Front Line Manufacturing Manager (Bulk Drug Substance - Upstream) - Night Shift

BioSpace; Holly Springs (NC); Sur place; USD 120 000 - 150 000; Plein temps

Avantages offerts par ce poste

Career development

Inclusive culture

Total rewards

Résumé du poste

Amgen is seeking a Manager Manufacturing (Upstream) - Night Shift to lead a team on the FleX Batch facility in North Carolina. You will oversee GMP drug substance production, drive safety and compliance, and champion Lean continuous improvement on the production floor.

You will supervise, coach, hire and develop staff, define objectives, and coordinate with cross-functional teams to meet short- and long-term operational goals in a high-regulation, fast-paced environment.

Qualifications

• Doctorate degree OR
• Masters degree with 3 years of Manufacturing and/or operations experience OR
• Bachelors degree with 5 years of Manufacturing and/or operations experience OR
• Associate degree with 10 years of Manufacturing and/or operations experience OR
• High school diploma / GED with 12 years of Manufacturing and/or operations experience AND prior managerial experience

Responsabilités

• Be the on-shift front line manager in manufacturing.
• Lead a team of experienced manufacturing associates responsible for GMP drug substance production.
• Champion a safe and compliant production environment and Lean culture on the floor.
• Supervise, coach, hire and develop floor staff.
• Define area objectives and drive improvement opportunities on the manufacturing floor.
• Collaborate with QA/QC, F&E, PPIC, Mfg, PD, Regulatory and others on production activities.

Connaissances

Leadership

Team management

Lean manufacturing

cGMP compliance

Regulatory knowledge

People development

Problem solving

Project management

Communication

Budget planning

Formation

Doctorate degree

Masters degree

Bachelors degree

Associate degree

High school diploma

Outils

Microsoft Office

EBR/MES

DeltaV

Electronic quality systems

Description du poste

HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Manager Manufacturing(Upstream)- Night Shift

What you will do

Lets do this. Lets change the world. 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.

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 problemsli>
• 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

Basic Qualifications

Other functional responsibilities may be assigned

• Doctorate degree OR
• Masters degree and 3 years of Manufacturing and/or operations experience OR
• Bachelors 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

• Bachelors 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

Thrive

Thrive

Some of the vast rewards of working here

• Full support and career-development resources to expand your skills, improve your expertise, and improve your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

As we work to develop treatments that look after others, we also work to care for our teammates professional and personal growth and well-being.

Objects in your future are closer than they appear. Join us.