Job#: 2082240 Job Description: GMP Manufacturing Specialist Apex Systems is a large staffing and consulting firm and we are looking for 3-5 GMP Manufacturing Specialist with a microbiology background with experience with mammalian cell culture, aseptic techniques, working in BSL-2 or Cleanrooms, and knowledge of GMP at our Biopharma client.

Client: Innovative Biopharma Start-up

Contract/Perm & duration: 18-24 months

• 5 days/week onsite*

Location: Downtown Toronto

The GMP Manufacturing Specialist will work closely with GMP Manufacturing team in developing and executing cGMP manufacturing processes to support production of cell therapeutics for pre-clinical studies and human clinical trials. The Specialist will assist in technology transfer of manufacturing processes internally and to external collaborators. Duties will include raw material ordering, inventory management, raw material preparations (e.g media, buffers etc.), assisting in cell manufacturing process, writing standard operating procedures (SOPs), and other GMP documents that are necessary for ensuring compliance with applicable U.S., Canadian and global standards.

Responsibilities:

• Perform duties as dictated by standard operating procedures for cell manufacturing and under cGMP guidelines as directed
• Perform duties in a clean room environment following cGMP guidelines and operate instrumentation as needed for cell manufacturing such as cell separators, cell counters etc.
• Assist in technology transfer of procedures from research & development environment into cGMP environment
• Assist manufacturing team for routine expansion and differentiation of PSCs, and executing qualification, and engineering studies
• Support preparation of documentation and reports for review by Quality Assurance and manufacturing management
• Assist manufacturing team in inventory management and raw material procurement
• Support validation / cleaning of equipment / facility including assisting in executing IQ/OQ/PQ protocols and prepare SOPs for equipment operation, maintenance and calibration
• Participate in required cGMP training activities including training on required SOPs and manufacturing procedures.
• Work with the manufacturing team to produce cell drug substance and product for non-clinical studies and human clinical trials by procuring raw materials, preparing manufacturing facility/equipment, and executing the approved MP
• Work with Quality Assurance to insure completion of all associated documentation to support cGMP manufacturing
• Assist QA/QC in the development of appropriate analytical methods, associated documentation as needed
• Support Quality Assurance documentation functions for cGMP production, in-process testing, and release testing of cell therapies. Work with QA to address quality events including deviations, CAPAs, OOS and other failure investigations as needed
• Support QA and QC functions for cleanroom operations including completing and tracking of equipment records for PM/calibration and cleanroom maintenance and cleaning.

Key Qualifications:

• BS in Biology, Biochemistry, Engineering, or related field
• 1-7+ years of experience in aseptic techniques and handling of mammalian cells is required
• Hands-on experience in human stem cell production is highly desirable
• Experience in PSC culture and differentiation techniques is highly desirable
• Experience in assisting SOPs writing and validation protocol for equipment and cell production processes is highly desirable
• Experience with Good Documentation Practices is preferred
• Willingness to accommodate various shift hours (evening, weekend, and holidays) is required
• Excellent written and oral communication skills and the ability to work in a fast paced, dynamic team environment is required
• Expertise using MS WORD, Excel, and database programs. Experience in working with an eQMS and/or LIMS is also desirable

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178 .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.

Apex Systems is part of the Commercial Segment of ASGN Incorporated.

NYSE: ASGN

4400 Cox Road

Suite 200

Glen Allen, Virginia 23060

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] (Do not submit resumes or solicit consultants to this email address). UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Apex Systems.