22 days old

Director of Manufacturing

Amgen
Woburn, MA 01801
  • Job Code
    120804720
Amgen

Job ID: R-100409
Location: Woburn, MA, US 01806

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.

As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and an unyielding focus on safety, quality, and compliance.

This role of Director of Manufacturing for AWM reports directly to the AWM Site Head. In this role, the incumbent has responsibility for leading the AWM manufacturing function in Woburn, MA and is a member of the site leadership team.

Responsibilities include, but are not limited to the following:

General:
  • Ensures safety, quality, and compliance in our cGMP operations
  • Establishes and executed sound plans that enable Amgen's operational and strategic imperatives
  • Leads and coordinates resources to ensure product quality standards and supply plans are met within planned budget
  • Contributes to the business results through quality of decisions, results and advice
  • Sets exciting performance expectations and provides timely feedback
  • Develops and implements metrics to track and lead successful, timely accomplishment of assigned goals, objectives and projects
  • Delivers strong results consistent with compliance requirements and Amgen values
  • Responsible for conducting all production related investigations, ensuring consistency and compliance with external regulatory requirements
  • Prepares and maintains department budget and workforce model
  • Champions innovation and continuous improvement
  • Lead the Manufacturing Operational Excellence program and its execution
  • Executes with a desire and purpose that drives course correction where appropriate
  • Anticipates and adapts to environmental factors and analyzes and forecasts business trends
  • Builds compelling strategies that help deliver the company's aspiration
  • Plans and executes the implementation of major change efforts
  • Recruits, retains and develops high-performing and diverse teams
  • Builds empowered teams that put patients and Amgen first
  • Serves as a role model and coaches and develops team towards their fullest potential.
  • May represent department to regulatory authorities
  • Provide organizational leadership of the manufacturing operations team. Lead all aspects of team talent management, including performance, career development, and succession planning
  • Develop short/long term strategies, goals, objectives, and associated budgets required to ensure appropriate manufacturing operations and site deliverables
  • Foster and maintain relationships with key site and network partners


Basic Qualifications:

  • Doctorate degree and 4 years of experience in a Manufacturing/Operations field
  • OR
  • Master's degree and 8 years of experience in a Manufacturing/Operations field
  • OR
  • Bachelor's degree and 10 years of experience in a Manufacturing/Operations field
  • AND
  • 4 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources


Preferred Qualifications:

  • Experience in a technical manufacturing operations leadership field, preferably in the Pharmaceutical and/or Biotech industry
  • Diverse, hands-on operations experience in the manufacture of biologics with aseptic processing, drug substance and drug products focus
  • Proven managerial experience and track record of compliance in a highly regulated GMP environment
  • Strong leadership experience and aptitude with demonstrated ability to effectively lead and partner in a complex, matrix environment
  • Cross-functional work experience in either Process Development, Quality or Engineering
  • Excellent communication skills, drive, purpose, energy level and problem-solving
  • Demonstrated ability to develop and maintain positive relationships with other functional areas
  • Ability to effectively develop and coach staff and positively advance the culture of an organization
  • Operational Excellence mentality with diverse, and profound Continuous Improvement methodology experience (e.g., Lean, Six Sigma, Total Quality Management (TQM), etc.)


Competencies:

  • Established Leadership capabilities
  • Passion for Operational Excellence
  • Financial acumen
  • Communications skills, both oral and written, including executive presentation skills
  • Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met
  • Ability to tactfully negotiate and positively influence peers and executive leadership
  • Analytical skills to identify potential improvement opportunities
  • Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.)


We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

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.



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Posted: 2020-06-12 Expires: 2020-07-13

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Director of Manufacturing

Amgen
Woburn, MA 01801

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