Cellipont Bioservices
Join to apply for the
Manufacturing Associate III
role at
Cellipont Bioservices .
1 day ago Be among the first 25 applicants.
“Bridging Innovation to Cure.”
“Developing and Manufacturing your cell therapies from benchtop to bedside.”
Job Summary
Cellipont Bioservices is growing, and we are looking for a
Manufacturing Associate III
who believes in the potential of bridging clients’ discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.
The Manufacturing Associate III is responsible for assisting in the planning and timely execution of manufacturing operations for a cGMP-compliant state-of-the-art cell processing/clinical manufacturing facility with emphasis on primary cell isolation and cell culture in an aseptic processing environment.
The Manufacturing Associate III is responsible for following the standard practices outlined for the operation of the facility in accordance with the regulatory requirements for the manufacture of materials for our clinical studies, clinical trials and products.
THE ROLE
Assists the operation of a state-of-the-art GMP cell manufacturing plant in accordance with FDA, ISO, Environmental Health & Safety, Human Resources, EMA regulations and other Quality System regulations, as applicable
Ensures production area, processes and procedures are maintained in compliance with internal and external compliance and operating standards
Conducts ancillary activities in support of processing functions, e.g., lab and equipment cleaning and maintenance, inventory management and stocking, preparing shipping/packaging materials
Maintains a strong culture of safety, quality, accountability, cost efficiency, on‑time delivery and customer service
Ensures facilities are maintained in a continuous state of readiness. Identifies and mitigates risks for the operation and timely brings them to the attention of a supervisor
Ensures relevant manufacturing data are captured appropriately and accurately for supporting regulatory filings for clinical trials
Discover/implement continuous improvement projects that improve department safety and efficiency
Expert level aseptic processing
Trains new associates in process flows and aseptic techniques
Subject matter expert of manufacturing processes and procedures
THE CANDIDATE
Bachelor’s Degree in the Biologic Sciences or Bioengineering, with demonstrated technical experience in Bioprocessing, Cell Line Engineering or Tissue Engineering
3+ years of direct experience in cell manufacturing/commercial biologic drug manufacturing operations in a GMP environment
3+ years of direct experience working within manufacturing operations and leading by example; capable of helping to train other manufacturing technicians
Understanding of GMP and GDP requirements
Excellent time management and organizational skills, demonstrated ability to manage and prioritize multiple projects and meet deadlines
Willingness to problem solve and/or diagnose process/product/equipment problems
Excellent oral and written communication skills. Strong technical writing ability required
Highly motivated, follows oral and written instructions, communicates effectively, thinks logically, and thrives independently and/or in a fast‑paced team environment
Proficient in Microsoft Word and Excel. Experience in Microsoft Projects and Visio preferred
Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines
PHYSICAL DEMANDS
While performing the duties of this job, the employee is frequently required to stand and/or sit for extended periods. The employee is occasionally required to walk; has high levels of hand/finger dexterity; climbs or balances and stoops, kneels, crouches, or crawls.
The employee must occasionally lift and/or move up to 25 pounds
WORK ENVIRONMENT
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; biological materials or caustic cleaning chemicals; strong magnets; and sensitive calibrated equipment.
Noise level in the work environment is usually moderate
A marginal amount of the work is completed in a cleanroom environment; employees may be expected to work in cleanroom conditions for up to 4-6 hours at a time
Gowning requirements are safety goggles, shoe covers, hood, gown, mask, boots and gloves
Working conditions can include standing for long periods of time
Position Benefits
Opportunities for career growth within an expanding team
Defined career path and annual performance review & feedback process
Cross‑functional exposure to other areas within the organization
Robust benefit package designed for unique health & wellness needs, including coverage for your furry family members
401(k) robust employer match
Tuition reimbursement
Employee referral bonuses
Flexible work schedules and PTO based on role/level, increasing one PTO day each year and paid holidays
Gain experience in the cutting‑edge cell therapy space
“At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our “family” approach ensures you will get the mentorship you need to develop a satisfying career here!”
Notice to Agency and Search Firm Representatives
Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third‑party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
Referrals increase your chances of interviewing at Cellipont Bioservices by 2x.
#J-18808-Ljbffr
Manufacturing Associate III
role at
Cellipont Bioservices .
1 day ago Be among the first 25 applicants.
“Bridging Innovation to Cure.”
“Developing and Manufacturing your cell therapies from benchtop to bedside.”
Job Summary
Cellipont Bioservices is growing, and we are looking for a
Manufacturing Associate III
who believes in the potential of bridging clients’ discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.
The Manufacturing Associate III is responsible for assisting in the planning and timely execution of manufacturing operations for a cGMP-compliant state-of-the-art cell processing/clinical manufacturing facility with emphasis on primary cell isolation and cell culture in an aseptic processing environment.
The Manufacturing Associate III is responsible for following the standard practices outlined for the operation of the facility in accordance with the regulatory requirements for the manufacture of materials for our clinical studies, clinical trials and products.
THE ROLE
Assists the operation of a state-of-the-art GMP cell manufacturing plant in accordance with FDA, ISO, Environmental Health & Safety, Human Resources, EMA regulations and other Quality System regulations, as applicable
Ensures production area, processes and procedures are maintained in compliance with internal and external compliance and operating standards
Conducts ancillary activities in support of processing functions, e.g., lab and equipment cleaning and maintenance, inventory management and stocking, preparing shipping/packaging materials
Maintains a strong culture of safety, quality, accountability, cost efficiency, on‑time delivery and customer service
Ensures facilities are maintained in a continuous state of readiness. Identifies and mitigates risks for the operation and timely brings them to the attention of a supervisor
Ensures relevant manufacturing data are captured appropriately and accurately for supporting regulatory filings for clinical trials
Discover/implement continuous improvement projects that improve department safety and efficiency
Expert level aseptic processing
Trains new associates in process flows and aseptic techniques
Subject matter expert of manufacturing processes and procedures
THE CANDIDATE
Bachelor’s Degree in the Biologic Sciences or Bioengineering, with demonstrated technical experience in Bioprocessing, Cell Line Engineering or Tissue Engineering
3+ years of direct experience in cell manufacturing/commercial biologic drug manufacturing operations in a GMP environment
3+ years of direct experience working within manufacturing operations and leading by example; capable of helping to train other manufacturing technicians
Understanding of GMP and GDP requirements
Excellent time management and organizational skills, demonstrated ability to manage and prioritize multiple projects and meet deadlines
Willingness to problem solve and/or diagnose process/product/equipment problems
Excellent oral and written communication skills. Strong technical writing ability required
Highly motivated, follows oral and written instructions, communicates effectively, thinks logically, and thrives independently and/or in a fast‑paced team environment
Proficient in Microsoft Word and Excel. Experience in Microsoft Projects and Visio preferred
Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines
PHYSICAL DEMANDS
While performing the duties of this job, the employee is frequently required to stand and/or sit for extended periods. The employee is occasionally required to walk; has high levels of hand/finger dexterity; climbs or balances and stoops, kneels, crouches, or crawls.
The employee must occasionally lift and/or move up to 25 pounds
WORK ENVIRONMENT
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; biological materials or caustic cleaning chemicals; strong magnets; and sensitive calibrated equipment.
Noise level in the work environment is usually moderate
A marginal amount of the work is completed in a cleanroom environment; employees may be expected to work in cleanroom conditions for up to 4-6 hours at a time
Gowning requirements are safety goggles, shoe covers, hood, gown, mask, boots and gloves
Working conditions can include standing for long periods of time
Position Benefits
Opportunities for career growth within an expanding team
Defined career path and annual performance review & feedback process
Cross‑functional exposure to other areas within the organization
Robust benefit package designed for unique health & wellness needs, including coverage for your furry family members
401(k) robust employer match
Tuition reimbursement
Employee referral bonuses
Flexible work schedules and PTO based on role/level, increasing one PTO day each year and paid holidays
Gain experience in the cutting‑edge cell therapy space
“At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our “family” approach ensures you will get the mentorship you need to develop a satisfying career here!”
Notice to Agency and Search Firm Representatives
Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third‑party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
Referrals increase your chances of interviewing at Cellipont Bioservices by 2x.
#J-18808-Ljbffr