21 days old

Sr. Associate Manufacturing AML 6 Upstream Operations

Amgen
Juncos, Puerto Rico 00777
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  • Job Code
    123335642
Amgen

Job ID: R-103447
Location: Juncos, PR, US 00777

Are you looking for a Senior role to apply your Manufacturing knowledge and expertise? We have a Sr. Associate Manufacturing position to support our AML6 Drug Substance Upstream organization! Under limited supervision, this role will perform manufacturing processes according to Standard Operating Procedures.

The role:

This is an outstanding opportunity to take on a variety of challenges and responsibilities around our outstanding Mammalian Cell Culture facility. After the completion of the onboarding and applicable training qualifications; you will set about preparing and operating critical equipment's. And by doing so, developing your experience with some or all following processes: bioreactors, chromatography & filtration skids, buffer/media preparation, autoclave and part washer systems.

The department:

The AML-6 Facility is the home of outstanding, multi-product Drug Substance Manufacturing Operations. We highlight the combination of groundbreaking manufacturing sciences and process technology, sophisticated equipment engineering and automation, and a high-performance culture 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 shift, the team focuses on a range of readiness, setup, manufacturing processing, investigations support and analytical testing duties. With both formal learning and on the job training, it is the perfect place to develop.

Time spent in a classified room performing and monitoring critical processes or executing testing on the floor such as pH, conductivity; hands on experience with SAP, EBR and Equipment Interphase (HMIs) systems and equipment preparations (CIP/PT/SP) would help. But if you are driven, enjoy taking on new challenges, love to work in teams and are a confident communicator, you will thrive here.

Specific responsibilities include but are not limited to:

  • Support non-standard 7/24 shift manufacturing operations that may include weekends and night shifts.
  • Schedule operations and perform initial review or evaluations of manufacturing process & procedures/batch records
  • Train Mfg Operators and Associate Manufacturing on process theory and advise them on critical processes
  • Draft and revise more sophisticated documents (e.g. MPs, SOPs, technical reports, validation documents, investigation reports, etc.)
  • Audit critical records and propose corrective action for Quality incidents
  • Assist, & plan improvement implementation related to routine functions
  • Interact with other departments to implement planned improvements
  • Identify and propose solutions to sophisticated problems.
  • Perform data analysis (e.g., SPC, CPV) and verification of critical process parameters
  • Lead capacity for equipment/process operations
  • Initiate Quality incidents.
  • Identify, evaluate and recommend process improvements related to routine functions and implement after approval.
  • Basic troubleshooting.
  • Recognize & accurately report problems
  • May assist with recruiting effort and supervise staff
  • May perform system owner responsibilities (i.e., process, document)
  • Negotiate actions with Stakeholders
  • Evaluate training requirements for technical aspects of the process
  • Identify training opportunities
  • May interact with diverse multi-functional department including Process Development and Quality
  • Apply technical writing techniques proficiently
  • Ensure timely report approval
  • Participate in the new product introduction (NPI) process to assess requirements for documentation, materials, training, and equipment modifications
  • Participate in the assessment or implementation of special projects or initiatives.


Basic skills and education needed:

Master's degree

Or

Bachelor's degree & 2 years of Manufacturing experience in GMP regulated industry

Beyond that, the preferred qualifications are:

  • Educational background in Life Science and/or Engineering
  • GMP regulated industry experience
  • Understand equipment/processes which leads to greater independent judgment
  • Basic statistical mathematical skills
  • Technical writing capability
  • GMP knowledge with ability to interpret & apply
  • Understand analytical methods for manufacturing area
  • Specific system/equipment skills
  • Basic project management skills
  • Availability to support non-standard shift.
  • Strong presentation skills.
  • Project management skills.
  • Knowledge of control charting.
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Detailed technical understanding of bio-processing unit operations.
  • Compliance/Regulatory knowledge and interaction experience.
  • Exhibits Amgen's values.


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.

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 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.

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.



PI123335642
Posted: 2020-09-04 Expires: 2020-10-06

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Sr. Associate Manufacturing AML 6 Upstream Operations

Amgen
Juncos, Puerto Rico 00777

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