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.
Primary Responsibilities:
- Performs Aseptic operations in a Grade A controlled environment and train staff on aseptic operation
- Support 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 protocols
- Under 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 review
- Assists in the development of manufacturing electronic batch records
- Author drafts and revision of standard operating procedures, /work instructions/batch records of existing and new processes and or equipment as needed
- Support routine maintenance and cleaning of rooms and equipment
- Identifies and implements continuous improvements
- Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
- Support training of staff as need
- Initiate Work orders as needed
- Independently supports initiation and investigation of minor deviations
- Support as SME training of staff as applicable
- Maintain inventory of equipment and supplies
- Support Process improvements and Process Transfer activities as needed
- Initiates deviations and participates in root cause investigations and CAPA
- Assists in the development of manufacturing electronic batch records
Qualifications:
- Bachelor of Science (B.Sc.) with 3+ years of experience; or
- Associate degree with 4+ years of experience; or
- High School Diploma 5 + years of experience
Preferred Qualifications:
- Ability to follow verbal and written instructions
- Problem solving skills
- Detail oriented
- Team player
- Ability to work with minimal supervision
- Strong communication skills
- Strong 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
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 nails
- Hair products (spray, gel, wax)
- Perfume and cologne
- Jewelry (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 PPE
- Required 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 and climb ladders
- Position requires a combination of standing in the manufacturing environment and walking around the facility
- Open to work various shifts (all shift times are 6 am)
- 4 days a week /10 hours per day Shift (6 am – 04:30 pm; Sunday through Wednesday or Wednesday through Saturday)
- 4 days a week /10 hours per day Shift (6 am – 04:30 pm; Monday, Tuesday, Thursday and Friday)
- Required to work weekends and some holidays
Salary and Benefits:
- $36 to $42.75 per hour, depending on experience
- Medical, 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.