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.
POSITION SUMMARY
Abucro, Inc. is seeking a Senior Manager, CMC Drug Product Manufacturing. In this role you will be responsible for leading the drug product 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 drug product development, optimization, and troubleshooting of biological process development and manufacturing in support of clinical 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 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.
- Author and/or review protocols, 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 and/or review technical risk assessments.
- Participate in the identification and selection of CDMOs.
- Support regulatory filings including the writing and/or review of reports.
- Effectively translate technical CMC Manufacturing issues and topics for others.
- Participate and represent CMC Manufacturing in process teams.
EDUCATION AND WORK EXPERIENCE
- Bachelors, MS or Ph.D. in Chemical Engineering, Bioengineering, Biology, Protein Chemistry, Biochemistry or related field.
- A minimum of 6+ years industry experience in the biopharmaceutical industry.
- Demonstrated success in supplier/vendor management experience in a cGMP regulated environment.
- Hands-on experience with unit operations including transfer to cGMP manufacturing and validation of DP filling lines and processes
- Working knowledge of FDA and international cGMP regulation guidelines.
- Experience with regulatory submissions.
- 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 adapt communication approach based on needs of others.
- 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.
- Microsoft Office proficiency.
- Familiar with basic data processing and analysis.
If interested in this role, please email your resume to careers@abcuro.com.
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 provide reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.