Position OverviewThe Associate Manager of Manufacturing Downstream leads daily manufacturing operations during a 12-hour shift (Days - 7am - 7pm). This position is responsible for managing a cross-functional team of technicians executing Recovery and Chromatography processing using Chromatography skids and UFDF skids, ensuring compliance and efficiency in a fast-paced, modular multiproduct environment. This role has direct impact on the delivery of manufacturing focused site key performance indicators (KPIs). Additionally, this role incorporates prior hands-on bioprocessing experience, thrives in a regulated and client-facing environment, and demonstrates operational leadership and mentorship across varying clinical and commercial production phases.
Shift: Rotating 12-hour schedule 7am - 7pm
Job DescriptionWhat You'll Do: - Manages daily and weekly operations, including shift scheduling, task delegation, and execution of production plans per batch records and manufacturing standard of work.
- Leads all shift-level Downstream manufacturing activities, including Chromatography for mammalian and microbial fermentation operations, and associated recovery operations.
- Executes production campaigns supporting pre-clinical, clinical (Phase I-III), PPQ, and commercial batches across multiple client programs.
- Ensures equipment, materials, and supplies are available and successful delivery upon production supply schedule by proactively reviewing the schedule in advance to plan for manufacturing needs.
- Coordinates resources and facilitates effective communication across management and across manufacturing to ensure adequate coverage and operational efficiency.
- Serves as the primary point of contact during shift for cross-functional teams, troubleshoots upstream operations and equipment (including fermentation, cell culture, CIP/SIP, etc.) while ensuring manufacturing suites remain inspection ready.
- Enforces team adherence to Good Manufacturing Practice (GMP), Environmental Health and Safety (EHS), standard operating procedures (SOPs) and compliance through GMP documentation review (including batch, formulation, and logbook records).
- Participates in audits, regulatory inspections, and internal quality investigations, as needed.
- Initiates real-time deviations, escalates quality trends, process deviations or equipment failures, and supports related investigations or root cause analysis (RCA) and corrective and preventive action (CAPA) implementation.
- Collaborates cross-functionally (e.g., Process Science, Operational and Business Excellence (OBX), Manufacturing Technology and Support (MT&S)) for equipment lifecycle, technology transfer, and continuous improvement projects to ensure operational success.
- Administers company policies such as time off, shift work, and inclement weather that directly impact employees.
- Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports).
- Serves as a coach and technical mentor for direct reports to foster professional development, enhance capabilities, and encourage empowerment.
- Recognizes achievements, addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution.
- Supports departmental goals by aligning team efforts to organizational goals and assessing development needs to improve team performance.
Knowledge, Skills, and Abilities: - Knowledge of Chromatography techniques, UFDF systems, and Downstream single use equipment.
- Comprehensive knowledge of CGMP and EHS regulations
- Familiarity with production scheduling, planning, quality assurance practices, and audit processes
- Understanding of equipment lifecycle management and technology transfer principles
- Demonstrated leadership ability to hire, coach, and develop individual contributors and team, providing training and resolving conflicts
- Strong technical aptitude and problem-solving skills with in-shift troubleshooting capabilities for unit operations
- Effective communication, both written and verbal to effectively present information and liaise with cross-functional teams
- Strong organizational skills and ability to manage multiple priorities
- Ability to foster a collaborative team environment, including motivating and empowering others
- Ability to maintain compliance and inspection readiness, execute production campaigns across various phases, and achieve operational efficiency
- Strong focus on continuous improvement, ability to adapt to an evolving environment, and effective risk management
- Ability to handle emergency situations and build consensus among departments to streamline operations and decision-making
- Must be flexible to support 24/7 manufacturing facility
- Chromatography techniques, UFDF systems, and Downstream single use equipment.
- CGMP certification or training
Education & Experience Requirements: - Master's degree in an engineering discipline, Life Sciences, or other technical field with 3+ years of related experience; or
- Bachelor's degree in chemical, biochemical, mechanical engineering, life sciences or other technical field with 5+ years of related experience; or
- Military technical training in science, engineering, or other technical field with 5+ years of supervisory experience in a related technical field; or
- Associate's degree in chemical, biochemical, mechanical engineering, life sciences or other technical field with 7+ years of related experience; or
- High school diploma with 9+ years of related experience
- 2-4 years of people management experience
- Experience operating distributed control system (DCS) software, such as DeltaV, 800xA, or Unicorn
Preferred Training & Experience:- Lean Six Sigma Yellow or Green belt
- Bioworks, Biomanufacturing or relevant certificate
Physical Requirements:
- Work in environment which may necessitate respiratory protection
- May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
- Ability to discern audible cues.
- Ability to ascend or descend ladders, scaffolding, ramps, etc.
- Ability to stand or sit for prolonged periods of time (60 minutes)
- Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
- Ability to operate machinery and/or power tools.
- Ability to conduct work that includes moving objects up to 50lbs.
Environmental Conditions: - Will work in heights greater than 4 feet.
Benefits:Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!
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To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
