Associate Manager, Manufacturing Upstream

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Associate Manager of Manufacturing leads daily manufacturing operations during a 12-hour shift. This position is responsible for managing a cross-functional team of technicians executing cell culture and microbial fermentation processes using both single-use technologies and stainless steel 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.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll 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 upstream manufacturing activities including single-use cell culture processing for mammalian systems 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 etc.)
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
Performs other duties as assigned

Knowledge and Skills

Knowledge of bioprocessing techniques including cell culture and microbial fermentation using single-use and stainless-steel technologies
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
Proficient using Microsoft Office Suite (Word Excel PowerPoint) for data gathering entry and reporting
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

Basic Requirement

Masters degree in an engineering discipline Life Sciences or other technical field with 3 years of related experience; or
Bachelors 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
Associates 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
Equipment-specific training on technologies related to a single-use and stainless-steel systems and processes
CGMP certification or training

Preferred Requirements

Lean Six Sigma Yellow or Green belt
Bioworks Biomanufacturing or relevant certificate

Working Conditions & Physical Requirements

Will 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 for prolonged periods of time up to 60 minutes.
Ability to sit for prolonged periods of time up to 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 50 pounds.

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 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.

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EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Manager

Position OverviewThe Associate Manager of Manufacturing leads daily manufacturing operations during a 12-hour shift. This position is responsible for managing a cross-functional team of technicians executing cell culture and microbial fermentation processes using both single-use technologies and sta...