Associate scientist Jobs in Burlington, ON

MSAT ScientistApex Systems is a large staffing and consulting firm and we are looking for 1-2 MSAT Scientists with a 5+ years of experience in MSAT domain, CMO experience, strong knowledge of GMP / cGMP, and tech transfer and validation experience to place at our Biotech client. Client : Innovative Biotech clientContract / Perm & duration : 6 month contract (possibility of conversion or extension)Location : HamiltonResponsibilities : We are seeking an experienced and highly motivated Scientist to be responsible to aid in providing direct and detailed GMP manufacturing set-up and oversight for gene therapy products at in manufacturingThe ideal candidate will be able to apply strong depth of applied manufacturing sciences and technical project management to deliver all manufacturing preparations to meet quality requirements while coordinating across internal and external stakeholders including Quality, Regulatory, and CMO functionsDrive GMP Compliance and evaluate all aspects of ongoing production and understand when to intervene on company’s behalf and when to escalate more significant issues for resolutionWork in close collaboration with the CMO and internal teams to support manufacturing investigations and change controlsProvide assessments of product and process impact and contribute to the identification of root cause and determination and development of appropriate action plansReview and / or approve of CMO documentation including manufacturing bill of materials, production master batch records, and executed production record reviewCommunicate routine production manufacturing status to company stakeholders and assist as necessary with process data retrieval, processing, analysis, through written, verbal, and presentation at various company meeting forumsAuthor key technical documentation supporting manufacturing activities including technical risk assessments, manufacturing protocols, campaign reports, and descriptions of manufacturing process and controlsAuthor supporting documentation for relevant CMC manufacturing content of various regulatory submissions as neededDemonstrated experience managing projects in the pharmaceutical industryExperience engaging with external suppliers and partnersGeneral knowledge of process development and pharmaceutical manufacturing for biologics including cell culture, purification, and / or fill / finish operationsAbility to multitask and handle multiple competing priorities and projects at once in a changing and fast-paced environmentKey Qualifications : 5+ years of experience in MSAT domainExperience with tech transfer, validation, and compliance documentations for CMOKnowledge of CVQ - Commissioning, Qualification, and Validation - in an industry settingKnowledge and experience working in accordance with cGMP, GDP, and GCPStrong interpersonal flexibility with ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goalsExcellent communication skills, both oral and written, which may include planning and execution of meetings and presentationsBachelor’s degree in science or equivalent with 5+ years of experience working in a related pharmaceutical environment