Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Comprehensive employee benefits

Retirement and Savings Plan

Annual bonus program

Stock-based long-term incentives

Flexible work models

Job summary

Amgen is seeking a Front Line Manufacturing Manager in Holly Springs, North Carolina. This role involves leading a team in manufacturing operations for cell culture processes, ensuring compliance with regulatory standards, and supporting facility startup. Ideal candidates will have a strong background in biotechnology, regulatory knowledge, and proven leadership skills. This position offers a competitive salary and a comprehensive benefits package including health insurance, retirement plans, and flexible work arrangements.

Qualifications

• Experience leading manufacturing teams in a biotech environment.
• Familiarity with facility startup and operational readiness.
• Strong knowledge of cGMP regulations.

Responsibilities

• Lead and coach manufacturing teams for operational success.
• Support facility startup activities and ensure operational readiness.
• Drive compliance with regulatory and quality standards.

Skills

Leadership

Performance management

Conflict resolution

Education

Doctorate degree or equivalent experience

Bachelor's degree in Life Sciences or Engineering

Tools

MES/EBR

DeltaV

Maximo

Veeva

LIMS

Job description

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

Join Amgens Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

What you will do

Amgen is seeking a Manager Manufacturing Upstream to provide frontline leadership supporting the facility expansion program and facility startup. This essential role will lead a team responsible for manufacturing cell culture operations including seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation, while partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility.

The Manager will play a critical role supporting the design, build, startup, and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities, transitioning to manufacturing leadership as the facility becomes operational. During this phase of the startup, you will be expected to work a Monday Friday schedule from 8am to 5pm. This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.

As the business moves from C&Q to manufacturing operations, this essential position will work on a 12-hour 2-2-3 schedule from 5:45am to 6:15pm supporting our critical 24/7 manufacturing operations. As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12‑hour shift, including during inclement weather, some holidays and requested overtime in support of our operations.

Responsibilities

• Frontline Leadership: Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety, quality, and accountability.
• Facility Startup & Operational Readiness: Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility.
• Manufacturing Operations: Ensure safe, cGMP‑compliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues.
• Technology Transfer & Process Implementation: Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshooting, and continuous improvement.
• Cross‑Functional Collaboration: Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp‑up.
• Compliance & Inspection Readiness: Maintain inspection readiness and adherence to regulatory and Amgen quality standards.
• Continuous Improvement: Identify and drive efficiency, reliability, and scalability improvements as operations mature.
• Shift Support: Work nonstandard hours as required, transitioning to a 12‑hour 2‑2‑3 day shift supporting 24/7 operations.

What we expect from you

We seek a manager who brings strong leadership, performance management, and conflict resolution skills, and who can lead people, projects, programs and resource allocation in a manufacturing environment.

Basic Qualifications

• Doctorate degree OR
• Masters degree and 3 years of Manufacturing or Operations experience OR
• Bachelor's degree and 5 years of Manufacturing or Operations experience OR
• Associate's degree and 10 years of Manufacturing or Operations experience OR
• High school diploma / GED and 12 years of Manufacturing 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 with facility startup, commissioning, or operational readiness
• Biologics / drug substance manufacturing experience (Upstream)
• cGMP manufacturing experience (5+ years preferred)
• Experience with technology transfer and process implementation
• Prior Area Lead / Specialist / Manager experience
• Strong leadership, performance management, and conflict resolution skills
• Solid understanding of regulatory requirements
• Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and electronic quality systems

What you can expect of us

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

The annual base salary range for this opportunity in the U.S. is provided below.

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.