A biotechnology pioneer since 1980, Amgen has grown to be the worlds largest independentbiotechnology company, has reached millions of patients around the world and is developing a pipelineof medicines with breakaway potential. Amgen is committed to unlocking potential treatments forpatients suffering from serious illnesses by discovering, developing, manufacturing and deliveringinnovative human therapeutics
Amgen runs a Formulation Development facility in Thousand Oaks as part of its Drug Product Technologies (DPT) GMP and non-GMP for solid Oral dosage forms strategy. Our existing facility is currently preparing for a rejuvenation and expansion project to support our exciting pipeline and associated GMP campaigns. We are seeking to appoint an experienced leader to assume the role of Sr. Engineer to manage the Formulation Development lab, equipment, facility and compliance. This leader will be responsible for two GMP areas.
Scope of Responsibility
The Sr Engineer is responsible for managing the life cycle and day to day production support requirements associated with the products and process equipment at the Thousand Oaks DPT facilities. Specific responsibilities include:
- Serve on the formulation leadership team for the labs
- Provide technical support to troubleshoot, identify and resolve process and system issues as needed and manage call coverage
- Own and lead investigations associated with process deviations and non-conformances
- Manage change controls, corrective actions and preventative actions associated with products and process equipment
- Responsible for the validation master plan, including strategy, cleaning validation, etc.
- Responsible for product lifecycle management and associated electronic batch records
- Effectively collaborate with key customers and support groups (Quality, Process Development, network partners)
- Deliver results in accordance with cGMP and safety requirements
- Build, develop and maintain a manufacturing training team that ensure effective and efficient staff training
- Lead and support regulatory inspections for areas of responsibilities including develop playbooks for the inspections
- Build, develop and retain a diverse and high performing team
- Deliver against organizational financial commitments
- Develop and implement departmental strategy and plans that are aligned with the broader organizational strategy
- Doctorate degree
- Masters degree and 3 years of GMP manufacturing experience
- Bachelors degree and 5 years of [Job Codes Discipline and/or Sub-Discipline] experience
- Associates degree and 10 years of [Job Codes Discipline and/or Sub-Discipline] experience
- High school diploma / GED and 12 years of [Job Codes Discipline and/or Sub-Discipline] experience
- Demonstrated managerial experience in a GMP manufacturing plant, preferably a drug substance plant for solid oral dosage forms.
- Demonstrated knowledge of regulations for the manufacture of solid orals dosage forms
- Demonstrated experience in applying Six Sigma, Lean and Operational Excellence concepts and work processes
- Ability to do data analysis, data management and create visualization tools to manage day to day operations as well as drive higher level facility and operational decisions.
- Cross-functional work experience in either Process Development, Quality or Engineering
- Excellent written and verbal communication skills, drive, sense of urgency, energy level and problem-solving abilities
- Proactive and Enthusiastic
- Demonstrated ability to forge and maintain strong relationships and benchmark with other functional areas
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects
- Experience in matrixed, cross-site network environments
- Ability to effectively develop and coach staff and positively advance the culture of the organization
- Proven projectmanagementexperience, including the ability to manage multiple projectssimultaneously
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey.
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Equal Opportunity Statement
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 a 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 an accommodation.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.