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 Cell Culture Manufacturing. In this role you will be responsible for leading the cell culture manufacturing oversight of one or several Contract Development and Manufacturing Organizations (CDMO’s) contracted for the development and cGMP manufacturing of Abcuro’s investigational products. As a member of the CMC function this position will primarily be responsible for the oversight of cell culture manufacturing and process optimization in support of clinical development and commercialization 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 CDMOs in order to effectively oversee manufacturing of our investigational products.
- In addition to using your technical expertise, effectively guiding and troubleshooting with our CDMO partners will be the key to success in this role.
- Evaluate process parameters, specifications, and rationale for specifications.
- Own internal change controls, deviations and CAPAs.
- Review batch data for trends including assessment of any OOT or OOS.
- Review batch records to support batch release.
- Author and/or review protocols, reports and technical transfer documents.
- Author and/or review technical risk assessments.
- Support regulatory filings including the writing and/or review of reports.
- Effectively translate technical CMC Manufacturing issues and topics for others.
- Participate in the identification and selection of CDMOs.
EDUCATION AND WORK EXPERIENCE
- Bachelors, MS or Ph.D. in Chemical Engineering, Bioengineering, Biology, Biochemistry or related field.
- A minimum of 8+ years industry experience in the biopharmaceutical industry with proven success in product launches.
- Led process transfer, PPQ and supporting validation activities for cell culture manufacturing.
- In-depth knowledge of current FDA and EU regulations; success in authoring sections of BLA and/or MAA submissions.
- Demonstrated success in supplier/vendor management experience in a cGMP regulated environment.
- Demonstrated ability to work autonomously with strong prioritization and problem resolution skills.
- Demonstrated success working on cross functional teams and global CDMOs.
- Demonstrated project management skills, excellent attention to detail and organizational skills.
- Ability to adapt in a fast-paced environment with competing priorities.
- Some travel is required for PIP activities and onsite meetings.
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
