Job Description

The Manager, Analytical Development, will be responsible for facilitating the organization and execution of all laboratory work for the analytical development group on a day-to-day basis, management of laboratory resources, ensuring for their distribution to analytical projects and platform operations. Additional activities include report review and issuance for routine analyses.

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Key responsibilities:

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• Supervise a team of Research Associates providing adequate guidance, training and mentorship.
• In conjunction with the Director, Analytical Development, and the Analytical Scientists organise, assign, and assist with the execution of daily laboratory work to ensure that it is prioritized properly and efficiently. This includes routine analysis requests, the implementation and optimization of new analytical assays, the execution of formulation and stability studies, and other specialized studies.
• Manage the turnaround time and lifecycle of analytical samples in accordance with the guidance set by the Director, Analytical Development, and the urgency of the requested analysis.
• Review analytical reports for all routine analyses prior to release to ensure proper assay execution and reporting.
• Flag sources of inefficiency within the laboratory to the Director, Analytical Development, and propose/implement resolution plans.
• Flag all unexpected or unusual analytical results, data trends, or instrumentation behaviour to the Director, Analytical Development and the assay SME.
• Manage and participate in the drafting and revision of analytical laboratory forms, procedures, and methods.
• Assist with the implementation and optimization of analytical assays.
• Draft certificates of testing and analysis, when required.
• Be responsible for the management of the consumable inventory for the analytical team, ensuring that all required consumables are ordered / re-ordered as needed to ensure that no rupture in stock occurs.
• Ensure that all instruments are maintained in a proper working state through routine cleaning and maintenance. Participate in annual preventative maintenance planning and execution for all identified instruments.
• Implement and manage the drafting and revision of analytical instrumentation maintenance logs and procedures for all equipment under the responsibility of the analytical development group.

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Qualifications:

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• At a minimum a graduate level (M.Sc.) in biochemistry, biotechnology, life sciences or equivalent.
• At least 5 years of experience in analytical development or quality control, or relevant experience in the biopharmaceutical or biotechnology industry.
• At least 5 years of employee line management.
• Effective verbal and written communication in order to successfully lead others in a fast-paced, team environment.
• Be able to effectively plan experiments and organize others to carry out all required work in an effective and accurate manner.
• Be keen at implementing and facilitating changes required by management.
• Be able to execute experiments independently and efficiently.
• Hands on experience with HPLC and/or Capillary Electrophoresis (CE), Dynamic Light Scattering (DLS) and/or immunological techniques (ELISA).
• Experienced in experimental planning, problem solving and troubleshooting.
• Demonstrated structured analytical thinking, precision and attention to details.
• Experience with current Good Manufacturing Practices (cGMP) is an asset.

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Key words: Analytical Operations, Team Supervision, Protein Analyses, Assay Development, HPLC, Capillary Electrophoresis, DLS, ELISA

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Perks:

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• Comprehensive group insurance plan.
• Paid public transit.
• Beautiful office space in Montreal’s Old Port.
• Onsite yoga and healthy snacks.
• A team and culture committed to learning and high performance.

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Contact:

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Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting  “35Pharma Posting LOM0618” in the subject line – we are looking forward to hearing from you!