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. The Sr. Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and continuous improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.
External US
Senior Manufacturing Associate
The Sr. Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and continuous improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.
Location: Thousand Oaks
Reports To: Manufacturing Supervisor
Primary 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 equipmentIdentifies and implements continuous improvementsPerform tasks in a manner consistent with the safety policies, quality systems, and GMP requirementsSupport training of staff as needInitiate Work orders as neededIndependently supports initiation and investigation of minor deviationsSupport as SME training of staff as applicableMaintain inventory of equipment and suppliesSupport Process improvements and Process Transfer activities as neededInitiates deviations and participates in root cause investigations and CAPAAssists in the development of manufacturing electronic batch records
Qualifications:
Bachelor of Science (B.Sc.) with 3+ years of experience; orAssociate degree with 4+ years of experience; or High school diploma with 5+ years of experience
Preferred Qualifications:
Ability to follow verbal and written instructionsProblem solving skillsDetail orientedTeam playerAbility to work with minimal supervisionStrong communication skillsStrong demonstrated aseptic techniques
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
Essential Physical Requirements:
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/ear piercings, 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 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 respirator.Position requires a combination of standing in the manufacturing environment and walking around the facility.Open to work various shifts (all shift times are 4 am)4 days a week /10 hours per day Shift (4 am – 02:30 pm, Sunday through Wednesday or Wednesday through Saturday) 5 days a week /08 hours per day Shift (4 am – 12:30 pm)Open to potential swing shift hours (11 am - 09:30 pm)4 days a week /10 hours per day Shift (Sunday through Wednesday or Wednesday through Saturday)Required to work weekends and some holidays.
Salary and Benefits:
$43 to $53 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.
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.
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