Director Quality Control- Microbiology

Come and Grow with us!

We are looking for creative, highly motivated and strategically Director Quality Control professional to be part of the world's leader biopharmaceutical company with a versatile portfolio of products. Our science-based approach has led to the discovery of novel therapies in the areas of cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. Our patient-centered culture fuels our dedication to delight their experience with innovative medicine delivery systems. At Amgen, new insights are not just welcomed, but celebrated. You will be joining a team of over 20,000 inspirational colleagues eager to have a positive impact with one mission: to serve every patient every time.

Located in Juncos, Puerto Rico, Amgen Manufacturing Limited (AML) is Amgen's largest multi-product end-to-end manufacturing site where most of the combination products portfolio move through our 1.7 million square foot biotechnology facility.

You will be interacting directly with the Executive Leadership Team forum and at the same time lead the Department's continuous improvement initiatives/projects. In order to do so, you also will collaborate and closely work with Amgen's manufacturing network to ensure innovation is incorporated into our processes and ensure to meet the expected results.

The role

The Director QC will lead the Microbiology Labs organization that supports our state-of-the-art Quality laboratories. This role will also ensure product quality standards are met in compliance with regulatory requirements. As part of this leadership role, he/she will develop strong teams and support staff in career development. In addition, the position will lead and support efforts to develop and implement new technologies and new business strategies to drive organizational efficiency. Will be also responsible for determining all Quality Control objectives activities in the areas of Biochemistry and Microbiology Laboratory. Complete work is reviewed, from a long-term perspective, for desired results. Assures areas comply with the established policies, procedures analytical methods, and cGMP. The scope of work and responsibility span commercial process development, support of technology transfer, authoring regulatory CMC documents, and interacting with regulatory agencies.

Specific responsibilities include but are not limited to:

• Responsible of Quality Control Lab (QCL) area ongoing operation.
• Generally accomplishes results through personnel supervision assuring on time and high quality results and reports.
• Perform timely policy, process related and operational decisions that are within the limits of the company policies, procedures, as well as the regulatory agencies standards and regulations.
• Recruit, develop, retrain and motivate outstanding staff. Assures compliance with cGMP training requirements for all QAL staff.
• Assure on-time dependable analysis and reliable data of in process, utilities and environmental samples are provided.
• Support validation and production assignments according to schedule without compromising quality. Maintain high professional and compliance standards during production without sacrificing schedule.
• Ensure that laboratory equipment and instrumentation is specified, procured, operates and maintained.
• Develops and maintains appropriate protocols and procedures as needed.
• Interact with regulatory agencies as needed.
• Troubleshoots and provides supports manufacturing and process development groups.
• Review QCL documents, coordinates method development and validation in analytical chemistry lab.
• Maintain positive relationship internally and with the Amgen Network.
• Coordination of Incident and formal investigations.
• Perform management responsibilities associated to development, coaching, mentorship of Quality Control Lab area staff, as well as the performance evaluation of direct reports.
• Throughout subordinates, ensure that performance evaluations for QCL area

For this opportunity the basic requirements are:

Doctorate degree and 4 years of experience in a Pharmaceutical, Medical Device and/or Biotechnology industry.

Or

Master's degree and 8 years of experience in a Pharmaceutical, Medical Device and/or Biotechnology industry.

Or

Bachelor's degree and 10 years of experience in a Pharmaceutical, Medical Device and/or Biotechnology industry.

And

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Beyond that, additional preferred qualifications are:

• 10+ years of Manufacturing and/or Quality leading experience.
• Life Science and/or Engineering educational background.
• Knowledge of and previous experience in Quality Control-Labs Operations.
• Proven Continuous Improvement culture
• Strong group presentation skills with previous experience in presentations to both large and small groups.
• Computer literate.
• Self-motivated; works as a team player and/or independently.
• Superb knowledge of cGMP's and CFR's EC GMPs.
• Good verbal and written communication skills.
• Good analytical/critical thinking skills with an experienced global perspective.
• Strong persuasion and negotiation skills and the ability to interact successfully and partner with management within and outside of Quality Operations.
• Team development and leadership skills.
• Fully bilingual (Spanish/English).

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 is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.