Senior Associate Manufacturing - New Product Introduction Systems(Multiple Positions)

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision

Life and disability insurance

Stock-based incentives

Flexible time off

Remote work options

Job summary

Amgen North Carolina Biologics Drug Substance Manufacturing plant seeks an experienced Senior Associate Manufacturing for New Product Introduction systems. You will coordinate cross-functional activities to enable compliant and timely implementation, focusing on QRAs, FMEAs, and change controls.

This role requires strong documentation, quality-system skills, and the ability to navigate ambiguity while building relationships across Manufacturing, Quality, Process Development, and Supply Chain.

Qualifications

• Experience in GMP manufacturing or manufacturing support.
• Strong cross-functional coordination and meeting facilitation.
• Technical writing and thorough documentation skills.
• Familiarity with Quality Management Systems and change controls.
• Ability to manage multiple priorities and strict timelines.
• Experience with QRAs and FMEAs is a plus.

Responsibilities

• Coordinate New Product Introduction (NPI) programs with cross-functional teams.
• Lead QRAs, FMEAs, risk action logs, and associated records.
• Create and maintain process Bills of Materials (BOMs).
• Coordinate BOM inputs across Supply Chain, MES, SUS, Manufacturing.
• Own NPI Change Control records and planning.
• Track pre-/during-/post-implementation tasks and deliverables.
• Maintain trackers and provide status updates to NPI management.
• Build cross-functional relationships and solve problems to enable timely execution.

Skills

GMP manufacturing

Cross-functional coordination

Meeting facilitation

Technical writing

Quality-system knowledge

Effective communication

Education

Master's degree

Bachelor's degree in Manufacturing or related field

Associates degree in a related field

High school diploma or GED

Tools

Veeva QMS

TrackWise

Job description

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.

Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions)

Live

What you will do

Lets do this. Lets change the world. In this vital role, you will be a key member of the Manufacturing Support team at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This individual contributor will provide focused execution support for New Product Introduction (NPI) programs by coordinating cross-functional activities that enable compliant and timely implementation. The role will primarily work on Quality Risk Assessments, maintain associated Continuous Improvement records, create and maintain process Bills of Materials, and own assigned Change Control records under the guidance of NPI management. The position interacts broadly with Manufacturing, Quality, Process Development, Supply Chain, Manufacturing Execution Systems (MES), and Single-Use Systems (SUS) to align requirements, track execution, and maintain complete and inspection-ready documentation.

Responsibilities:

• Facilitate cross-functional Quality Risk Assessments (QRAs), including planning sessions, coordinating participants and source information, guiding structured risk discussions, documenting decisions, and supporting review and approval.

• Prepare and maintain QRA reports, Failure Modes and Effects Analyses (FMEAs), risk action logs, and supporting records in accordance with applicable procedures and quality requirements.

• Create and maintain process Bills of Materials (BOMs) based on approved process and manufacturing requirements.

• Coordinate BOM inputs, reviews, and reconciliation across Supply Chain, MES, SUS, Manufacturing, and other stakeholders to support accurate material readiness and alignment across systems and documents.

• Own assigned NPI Change Control records under management guidance; prepare and maintain record content, coordinate required impact assessments and implementation planning, and manage records through applicable lifecycle phases.

• Track pre-implementation, implementation, and post-implementation tasks, dependencies, due dates, and deliverables; follow up with task owners and elevate risks or delays.Verify that task completion documentation includes the required objective evidence, traceability, and supporting information before routing for approval or closure.

• Maintain trackers and provide clear, routine status readinessupdates to NPI management and cross-functional partners.

• Build effective relationships across functions, communicate moderately complex issues clearly, navigate ambiguity, and apply structured problem-solving to support timely execution.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The detail-oriented manufacturing professional we seek has experience in GMP manufacturing or manufacturing support, with strong cross-functional coordination, meeting facilitation, technical writing, and quality-system skills as well as the below qualifications.

Basic Qualifications:

• Masters degree OR

• Bachelors degree and 4 years of Manufacturing or Operations experience OR

• Associates degree and 8 years of Manufacturing or Operations experience OR

• High school diploma / GED and 10 years of Manufacturing or Operations experience

Preferred Qualifications:

• Degree in Science, Engineering, Supply Chain, Operations, or a related field.

• Experience in GMP biotechnology or pharmaceutical manufacturing, manufacturing support, Process Development, Quality, or Supply Chain.

• Experience facilitating cross-functional Quality Risk Assessments, FMEAs, or similar structured risk-management activities.

• Experience using Quality Management Systems such as Veeva QMS or TrackWise for Change Controls, Continuous Improvement records, deviations, CAPAs, or risk-related records.

• Experience creating or maintaining process or manufacturing Bills of Materials and coordinating material readiness across multiple functions.

• Working knowledge of drug substance manufacturing and the relationship between process requirements, materials, manufacturing documents, and electronic batch records or MES.

• Strong cross-functional project coordination, meeting facilitation, technical writing, and compliant documentation skills.

• Ability to manage multiple priorities, maintain trackers, follow up on actions, and deliver work to established timelines.

• Excellent written and verbal communication skills with the ability to build effective relationships in a matrix environment.

• Ability to work independently within a defined scope, recognize when guidance is needed, and elevate risks promptly.

Thrive

What you can expect of us

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

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.