Sr. Director, Quality Control, Bioanalytical

Overview

The Senior Director of Quality Control is the recognized Bioanalytical expert and leads all Bioanalytical quality control operations. The incumbent will direct all Bioanalytical quality control programs for the clinical and commercial cell therapy programs. The quality control programs include all Bioanalytical in-process and final drug product testing, for example, Cell-Based Potency Bioassays, Flow Cytometry, Cell Counting techniques, PCR (Quantitative, Droplet Digital or Digital, etc.), and others. The Senior Director will apply practical knowledge of cGMPs and regulatory requirements in the product life cycle as related to quality control.

Essential Functions and Responsibilities

• All duties are performed independently with minimal supervision and oversight.
• Direct the day-to-day GMP QC testing activities including quality control testing for cell therapy intermediates and final products.
• Build and lead the QC function with hands-on work to instruct and build the expertise through each phase of facility expansion and product validations.
• Manages product lot release with adherence to turnaround times.
• Manage the Bioanalytical program for the facility.
• Coordinates quality control-related activities with respect to timelines and compliance.
• Lead and facilitate thorough GMP investigations for Laboratory investigations, out of specification test results, corrective actions, and verification of effectiveness.
• Support problem solving for issues pertaining to GMP quality control, working collaboratively with technical SMEs as needed.
• Support product stability programs including testing according to the agreed stability strategy, and approved Provide data in support of stability data analysis, and final reporting of stability data.
• Receive the technical transfer of revised or new methods, ensuring that adequate documentation (i.e., written test method), controls, and training are in -place.
• Ensure that QC staff are adequately trained and are performing tests in accordance with method procedures and are consistent with implementing the required techniques.
• Initiate, revise, and approve site-related quality control procedures. Ensure all procedures reflect current Serve as a document reviewer, owner, and approver as appropriate.
• Establish, maintain, and/or participate in processes for all the above.
• Participate in the preparation of CMC regulatory submissions and associated Health Authority interactions (e.g., IND, BLA submissions).
• Lead the QC function interface during facility tours and pre-approval inspections.
• Accurately interpret and discuss all laboratory related data within cross-functional teams and with health authorities.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
• Must adhere to core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum ten (10) years of experience in the pharmaceutical industry within a Quality Control role
• Quality Control laboratory management experience, including management of direct reports
• Broad knowledge of quality control for biologics with experience in a leadership role
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
• High level of ownership and accountability
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges
• Problem solver who not only identifies issues but leads efforts to resolve them

Preferred Education, Skills, and Knowledge

• Advanced degree preferred
• Experience with cell therapy products is a plus