Downstream/Purification Process Owner Manager

West Greenwich, RI
Oct 07, 2021
Required Education
High School or equivalent
Position Type
Full time

Job description (Downstream/Purification Process Owner Manager in AR30)

Amgen Rhode Island is one of the premier biologics drug substance manufacturing sites in the world with a long history of operational excellence and highly successful commercial and clinical operations. Amgens new plant, AR30, is responsible for drug substance manufacturing and release of Amgens commercial product using innovative single use manufacturing platforms and technologies.

We are looking for a talented Downstream/Purification Process Owner Manager AR30 to join the manufacturing technical support function in our Next Generation Bio-manufacturing plant AR30.

This position reports into the Senior Manager of the AR30 Manufacturing Support Team and interacts broadly across the site/plant to implement key business deliverables, quality initiatives, and continuous improvement projects

Key Responsibilities include (but not limited to):

  • Develop and oversee a high performing team, build technical and leadership capabilities within the organization to meet current and future business needs
  • Ensure the right people and resources are in place and optimally allocated to achieve results
  • Create an environment that fosters accountability, innovation, continuous improvement, learning and knowledge-sharing
  • Ensure effective decision-making
  • Responsible for overseeing new technology and new product introduction in manufacturing
  • Attracting, developing and retaining diverse talent
  • Conducts short and long-range talent planning to ensure readiness of talent to execute future organizational objectives
  • Works across functions to build organization and individual capabilities
  • Develops strong relationships with staff members, provides open and clear feedback to improve individual and team performance

  • Provide data to support management evaluation of performance trends
  • Provide subject matter expertise and on the floor support for area of responsibility/ownership
  • Own quality records (change control, CAPA, deviations) and deliver to timelines
  • Oversee Downstream process owners quality records
  • Identify and autonomously implement continuous improvement opportunities
  • Creation of solid business cases for improvement ideas
  • Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement Buffer/Media Preparation, Cell Culture and/or Purification and drug substance filling processes and process improvements
  • Support of front-line managers through on the floor presence
  • Own and author critical standard operating procedures and supporting documentation/training.
  • Lead and/or support root cause investigations related to performance trends and formal deviations
  • Support of product reintroductions
  • Develop, implement and assess solutions for complex problems
  • Anticipate risk and builds contingencies to help mitigate impact
  • Participate in regulatory audits

Basic Qualifications

  • Doctorate Degree OR
  • Master's Degree and 3 years of Manufacturing and Operations experience OR
  • Bachelor's Degree and 5 years of Manufacturing and Operations experience OR
  • Associate's degree and 10 years of Manufacturing and Operations experience OR
  • High school diploma/GED and 12 years of Manufacturing and Operations experience AND
  • Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

  • Single use technology experience
  • Extensive experience defending approaches during regulatory audits
  • Purification Experience
  • Knowledge and experience within a cGMP or other highly regulated environment including a basic understanding of technical elements across engineering, biological or chemical processing
  • Strong knowledge of cleaning and sterilization validation
  • In depth experience with New Product Introduction and technology transfer
  • Strong leadership and teambuilding skills (coaching, mentoring, counseling)
  • Experience with Lean Principles and continuous improvement
  • Experience with performance management including conflict resolution and performance reviews
  • Analytical problem-solving skills
  • Project Management skills
  • Thorough understanding of regulatory requirements
  • Ability to be flexible and manage change
  • Excellent verbal and written communication (technical) skills
  • Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
  • Strong project management skills with ability to multi-task and function in a dynamic environment
  • Excellent communication skills, drive, and sense of urgency
  • Demonstrated ability to forge and maintain strong relationships within other functional areas
  • Ability to recommend, judge, and make good decisions in complex situations
  • Ability to tactfully and effectively negotiate and influence

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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds 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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.