Amgen

Director Manufacturing - Inspection and Packaging

Employer
Amgen
Location
Juncos, PR, US
Posted
Mar 27, 2021
Ref
R-115245
Required Education
Other
Position Type
Full time
HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
Director Manufacturing - Inspection and Packaging

Live

What you will do

Let's do this. Let's change the world. In this dynamic role you will be responsible for leading all production operations at a single manufacturing facility. Manages and coordinates plant resources and personnel to ensure product quality standards and production schedules are met within budgeted costs. May also be responsible for the production of commercial, clinical or finished product. This role is key for Amgen's success and it will be a key contributor in the Inspection, Assembly & Packaging area.
  • Leads the Inspection, Assembly and Packaging manufacturing facility.
  • Responsible for management and oversight of more than one manufacturing production areas.
  • Ensures that clinical and licensed products manufactured at production facility are produced according to current Good Manufacturing Practices (cGMP) and other applicable regulations from international countries.
  • Ensures that manufacturing facilities, equipment, processes, and procedures are follows cGMP requirements and/or other applicable regulations.
  • Ensures that written procedures describing the manufacturing operations are accurate, approved, and implemented.
  • Responsible for ensuring that risks are identified, assessed and corrected to ensure the safety, purity, quality, identity and effectiveness of the product(s) manufactured.
  • Ensures that there is an adequate number of personnel who possess an adequate combination of education, experience and training in accordance with cGMP requirements.
  • Ensures that area staff are trained to perform assigned production activities.
  • Builds empowered teams.
  • Leads others in identifying business process improvements.
  • Ensures that deviations are reported promptly to the Quality unit and investigated per procedures.
  • Ensures that corrective actions and preventive actions (CAPA) are managed and closed according to procedures.
  • Ensures that the requirements of the Quality Management System are fulfilled.
  • Alerts senior management of important quality, compliance, supply and safety risks.
  • Provides input for Management Reviews.
  • Leads the preparation of the Business Reviews.
  • Promotes a culture that strives and looks for improvement opportunities as a change agent at the network level.
  • Responsible for achieving plant's Overall Equipment Effectiveness and Change Over Targets.
  • Supports the implementation of Lean Manufacturing and Operational Excellence initiatives in the production floor programs and projects
  • Responsible to maintain adequate manufacturing resources, human and physical asset capacity, to support customer demand.
  • Develops insightful strategies for staff development that are shared and adopted at site or network level.
  • Responsible for planning and maintaining budget for assigned areas.
  • Collaborates with cross-functional teams in completing production activities.
  • Support non-standard shift organization including extended hours, as per business needs.
  • Identify and advocates new technologies that could have important impact across the network.
  • Leads others in identifying risks and the vital actions for mitigation.
  • Lead and mentor of others around the risk management principles, the use of the DAI model during decision making processes.
  • Takes a leadership role with senior management to set strategic priorities that have a business impact across the network.
Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The Director Manufacturing professional we seek is a [type of person] with these qualifications.

Doctorate degree and 4 years of experience in GMP regulated environment
Or

Master's degree and 8 years of experience in GMP regulated environment
Or

Bachelor's degree and 10 years of experience in GMP regulated environment
And

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

Beyond that, additional preferred qualifications are
  • Educational Background in Life Science or Engineering ­­­­­­­­­­­
  • In-depth knowledge of parenteral drug product inspection and packaging operations.
  • In-depth knowledge of solid dosage operations.
  • Decision making and influencing skills.
  • Ability to manage a large number of sophisticated projects simultaneously.
  • Previous interactions with regulators both verbally and in writing.
  • Demonstrated proficiency in leading Lean Transformations across several functional areas.
  • Knowledge of US and International regulations and practices pertaining to the manufacture and testing of pharmaceutical/biological products.
  • Understanding of biopharmaceutical drug product manufacturing and distribution processes.
  • Understanding of production planning and supply chain operations in the biopharmaceutical finished product industry.
  • Ability to perform at Site Head level-through knowledge of GMP practices and international equivalents.
  • Ability to demonstrate leadership and teambuilding.
  • Conflict resolution oriented.
  • Analytical problem solving, negotiation, project management, coaching, mentoring and counseling skills.
  • Excellent presentation skills
  • Skills in principle and applications of validation processes.
  • Excellent oral and written communication skills (English and Spanish).
  • Computer Knowledge (MS Word, Excel, PowerPoint, Maximo).
  • Demonstrated/potential skills and competencies in the following:
  • Negotiating skills
  • Overall understanding of mechanical systems
  • Budgeting
  • Goal setting
  • Capacity Planning/Inventory
  • Understanding of Manufacturing/Pharma Business

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits


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.