Amgen

Specialist Manufacturing

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 17, 2019
Ref
R-83512
Required Education
High School or equivalent
Position Type
Full time
As a member of the Drug Product Assembly & Packaging organization, this role serves as project manager and technical expert for Final Drug Product New Process Introductions (NPI) and Technology Transfers (TT) into the clinical manufacturing facility. NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, blister, etc.), introduction of novel medical device final assembly processes/equipment, and implementation of new packaging configurations.

The specialist provides support for various Drug Product teams throughout the clinical/commercialization process, leading cross-functional NPI teams with support from Clinical Planning, Supply Chain, Quality, Engineering, Process Development, Operations, Device Technologies, and other business groups.

Primary responsibilities include assessment of NPI's and TT's for necessary process, facility, equipment, materials, and training modifications; development of NPI/TT execution plans in accordance to current business practices; ensuring process and design transfer information is completed and sufficient for manufacturing implementation; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology modifications (design through installation), and supporting commissioning and qualification activities.

The position will support and/or be responsible for proper execution of manufacturing and quality systems such as non-conformances, process qualification/validation, procedures, training, and technology and design transfer for the clinical packaging and device assembly processes.

Specific job activities may include the following:
  • Work with various NPI/TT support groups to develop, maintain, and execute the NPI/TT project plan. Specialist will function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and escalation to various levels of management as appropriate.
  • Engage with network partners in commercial manufacturing to develop process and technology solutions that support commercial development and reduces commercial transfer risks and cycle time while achieving clinical supply and commercial development timelines.
  • Facilitate the development and optimization of NPI/TT business processes. As applicable, serve as a representative on various global network teams or network-sponsored initiatives to advance the Final Drug Product operational practices and technologies.
  • Work with Packaging Engineering, Device Technologies, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI/TT.
  • Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications). Ensure all documents address design/process transfer requirements and are aligned with current manufacturing operations. Serve as a document author and owner, as applicable.
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.


Basic Qualifications:

Doctorate degree

OR

Master's degree & 3 years of directly-related experience

OR

Bachelor's degree or & 5 years of directly-related experience

OR

Associate's degree & 10 years of directly-related experience

OR

High school diploma / GED & 12 years of directly-related experience

Preferred Qualifications:
  • Engineering experience with process equipment design, construction, commissioning, and qualification
  • Experience with medical device design development and manufacturing
  • Knowledge and expertise in device design control, design transfer, and combination products manufacturing
  • Experience with the development and maintenance of device master records, device history records, and process risk assessments (pFMEA)
  • Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.)
  • Fundamentally sound project management/organization, technical writing, computer skills, and communication/presentation skills
  • Experience with various quality systems including change control, nonconformances, corrective and preventative actions, and/or validation practices
  • Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
  • Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
  • Experienced in managing multiple, competing priorities in a fast-paced environment
  • Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms


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.