Biologics Characterization Scientist II
At Agno Pharma, we provide a rewarding and challenging work environment. As a leader in the pharmaceutical CDMO space, we help our clients create products that save and improve lives. Your work will have a significant impact by helping us to elevate biologics characterization technologies and methods in R&D and GMP projects.
Role Overview:
We are seeking an experienced Biologics Characterization Scientist to join our Analytical Development team, with a strong background in the characterization of biologic drug substances and drug products. In this role, you will have the opportunity to lead development and execution of analytical methods for the physicochemical and molecular characterization of biologics. The Biologics Characterization Scientist makes a hands-on contribution from R&D method development through GLP/GMP method qualification, validation, and transfer in a fast-paced CDMO environment. Work will be both self-directed and under the guidance of an analytical director, while functioning as part of an interdisciplinary team. Your contributions will be laboratory-based and your high level of ability to perform complex analytical testing, interpret data, and communicate results is critical. The Biologics Characterization Scientist will have a high degree of autonomy, freedom to manage their own time, and the opportunity to collaborate with highly skilled teams including project managers, technical managers, formulation scientists, process development scientists, and other analytical scientists.
Key Responsibilities:
- Support and advance biologics characterization testing. You will support clinical drug development by testing, developing, documenting, and implementing analytical methods for the characterization of biologic products. You will execute analyses using PCR, electrophoresis, chromatography, capillary electrophoresis, UV/Vis spectroscopy, peptide mapping, ELISA, cell-based assays, flow cytometry, and other biologics characterization techniques.
- Independently develop characterization methods. You will develop, optimize, qualify, validate, and transfer analytical methods used to evaluate the identity, purity, potency, molecular integrity, and safety of biologic drug substances and drug products.
- Participate in diverse project work. You will rely on your pharmaceutical industry experience to support and lead multidisciplinary development programs. This is essential as you lead and participate in biologics development projects in partnership with process development, manufacturing, quality, and other analytical groups.
- Contribute to innovation. You will serve as a technical lead for biologics characterization activities on projects with high business impact and help drive pharmaceutical product development by solving complex analytical and molecular characterization challenges.
- Communicate scientific insights. As a key member of the analytical development group, your ability to interpret and communicate complex analytical data will provide customers, cross-functional teams, and management with meaningful scientific insights to support product development, process optimization, and manufacturing decisions.
- Complete other tasks as assigned by the Company
Factors for Success:
- Bachelor's degree or higher in biochemistry, molecular biology, biotechnology, pharmaceutical sciences, biology, chemistry, or a related scientific discipline with 2+ years of relevant pharmaceutical or biotechnology industry experience. PhD is preferred.
- Previous experience in the pharmaceutical or biotechnology industry, preferably in biologics analytical development, characterization, or a related laboratory role is required.
- Demonstrated experience with one or more of the following techniques: PCR (including quantitative PCR), ELISA, SDS-PAGE, Western blotting, capillary electrophoresis, peptide mapping, HPLC/UPLC, SEC, ion exchange chromatography, flow cytometry, UV/Vis spectroscopy, or other biologics characterization instrumentation and methodologies.
- Ability to independently develop analytical methods, execute laboratory analyses, troubleshoot instrumentation, and interpret complex biological datasets.
- Experience working in a cGMP environment.
- Practical knowledge of cGMPs, GLP, and FDA/ICH guidelines and their application to biologic product development and release.
- Experience in a CDMO environment is preferred.
- Experience characterizing complex biologic modalities, such as monoclonal antibodies, recombinant proteins, antibody-drug conjugates (ADCs), cell and gene therapy products, viral vectors, vaccines, oligonucleotides, or other advanced therapeutic products is highly preferred.
Agno Pharma is an Equal Opportunity Employer
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
