Job#: 2089020 Job Description: Scientist - Analytical QC Apex Systems is a large staffing and consulting firm and we are looking for a Scientist - Analytical QC with experience with assay development (both molecular and cellular), neural and ideally glial cells, PCR (ideally ddPCR), and knowledge of GMP and Significant Statistics and for one of our biotech clients in Toronto.

Client: Biotechnology company

Contract/Perm & duration: 12-month contract

Location: Toronto

This position will be working 5 days onsite per week.

We are seeking a Scientist to join our clients Analytical Technology (AT) team, a pillar of the greater Analytical and Quality Control (AQC) function that is responsible for the introduction of novel assays and technologies to AQC. As a central development resource at the company, the AQC team works closely with research, process development, non-clinical and clinical development, manufacturing and quality teams. The successful candidate will be a key scientific contributor and technical leader as part of the larger Technical Operations organization in a dynamic and progressive team developing industry-leading cell-based analytics to characterize cell therapy products and manufacturing processes.

Responsibilities:

• Design and execute in vitro experiments to assess, develop and optimize novel molecular and cell-based functional to characterize cell therapy products and raw materials
• Ensure that assays meet requirements for the intended use of the assays, which includes characterization, lot release, stability and comparability testing of development and manufacturing batches and establish phase-appropriate specifications
• Analyze experimental data to draw conclusions that support decision making and next steps within and across projects
• Perform other biochemical, cellular, and/or molecular assays as required
• Qualify assays as appropriate and provide training and further qualification/validation support as needed
• Prepare and present project plans and regular project progress updates and recommendations
• Document experimental data in electronic laboratory notebooks in a timely and accurate manner in accordance with the company quality management system
• Prepare, review, and approve experimental protocols, reports, standard operating procedures and other scientific and quality documents
• Requires hands-on laboratory work in addition to training and supervision of junior staff members in supporting analytical activities within the AQC team
• Identify and evaluate new technologies
• Present scientific data to colleagues in group meetings, prepare and present internal and external presentations as required
• Contribute to building a culture that embraces scientific excellence, integrity, urgency, courage and community

Key Qualifications:

• Advanced (PhD or MSc) degree in biological sciences, or similar with 1+ (PhD) or 9+ (MSc) years of relevant experience, preferably in an industry environment
• Significant hands-on experience in developing, optimizing and qualifying cell-based activity/potency assays using image-based and biochemical readouts (eg. Incucyte, western blot, immunoassays, enzymatic activity assays, etc.) according to industry and best practice standards is required
• Significant hands-on experience in developing, optimizing and qualifying molecular assays (eg. qPCR, ddPCR, etc) according to industry and best practice standards is required
• Extensive hands-on experience in mammalian cell culture and cell characterization experience is required
• Practical knowledge of statistical analysis of data is required
• Knowledge and understanding of statistical programming languages (R, python, etc.) and Design of Experiments (DoEs) is preferred
• Experience culturing and characterizing neuronal and glia cell types is an asset
• Proven ability to structure, plan, and execute experiments and independently execute complex tasks in a fast-paced environment
• Excellent organizational and problem-solving skills, with demonstrated ability to work cross-functionally
• Proficiency in technical scientific writing
• Excellent interpersonal, verbal and written communication skills
• Experience with GxP guidelines/documentation and general GxP experience in analytical development is an asset but not required

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.