drjobs Associate Manager, DSM

Associate Manager, DSM

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1 Vacancy
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Job Location drjobs

Holly Springs, MS - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Position Overview

The Associate Manager of DSM leads a team of manufacturing associates (MAs) for manufacturing bulk drug substance. The Associate Manager is responsible for the departments training and regulatory compliance ensuring schedule adherence and their associated activities to ensure compliant and reliable start up activities and production.

Company Overview

FUJIFILM Diosynth Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!


Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.


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

Project Phase (Through Mid-2025)


Supports Factory Acceptance Testing (FAT) at the vendor site as required
Supports Site acceptance Installation Verification (IV) Operational Verification (OV) and Performance Qualification (PQ) testing including protocol generation as applicable
Performs other operational readiness tasks as required such as: document review/approval team onboarding and materials management
Supervises manufacturing associates on technical and operational topics such as: area unit operations and equipment
Enforces company policies (e.g. travel & expense time reporting and time off that directly impact employees)
Leads peer department management in tactical and strategic development
Coaches direct reports to foster individual and team professional development and growth
Supports and leads water and engineering batch schedule attainment
Collaborates with partners vendors and key stakeholders as needed
Other duties as assigned


Operations Phase (Starting Mid-2025)


Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates
Coordinates the execution of the manufacturing schedule through daily shift assignments lead daily huddles and manages escalations
Fosters an inclusive people-first culture with regular communication conducting 1:1s on a defined cadence with direct reports
Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training
Supports manufacturing investigations and continuous improvement projects
Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment such as but not limited to: maintenance calibration activities and the use of manufacturing equipment
Administers company policies such as but not limited to: time reporting time off shift policies and inclement weather that directly impact manufacturing employees
Coaches and guides direct reports to foster individual and team professional development and growth
Participates in the recruitment process and retention strategies to attract and retain talent
Addresses performance gaps employee concerns and partners with HR as needed for resolution
Leads peer department management in tactical and strategic development
Supports and leads water and engineering batch schedule attainment as required for the tech transfer of new products
Collaborates with partners vendors and key stakeholders as needed while executing the day-to-day manufacturing activities
Other duties as assigned

Basic Requirements

High School Diploma/GED with 8 years of related experience; OR
Bachelors degree in Life Science Engineering or related field with 4 years of related experience; OR
Masters degree in Life Science Engineering or related field with 2 years of related experience
2 years of experience managing a team
Experience with regulatory inspections investigations and change management

Preferred Requirements

Experience leading a team in a pharmaceutical or biological manufacturing operations
Experience working in a changing and project driven organization
Previous experience directly supporting manufacturing

Lean Six Sigma or similar certification

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

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.

EEO Information

ADA Information


Required Experience:

Manager

Employment Type

Unclear

Department / Functional Area

Manufacturing

About Company

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