Director, Quality Control & Bioanalytics

Position Summary
We are seeking a highly motivated collaborative Director, Quality Control & Bioanalytics who will be responsible for supporting the launch, ramp-up, and production activities within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products. This individual will oversee the buildout and management of cGMP Bioanalytical and Microbiology Cell and Gene Therapy QC laboratories to support the release and distribution of cell therapy products through safe and compliant operations. This individual will also work closely with technical development teams to support the development, qualification, and tech transfer into cGMP QC laboratories for in-process and final drug product release. This role will have a large impact on ensuring robust production, testing, and the timely release of cost-effective, compliant, and high-quality cell therapy products. As such, the role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups. This is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Manufacturing, MS&T, Quality, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, HS&E, and Finance. The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows. 

Responsibilities

• Lead, direct, coach, and develop an effective QC Bioanalytics team supporting clinical production within a state-of-the art multi-product cell therapy manufacturing facility
• Provide technical and managerial leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture and disposition products to patients in a timely manner
• Collaborate with analytical and process development teams to develop core analytical testing capabilities for cell & gene therapy products using genomic analysis and flow cytometry techniques, and determination of critical quality attributes (CQAs)
• Work with analytical and process development teams to transfer biological and molecular assays, monitor process and method performance, troubleshoot and perform continuous improvement
• Serve as a subject matter expert on the phase appropriate validation of test methods for clinical products intended for early to late stage clinical trials
• Oversee the technical transfer between laboratories, qualification/validation of assays and QC activities for product release
• Qualify and Validate QC methods and set product control system specifications
• Perform analytical testing for manufacturing process characterization and validation
• Manage the clinical product QC testing, stability testing, method qualification, QC Microbiology and execution of cGMP lab operations
• Manage the GMP Quality Control lab operation, ensuring lab processes provide high quality analytical support for manufacturing, maintenance, engineering, and validation operations while ensuring compliance with protocols, GMP’s, and safety regulations
• Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed
• Actively manage a group of lab personnel and oversee their performance management, mentoring, and career development in line with their strengths
• Works with QA and Regulatory standards to ensure requirements are met and property documented, including leading and actively participate in all regulatory and internal audits of the facility
• Will work on more complex problems where analysis of situations or data requires in-depth evaluation of various factors, strong judgment is required in resolving problems and making recommendations - typically high impact issues that have implications across functions
• Supports and/or coordinates internal and external regulatory audits as required
• Implement and adhere to internal and external (ICH, GMP) requirements for analytical functions, including training, investigations, validation, and QC testing
• Oversee the hiring, development, and performance management of staff within QC Bioanalytics
• Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site
• Establish key stakeholder relationships with internal and external stakeholders

Requirements

• Bachelor’s, Master’s or Ph.D. degree in life sciences field
• 10+ years of experience within a cGMP environment in the biotech/biopharma industry concentrated within QC, MS&T/AS&T, Technical Operations,