Principal Engineer
1 month ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Principal EngineerLive
What you will do
Lets do this Lets change the world The Principal Engineer will join Amgens Drug Product Process Engineering team in the Drug Product Technologies organization. Working with the Associate Director of Amgen Thousand Oaks (ATO) Process Engineering, this role 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 in Thousand Oaks. This management role will contribute to the strategic direction of the group based on emerging business needs, industry trends and feedback from key collaborators. This role will be based in Thousand Oaks, CA. Some US or international travel may be required to support Amgens drug product network.Key responsibilities for this role include:
Accountable for successfully implementing all site process development activities to enable commercial tech transfers of parenteral drug products to Amgens drug product manufacturing facility in Thousand Oaks. Manage and supervise a team of tech transfer leads responsible to assess facility-to-process fit during make-a-batch exercise, ensure transferability of off-line characterization studies, design and implement on-site characterization studies and process validation runs, author/own high quality technical documents and regulatory files, provide on-site support and evaluate product impact due to process, scale, equipment and raw material changes. Accountable for process validation of commercial products in alignment to applicable laws (FDA, EU & global standards) and required policies and procedures, including safety and training. Be a key contributor to regulatory filings throughout the authoring, editing and submission process but also be responsible for responses to regulator questions as required, and support PAI, GMP inspections in the plant. 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 portfolio 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. Build, maintain and improve tech transfer efficiency tools, including utilization of offline characterization capabilities and predictive models, development of templated documents, implementation of lessons learned and more. Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of deviations. Demonstrate a deep understanding of Amgens drug product and primary container platforms, and support continuous evolution of platforms for agile tech transfers & improved manufacturability. Engage with the internal DP manufacturing network to guide the development and adoption of multi-site practices and process improvements. Participate in site selection to provide technical fit of new product process requirements to manufacturing capabilities and a realistic account of resources for tech transfer. Deliver progress reports and presentations, including generation and upkeep of dashboards to ensure management is aware of status and progress. Raise issues, recommendations on unresolved challenges in a professional and timely manner to the appropriate governance. Guide and mentor staff on day-to-day performance, long term career development and through change. WinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree & 2 years of Engineering or Process Development experience OR Masters degree & 4 years of Operations or Process Development experience OR Bachelors 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 Preferred Qualifications: 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 cGMPs and other global regulatory requirements. Demonstrated ability in leading multi-functional teams to advance complex projects to completion and positively influence 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. ThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. 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, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.-
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