Amgen Sr. Manager Process Development - Laboratories and Compliance in Juncos, Puerto Rico
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 read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Senior Manager Process Development – Laboratories & Compliance
What you will do
Let’s do this. Let’s change the world! In this vital role you will lead the team supporting forensic evaluations of primary components and drug product complaints, creation of standards used as defect panels, and validation lifecycle (Periodic Monitoring and Periodic Reviews) for the GMP equipment of three Drug Product Manufacturing facilities. The facilities include manufacturing of oral dosage form and parenteral products including all process stages from formulation, filling, inspection, assembly, and packaging. You will develop a deep understanding of the operations and lead the team in support of new product introduction, commercial investigations, improvement of existing processes and acquisition on new technologies.
Specific responsibilities include but are not limited to:
Provide guidance and serve as advisor on the development of Commissioning, Qualification, and Validation strategies.
Provide mentorship on the resolution of events/discrepancies as part of C&Q and Validation exercises.
Serve as owner of Process Development Drug Product programs related procedures and develop optimization plans to further improve the processes.
Ensure the organization is inspection ready and in compliance with regulations and procedures. Also generating robust and reliable data in compliance with the respective protocol, methods or SOPs.
Be responsible for the Laboratory Equipment Maintenance and the Process Development Compliance Oversight program addressing any areas of opportunity.
Monitor status of quality related records to ensure on time closure and escalate to leadership the records in risk of not meeting target due dates.
Ensure alignment and holistic impact evaluation for those corrective and preventive actions that impacts more than one area of the department.
Review changes to compendia and evaluate impact on laboratory operations.
Ensure laboratory operations for forensic evaluations and standards generation of defects meet agreed timelines.
Manage team workload and capacity, prioritize activities based on business needs and identify headcount needs.
Share knowledge and develop staff to ensure high performance team and creates redundancy of key capabilities.
Identify opportunities of productivity and continues improvement within own operations and in support of manufacturing plants.
Manage conflict resolution among team members and with external groups.
Monitor field of expertise including technology development and stay current with validation trends and regulatory expectations to apply to the department.
Meet specific project goals and timelines.
Work in teams with multiple fields and functional areas.
Communicates and/or presents scientific/ technical information within area of expertise across projects within a function/department, and occasionally to the external scientific community (i.e. regulatory agencies, review boards, conferences).
Contributes to and may author/review scientific/technical documents independently (i.e. protocols, experiments, technical reports, investigation reports, scientific reports, invention disclosure submissions and/or patents, posters, presentations, publications, regulatory marketing applications, patent applications).
Adheres to company policies and procedures to ensure a continuous state of compliance.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Senior Manager Process Development professional we seek is a strong leader with these qualifications.
- Doctorate degree & 2 years of experience in laboratories, validation or operations of GMP regulated industry
- Master’s degree & 6 years of experience in laboratories, validation or operations of GMP regulated industry
- Bachelor’s degree & 8 years of experience in laboratories, validation or operations of GMP regulated industry
2 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:
Educational background in Life Science and/or Engineering
Prior Validation experience in Drug Product
Extensive Quality and compliance knowledge of regulations and expectations.
Experience managing teams with a strong leadership skills, initiative and self-motivation.
Experience in laboratory operations
Proven experience of improving processes using operational excellence
Excellent communication skills: oral and written in Spanish and English. Interacts effectively with variety of communication and working styles
Demonstrated strong problem solving and conflict resolution
Excellent time and project management skills to deliver projects on time and budget.
Team player with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making
High quality and compliance mind set to work in a highly regulated GMP industry
Computer literacy (Windows environment: Word, Excel, Power Point, Minitab
What you can expect of us
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.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com
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.
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.