Upstream Manager, Manufacturing

AGC Biologics, Inc.; Bothell (WA); On-site; USD 108,000 - 149,000; Full time

Benefits offered by this job

annual bonus opportunities

paid time off

medical, dental and vision coverage

parental leave

education assistance

employee referral and recognition

Job summary

AGC Biologics, Inc. is seeking an Upstream Manufacturing Manager in Bothell, WA to lead GMP upstream manufacturing operations. This role ensures compliance and efficiency in clinical and commercial production campaigns while guiding manufacturing teams.

Ideal candidates have extensive experience in upstream biologics manufacturing and leadership skills. The position offers a full-time schedule with competitive compensation and various benefits including bonuses, paid time off, and health

Qualifications

• 8+ years of industry experience for Bachelor's or 6+ years for Master's.
• Experience leading upstream biologics manufacturing in a GMP environment.
• Prior experience managing teams in regulated manufacturing.

Responsibilities

• Lead upstream manufacturing operations across mammalian and microbial processes.
• Monitor and improve compliance with quality systems and safety procedures.
• Train, coach, and mentor manufacturing associates and supervisors.
• Review and approve manufacturing documentation.
• Drive continuous improvement initiatives for safety and quality.

Skills

Upstream biologics manufacturing

Mammalian cell culture

Microbial fermentation

Leadership skills

Communication skills

Problem-solving

Education

Bachelor's degree

Master's degree

Tools

Single-use bioreactor systems

Stainless steel bioreactor systems

Job description

Job Summary

We are looking for an Upstream Manufacturing Manager to lead GMP upstream manufacturing operations across mammalian and microbial production platforms. This role is responsible for overseeing daily manufacturing activities, ensuring compliance with established processes and standards, and delivering safe, reliable, and efficient execution of clinical and commercial production campaigns. The Upstream Manufacturing Manager provides leadership and direction to manufacturing teams, ensuring operational readiness, schedule adherence, and continuous improvement while supporting technology transfer, process implementation, and commercial manufacturing activities.

About the Manufacturing Team

You’ll join a Manufacturing organization responsible for the production of biologics across multiple modalities and stages of development. The team partners closely with Quality, MSAT, Engineering, Supply Chain, and other operational functions to ensure safe, compliant, and efficient manufacturing operations that support both clinical and commercial programs.

Key Responsibilities

• Lead upstream manufacturing operations across mammalian and microbial processes.
• Monitor and improve compliance with quality systems, safety procedures, and company policies.
• Determine production priorities, staffing requirements, and shift schedules to support manufacturing objectives.
• Ensure effective communication and operational alignment across shifts through the Daily Management System (DMS).
• Monitor manufacturing operations to ensure compliance with SOPs, batch records, and GMP requirements.
• Identify, address, and prevent operational issues that may impact safety, quality, reliability, identity, or purity (SQRIP).
• Train, coach, and mentor manufacturing associates and supervisors.
• Review and approve manufacturing documentation.
• Manage team performance, goal setting, development planning, and performance reviews.
• Coordinate resources and activities across manufacturing areas to meet production goals and timelines.
• Ensure equipment, personnel, materials, and manufacturing suites are prepared for scheduled operations.
• Support technology transfer, process implementation, PPQ, clinical manufacturing, and commercial manufacturing activities.
• Monitor production performance, equipment availability, schedule adherence, and operational risks.
• Drive continuous improvement initiatives focused on safety, quality, productivity, reliability, and cost.
• Establish and maintain manufacturing KPIs and performance metrics.

Skills

• Demonstrated knowledge of upstream biologics manufacturing, including mammalian cell culture and/or microbial fermentation.
• Experience supporting stainless steel and/or single-use bioreactor systems, harvest operations, aseptic processing, and CIP/SIP systems.
• Ability to lead manufacturing operations across multiple production areas, shifts, and modalities.
• Strong leadership, coaching, and employee development skills.
• Effective communication, problem-solving, and decision-making abilities.
• Ability to build cross-functional partnerships and drive operational results.

Qualifications & Experience Required

• Bachelor's degree with 8+ years of industry experience, or Master's degree with 6+ years of industry experience. Equivalent education and experience may be considered.
• Experience leading upstream biologics manufacturing operations in a GMP environment.
• Experience with mammalian cell culture and/or microbial fermentation manufacturing processes.
• Prior experience managing teams in a regulated manufacturing environment.

Location

Bothell, WA

Schedule

Full-time

Compensation

$108,080 - $148,610

Benefits

• annual bonus opportunities
• paid time off
• medical, dental and vision coverage
• parental leave
• education assistance
• employee referral and recognition programs
• additional wellbeing benefits

Who We Are

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in the United States. From our headquarters in Bothell, Washington, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial‑based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. We are a collaborative, inclusive, and equal‑opportunity organization where team members are valued for their expertise, teamwork, and ingenuity. AGC Biologics is Your Friendly CDMO Expert – dedicated partners with the expertise and commitment to support our customers and teams. We work with some of the world’s most innovative pharmaceutical companies to develop and manufacture their life-changing drug products.