Process Development Scientist

Process Development Scientist

Duties:
Provide technical input and support to Amgen's drug product commercialization team and advancement of synthetic process development. Contributes to drug product and process development, commercialization and life cycle management of Amgen's product portfolio. Operate in product and process development and/or manufacturing environments and responsible for the design and execution of characterization studies, evaluation of product impact from manufacturing processes, production scale, equipment, and raw material changes, authoring high-quality process transfer and other technical documents.

Participate in authoring relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities. Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to support nonconformance investigations and development of corrective/preventive actions. Contributes to Amgen's commercialization development and process introduction into clinical and commercial facilities. Integrate and utilize knowledge and information generated by cross functional (engineering, analytical, quality, regulatory, clinical and commercial manufacturing) teams to utilize Amgen platforms and capabilities to ensure success through the commercialization lifecycle.

Work within a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development and technology transfer, while applying their experience in oral solid dosage and synthetic characterization. Support technology transfers of pipeline and commercial products as well as lifecycle management of commercial products. May Telecommute.

Requirements:
Master's degree (or foreign equivalent) in Chemical Engineering, Biochemical Engineering, Biochemistry or a related field and 2 years of experience in the job offered or in Scientist – related occupation. The position requires 2 years of experience in the following:

• Conduct statistical evaluations of data to evaluate statistical significance, assess potential correlations, evaluate process capability, and perform data simulations;
• Employing engineering mathematical and physics principles to bench and pilot scale models for process performance characterization;
• Process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools;
• Design process performance validation and sampling plans, interpret results, and author process performance qualification reports;
• Develop statistical monitoring plans for continued process validation, triage excursions, and develop remediation plans;
• Author and review module 3 common technical documents for regulatory filings and strategize responses to health authority requests for information; and
• Chemistry and biology laboratory skills including chemical weighing dispensing and pipetting, aseptic handling, and performing bench scale fill-finish operations in a biosafety cabinet.