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Supervisor, RD Analytical (Stability)

Full Time Permanent
  • Full Time
  • Permanent
  • Anywhere

General Summary:

 

The main responsibilities of this position are to supervise, guide and coach a group of Analytical R&D Chemists. Furthermore, the Supervisor, R&D will be responsible to oversee daily activities, review analytical data generated to ensure compliance with GMP’s and Company SOP’s and provide guidance, directions and problem solving to this group.

Principal Duties and Responsibilities:

  • coach, guide and motivate reporting team to achieve high quality results in an effective manner
  • give scientific advice and direction on a daily basis for both routine and non-routine projects
  • review the daily work of Analytical Team
  • ensure timely initiation of all required stability studies and adherence to GMP and Company SOP’s
  • ensure timely completion of projects based on defined deadlines
  • review routine work in order to ensure adherence to GMP’s and Company SOP’s
  • participate in and give direction in Laboratory Investigations
  • Prepare review and correct reports (Stability Summaries, SSR, DL responses, memos, SOP’s) prior to submitting for review
  • ensure the quality of the GMP and development data generated by the Analytical Team
  • prepare raw material, finished product and packaging material & Stability specifications
  • obtain/evaluate project related chemistry information from suppliers or literature
  • maintain safe working conditions
  • write and/or revise SOP’s as necessary
  • interact with other Departments (i.e. P.D., Q.C.) as necessary
  • assists in the troubleshooting of instrument and method related problems
  • write and conduct performance reviews
  • participate in other (i.e. administrative) activities of the Department, as requested
  • Complete all GMP Documentation correctly and in a timely manner
  • Complete all training assignments and maintain personal training records
  • Participate in and/or lead Non Conformance Investigations
  • Complete Corrective and Preventive Actions (CAPA’s)
  • Initiate, and follow through with actions required to close Change Controls
  • Participate in Internal, Customer and Regulatory Audits
  • Other duties as assigned

Knowledge, Skills and Abilities:

 

  • superior knowledge of analytical, organic and physical chemistry as well as instrumentation in the Analytical R&D Lab
  • demonstrated leadership skills (ability to effectively communicate, motivate people and obtain results in a team based environment)
  • thorough familiarity with GMP’s, GLP’s and Company SOP’s
  • familiarity with relevant FDA/ICH/TPP guidelines
  • good interpersonal skills
  • good organizational and logical skills
  • excellent written and verbal communication skills
  • computer literacy
  • B. Sc. Degree in Chemistry combined with 5 + years
  • M.Sc degree in Chemistry combined with five years of pharmaceutical lab experience (or equivalent combination of education and experience) and demonstrated leadership skills

***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc.***

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