Senior Associate Manufacturing - Technical Training- Upstream Bulk Drug Substance

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Total Rewards Plan

Discretionary annual bonus

Stock-based incentives

Job summary

Amgen North Carolina Biologics Drug Substance Manufacturing plant seeks a Senior Associate Manufacturing- Technical Training to develop and deliver training programs across process areas, ensuring readiness and performance. You will support investigations, CAPAs, and change controls while maintaining alignment with HOP principles.

The role covers all shift operations in a 24/7 facility. Ideal candidates will have a strong background in biologics drug substance manufacturing, training

Qualifications

• Masters degree or higher in a relevant field.

Responsibilities

• Develop and facilitate training programs for MFG operations.
• Lead MFG New Hire Orientation and ensure content is up to date.
• Support investigations and change controls with training inputs.
• Collaborate with cross-functional teams to implement training and HOP deliverables.
• Maintain Training Assignment Profiles and LMS data.

Skills

Manufacturing training

Training development

Project management

Excellent communication

Cross-functional collaboration

Education

Master's degree

Bachelor's degree + 6 months of Manufacturing or Operations experience

Associates degree + 2 years of Manufacturing or Operations experience

High school diploma / GED + 4 years of Manufacturing or Operations experience

Tools

Learning Management System (LMS)

TrackWise or Veeva

Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, 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 teamand interacts broadly across the site to implement key trainingand (HOP) deliverables, quality initiatives. This role will focus on supportingmanufacturing training on and off the floor and supporting investigations when necessary. The flexibility tosupport all four shifts covering 24/7 operations is a requirement.

Responsibilities include:

• Supporting the development and execution of the manufacturing training strategy,ensuringoperational readiness andefficient time tocontribution.
• 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 floorto determine where Performance Supporting Materials (SOP updates, videos, one-slide updates etc.) are needed and then creating Performance Supporting Materials to createabest-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
• OR
• Bachelors degree and 6 months of Manufacturing or Operations experience
• OR
• Associates degree and 2 years of Manufacturing or Operations experience
• OR
• 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

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

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.