Job Description

Career Category Manufacturing


Role Description
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science\xe2\x80\x99s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines in both large and small molecules, Amgen remains committed to advancing science to dramatically improve people\xe2\x80\x99s lives.

This role will include a significant amount of small molecule exposure and is a full-time position responsible for manufacturing synthetic API. This position is the on-shift front line manager in manufacturing for day/or night shift (12 hour rotation). The successful candidate will be leading a team of manufacturing associates responsible for the manufacture of GMP drug substance. The manager will champion a safe and compliant production environment through structured on floor presence. The manager will be an active participant and role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.

With minimal direction the manager is responsible for leading on the floor operations and staff in manufacturing. The successful candidate must demonstrate strong leadership skills and technical understanding of production operations. This individual will be responsible for supervising, coaching, hiring, and development of floor staff.

The front line manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering on short and long term Amgen Operational goals.

Responsibilities
Compliance:

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  Ensure safe working environment
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  Ensure cGMP and CFR compliance of operating areas
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  Ensure Amgen policies are followed
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  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
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  Interact with regulatory agencies
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  Assure safety risk assessment, permits and PPE requirements are followed

Process/Equipment/Facilities:

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  Demonstrate technical mastery of process equipment and operational interactions.
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  Collaborate with cross-functional teams (i.e. QA/QC, F&E, Mfg, PD, Regulatory, Validation etc.) in completing production activities
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  Develop, implement and assess solutions for complex problems
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  Responsible for resolving problems during operation
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  Oversees set up of critical manufacturing processes

Staff Supervision:

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  Responsible for staff and team performance
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  Responsible for selection, training, evaluation, staff relations and development of staff
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  Ensure staff members live by the Amgen Values
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  Ensure training programs are maintained
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  Ensure adherence to production schedule and maintenance activities
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  Interacts with management in optimizing organizational structure and responsibilities
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  Ensure plant and operational safety through risk assessments, auditing and ensure safety CAPAs are implemented.

Administrative:

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  Interacts with management in planning, developing and maintaining budget
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  Assist in developing and maintaining department goals
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  Other functional responsibilities may be assigned

Basic Qualifications

• • Doctorate degree in Chemical Engineering or related technical field OR
• • Master\xe2\x80\x99s degree in Chemical Engineering or related technical field and 2 years of directly related experience OR
• • Bachelor\xe2\x80\x99s degree in Chemical Engineering or related technical field and 4 years of directly related experience OR
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  Diploma in Chemical Engineering or related technical field and 8 years of directly related experience AND
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  4+ years experience in GMP technical support/engineering or manufacturing support environment with at least 3 years experience in the Pharmaceutical or Biotechnology industries.

Preferred Qualifications

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  Bachelor\xe2\x80\x99s degree in Life Sciences or Engineering
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  Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
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  Knowledge and experience within a cGMP or other highly regulated environment including a basic understanding of technical elements across engineering, biological or chemical processing
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  5 years process experience in a cGMP manufacturing facility
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  3+ years of experience in a production Area Lead, Specialist or Manager role
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  Strong leadership and teambuilding skills (coaching, mentoring, counseling)
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  Experience with performance management including performance reviews
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  Conflict Resolution skills
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  Analytical problem solving skills
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  Project Management skills
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  Thorough understanding of regulatory requirements
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  Ability to be flexible and manage change
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  Excellent verbal and written communication (technical) skills
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  Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems

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