Abcuro, Inc. is a clinical-stage biotechnology company developing protein-based treatments for serious autoimmune and cancer indications modulated by cytotoxic T and NK cells that express the inhibitory immune checkpoint receptor KLRG1 (killer cell lectin-like receptor G1). The company is advancing ABC008, a first-in-class anti-KLRG1 antibody designed to deplete cytotoxic T cells that attack healthy muscle tissue in patients with inclusion body myositis (IBM), into clinical studies.
Abcuro, Inc. is seeking a Director/Sr. Director of Quality Control. In this role you will lead the Quality Control function for establishing Abcuro’s QC procedures, processes, and implementing the QC control strategy. This includes oversight of multiple Contract Development and Manufacturing Organizations (CDMO) and Contract Testing Laboratories (CTL) providing external QC analytical services. The role will be involved during all phases of the CDMO/CTL life cycle: selection, technology transfer, qualification, management and decommission. The Director/Sr. Director will be responsible for providing guidance regarding QC analytical oversight of starting material (SM), drug substance (DS) and drug product (DP) and finished goods (FG) development, manufacturing, release, and stability testing at CDMO. These activities include analytical method verification/qualification/validation and equipment validation, management of specifications, stability/reference standard programs, and product monitoring. Abcuro offers a dynamic and highly collaborative work environment with a generous compensation and benefits package. We welcome inquiries from qualified, enthusiastic candidates with a passion for excellence.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Lead all the CDMO/CTL subcontracted QC activities related to cell banking, reference standards and reference samples management, stability/retest expiry program, manufacturing, and testing operations.
- Design and build Abcuro QC strategies, procedures, specifications, and processes, and lead communication and understanding of these across the company.
- Lead method transfer, qualification, verification, validation, and troubleshooting in conjunction with Analytical Development, Process Development, and QA.
- Responsible for CDMO/CTL QC management and review/approval activities including deviations, OOS/OOT investigations, temperature excursions, change management, CAPAs, complaints, and product monitoring.
- Perform activities as the QC expert, such as review and approval of SOPs, methods, protocols, reports, batch release/stability data, test plans, CoAs, and product specifications.
- Represent QC to provide guidance to key stakeholder groups (PD, AD, QA, Supply Chain, Manufacturing, Legal) for the selection, technology transfer, qualification, and management of CDMOs.
- Management of stability and reference standards program and generate retest/expiry establishment and extension documentation.
- Lead and facilitate the Abcuro Specification Review Board as needed.
- Author, review, and/approve CMC modules of regulatory submissions.
- Define, monitor, and report product stability and quality performance metrics utilizing data analysis and trending tools, as applicable.
- Conduct technical quality risk assessments and product impact evaluations, including risk mitigation and CAPA plans.
- Maintain CDMO site readiness for Health Authority regulatory inspections and for Abcuro audits.
- Participate in internal and/or external audits as necessary.
- Maintain current analytical method knowledge of applicable Quality and Regulatory requirements and evolving trends and support the CDMO/CTL to meet these standards.
EDUCATION AND WORK EXPERIENCE
- BA, BS, and/or MS in analytical chemistry, biochemistry, biotechnology or chemistry with at least 10 years of relevant industry experience preferred.
- 7+ years of contract manufacturing/contract testing site QC leadership experience in a GMP regulated environment is required.
- Comprehensive working knowledge of FDA and international cGMP regulations, guidelines, and QC systems regulations to drive continuous improvement initiatives .
- Extensive experience with ICH guidelines and pharmacopeia methodology on analytical method transfer, qualification/validation/verification, and stability.
- Demonstrated leadership with excellent technical communication skills (both verbal and written) and an ability to deliver results through teamwork. Ability to flex communication approach based on the needs of others.
- In-depth expertise in creation, review, and approval of GMP documents such as specifications, method/reference standard validation protocols, stability protocols, reports, test methods, procedures, analytical data, OOS/OOT investigations, and change controls.
- Demonstrated ability to work autonomously, with strong prioritization and problem resolution skills.
- Ability to adapt in a fast-paced environment with competing priorities in a changing environment, with a growth mindset.
- Ability to build and maintain professional relationships and rapport with internal and external peers.
Abcuro believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of any legally protected status. Abcuro will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
**Please direct all inquiries and/or CV submissions to firstname.lastname@example.org