Engineering Manager - Synthetics Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Engineering Manager-Synthetics ManufacturingLive

What you will do

Lets do this. Lets change the world. In this vital role you will responsible for managing the life cycle and day to day production support requirements associated with the products and process equipment at the Thousand Oaks MCS Formulation Development Laboratory (FDL) facility. Specific responsibilities include:

• Lead the FDL operations from a manufacturing and engineering perspective in a safe and compliant manner.
• Provide technical support to troubleshoot, identify and resolve process and system issues as needed and manage on call coverage.
• Own and lead investigations in conjunction with the MCS deviation team to address 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.
• Responsible for product lifecycle management and associated electronic batch records in conjunction with the MCS MES team.
• Effectively collaborate with key customers and support groups (Quality, Process Development, network partners).
• 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 helping to develop playbooks for the inspections.
• Build, develop and retain a diverse and hard-working team.
• Deliver against organizational financial commitments.
• Develop and implement departmental strategy and plans that are aligned with the broader organizational strategy.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 3 years of Manufacturing & Operations experience Or
• Bachelors degree and 5 years of Manufacturing & Operations experience or
• Associates degree and 10 years of Manufacturing & Operations experience or
• High school diploma / GED and 12 years of Manufacturing & Operations experience And Previous managerial experience directly managing people and/or experience leading teams, projects, programs or advising the allocation of resources

Preferred Qualifications

• Demonstrated managerial experience in a GMP manufacturing plant, preferably a drug substance or drug product plant for solid oral dosage forms.
• Knowledgeable of regulations for the manufacture of solid orals dosage forms
• Demonstrated experience in applying Operational Excellence and Lean Manufacturing
• Cross-functional work experience in either Process Development, Quality or Engineering
• Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities
• Proactive and Enthusiastic
• Demonstrated ability to forge and maintain strong relationships with other functional areas
• Experience in matrixed, cross-site network environments
• Ability to effectively develop and coach staff and positively advance the culture of the organization

Thrive

Some of the vast rewards of working here

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.

• 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

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Join Us

If 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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.