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 Analytical Development. In this role you will be responsible for leading the analytical development oversight of Contract Development and Manufacturing Organizations (CDMOs) contracted for the development and manufacturing of Abcuro’s investigational products. As a key member of the CMC function, this position will primarily oversee development, optimization, and troubleshooting of assay development and manufacturing in support of clinical development and commercialization of Abcuro’s antibody therapeutics. Activities include but are not limited to assay development, optimization, phase appropriate validation, assay transfer, product characterization, and formulation at external CDMOs and Contract Testing Laboratories (CTLs). 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
- Provide technical oversight and guidance to the CDMO teams; build and maintain productive working relationships with CDMOs in order to effectively oversee assay development of investigational products, including effective problem solving.
- Demonstrate technical expertise and leadership in analytical techniques for the characterization of biologics. Effectively influence and manage CDMOs. Support troubleshooting activities at CDMOs.
- Evaluate key assay parameters, specifications, and rationale for specifications.
- Review method development summary reports, test methods, phase appropriate validation protocols and reports, and comparability reports.
- Analyze and assess analytical data for trends, including assessment of any OOT or OOS.
- Build collaborative relationships with other stake holders including DS and DP manufacturing, Process Development, Project Management, Quality Control, Quality Assurance, and Regulatory Affairs.
- Author or review the technical risk assessment.
- Participate in the identification and selection of CDMOs/CTLs.
- Support regulatory filings, including writing, reviewing and regulatory responses.
- Effectively translate highly technical CMC (assay development) issues and topics for other stakeholders.
EDUCATION AND WORK EXPERIENCE
- Bachelors, MS or Ph.D. in Chemical Engineering, BioEngineering, Biology, Chemistry, Biochemistry or related field
- A minimum of 12+ years with BS, 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
- Demonstrated success in supplier/vendor management leadership experience in a GMP-regulated environment
- Demonstrated hands on working knowledge of multiple analytical instruments/Assays such as, HPLC, LC-MS, CE, iCE, GC, GC-MS, NMR, FTIR, Binding and Cell Based Assays, Compendial Assays
- Strong knowledge of relevant regulatory agencies and guidelines (cGMP, ICH, USP, EP, FDA, EMA)
- Demonstrated ability to work autonomously, with strong prioritization and problem-resolution skills
- Demonstrated success working on cross-functional teams and with global CDMOs
- 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
- Additional skills considered desirable: design of experiments, statistical analysis
- Other responsibilities as assigned/delegated by management
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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