Associate Manager, DSM (Downstream) - Holly Springs
Holly Springs
Overview:
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business.This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services.The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US:
About This Role
The Associate Manager of DSM leads a team of manufacturing associates (MA’s) 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.
What You’ll 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
- 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
Who You Are
You have the ability to collaborate with cross-functional areas and global teams. You demonstrate strong organizational skills and project management capabilities. You actively champion continuous imprvement practices and ideas. You have the ability to coach, lead and develop individual contributor and department peers.You have the ability to effectively present information to others. You have an advanced understanding of good manufacturing practices, inspection requirements, safety and manufacturing operations. You have a thorough understanding of CAPx and OPEx budgets.
Basic Requirements- High School Diploma/GED with 8 years of related experience; OR
- Bachelor’s degree in Life Science, Engineering, or related field with 4 years of related experience; OR
- Master’s 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
- 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
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS- Will work in an environment which may necessitate respiratory protection
- May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearting conservation program
- Ability to discern audible cues
WORKING ENVIRONMENT
PHYSICAL DEMANDS- Ability to ascend or descend ladders, scaffolding, ramps, etc.
- Ability to stand for prolonged periods of time
- Ability to sit for prolonged periods of time
- Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers.
- Ability to conduct work that includes moving objects up to 33 lbs
- Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height and use twisting motions
- Will work in heights greater than 4 feet
- Will work in warm/cold environments
If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.
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.
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