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 an Associate Director/Director of CMC Manufacturing Operations. In this role you will be responsible for leading the manufacturing oversight of one or several Contract Development and Manufacturing Organizations (CDMO’s) contracted for the development and manufacturing of Abcuro’s investigational products. As a key member of the CMC function, this position will primarily be responsible for the oversight of development, optimization, and troubleshooting of biological processes development and manufacturing in support of clinical development of Abcuro’s antibody therapeutics. Activities include, but are not limited to, cell line development, cell culture, protein purification, formulation, and liquid sterile fill finish at external CMO partners. 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
- Participate in the identification and selection of CDMOs
- Provide technical oversight and guidance to the CDMO teams; build and maintain productive working relationships with all CDMOs, in order to effectively oversee manufacturing of investigational products. In addition to using your technical expertise, effectively influencing, guiding, negotiating, and troubleshooting with CDMO partners will be key to success in this role.
- Evaluate key process parameters, specifications, and rationale for specifications
- Review process development protocol, reports, and technical transfer documents
- Review batch data for trends including assessment of any OOT or OOS
- Review batch records to support batch release and campaign report
- Author or review technical risk assessment
- Support regulatory filings including the writing and/or review of reports
EDUCATION AND WORK EXPERIENCE
- MS or Ph.D. in Chemical Engineering, Bioengineering, Biology, Protein Chemistry, Biochemistry, or related field
- A minimum of 10+ years with an MS, or 8+ years (with a Ph.D.) , or the equivalent in a combination or industry experience in the biopharmaceutical industry and relevant education
- 5+ years of supplier/vendor management leadership experience in a GMP regulated environment
- Prior hands-on experience with unit operations including scale-up and transfer to GMP manufacturing using Quality by Design (QbD)
- Comprehensive working knowledge of FDA and international cGMP regulations, guidelines, and subsequent applications to drug development
- Demonstrated ability to work autonomously with strong prioritization and problem resolution skills
- Demonstrated success working on cross functional/global teams
- Excellent verbal/written communication skills, including knowing when email or conversations are appropriate, and ability to adapt 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 professional relationships and rapport with internal and external colleagues
- Ability to adapt in a fast-paced environment with competing priorities, in a changing environment
- Additional skills considered desirable: design of experiments, statistical analysis
- Other responsibilities as assigned/delegated by management
- Microsoft Office proficiency
- Familiar with basic data processing and analysis
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.