Front Line Manufacturing Manager (Bulk Drug Substance - Upstream) - Night Shift
Amgen
Summary
In this dynamic role you will be the on-shift front line manager in manufacturing. The schedule is night shift (2-2-3, 12-hour rotation), 5:45PM to 6:15AM. The successful candidate will be leading a team of experienced manufacturing associates responsible for the manufacture of GMP (Good Manufacturing Practices) 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 biotechnology 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.
Job description
Responsibilities
Compliance
- Ensure safe working environment for all
- Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas
- Evaluate and implement process improvements and optimizations, partnering with Quality, compliance, and EHSS (Environmental, Health, Safety and Sustainability) on change controls
- Interact with regulatory agencies as needed
- Assure proper gowning and aseptic techniques are followed
Staff Supervision
- Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement
- Responsible for selection, training, evaluation, staff relations and staff development
- Mentor and coach staff members to live by the Amgen Values
- Develop and implement trainings plans and programs, to ensure staff are prepared and compliant
- Ensure adherence to production schedule and maintenance activities
- Interacts with management in optimizing organizational structure and responsibilities
- Ensure plant safety through auditing, evaluations, and cross functional walks
Process/Equipment/Facilities
- Demonstrate technical mastery of manufacturing processes
- Collaborate with cross-functional teams (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg, PD (Process Development), Regulatory, etc.) in completing production activities
- Develop, implement, and assess CAPAs (Corrective Action Preventive Action) and solutions to complex problems
- Responsible for elevating and resolving problems during daily operations
- Oversees set up, execution, and completion of critical manufacturing processes/tasks
Administrative
- Interacts with management in planning, developing, and maintaining budget
- Assist in developing and maintaining department goals
- Other functional responsibilities may be assigned
Basic Qualifications
- Doctorate degree OR Master’s degree and 3 years of Manufacturing and/or operations experience OR Bachelor’s degree and 5 years of Manufacturing and/or operations experience OR Associate degree and 10 years of Manufacturing and/or operations experience OR High school diploma / GED and 12 years of Manufacturing and/or operations experience
- AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
- Bachelor’s degree in Life Sciences or Engineering
- Experience in biotechnology or pharmaceutical plant start up
- Basic understanding of upstream and/or downstream operations
- Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
- Knowledge and experience within a cGMP or other highly regulated environment
- 5 years process experience in a cGMP manufacturing facility
- 3+ years of experience in a production Area Lead, Specialist or Manager role
- Strong leadership and teambuilding skills (coaching, mentoring, counseling)
- Experience with performance management including performance reviews
- Conflict Resolution, analytical problem solving, and project management skills
- Thorough understanding of regulatory requirements
- Excellent verbal and written communication (technical) skills
- Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems
Requirements
- Doctorate degree OR Master’s degree and 3 years of Manufacturing and/or operations experience OR Bachelor’s degree and 5 years of Manufacturing and/or operations experience OR Associate degree and 10 years of Manufacturing and/or operations experience OR High school diploma / GED and 12 years of Manufacturing and/or operations experience
- Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
- Bachelor’s degree in Life Sciences or Engineering
- Experience in biotechnology or pharmaceutical plant start up
- Basic understanding of upstream and/or downstream operations
- Knowledge and experience within a cGMP or other highly regulated environment
- 5 years process experience in a cGMP manufacturing facility
- 3+ years of experience in a production Area Lead, Specialist or Manager role
- Strong leadership and teambuilding skills (coaching, mentoring, counseling)
- Experience with performance management including performance reviews
- Conflict Resolution, analytical problem solving, and project management skills
- Thorough understanding of regulatory requirements
- Excellent verbal and written communication (technical) skills
- Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems
Benefits
- Health insurance
- Financial and wealth planning
- Work/life balance programs
- Career development resources
- Inclusive community
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.