19 days old

Manager Manufacturing - Inspection & Packaging

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    114956031
Amgen

Job ID: R-86641
Location: Juncos, PR, US 00777

Are you looking for a meaningful new opportunity to test and growth your managerial skills? We have an immediate need for various Manufacturing Managers to join AML's Inspection and Packaging Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role

The Manager Manufacturing role is responsible for leading and supervising either a small manufacturing production area, or a section of a larger productionarea in an Inspection and Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed in a Third Shift, Non Standard shift, 12 hours-shift and weekends. Various positions available.

Specific responsibilities include but are not limited to:

Compliance:
  • Evaluate and approve reports and protocols.
  • Ensure cGMP and CFR compliance of operating areas.
  • Revise, update, and review procedures
  • Handle the development and revision of SOPs.
  • Act as a Lead for all Human Performances Deviations
  • Evaluate current operating procedures and recommend changes to management to optimize production.
  • Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes.
  • Interact with the FDA.
  • Ensure Amgen policies are followed


Process/Equipment/Facilities:

  • Ensure maintenance and re validation of systems.
  • Collaborate with cross-functional teams (i.e. Quality Assurance/Quality Control, PPIC, Clinical Manufacturing, Process Development, Regulatory, etc.) in completing production activities.
  • Develop, implement and assess solutions for complex problems.
  • Responsible for resolving problems during operation.
  • Coordinates set up of critical new manufacturing processes.


Staff Supervision

  • Responsible for selection, training, evaluation, staff relations and development of staff.
  • Ensure training programs are maintained
  • Ensure scheduling of production and maintenance activities.
  • Interacts with management in optimizing organizational structure and responsibilities
  • Ensure plant safety through auditing and evaluations.
  • Lead the process to maintain focus of the group on continuous improvement and the use of ideas initiative or/and kaizen process in the inspection/packaging areas.
  • Control and monitor budget area expenses, including meal penalty and overtime


Administrative:

  • Interacts with management in planning, developing and maintaining budget.
  • Drive and Lead Daily Meeting with the functional area team.
  • Assist in developing and maintaining department goals
  • Monitor and communicate progress and adherence to timelines
  • Daily schedule alignment
  • Utilize appropriate systems to perform job duties (SAP/MES, QMTS, LMS etc.)
  • Ensure batch record review is completed accurately to support disposition timelines
  • Effectively elevate critical and impactful events to senior management


Basic education & experience

Doctorate degree

or

Master's degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry

or

Bachelor's degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry.

And

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.

Preferred qualifications

  • Educational background in Science, Engineering or Business Administration
  • Knowledge of biopharmaceutical compliance
  • Availability to work any shift in support of operations that may include 24/7
  • Strong Managerial skills and ability to successfully prioritize a diverse workload to meet deadlines
  • Experience Managing Deviations and CAPA
  • Ensure that all Non-conformance are triage within the established goal.
  • Leadership and team building
  • Verbal and written communication skills in Spanish and English that will include technical terminology
  • Ability to anticipate and resolve problems
  • Conflict Resolution
  • Analytical Problem Solving
  • Project Management
  • Coaching, Mentoring and Counseling
  • Ability to be flexible and manage change
  • Regulatory requirements
  • Computer literacy
  • Scheduling
  • Presentation Skills


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages 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.

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.

PI114956031

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86641<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/>Are you looking for a meaningful new opportunity to test and growth your managerial skills? We have an immediate need for various Manufacturing Managers to join AML's Inspection and Packaging Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.<br><br><b><b>The Role</b></b><br><br>The Manager Manufacturing role is responsible for leading and supervising either a small manufacturing production area, or a section of a larger productionarea in an Inspection and Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed in a Third Shift, Non Standard shift, 12 hours-shift and weekends. Various positions available.<br><br><b><b>Specific responsibilities include but are not limited to:</b></b><br><br>Compliance:<br><ul><li>Evaluate and approve reports and protocols.</li><li>Ensure cGMP and CFR compliance of operating areas.</li><li>Revise, update, and review procedures</li><li>Handle the development and revision of SOPs.</li><li>Act as a Lead for all Human Performances Deviations</li><li>Evaluate current operating procedures and recommend changes to management to optimize production.</li><li>Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes.</li><li>Interact with the FDA.</li><li>Ensure Amgen policies are followed</li></ul><br><br><b>Process/Equipment/Facilities:</b><br><br><ul><li>Ensure maintenance and re validation of systems.</li><li>Collaborate with cross-functional teams (i.e. Quality Assurance/Quality Control, PPIC, Clinical Manufacturing, Process Development, Regulatory, etc.) in completing production activities.</li><li>Develop, implement and assess solutions for complex problems.</li><li>Responsible for resolving problems during operation.</li><li>Coordinates set up of critical new manufacturing processes.</li></ul><br><br><b>Staff Supervision</b><br><br><ul><li>Responsible for selection, training, evaluation, staff relations and development of staff.</li><li>Ensure training programs are maintained</li><li>Ensure scheduling of production and maintenance activities.</li><li>Interacts with management in optimizing organizational structure and responsibilities</li><li>Ensure plant safety through auditing and evaluations.</li><li>Lead the process to maintain focus of the group on continuous improvement and the use of ideas initiative or/and kaizen process in the inspection/packaging areas.</li><li>Control and monitor budget area expenses, including meal penalty and overtime</li></ul><br><br><b>Administrative:</b><br><br><ul><li>Interacts with management in planning, developing and maintaining budget.</li><li>Drive and Lead Daily Meeting with the functional area team.</li><li>Assist in developing and maintaining department goals</li><li>Monitor and communicate progress and adherence to timelines</li><li>Daily schedule alignment</li><li>Utilize appropriate systems to perform job duties (SAP/MES, QMTS, LMS etc.)</li><li>Ensure batch record review is completed accurately to support disposition timelines</li><li>Effectively elevate critical and impactful events to senior management</li></ul><br><br><b>Basic education & experience</b><br><br>Doctorate degree<br><br><b>or</b><br><br>Master's degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry<br><br><b>or</b><br><br>Bachelor's degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry.<br><br><b>And</b><br><br>Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.<br><br><b><b>Preferred qualifications</b></b><br><br><ul><li>Educational background in Science, Engineering or Business Administration</li><li>Knowledge of biopharmaceutical compliance</li><li>Availability to work any shift in support of operations that may include 24/7</li><li>Strong Managerial skills and ability to successfully prioritize a diverse workload to meet deadlines</li><li>Experience Managing Deviations and CAPA</li><li>Ensure that all Non-conformance are triage within the established goal.</li><li>Leadership and team building</li><li>Verbal and written communication skills in Spanish and English that will include technical terminology</li><li>Ability to anticipate and resolve problems</li><li>Conflict Resolution</li><li>Analytical Problem Solving</li><li>Project Management</li><li>Coaching, Mentoring and Counseling</li><li>Ability to be flexible and manage change</li><li>Regulatory requirements</li><li>Computer literacy</li><li>Scheduling</li><li>Presentation Skills</li></ul><br><br>Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br>Amgen focuses on areas of high unmet medical need and leverages 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.<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/JBG5AAfpnygVsPJVfXzVe"> <p>PI114956031</p>

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Posted: 2019-10-30 Expires: 2019-11-30

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Manager Manufacturing - Inspection & Packaging

Amgen
Juncos, Puerto Rico 00777

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