The Manufacturing Senior Associate works as part of the manufacturing team to deliver high quality therapeutics. This role is focused on processing of cell therapy technologies where Aseptic Processing is of the utmost importance. This role contributes to the successful delivery of released product in support of clinical trials and commercial production.
Company OverviewJoin us! FUJIFILM Diosynth Biotechnologies 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.
Job DescriptionManufacturing Senior Associate
Department: Internal Manufacturing
Location: Thousand Oaks, CA
Reports To: Manufacturing Supervisor
SUMMARY OF POSITION:
The Manufacturing Senior Associate works as part of the manufacturing team to deliver high quality therapeutics. This role is focused on processing of cell therapy technologies where Aseptic Processing is of the utmost importance. This role contributes to the successful delivery of released product in support of clinical trials and commercial production.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
Performs Aseptic operations in a Grade A controlled environment and train staff on aseptic operationSupport production in a controlled environment and train staff as needed Under minimum supervision, executes on production batch records and according to standard operating procedures and protocolsUnder minimum supervision, assist in all areas of cell processing and all related duties as required including (stocking, inventory management, material movement and reconciliation, controlled forms management, planner entry form issuance and other tasks)Independently support manufacturing batch record reviewAssists in the development of manufacturing electronic batch recordsAuthor drafts and revision of standard operating procedures, /work instructions/batch records of existing and new processes and or equipment as neededSupport routine maintenance and cleaning of rooms and equipmentPerform tasks in a manner consistent with the safety policies, quality systems, and GMP requirementsInitiate Work orders as neededIndependently supports initiation and investigation of minor deviations and supports root cause investigations and CAPA recordsSupport as SME training of staff as applicableIdentifies and implements continuous improvements Support NPI and Process Transfer activities as neededExecute visual inspection of final drug product.Will be managing D space during production (sample handoff, material ingress as needed, print documents as needed). Assist the team with maintaining an up-to-date working inventory for the equipment/supplies Document and review appropriate paperwork, daily logs, and documentation per Good Documentation Practices, to include electronic documentationParticipate in a detailed training program and develop training plan Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
BACKGROUND REQUIREMENTS (Education, Behavioral, Professional & Technical Capabilities Experience):
QUALIFICATIONS:
Bachelor of Science (B.Sc.) with 2 + years of applicable biopharma experience; orAssociate degree with 4+ years of applicable biopharma experience; orHigh school diploma with 7+ years of applicable biopharma experiencePreferred Qualifications Ability to follow verbal and written instructionsProblem solving skillsDetail orientedTeam playerAbility to work with minimal supervisionStrong communication skillsUnderstanding of Aseptic Behaviors / TechniquesExperience in biomanufacturing environments
WORK ENVIRONMENT:
Work is generally performed in a Good Manufacturing Practice (GMP) facility. A GMP facility is governed by regulatory agencies in which there are specific requirements for hygiene and acceptable clothing. The following items are restricted when accessing the GMP manufacturing area:Makeup, painted nailsHair products (spray, gel, wax)Perfume and cologneJewelry (rings, watches, bracelets, fitness bands, necklaces, and facial/earpiercings, etc.)Donning of gowns requires ability to physically don gowns while balancing in a cleanroom environment Personal Protective Equipment is required to perform certain tasks (i.e., latex/nitrile gloves, respirators and or masks, goggles, plant dedicated scrubs/shoes, full body gown that covers all exposed skin)Subject to extended periods of standing, to include crouching / kneeling (8 plus hours) while being donned in applicable PPERequired to handle biohazardous and hazardous material via direction of Standard Operating Procedures
PHYSICAL REQUIREMENTS:
Medium work that includes moving, lifting, pushing and or pulling objects up to 50 pounds. Medium work that includes pushing and or pulling equipment with up to 50 pounds of force assisted by wheels.Must be willing and able to bend, stoop, squat, crawl, twist, climb ladders, and wear a respiratorPosition requires a combination of standing in the manufacturing environment and walking around the facility.Open to work various shifts as neededRequired to work weekends and holidays
SALARY AND BENEFITS:
$38.25 to $42.75 per hour, depending on experienceMedical, Dental and 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.
EEO Information
Fujifilm is committed to 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 InformationIf 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 (FDBCHR@fujifilm.com).
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