Senior Associate Manufacturing - Technical Training - Upstream Bulk Drug Substance

Amgen Inc. (IR); Holly Springs (NC); Hybrid; USD 86,000 - 116,000; Full time

Benefits offered by this job

Health, dental & vision insurance

Retirement & Savings Plan

Stock-based long-term incentives

Discretionary annual bonus

Flexible spending accounts

Job summary

Amgen Inc. in North Carolina is seeking a Senior Associate Manufacturing - Technical Training to develop and deliver training for Upstream Bulk Drug Substance with a focus on HOP, quality initiatives, and 24/7 operations readiness.

You will drive training strategy for cell culture, purification, and MFG services, lead new hire orientation, and act as LMS SME, collaborating across functions to improve reliability and effectiveness.

Qualifications

• Master's degree or Bachelor's with manufacturing or operations experience.
• Associate's degree with manufacturing or operations experience.
• High school diploma/GED with manufacturing or operations experience.

Responsibilities

• Support development and execution of the manufacturing training strategy.
• Provide training expertise for MFG areas (cell culture, purification, MFG Services).
• Lead and organize MFG New Hire Orientation.
• Perform Job Task Analysis and create Performance Supporting Materials.
• Support investigations and change controls during manufacturing.
• Use Learning Team strategies to maximize learning and investigations.
• Support annual requalification programs and maintain Training Assignment Profiles.
• Serve as LMS SME and primary contact for training questions.
• Present complex topics to varied audiences and build cross-functional relationships.
• Navigate ambiguity with structured problem-solving.

Skills

Training development

Training facilitation

SOP writing

Technical writing

Learning Management Systems

Project management

Communication skills

Interpersonal skills

Team collaboration

Education

Master's degree

Bachelor's degree + 6 months experience

Associate's degree + 2 years experience

High school diploma / GED + 4 years experience

Degree in Science or Engineering

Tools

TrackWise

Veeva

Laminar flow hood operation

Job description

Senior Associate Manufacturing - Technical Training - Upstream Bulk Drug Substance Live

Let's do this. Let's 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

• 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.

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

• Master's degree OR Bachelor's degree and 6 months of Manufacturing or Operations experience OR Associate's 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

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.

• 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.

Salary Range 86,048.05USD -116,417.95 USD

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. #AmgenNorthCarolina

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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen