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Job Title: Project Manager Senior, BiopharmaManufacturing(JP10103) Location: Edmonton, Alberta, CANADA T6X2B7 Employment Type: Contract Business Unit: ACDM Synthetics DP/FDP Duration: 8 months with likely extensions Posting Date: 04/21/2022 3 Key Consulting is hiring Senior Project Managerfor a consulting engagement with our direct client, a leading global biopharmaceutical company. Job Description: Onsite at Canada location; North of Toronto (site in Whitby, ON, Canada) With minimal supervision, apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. Responsibilities include, but are not limited to the following: Act as technical ADVISOR to manufacturing team Support the execution of manufacturing/quality systems such as deviations, CAPAs, change controls, procedures, training, and new product introductions Provide oversight of production runs and closely monitor high risk operations as defined by the risk assessments Successfully detect, identify & resolve issue/defect through in-place Quality systems Communicate newly identified risks during operation or in related Quality System documents / procedure / practices Act as primary client contact while on site for any troubleshooting during production Escalate as needed per escalation process Collect information and data as provided by the local team to facilitate effective communication with the extended team Provide periodic update on the status of the campaign Identify optimization/improvement opportunities for the future activities Why is the Position Open? Team need/ backfill Top Must-Have Skill Sets: Quality records experience; deviation process. etc required Detailed technical understanding of Oral Solid Dosage (OSD) DP/FDP unit operations Skilled in performance of GMP production operations Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality Organizational, technical writing and presentation skills Regulatory knowledge and interactions Day to Day Responsibilities: Including, but not limited to providing oversight of DP and FDP production Employee Value Proposition: Growth/ opportunity Red Flags: Must have GMP Knowledge. Must be able to work with 3rd party vendors/ suppliers Interview process: Pls expect 4-6 interviews: Groups: ACDM QA Packaging PD DP-PD We invite qualified candidates to sendyour resume to Ifyou decide that you''re not interested in pursuing this position, please feel free to look at the other positions on our website You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team