Amgen

Sr Manager Manufacturing - Systems Lead

Employer
Amgen
Location
Woburn, MA, US
Posted
Sep 15, 2020
Ref
R-100726
Required Education
Bachelors Degree
Position Type
Full time
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 attitude, and an unyielding focus on safety, quality, and compliance.

This role of Senior Manager Manufacturing - Systems Lead for AWM reports directly to the Director of Manufacturing and has ownership and management of AWM Manufacturing Systems including: gowning program, environmental monitoring execution, investigations, and electronic batch record system (MES). In this role, the incumbent has responsibility for leading a manufacturing team including Manufacturing Specialists, Sr. Associates and Associates. The Sr Manager will be a key interface between Manufacturing, Quality, Facilities, Engineering and Supply Chain teams.
Responsibilities include, but are not limited to the following:

General:
  • Ensures safety, quality, and compliance in our cGMP operations
  • Executes sound plans that enable Amgen's operational and strategic imperatives
  • Leads and coordinates resources to ensure product quality standards and supply plans are met
  • Contributes to the business results through quality of decisions, results and advice
  • Ensures production areas are effective at delivering to short and long-term Amgen Woburn site operational goals
  • Develops, maintains, and delivers results to departmental goals
  • Lead culture of continuous improvement through application of Lean principles
  • Sets performance expectations and provides timely feedback
  • Delivers strong results consistent compliance requirements and Amgen values
  • Champions innovation and continuous improvement
  • Executes with a desire and purpose that drives course correction where appropriate
  • 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
  • Foster and maintain relationships with key site partners


Basic Qualifications:
  • Doctorate degree and 2 years of Manufacturing or Operations experience
  • OR
  • Master's degree and 6 years of Manufacturing or Operations experience
  • OR
  • Bachelor's degree and 8 years of Manufacturing or Operations experience
  • OR
  • Associate's degree and 10 years of Manufacturing or Operations experience
  • OR
  • High school diploma / GED and 12 years of Manufacturing or Operations experience
  • AND
  • 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources


Preferred Qualifications:
  • Bachelor's Degree
  • Experience with staff and team development, performance management and managing and coaching
  • Experience in a highly regulated organization, cGMP or other, including advancing compliant operations and in-depth business understanding of manufacturing or operations in biotechnology / biopharmaceuticals / pharmaceuticals industry
  • Aseptic production expertise (e.g. manufacturing production or process validation), or aseptic area (e.g. maintenance or troubleshooting) expertise
  • Experience with technical writing and communication
  • Overall understanding of mechanical, technical and operational systems -able to recommend, judge, and make good decisions in complex situations
  • Strong negotiating, partnering, influencing skills
  • Able to positively advance the culture of an organization
  • Budgeting, goal setting, capacity planning, inventory control, and Lean Manufacturing principles
  • Strong leadership experience and aptitude with demonstrated ability to effectively lead and partner in a complex, matrix environment
  • Proven experience and track record of compliance in a highly regulated GMP environment
  • Diverse operations experience preferably in the manufacture of biologics with aseptic processing, drug substance and/or drug products focus
  • Operational Excellence approach 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.

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.

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.