Training Specialist, Manufacturing

Overview

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Manufacturing Training Specialist works as part of the manufacturing team to deliver high quality cell therapy training, process transfers, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.

External US

The work we do at FDBC 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 our new FDBC facility in Thousand Oaks, CA and help manufacture the next cell 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.

The Manufacturing Training Specialist works as part of the manufacturing team to deliver high quality cell therapy training, process transfers, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.

Reports to: Manufacturing Director

Function: Technical Operations

Location: Thousand Oaks, CA

Schedule: Monday through Friday (occasional weekend work) normal business hours or as required by manufacturing schedule

Primary Responsibilities

Previous experience on cell therapy, or cell culture manufacturing operations as this role will be required to train and qualify new staff on critical manipulations and theory

Establish a boot-camp type of training program for the manufacturing department to prepare staff on use of equipment and manufacturing manipulations

Knowledgeable and hands on experience with manufacturing equipment such as, but not limited to, bio safety cabinets, pipetting, micro pipetting, cell counters, centrifuge, incubators, Sepax, Sysmex, vial filling machines (manual and automated,) weight scales, Plasmatherm, Cryo PODs, visual inspection booths. The training specialist will be responsible for training and qualifying new staff.

Lead evaluate and develop training program for the manufacturing department to ensure the training strategies remain relevant and in support of new client needs.

Will have oversight of all On-The-Job (OJT) forms in manufacturing to ensure they remain relevant with critical training and qualification requirements.

Develop qualification pathways and work with supervisors and managers within the manufacturing department to identify most efficient training strategies, identify skill gaps, training opportunities, and deliver develop/deliver training solutions.

Conduct analyses to guide the creation of new training curricula. Ensure curricula address needs of new and existing manufacturing staff. Monitor, revise, and add content, as needed.

Evaluate effectiveness of training programs. Partner with internal stakeholders and SMEs to determine appropriate modifications or elimination of existing training.

Ensure skills and training matrix is kept up to date and available for review.

Deliver training programs/sessions pertaining to manufacturing operations. When applicable, partner with internal stakeholders to determine additional support, as needed.

Manage the Aseptic Operator Qualification (AOQ) program to ensure assessments are complete as part of new product introductions and remain relevant to critical manipulations.

Assist supervisors and managers within the manufacturing department establish additional training metrics and feedback loops to further evaluate.

Active participant in the New Product Introduction (NPI) sub-team meetings to assess impact to current training curricula and to develop training strategies to ensure readiness of manufacturing staff

Manage materials needed to support training program to ensure inventory levels and their traceability.

Ability to train staff on proper aseptic techniques in grade A and B environment and participate in the Aseptic Technique Mentoring program to ensure training remains relevant.

Adhere to all safety protocols and procedures while training staff.

Collaborate with clients, PD and NPI team to gain knowledge of new equipment that will be introduced into the manufacturing area (Grade A and B).

Maintain and take ownership of the training area/room to mirror the manufacturing suites.

Draft and revise documents, as necessary

Identifies and implements continuous improvements with training and the manufacturing process.

Knowledgeable and hands on experience with Environmental and Personal Monitoring.

Participate in Safety and Gemba walks, as applicable.

Education and Professional Experience:

Bachelor of Science (B.Sc.) with 5+ years of experience or an equivalent combination of education; or

Master of Science (M. Sc.) with 3+ years of experience

Position Requirements

Experience with technology transfers and new product introductions

Demonstrated subject matter expert in aseptic technique, and cell culture, or cell therapy critical operations

Must possess strong organizational skills and a demonstrated ability to be self-directed while managing multiple projects

Have strong leadership skills, including cross-functional team integration and advising

Must possess effective communication and presentation skills that effectively facilitate project or workflow efficiency and/or information distribution

Effective listening and coaching skills

Strong attention to detail

Proven record delivering high impact projects

Strong understanding of aseptic technique and regulatory requirements

Will be required to maintain grade B gowning qualification

Clear understanding of cGMP process

Hands on training experience

Clean room experience

Ability to follow verbal and written instructions.

Problem Solving skills.

Salary and Benefits:

$95,000 to $110,000 per year, depending on experience.

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

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.