The pharmaceutical development group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other biologics by state of the art formulation and analytical technologies. We create intellectual property through new formulation compositions, cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
We are looking for a highly motivated person to join analytical development team of new biologics. The candidate will be part of a group of motivated scientists who provide analytical characterization of new biologic development programs and provide key data for regulatory submissions. Working closely with formulation and process development scientists, the candidate will d evelop productive collaborations and communications with these scientific teams.
Section I: Major Responsibilities:
Level and compensation will be commensurate with experience.
- Design and execute experiments for analytical characterization and assessment of development samples and clinical trial supplies (e.g. GMP compliant stability and release testing).
- Support development of therapeutic proteins at various stages
- Collect data for elucidation of structure and impurity/variant characterization of antibody-based drug materials.
- Author and/or review key regulatory documents, laboratory data, technical memos and reports.
- Advance science in characterization of novel biologics by generating original ideas for analytical technologies.
- Mentor junior staff on troubleshooting equipment and experimental problems.
- Propose ideas for continuous improvement activities and initiatives within work group.
- Understand and adhere to corporate standards regarding code of conduct, safety and GXP compliance.
Section II: Qualifications :
Key AbbVie Competencies:
- BS (10+ years); MS (8+ years) or PhD (3+ years) in Chemistry, Biochemistry, or Biology, Ph.D. on protein analysis with mass spectrometry preferred.
- Previous work experience in a pharmaceutical laboratory setting. Experience with late-stage therapeutic protein characterization for BLA preferred. Experiences with regulatory document drafting preferred.
- Experience in analytical methodology, such as chromatography, KF, UV and compendial methods and bioanalytical techniques preferred (WCX, HIC, SEC, CGE, icIEF, particle imaging, ELISA and LC-MS).
- Experienced in GMP laboratory systems (LIMS, CDS, ELN) preferred.
- Statistical knowledge and experience is preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies.
- Good communication and interpersonal skills
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
- Builds strong relationships with peers and cross functionally with partners outside of teams to enable higher performance.
- Learns fast, grasps the \"essence\" and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Associated topics: bioinformatic, biology, biomaterials, biomedical engineer, biosynthetic, fermentation, neuro, nutrition, parenteral, pathogenesis