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Project Manager Senior, Biopharma Manufacturing (JP10103)

Edmonton, Alberta, Canada · Biotech/Pharmaceutical
Job Title: Project Manager Senior, Biopharma Manufacturing (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 Manager for 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:
G
rowth/ 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 send your resume to recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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