Manufacturing Associate I -Cell Based Manufacturing

About BPS Bioscience 

BPS Bioscience is a leading provider of recombinant proteins, assay kits, and cell lines, specializing in supporting drug discovery across various research areas, including cancer, neurology, immunotherapy, epigenetics, and more. We are dedicated to advancing scientific discovery by offering high-quality products and services to researchers worldwide. 

Job Overview

The Manufacturing Associate I, Cell-Based Manufacturing, supports the production of cell-based reagents, assay components, cell culture media, and production of cell lines used in cell-based assay manufacturing.

This role is responsible for preparing and formulating reagents and media, performing routine mammalian cell culture activities, supporting cell line expansion and banking, and quality control testing to ensure materials meet established specifications.

The ideal candidate is detail-oriented, dependable, and comfortable working in a fast-paced, quality-driven laboratory manufacturing environment. This position requires strong documentation practices, careful execution of procedures, good organizational skills, and the ability to work collaboratively with QC, QA, and R&D teams. All work must be performed in accordance with applicable procedures, safety requirements, and ISO 9001:2015 quality system expectations.

Responsibilities

Reagent and Media Preparation

• Accurately retrieve, weigh, measure, mix, formulate, and filter raw materials, reagents, buffers, supplements, and cell culture media according to approved procedures.
• Verify formulation accuracy, lot information, labeling, and documentation prior to release or further use.
• Maintain proper handling, storage, and traceability of raw materials, intermediates, and finished components.

Cell Culture, Expansion, and Banking

• Perform routine mammalian cell culture activities, including cell thawing, feeding, passaging, subculturing, expansion, counting, and cryopreservation.
• Support the generation and maintenance of Master Cell Banks and Working Cell Banks.
• Monitor cell growth, morphology, viability, and recovery following established procedures.
• Maintain accurate cell bank inventory records and ensure proper storage and traceability.

Quality Control Testing

• Perform QC testing of cell culture media, reagents, and cell lines, including viability testing, growth curve analysis, sterility testing, and mycoplasma screening.
• Document QC results accurately and promptly in accordance with internal quality system requirements.
• Communicate any unexpected results, deviations, or potential quality concerns to the supervisor or quality representative.

Documentation and Compliance

• Complete batch records, worksheets, forms, labels, and electronic records accurately, clearly, and in a timely manner.
• Follow approved SOPs, work instructions, and ISO 9001:2015 quality system requirements.
• Support documentation accuracy, product traceability, and change control expectations as applicable.

Labeling, Packaging, and Inventory Support

• Dispense, label, and package final products and components with attention to accuracy, consistency, and traceability.
• Use Labguru ELN software to track material usage, manage raw material and cell bank inventory, and support restocking activities.
• Assist with routine inventory checks and communicate supply needs to support production continuity.

Laboratory Organization and Safety

• Maintain a clean, organized, and safe work area in accordance with 5S principles, laboratory safety procedures, and PPE requirements.
• Properly handle biological materials, chemicals, and laboratory equipment according to established safety practices.
• Support routine cleaning, equipment preparation, and general laboratory readiness.

Process and Cross-Functional Support

• Assist with process development, troubleshooting, optimization, and scale-up activities for new or existing reagent and cell-based manufacturing processes.
• Collaborate with QC, QA, R&D, and other internal teams to support product quality, process transfer, and production goals.
• Perform other duties as assigned to support department and company objectives

Requirements

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Cell Biology, Biotechnology, or a related scientific discipline.
• 0–2 years of experience in a laboratory, manufacturing, cell culture, reagent production, or assay production environment.
• Basic understanding of aseptic technique and laboratory safety practices.
• Ability to follow written procedures, accurately complete documentation, and maintain strong attention to detail.
• Strong organizational, communication, and teamwork skills.
• Ability to manage multiple tasks and adapt to changing production priorities.
• Comfortable working with biological materials, cell culture media, reagents, and standard laboratory equipment.

Preferred Qualifications

• Hands-on experience with mammalian cell culture, including media preparation, cell line maintenance, expansion, and cryopreservation.
• Experience with cell counting & viability assessment, sterility testing, mycoplasma testing, or growth curve analysis.
• Experience working in an ISO 9001, GMP, GLP, or other regulated quality system environment.
• Familiarity with ERP systems, electronic lab notebooks, Labguru, or similar inventory/documentation platforms.
• Prior experience in biotechnology, life sciences manufacturing, reagent production, or cell-based assay support.

 Benefits!

• 401k with 4% company match
• Medical/Dental/Vision health insurance plans
• Vacation and paid holidays
• Companywide lunches provided quarterly 

BPS Bioscience Inc. is an equal opportunity employer, without regard to race, color, religion, age, gender, sexual orientation, disability, or any other characteristic protected by applicable law.