Manager Manufacturing - AML6 Drug Substance

Are you looking for a challenging new opportunity to test and growth your managerial skills? We have an immediate need for two Manager Manufacturing roles to join the AML6-Drug Substance team to support the non-standard shift operations that may include first, second, third and/or 12 hrs regular work schedule. This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The role

If you're the right person for this opportunity you will have a passion to ensure compliance and lead continuous improvement projects. We seek a lead by example Manager, and someone comfortable within an innovative, fast paced environment.

As Manager Manufacturing you will have a meaningful role for AML6 facility by leading the Downstream day to day activities solving operational issues and maintaining the applicable activities in full cGMP compliance

In addition, you will be accountable for supervising, hiring, and developing staff. Ensuring floor activities are completed on time while meeting safety, quality, and financial objectives. You will also assist the team delivering training, sharing knowledge and even may lead responsibilities within the work team.

Additional objectives are:

• Management, planning and oversight of manufacturing functions.
• Ensures that manufacturing facilities, equipment, processes, and procedures are compliant with cGMP requirements and/or other applicable regulations.
• Make sure that written procedures describing the manufacturing operations are controlled and followed. Also ensuring that area staff are trained to perform assigned production activities.
• Guarantee that the manufacturing activities follow approved cGMP procedures and are documented according to cGMP requirements.
• Responsible for ensuring that risks are identified, assessed and corrected to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured.
• Evaluate and maintain an adequate number of personnel who possess the applicable combination of education, experience and trainings in accordance with cGMP requirements.
• Report non-conformances promptly to the Quality unit and investigate per procedures.
• Manage and close corrective actions and preventive actions (CAPA) according with the procedures.
• Ensures the requirements of the Quality Management System are fulfilled.
• Alerts senior manager of significant quality, compliance, supply and safety risks.
• Provides input for Management Reviews.
• Lead continuous Improvement initiatives, programs and projects.
• Support first, second, third and 12hrs shifts including extended hours, as per business needs.

The department

The AML-6 Facility is the home of elite, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best mammalian drug substance manufacturing facility in the world.

As part of a non-standard rotating shift, the team focuses on a range of readiness and setup to precisely execute cleaning/sanitation/floor care of the manufacturing areas and equipment duties.

Basic skills and education

Doctorate degree
or
Master's degree and 3 years of Manufacturing and/or Operations experience in GMP regulated industry
or
Bachelor's degree and 5 years of Manufacturing and/or Operations experience in GMP regulated industry
And
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.

Beyond that, the preferred qualifications are:

• Education discipline/background in Business Administration, Life Sciences and/or Engineering
• Biotech/Pharma industry experience
• Senior Associate or Managerial Manufacturing previous experience
• Lean Certified and/or experience working in Operational Excellence teams and/or projects
• Coaching, Mentoring and Counseling previous experience
• Flexibility to work different work schedules
• Skills in the following areas:
  • Leadership and teambuilding
  • Verbal and written communication in English and Spanish, including technical writing and Computer literacy
  • Analytical Problem Solving and Conflict Resolution
  • Project Management, scheduling and presentation for different levels/forums
  • Ability to be flexible and manage changes
  • Regulatory requirements

.

The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.