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

Career Category

Manufacturing

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve 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 mission, to serve patients, drives all that we do. It is key to our becoming one of the world’s 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

Let’s do this. Let’s 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 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

Thrive

Some of the vast rewards of working here

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.

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 Plan, comprising health, finance and wealth, work/life balance, and career benefits, with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

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

careers.amgen.com

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Please note that you should be in your current position for at least 18 months before applying for internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a “Partially Meets Expectations” or higher.

. Salary Range

106,148.00USD -143,612.00 USD