Senior Process Engineer

4 weeks ago

Thousand Oaks, California, United States Amgen Full time
Job Description

Career Category: Engineering

Job Summary

Amgen is seeking a highly skilled Principal Engineer to join our Drug Product Process Engineering team in Thousand Oaks, CA. As a key member of our team, you will be responsible for managing a team of commercial process validation subject matter experts to ensure execution excellence of commercial technology transfers into the drug product manufacturing facility.

Key Responsibilities
  • Accountable for successfully implementing all site process development activities to enable commercial tech transfers of parenteral drug products to Amgen's drug product manufacturing facility in Thousand Oaks.
  • Manage and supervise a team of tech transfer leads responsible for assessing facility-to-process fit during make-a-batch exercise, ensuring transferability of off-line characterization studies, designing and implementing on-site characterization studies and process validation runs, authoring/owning high-quality technical documents and regulatory files, providing on-site support, and evaluating product impact due to process, scale, equipment, and raw material changes.
  • Accountable for process validation of commercial products in alignment with applicable laws (FDA, EU & global standards) and required policies and procedures, including safety and training.
  • Build and sustain excellent relationships with partners – drug product teams, NPI, QA, Supply Chain, Process Development, and manufacturing teams to ensure alignment between program needs and site capabilities.
  • Accountable for building, owning, and maturing business processes to manage tech transfer portfolios for all drug product commercial tech transfers to the Thousand Oaks manufacturing facility in a tactical, strategic, and agile manner, ensuring successful project completion and increasing team productivity and efficient use of available resources, as demonstrated by performance metrics.
Requirements
  • Doctorate degree & 2 years of Engineering or Process Development experience OR Master's degree & 4 years of Operations or Process Development experience OR Bachelor's degree & 6 years of Operations or Process Development experience OR Associate's degree & 10 years of Operations or Process Development experience OR High school diploma / GED & 12 years of Operations or Process Development experience.
  • Advanced Degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry/Biochemistry, Biotechnology, Mechanical Engineering, or a related field, and 6+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
  • Knowledge of bringing new biotech products to market, across various dosage forms and delivery systems, and experience with process validation and marketing application regulatory filings.
  • Technology transfer experience across different development phases, fill-finish process scale-up, and the use of gap analysis, root cause analysis, and risk assessment tools.
  • Knowledge of aseptic processing and strong skills in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
  • Experience in cGMP manufacturing environment, knowledge of cGMP's and other global regulatory requirements.
  • Demonstrated ability in leading multi-functional teams to advance complex projects to completion and positively influencing peers and executive leadership on decision-making.
  • Project management skills, including the ability to manage numerous projects and evaluate project resource requirements.
  • Experience with building strong relationships in a matrix team environment, collaborating with Process Development, Project Management, Manufacturing, Regulatory, Quality, and Compliance.
  • Ability to learn and act on dynamic information at a rapid pace and advance relevant issues to management when required.
  • Interpersonal and facilitation skills necessary to represent functional position and forge consensus among competing client interests while ensuring objectives are met.
  • Strong focus on mentoring, motivating, and providing career and scientific/technical advice to staff.
  • Demonstrated track record of taking initiative in identifying and implementing innovative approaches and ideas.
  • Ability to think strategically to align and identify needs with incoming portfolio opportunities.
What We Offer

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities, including comprehensive employee benefits package, discretionary annual bonus program, stock-based long-term incentives, award-winning time-off plans, and flexible work models.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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