Principal Engineer

Amgen - Thousand Oaks, CA

Full-time - Principal

Remote - Thousand Oaks, CA

Chemical Manufacturing

About the position

At Amgen, our shared mission—to serve patients—drives all that we do. The Principal Engineer will join Amgen's Drug Product Process Engineering team in the Drug Product Technologies organization. This role is pivotal in 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, California. The Principal Engineer will work closely with the Associate Director of ATO Process Engineering and will be responsible for contributing to the strategic direction of the group based on emerging business needs, industry trends, and feedback from key collaborators. This position may require some US or international travel to support Amgen's drug product network. The Principal Engineer will be accountable for successfully implementing all site process development activities to enable commercial tech transfers of parenteral drug products to Amgen's manufacturing facility. This includes managing and supervising a team of tech transfer leads, ensuring the transferability of off-line characterization studies, designing and implementing on-site characterization studies and process validation runs, and authoring high-quality technical documents and regulatory files. The role also involves being a key contributor to regulatory filings and supporting PAI and GMP inspections in the plant. Building and sustaining excellent relationships with partners across various teams such as drug product teams, NPI, QA, Supply Chain, Process Development, and manufacturing is essential to ensure alignment between program needs and site capabilities. The Principal Engineer will also be responsible for developing and maturing business processes to manage the tech transfer portfolio effectively, ensuring successful project completion and increasing team productivity. In addition, the Principal Engineer will provide process development expertise for commercial drug product processing, support commercial drug product manufacturing operations, and engage with the internal DP manufacturing network to guide the development and adoption of multi-site practices and process improvements. The role requires delivering progress reports and presentations, guiding and mentoring staff, and demonstrating a deep understanding of Amgen's drug product and primary container platforms.

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 exercises and ensuring transferability of off-line characterization studies.
• Design and implement on-site characterization studies and process validation runs, author high-quality technical documents and regulatory files, and provide on-site support.
• 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.
• Contribute to regulatory filings throughout the authoring, editing, and submission process, and support responses to regulator questions as required.
• Build and sustain excellent relationships with partners across various teams to ensure alignment between program needs and site capabilities.
• Accountable for building, owning, and maturing business processes to manage the tech transfer portfolio for all drug product commercial tech transfers.
• Build, maintain, and improve tech transfer efficiency tools, including utilization of offline characterization capabilities and predictive models.
• Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer, and validation.
• Engage with the internal DP manufacturing network to guide the development and adoption of multi-site practices and process improvements.

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.

Nice-to-haves

• 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.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• 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.