13 days old

Senior Associate Manufacturing - NPI (New Product Introduction)

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114997179
Amgen

Job ID: R-84365
Location: Thousand Oaks, CA, US 91360

As a member of the Drug Product Assembly & Packaging organization, this role provides project execution support for Final Drug Product New Process Introductions (NPI) and Technology Transfers (TT) into clinical manufacturing facilities. NPI/TT scope may include the implementation of various drug product formats (e.g. vial, syringe, blister, etc.), introduction of medical device final assembly processes/equipment, and implementation of new packaging configurations.

Under minimal supervision, the Sr. Associate will routinely serve as the project manager and technical expert for low/moderate complexity NPI projects, leading cross-functional teams with support from Clinical Planning, Supply Chain, Quality, Engineering, Process Development, and other business groups. Additionally, the Sr. Associate supports high-complexity NPI projects as a team member responsible for execution of specific project workstreams or phases under the direction of another NPI project manager.

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 processes; and coordination/execution of required 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 the execution of manufacturing/quality systems such as deviations, system qualification, procedures, training, and technology/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 project plans for low/medium complexity projects. Serve as the NPI lead that is accountable for managing NPI scope, schedule, resources, and risks. Responsibilities include timely issues resolution and escalation, as appropriate.
  • 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 document author and owner, as applicable.
  • Support the change control process as NPI change owner or SME. Coordinate timely execution of change control activities to achieve phase milestones.
  • Support NPI/TT business process optimization and development. Apply lean continuous improvement practices to solve problems and implement appropriate countermeasures that improve NPI execution quality and efficiency.
  • Supports maintenance and improvements to NPI business systems for portfolio and performance management.
  • Assist with NPI/TT investigations and support performance trend and process execution evaluations.
  • Train operations personnel on new manufacturing processes or changes to existing manufacturing processes.
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.


Basic Qualifications

Master's degree

OR

Bachelor's degree & 2 years of Operations or Process Development experience

OR

Associate's degree & 6 years of Operations or Process Development experience

OR

High school diploma / GED & 8 years of Operations or Process Development experience

Preferred Qualifications
  • Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.)
  • Working knowledge and experience with cGMP procedures and on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, deviations, corrective and preventative actions, and/or validation practices.
  • Demonstrated ability organizing and leading projects, applying fundamentally sound project management/organization, technical writing, and communication/presentation skills.
  • Strong computer/technical skills and proficiency with learning new software systems/platforms.
  • Engineering experience with equipment system ownership and or design/implementation/qualification.
  • Basic or advanced knowledge and experience in device concepts and industry practices is preferred. Experiences may include: medical device design development, 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
  • Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.


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.

PI114997179

<b>Amgen</b><br/><br/><b>Job ID: </b>R-84365<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>As a member of the Drug Product Assembly & Packaging organization, this role provides project execution support for Final Drug Product New Process Introductions (NPI) and Technology Transfers (TT) into clinical manufacturing facilities. NPI/TT scope may include the implementation of various drug product formats (e.g. vial, syringe, blister, etc.), introduction of medical device final assembly processes/equipment, and implementation of new packaging configurations.<br><br>Under minimal supervision, the Sr. Associate will routinely serve as the project manager and technical expert for low/moderate complexity NPI projects, leading cross-functional teams with support from Clinical Planning, Supply Chain, Quality, Engineering, Process Development, and other business groups. Additionally, the Sr. Associate supports high-complexity NPI projects as a team member responsible for execution of specific project workstreams or phases under the direction of another NPI project manager.<br><br>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 processes; and coordination/execution of required 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.<br><br>The position will support and/or be responsible for the execution of manufacturing/quality systems such as deviations, system qualification, procedures, training, and technology/design transfer for the clinical packaging and device assembly processes.<br><br>Specific job activities may include the following:<br><ul><li>Work with various NPI/TT support groups to develop, maintain, and execute project plans for low/medium complexity projects. Serve as the NPI lead that is accountable for managing NPI scope, schedule, resources, and risks. Responsibilities include timely issues resolution and escalation, as appropriate.</li><li>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 document author and owner, as applicable.</li><li>Support the change control process as NPI change owner or SME. Coordinate timely execution of change control activities to achieve phase milestones.</li><li>Support NPI/TT business process optimization and development. Apply lean continuous improvement practices to solve problems and implement appropriate countermeasures that improve NPI execution quality and efficiency.</li><li>Supports maintenance and improvements to NPI business systems for portfolio and performance management.</li><li>Assist with NPI/TT investigations and support performance trend and process execution evaluations.</li><li>Train operations personnel on new manufacturing processes or changes to existing manufacturing processes.</li><li>Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.</li></ul><br><br><b>Basic Qualifications</b><br><br>Master's degree<br><br>OR<br><br>Bachelor's degree & 2 years of Operations or Process Development experience<br><br>OR<br><br>Associate's degree & 6 years of Operations or Process Development experience<br><br>OR<br><br>High school diploma / GED & 8 years of Operations or Process Development experience<br><br><b>Preferred Qualifications</b><br><ul><li>Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.)</li><li>Working knowledge and experience with cGMP procedures and on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, deviations, corrective and preventative actions, and/or validation practices.</li><li>Demonstrated ability organizing and leading projects, applying fundamentally sound project management/organization, technical writing, and communication/presentation skills.</li><li>Strong computer/technical skills and proficiency with learning new software systems/platforms.</li><li>Engineering experience with equipment system ownership and or design/implementation/qualification.</li><li>Basic or advanced knowledge and experience in device concepts and industry practices is preferred. Experiences may include: medical device design development, device design control, design transfer, and combination products manufacturing.</li><li>Experience with the development and maintenance of device master records, device history records, and process risk assessments</li><li>Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.</li></ul><br> <br> Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/X7KoGGTXbK8kilR4ueYQ8"> <p>PI114997179</p>

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Posted: 2019-10-31 Expires: 2019-12-01

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Senior Associate Manufacturing - NPI (New Product Introduction)

Amgen
Thousand Oaks, CA 91360

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