsheet desirable.
• Knowledge of bioanalytical and analytical methods, including but not limited to LC-MS, GC-MS, UV-vis, IR/FT-IR, HPLC (SEC, icIEF), CE-SDS, ELISA, cell-based potency assays.
• Working knowledge of quality systems, global regulatory requirements (example: 21 CRF Part 11/210/211,820), and Guidance documents.
• Knowledge of technical writing for CMC sections of regulatory documents (IND, MAAs)
• Exceptional organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training, and to present information in an advisory capacity.
• Attention to detail, excellent review skills, and the ability to organize and manage multiple tasks in a fast-paced environment.
• Able to travel up to 25%.
• Ability to work both independently and collaboratively with project teams and cross-functionally, to build productive relationships with internal and external partners, to influence decision-making, and to engage in conflict resolution.

Benefits

• Comprehensive benefits
• Competitive compensation packages
• Flexible work environment