Process Development Scientist

Amgen; Cambridge (MA); On-site; USD 112,000 - 145,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Bonus eligibility

Job summary

Amgen is seeking a Process Development Scientist to support drug product commercialization and scale-up in a fast-paced environment. You will design and execute characterization studies, assess manufacturing impacts, and drive technology transfer across clinical and commercial facilities.

Collaboration with engineering, analytics, quality, and regulatory teams is essential to ensure lifecycle success. The role requires applying biochemical, biophysical, and statistical principles to

Qualifications

• Statistical evaluations of data for significance and correlations.
• Engineering/physics principles used for bench and pilot-scale models.
• Experience with process scale-up and technology transfer tools.
• Design and interpret process validation and sampling plans.
• Develop ongoing statistical monitoring and remediation plans.
• Prepare regulatory module 3 technical documents and responses.
• Laboratory skills: weighing, dispensing, aseptic handling, fill-finish work.

Responsibilities

• Provide technical input to commercialization teams and process development.
• Design, execute, document characterization studies and data packages.
• Evaluate product impact from manufacturing changes and raw materials.
• Lead technology transfers for pipeline and commercial products.
• Collaborate with cross-functional teams to ensure lifecycle success.
• Contribute to regulatory submissions enabling new processes.

Skills

Statistical data analysis

Process modeling

Process scale-up

Regulatory documentation

Statistical monitoring

Cross-functional collaboration

Bench and pilot scale work

Job description

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.

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:

• 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.

Job type: Full-Time position. The annual salary range for this position in the U.S. is $111,685.00 – $144,605.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visithttps://careers.amgen.com/life-at-amgen/benefits/