AffyImmune Therapeutics, a clinical stage biotechnology company focused on developing technologies that expand the utility and improve the safety and efficacy of cell-based immunotherapy for cancer, is seeking a Quality Control professional to help advance the use of CAR T cell therapy for solid tumors. As part of the Quality team, you will play a key role in overseeing and partnering with contract QC laboratories.
Reporting to the Vice President of Quality, the Associate Director of Quality Control will directly oversee activities at contract QC laboratories including data analysis, investigations, deviations, change controls, and corrective/preventive actions. You will also collaborate with internal Analytical Development and the CMC team to develop strategies for analytical method qualification, validation, stability programs, bridging studies, and comparability assessments.
Location: Natick, Massachusetts; or Remote
Responsibilities:
Quality Control Operations (75%)
- Oversee QC testing at multiple contract laboratories; participate in day-to-day issue resolutions.
- Lead OOS/OOT investigations; identification, implementation, and follow up of corrective/preventive actions.
- Perform data analysis and propose product release specifications.
- Lead method transfers, qualification, and validations. In collaboration with Analytical Development author/review method qualification / validation protocols and reports.
- Lead GMP stability programs and shelf-life assignments.
- Issue Certificate of Analysis in support of product release.
- Ensure vendor QC test methods comply with Regulatory requirements and AffyImmune Quality Standards.
- Author / review relevant section of regulatory filings.
Quality Control Systems Build (25%)
- Assess gaps in internal QC systems and develop phase appropriate processes and procedures.
- Develop and implement strategies for method qualification and validation.
- Develop and implement strategies for GMP stability, bridging studies, and comparability assessments.
- Contribute to critical starting materials risk mitigation plans.
- Participate in qualification audits of contract QC laboratories.
- Develop metrics and monitor the performance of contract QC laboratories and report trends to management.
Qualifications:
- BS/MS in Bioanalytical Sciences with experience in cell therapy or related fields.
- In-depth knowledge of relevant cell therapy analytics including Flow Cytometry, qPCR, ddPCR/dPCR, cell-based assays, sterility, and biological potency.
- Minimum 8 years direct QC laboratory experience including routine testing, reference standards and reagents management, instrument calibration/maintenance regimen.
- Demonstrated experience overseeing contract QC testing organizations.
- Demonstrated success in analytical methods transfer, qualification, and validation.
- Experience in contributing to Module 3 IND filings.
- Excellent understanding of FDA, EMA, and ICH regulations and guidelines for Quality Control.
- Ability to manage multiple activities in a fast-paced drug development environment.
- Ability to interpret, summarize, and discern criticality of issues for escalation to management.
- Strong work ethic, enthusiasm, eagerness to learn, and willingness to perform ad-hoc tasks.
- Experience working with electronic systems (e.g., LIMS, Veeva) a plus.
- Excellent written and verbal communication and data analysis skills.
