James Cundiff
Winchester
Summary
Dynamic Fermentation Team Lead at Danimer Scientific with a proven track record in employee training and process improvement. Demonstrated leadership in fostering teamwork and adherence to cGMP compliance, enhancing operational efficiency and safety. Resourceful in implementing innovative solutions, driving productivity, and ensuring quality standards in fast-paced environments.
Overview
20
20
years of professional experience
Work History
Fermentation Team Lead/Operator Technician
Danimer Scientific
03.2020 - 03.2025
- Trained new team members by relaying information on company procedures and safety requirements.
- Promoted a positive work environment by fostering teamwork, open communication, and employee recognition initiatives.
- Served as a role model for the team by demonstrating commitment to excellence, professionalism, and adherence to company values at all times.
- Coached team members in techniques necessary to complete job tasks.
- Collaborated with other department leads to streamline workflows, improve interdepartmental coordination, and achieve business goals collectively.
- Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
- Devised and implemented processes and procedures to streamline operations.
- Pressure testing of fermentation vessels
- Sterilization of fermentation vessels
- Verification/Mixing of media
- Batching media into fermentation vessels
- CIP of fermentation vessels
- Performed audits of cGMP documentation
Refinement Technician/Research & Development
GenCanna Global
10.2018 - 01.2020
- Maintained a safe work environment by strictly adhering to established safety protocols and guidelines.
- As a Refinement Technician I oversaw multiple types of distillation as well as numerous steps involved in the production of CBD crystal
- As a Research & Development Specialist I was responsible for several roles. One of my major roles was equipment implementation and process improvement. I worked closely with the Training Department, EHS/Compliance, and Document Control to ensure that new processes were successfully transitioned to production. This included authoring SOPs, sample techniques and Job Safety Analysis. I also worked closely with Production Management on continuous improvement strategies to save the company both time and revenue
Fluid Bed Room Lead/Level IV Operator
Catalent Pharma Solutions
12.2012 - 08.2018
- Maintained a safe working environment by enforcing strict adherence to safety guidelines and protocols.
- Followed detailed technical documents to complete successful product campaigns
- Initiate and carry out full-scale pharmaceutical batches to completion
- Ensure quality and compliance by adhering to cGMP guidelines
- Maintain training on relevant manufacturing/safety methods and SOPs
- Work with quality assurance group to ensure batch and documentation integrity
- Work with maintenance/engineering group to maintain sensitive manufacturing equipment
- Maintain compliance with FDA/DEA guidelines for pharmaceutical manufacturing
- Work hands-on with customer representatives to optimize processes
- Train employees in cleaning validation and record completion to ensure cross contamination elimination and safe, quality, and effective product
Slicing Room Supervisor
Affiliated Computer Services, ACS
05.2005 - 07.2008
- Manage communications with staff
- Obtain pre-authorizations
- Verify billing codes, document narratives and submit claims
- Medical claim retention, organization, and destruction
- Pick up and process daily incoming mail to include sorting, stamping, and recording of incoming packages
- Maintain daily work log
- Data entry and analysis
- Track/Document employee attendance and performance
Education
High School Diploma -
Bourbon County High School
Paris, KY05-2002
Skills
- Employee training
- Process improvement
- cGMP compliance
- Batch documentation
- Leadership
- Customer Service
- Oral and Written Communication
- Multi-tasking
- Flexabilty
- Quick learner
- Resourceful
Timeline
Fermentation Team Lead/Operator Technician
Danimer Scientific
03.2020 - 03.2025
Refinement Technician/Research & Development
GenCanna Global
10.2018 - 01.2020
Fluid Bed Room Lead/Level IV Operator
Catalent Pharma Solutions
12.2012 - 08.2018
Slicing Room Supervisor
Affiliated Computer Services, ACS
05.2005 - 07.2008
High School Diploma -
Bourbon County High School
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