Job Description
Amgen is committed to unlocking the potential of biology for patients suffering from serious illness in areas of high unmet medical need by discovering, developing, manufacturing and delivering innovative human therapeutics.
Based at Amgen’s headquarters in Thousand Oaks, CA, the role of Sr. Associate in Pivotal Drug Product Technologies will be to provide support for Amgen’s biologics drug product and process design. The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen’s drug product commercialization and lifecycle management. The Sr. Associate will integrate and utilize platform capabilities and data analytics/visualization to advance Amgen’s pipeline and ensure success of the commercialization process.
The Sr. Associate will operate in a fast-paced, matrixed environment and collaborate successfully cross-functionally to progress product development in support of various modalities across the Amgen network.
Responsibilities will include:
• Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development in support of commercialization and life cycle management of biologics.
• Support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).
• Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization (cake appearance, moisture, reconstitution time), and particle quantitation/characterization.
• Provide support for clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
• Conduct analysis of data generated from the above listed activities, including statistical analysis using JMP, SAS, etc.
• Apply digital tools and techniques to automate data structuring, integration with electronic notebooks and analysis of large and diverse datasets.
• Author/review technical documents: technical protocols, technical reports, regulatory documents, etc.
• Clearly and consistently communicate progress reports and presentations to ensure management and functional awareness of and engagement in current status, plan forward, and forthcoming program needs.
• Participate in cross-functional teams in a fast-paced environment to progress product development.
Basic Qualifications:
Master's Degree
OR
Bachelor's Degree and 2 years of Scientific, Engineering or Operations experience
Preferred Qualifications:
• Degree in Engineering, Chemistry, Pharmaceutics, Materials Science, or related discipline.
• Aseptic processing experience and familiarity with cGMPs.
• 2+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development.
• Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, CE, HIAC, MFI).
• Understanding of physical/chemical stability of proteins and how process-related stresses impact molecule attributes and product quality.
• Experience with regulatory filings and compliance issues
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
• Self-motivation, adaptability and a positive attitude.
• Critical thinking, problem solving and independent research skills.
• Good organizational skills with strong attention to detail.
• Excellent communication (oral and written).