Manager Quality Control
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.
Manager Quality ControlLive
What you will do
Lets do this! Lets change the world! In this vital role, you will be responsible for supervision of all technical and operational activities within the QC Bioanalytics Laboratory at Amgen, Rhode Island.Responsibilities:
- Coordinates the scheduling and execution of testing including routine analysis and testing in support of technology transfer for product
- Provides technical expertise/guidance to lab staff and within cross-functional Amgen teams
- Leads the Bioanalytics Laboratory daily operations in relation to scheduling testing, project planning, management of materials, reagents, equipment, and laboratory staff
- Oversee labatories for the following tasks: Bioassay, Capillary Electrophoresis (CE SDS, cIEF, and/or cOligo), ELISA Laboratory techniques
- Reviews and approves controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Bioanalytics Lab activities
- Ensures that the Lab operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory Controls
- Represents the Bioanalytics Lab during Amgen internal/external audits and inspections. Direct interaction with regulatory agencies during on-site inspections
- Provides oversight of Bioanalytics Lab Quality Systems records including, lab investigations, Deviations, CAPAs and Change Controls
- Selects, develops, and evaluates laboratory staff to ensure functional objectives are met
- Handles assignment and accuracy of staff training
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a strong leader with these qualifications.
- Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
- Doctorate degree OR
- Masters degree and 3 years of biotechnology/pharmaceutical GMP laboratory experience OR
- Bachelors degree and 5 years of biotechnology/pharmaceutical GMP laboratory experience OR
- Associates degree and 10 years of biotechnology/pharmaceutical GMP laboratory experience OR
- High school diploma / GED and 12 years of biotechnology/pharmaceutical GMP laboratory experience
- Advanced Degree in Scientific Discipline
- Strong knowledge in Bioassay, Capillary Electrophoresis (CE SDS, cIEF, and/or cOligo), ELISA Laboratory techniques and general chemistry testing including solid phase extraction, UV, Osmolality and pH
- Familiarity with technology transfer process. Experience with validating analytical methods and ensuring that project deliverables meet established timelines
- Strong level of analysis skills to evaluate and interpret data to arrive at logical and quality-minded conclusions. Experience applying problem-solving tools for root cause analysis
- Proven leadership capabilities and experience applying GMP requirements in a Quality Control setting
- Demonstrated ability to develop, coach and mentor employees
- Excellent interpersonal, verbal and written communication skills with all levels within the organization
- Experience with successfully managing a team and delivering results in fast-paced and dynamic work environment
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.
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.