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Posted : Thursday, May 30, 2024 03:59 AM
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are.
At Amgen, our shared mission—to serve patients—drives all that we do.
It is key to our becoming one of the world’s leading biotechnology companies.
We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.
It’s time for a career you can be proud of.
Director, Process Development: Drug Substance Technology & Engineering Live What you will do Let’s do this! Let’s change the world! In this vital role you will develop a team within Drug Substance Technology and Engineering at Amgen Thousand Oaks (ATO).
You will be responsible for technical oversight of process engineering activities associated with biologics process development, scaling up bench scale processes, transferring into internal and external clinical and commercial manufacturing sites, and supporting clinical and commercial biologics manufacturing.
The Director confirms the group’s outputs are safe, compliant, and aligned with organizational goals.
Specifically, this individual will: Collaborate with the biologics process design teams in ATO pivotal process development to provide facility and manufacturing considerations to ensure the developed processes can be implemented in a GMP facility Support process scale-up and technology transfer to production facilities where ATO serves as sending site.
Partners closely with receiving site process teams to ensure successful implementation Work with Manufacturing and Clinical Supply (MCS) to ensure cell banking, clinical and commercial manufacturing in ATO are executed flawlessly Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives Advance new technologies optimizing for GMP implementation Provides regulatory acumen enabling compliance and agency filing excellence Lead high performing team and provide innovative strategies to improve team engagement and ensure team reaches full potential Serve as member of DSTE leadership team and apply network thinking and innovative ways to advance global process engineering function Ensure group’s outputs are safe, compliant, and aligned with functional performance goals Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.
The professional we seek is a leader with these qualifications.
Basic Qualifications: Doctorate Degree and 4 years of Process Development, Engineering or Manufacturing experience Or Master’s Degree and 8 years of Process Development, Engineering or Manufacturing experience Or Bachelor’s Degree and 10 years of Process Development, Engineering or Manufacturing experience And 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Master’s Degree in Chemistry, Biochemistry, Biochemical or Chemical Engineering, or in a technological field 10+ years of experience in pharmaceutical/biopharmaceutical process development, manufacturing, or process support in a current Good Manufacturing Practices (cGMP) environment and global regulatory expectations Demonstrated ability in providing engineering expertise to cross-functional teams in manufacturing, quality, and supply chain to advance complex projects to completion and to interface on technical problem resolution Ability to compile and statistically analyze data, draw appropriate conclusions, and make presentations to cross-functional audience and senior management.
Thorough understanding of all stages of Process Validation lifecycle in biologics: Process Design, PPQ, Continued Process Verification (CPV) Understanding of quality attributes of protein products and analytical methods for determination of these attributes Knowledge and understanding of software tools for modeling of fluid flow, mixing, mass and energy balance, and facility utilization Demonstrated skills in negotiation, conflict resolution and managing customer expectations Ability to travel as needed Thrive What 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.
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 now for a career that defies imagination Objects in your future are closer than they appear.
Join us.
careers.
amgen.
com 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.
At Amgen, our shared mission—to serve patients—drives all that we do.
It is key to our becoming one of the world’s leading biotechnology companies.
We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.
It’s time for a career you can be proud of.
Director, Process Development: Drug Substance Technology & Engineering Live What you will do Let’s do this! Let’s change the world! In this vital role you will develop a team within Drug Substance Technology and Engineering at Amgen Thousand Oaks (ATO).
You will be responsible for technical oversight of process engineering activities associated with biologics process development, scaling up bench scale processes, transferring into internal and external clinical and commercial manufacturing sites, and supporting clinical and commercial biologics manufacturing.
The Director confirms the group’s outputs are safe, compliant, and aligned with organizational goals.
Specifically, this individual will: Collaborate with the biologics process design teams in ATO pivotal process development to provide facility and manufacturing considerations to ensure the developed processes can be implemented in a GMP facility Support process scale-up and technology transfer to production facilities where ATO serves as sending site.
Partners closely with receiving site process teams to ensure successful implementation Work with Manufacturing and Clinical Supply (MCS) to ensure cell banking, clinical and commercial manufacturing in ATO are executed flawlessly Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives Advance new technologies optimizing for GMP implementation Provides regulatory acumen enabling compliance and agency filing excellence Lead high performing team and provide innovative strategies to improve team engagement and ensure team reaches full potential Serve as member of DSTE leadership team and apply network thinking and innovative ways to advance global process engineering function Ensure group’s outputs are safe, compliant, and aligned with functional performance goals Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.
The professional we seek is a leader with these qualifications.
Basic Qualifications: Doctorate Degree and 4 years of Process Development, Engineering or Manufacturing experience Or Master’s Degree and 8 years of Process Development, Engineering or Manufacturing experience Or Bachelor’s Degree and 10 years of Process Development, Engineering or Manufacturing experience And 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Master’s Degree in Chemistry, Biochemistry, Biochemical or Chemical Engineering, or in a technological field 10+ years of experience in pharmaceutical/biopharmaceutical process development, manufacturing, or process support in a current Good Manufacturing Practices (cGMP) environment and global regulatory expectations Demonstrated ability in providing engineering expertise to cross-functional teams in manufacturing, quality, and supply chain to advance complex projects to completion and to interface on technical problem resolution Ability to compile and statistically analyze data, draw appropriate conclusions, and make presentations to cross-functional audience and senior management.
Thorough understanding of all stages of Process Validation lifecycle in biologics: Process Design, PPQ, Continued Process Verification (CPV) Understanding of quality attributes of protein products and analytical methods for determination of these attributes Knowledge and understanding of software tools for modeling of fluid flow, mixing, mass and energy balance, and facility utilization Demonstrated skills in negotiation, conflict resolution and managing customer expectations Ability to travel as needed Thrive What 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.
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 now for a career that defies imagination Objects in your future are closer than they appear.
Join us.
careers.
amgen.
com 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.
• Phone : NA
• Location : Thousand Oaks, CA
• Post ID: 9006099703
