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 of GMP Quality Drug Substance. In this role you will be responsible for Quality Assurance oversight of one or several Contract Development and Manufacturing Organizations (CDMO) in charge of development and manufacturing of Abcuro’s drug substance products. The role will be involved during all steps of the CDMO life cycle: qualification and selection, technology transfer, management and decommission. The Director will be responsible for providing quality oversight and decision making regarding the starting material (SM) and drug substance (DS) development and manufacturing at the CDMO. This includes cell line development, master cell banking, toxicology batch manufacturing, analytical method verification/qualification/validation, and clinical drug substance product batch manufacturing and testing. 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
- Oversee all the CDMO’s subcontracted activities from a quality perspective such as cell banking, reference standard, reference samples and reference material management, stability program, manufacturing D and testing operations.
- Responsible and accountable for CDMOs quality management activities including deviations, change management, CAPAs, complaints, and batch release.
- Independently complete quality activities such as writing and review of Abcuro SOPs, CDMO batch records, methods, CoA release/stability data, process and method qualification/validation documents, specifications, label proofs, technical protocols, reports, including source data verification.
- Work with CDMOs and internal functional colleagues to facilitate resolution of quality issues and ensure that products meet all required quality standards and specifications.
- Provide quality guidance and support to key stakeholder groups (Process Development, QC, Supply Chain, Manufacturing, Legal) for the qualification and selection of CDMOs, technology transfer, qualification, and management of CDMOs.
- Negotiate and maintain quality agreements between Abcuro and CDMOs.
- Support quality review of CMC modules of regulatory submissions as needed.
- Represent Quality for analytical / process development and technical transfers to/from CDMOs
- Define, monitor, and report quality performance metrics utilizing data analysis and trending tools, as applicable.
- Ensure implementation of Abcuro quality initiatives, data integrity and continuous process activities, as applicable.
- Perform quality risk assessments, develop mitigation plans, and follow up on implementation.
- Support the quality management system (QMS) function in the development and maintenance of internal quality system processes and procedures (e.g., training, audit, deviation and change control) that complies with applicable GMP standards, guidelines, and regulations.
- Drive continuous improvement utilizing tools such as l process excellence, root cause analysis (RCA) and risk management.
- Maintain CDMO site readiness for Health Authority regulatory inspections and for Abcuro audits.
- Participate in on-site regulatory inspections and Abcuro audits.
- Report on the Health Authority inspections and audit outcomes and ensure implementation and completion of associated action plans.
- Maintain current knowledge of applicable Quality and Regulatory requirements and evolving trends and support the CDMO to meet these standards.
- Other responsibilities as assigned/delegated by management, as appropriate.
EDUCATION AND WORK EXPERIENCE
- Bachelor’s degree in Chemistry, Biology, Engineering or related field plus 12 years biopharma manufacturing and laboratory experience in the Biopharma/Biotech GMP Environment; or Master’s degree in Chemistry, Biology, Engineering or related field plus 7 years relevant industry experience in Quality Assurance in the Pharma/Biotech GMP environment.
- Demonstrated experience in supplier/vendor quality management leadership experience in a GMP regulated environment.
- At least 7 years of direct QA/compliance experience working in biotechnology, biopharmaceutical, laboratory, CRO or CDMO environment.
- Comprehensive working knowledge of FDA, ICH and international cGMP regulations, guidelines, and application to drug development.
- In-depth Quality experience in biologics drug substance through the product lifecycle.
- Strong prioritization and problem-solving skills.
- Thorough understanding of creation, review, and approval of GMP documents such as specifications, test methods, stability/validation protocols, batch records, deviations, investigations, change controls, and CAPAs.
- Demonstrated experience working autonomously and on cross functional/global teams .
- Excellent verbal/written communication skills, including knowing when email or conversations are appropriate; Ability to flex communication approach based on needs of others.
- Demonstrated project management skills; excellent attention to detail and organizational skills.
- Capable of analyzing a wide variety of information and data to make decisions regarding potential risks associated with product quality or regulatory compliance.
- Ability to build and maintain professional relationships and rapport with internal and external colleagues.
- Ability to adapt in a fast-paced environment with competing priorities.
- Root Cause Analysis, Investigator and/or Operational Excellence (e.g., Six Sigma, Kaizen qualification) skills are desirable.
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.
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