Senior Associate Manufacturing - Technical Training- Upstream Bulk Drug Substance

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Bonus program

Stock incentives

Paid time off

Flexible work model

Job summary

Amgen North Carolina is seeking a Senior Associate Manufacturing-Technical Training to develop and deliver training and HOP initiatives at the ANC Biologics Drug Substance Manufacturing plant. You will support reliability, efficiency, and agility while collaborating across site teams to advance training programs.

The role emphasizes manufacturing training on the floor, investigations support, and ensuring readiness for 24/7 operations, with Senior Manager reporting lines and a focus on

Qualifications

• Master's degree required; Bachelor's with 6 months Manufacturing/Operations experience also acceptable; Associate with 2 years experience acceptable; High school diploma with 4 years experience accepted.
• Experience in training development and facilitation in biotech/pharma environment.
• SOP writing and technical writing skills.
• Experience with Quality Management Systems (e.g., TrackWise or Veeva) for deviations and CAPAs.
• Demonstrated project management ability.
• Excellent written and verbal communication and ability to work in a matrix environment.

Responsibilities

• Develop and facilitate training programs and the HOP philosophy at the NC biologics drug substance plant.
• Deliver training on manufacturing areas: cell culture, purification, and MFG services.
• Lead New Hire Orientation and ensure content is current and relevant.
• Create performance supporting materials (SOP updates, videos, updates) for a best-in-class training program.
• Support investigations and change controls; assist with 24/7 shift coverage.
• Promote collaboration and learning opportunities across functions.

Skills

Training development

Facilitation

SOP writing

Quality systems

Project management

Communication

Teamwork in matrix

Education

Master's degree

Bachelor's degree with 6 months experience

Associates degree with 2 years experience

High school diploma with 4 years experience

Tools

Learning Management Systems

Aseptic techniques

Job description

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, its because you are. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve together researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

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 single use 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.

Senior Associate Manufacturing- Technical Training- Upstream Bulk Drug Substance

Live

What you will do

Lets do this. Lets change the world. In this vital role, you will be a key member of the team that develops and facilitates training and the Human and Organizational Performance (HOP) philosophy in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. We are looking for a talented Manufacturing team member to help deliver opportunities for reliability, efficiency, agility and differentiation for the ANC Manufacturing plant.

This individual contributor position reports into the Senior Manager of the MFG Technical Training team and interacts broadly across the site to implement key training and (HOP) deliverables, quality initiatives. This role will focus on supporting manufacturing training on and off the floor and supporting investigations when necessary. The flexibility to support all four shifts covering 24/7 operations is a requirement.

Responsibilities Include

• Supporting the development and execution of the manufacturing training strategy, ensuring operational readiness and efficient time to contribution.
• Providing training expertise for MFG area of responsibility (i.e. cell culture, purification, MFG Services).
• Leading and organizing MFG New Hire Orientation, ensuring content is up to date and relevant.
• Performing Job Task Analysis on the floor to determine where Performance Supporting Materials (SOP updates, videos, one-slide updates etc.) are needed and then creating Performance Supporting Materials to create a best-in-class training program.
• Supporting Manufacturing teams during complex investigations and change controls.
• Use operational Learning Team strategies to promote open collaboration with staff to maximize learning opportunities and investigation findings.
• Support annual requalification programs for manufacturing to ensure training compliance.
• Maintain accurate Training Assignment Profiles and Assignment Vehicles for Manufacturing areas.
• Serve as Learning Management System SME and first stop for questions from MFG staff and management about the training program.
• Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
• Build effective relationships across functions.
• Navigate through ambiguity and provide a structured problem-solving approach.
• Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications

• Masters degree
• Bachelors degree and 6 months of Manufacturing or Operations experience
• Associates degree and 2 years of Manufacturing or Operations experience
• High school diploma / GED and 4 years of Manufacturing or Operations experience

Preferred Qualifications

• 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Experience in training development and facilitation
• Training content creation expertise in systems
• SOP writing & technical writing skills
• Experience working in Learning Management Systems
• Degree in Science or Engineering
• Experience with Aseptic techniques and laminar flow hood operation.
• Experience using Quality Management Systems (i.e. Track Wise or Veeva) for Deviation investigations and CAPAs
• Demonstrated project management ability
• Experience presenting to inspectors during regulatory inspections and internal audits.
• Excellent written and verbal communication skills
• Ability to work in a team matrix environment and build relationships with partners
• Strong interpersonal skills

Thrive

What you can expect of us

The annual salary range for this opportunity in the U.S. is [HR to input market pay range].

In Addition To The Base Salary, Amgen Offers a Total Rewards Plan Comprising Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities Including

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

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

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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