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 ulviprubart (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) and TLGLL, into clinical studies.

POSITION SUMMARY

Abcuro, Inc. is seeking a Senior Manager, CMC Purification Process Development. In this role you will be responsible for leading the process development oversight of one or several Contract development and manufacturing organizations (CDMOs) contracted to develop and manufacture Abcuro’s investigational products. As a key member of the CMC function, this position will primarily be responsible for the oversight of purification process development, optimization, and troubleshooting of biological processes development in support of clinical or post commercial development of Abcuro’s antibody therapeutics.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Provide technical oversight and guidance to the CDMO teams; build and maintain productive working relationships with all our important CDMOs, effectively oversee process development of our investigational products.
• Development of purification scale up processes that are scalable, and robust and transferable to GMP manufacturing operations to produce high-quality protein therapeutics
• Optimize of appropriate chromatography and UF/DF steps for purification of a protein therapeutic
• Evaluation of appropriate in-process controls and monitoring, including any hold steps
• Establishment of proven acceptable ranges and critical process parameters
• Review process development protocol, reports and technical transfer documents
• Perform gap and risk analysis as required. Author or review the technical risk assessment
• Participate in the identification and selection of CDMOs
• Support regulatory filings including the writing and/or review of reports

EDUCATION AND WORK EXPERIENCE

• Bachelors, MS or Ph.D. in Chemical Engineering, Bioengineering, Biology, Protein Chemistry, Biochemistry or related field
• A minimum of 10+ years with BS, 8+ years with an MS, or 5+ years (with a Ph.D.), or the equivalent in a combination or industry experience in the biopharmaceutical industry and relevant education
• Proven success in product launches and authorship in Biologics License Applications and/or Marketing Authorization Applications.
• Process Development Experience in high concentration tangential flow ultrafiltration, downstream high throughput screening, cation/multimodal chromatography, and viral clearance.
• Demonstrated success in supplier/vendor management leadership experience in a GMP regulated environment
• Hands-on experience with unit operations, including scale-up and transfer to GMP manufacturing using Quality by Design (QbD)
• Demonstrated ability to work autonomously, with strong prioritization and problem resolution skills
• Demonstrated success working on cross functional teams and 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
• Familiar with basic data processing and analysis
• Some travel is required

COMPENSATION & BENEFITS

At Abcuro, your base salary is one component of your total compensation package. Base salary for this role will depend on your skills, qualifications, experience, and market benchmarking. Compensation and benefits include, but are not limited to:

• Annual base salary target is between $150,000 to $180,000
• Annual cash bonus opportunity
• Employee stock options
• Health insurance benefits, including medical, dental, vision, STD/LTD, Life & Disability
• 401(k) plan with employer match
• Flexible PTO plan

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 careers@abcuro.com