Scientist II / Sr. Scientist

Job#: 3017592

Job Description:

Client: Biotechnology company

Contract/Perm & duration: 12-month contract (possibility of extension/conversion)

Location: Toronto, Hybrid (1-3 days)

Pay Rate: $60-80 / hour (T4)

Title: Scientist II / Sr. Scientist

Description of Position

Our biotech client is looking for a Scientist, specialized in cellular and molecular biology, to support a dynamic and progressive Analytical and Quality Control team (A&QC). The position requires a data driven scientist with an analytical mindset who has great communication skills and will thrive in a cross-functional team environment. Familiarity with work under GLP or GMP regulations is a must.

Reporting to the Associate Director within the Analytical Strategy & Execution (AS&E) team, the Scientist will be a key analytical contributor of the ASE team establishing the analytical strategy, life-cycle improvements, and control strategies to progress clinical programs to commercial readiness, with a focus on critical and raw materials testing approaches supporting the differentiated cell therapy process.

The successful candidate will drive consistent analytics, data and quality alignments for critical and raw materials that support the product analytical strategies, coordinating analytical deliverables and providing analytical assessments for risk mitigations, testing strategies, specifications and material characterization. The candidate will facilitate appropriate method development and implementation strategies in a GMP compliant manner and drive the design and execution of studies as required, such as evaluation of, but not limited to, stability, and performance. The ideal candidate will be highly motivated and able to lead by example in technically complex scientific discussions, solving a wide range of challenging problems in creative and practical ways with a collaborative approach across a matrix of functional groups.

Responsibilities

• Champion material safety and quality, supporting a proactive team approach to analytical evaluation of the critical and raw material inputs that support the end-to-end process for cellular therapeutics ( cell seeds, banks, intermediates, drug substance, drug products, formulations).
• Work with project teams and different departments across CMC to establish alignment on analytical strategies throughout the lifecycle of the critical and raw materials. Track progress of activities supporting the analytical strategy, and their impacts to product safety and quality.
• Drive risk assessments, evaluate material quality, define testing strategies and analytical methods to evaluate attributes, mitigate risk, and build on compliance from early phase to commercial readiness. Collate, analyze and trend data from various assays, as appropriate, determining target criteria and release specifications.
• Drive scientific coordination of analytical studies, establishing study design, protocol writing, experimental planning, logistical coordination, internal/external partner management, data analysis and report writing, and collaboration with local/external sites for execution.
• Collaborate on the design, development, evaluation and/or implementation of novel technologies, processes and methods at both internal sites and external vendors, as required, to bolster the analytical testing strategies for critical and raw materials, with the appropriate level of compliance.
• Support as an analytical SME, change controls, deviation investigations, and CAPAs related to raw materials, collaborating within TechOps to assess, investigate and resolve material-related issues.
• Ensure that material quality, analytical methods and data align with regulatory requirements in all regions relevant to the company, in compliance with the Quality Management System. Author and review overarching technical protocols and reports and analytical sections of regulatory documents for submission to Health Authorities/ Regulatory agencies.
• Prepare and present scientific and technical information relating to material quality, analytical strategies and/or executed studies internally and externally. Author and review SOPs, reports and other scientific and quality documents.

Minimum Requirements

• PhD or equivalent in Biological Sciences or related field plus 2 years of relevant experience or Master’s degree in Biological Sciences with minimum of 11 years of relevant experience or Bachelor’s degree in Biological Sciences with minimum of 12 years of relevant experience.
• Good understanding of cell biology and critical and raw materials is required, where working knowledge of regulatory guidelines and product attributes of cellular therapeutics are an asset.
• Extensive experience with analytical technologies and characterization methods used to define safety, identity, strength and/or purity of critical and raw materials, such as spectroscopy, HPLC, ELISA, physico-chemical methods, bioburden, endotoxin, is required.
• Strong preference for experience in the Biotechnology setting, particularly cell therapy, pluripotent stem cells, gene editing.
• Experience with Good Documentation Practices and working in a cGMP or equivalent environment is preferred.
• Experience in qualification, validation, transfer, and life cycle management of analytical methods is desirable but not required.
• Experience with writing technical reports, and regulatory documents presenting data clearly and concisely.
• Excellent organizational and problem-solving skills, with demonstrated ability to work cross-functionally and manage multiple projects.
• Excellent written and oral communication skills, with strong organizational skills and keen attention to detail.
• Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).

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 uses a virtual recruiter as part of the application process. Click here for more details.

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.