- Degree with 7+ years experience in a pharma GMP environment
- Experience in analytical development/ analysis of pharmaceutical products
- Strong communication with experience working with external clients
- Work with clients directly for day to day laboratory work, negotiated deliverables and complaints
- Understand client needs and organize lab to ensure expectations are met
- Implement new programs, tests, methods, instrumentation, and procedures by investigating alternatives
- Ensure calibration and maintenance is performed.
- Ensure compliance with current GMP requirements
- Draft, review and have executed all analytical methods; method validations and method technology transfer studies
- Review investigation and documentation of all laboratory OOS occurrences
- Review COAs and approve validation protocols
- Review and have executed all analytical methods; method validations and method technology transfer studies
- Write or have written required SOPs and work instructions related to laboratory operation
- Ensure GMP training is provided
- Implement CAPA when initiated to include investigation, root cause analysis, corrective and preventative actions and documentation
- Facilitate internal audits/customer/regulatory audits; and evaluate and implement effective corrective actions
- Maintain laboratory staff by recruiting, selecting, orienting, and training employees
- Host GMP audits from clients and regulatory agencies such as Health Canada
- Oversee supervisors and group leaders such that a strict adherence to a defined hierarchy is maintained
- Evaluate the abilities and performance of subordinates, mentoring and setting appropriate individual goals
- B.Sc. or higher with 7+ years’ experience supervising a pharmaceutical laboratory
- Effective communicator with the ability to lead audits and experience in communicating directly with external clients
- A strong working knowledge of regulatory requirements
- A thorough understanding of laboratory safety requirements, MSDS’s and WHMIS
- A thorough understanding of analytical chemistry and chemical instrumentation, including HPLC, GC, and other common pharmaceutical laboratory instrumentation.
- Experience with raw material, finished product, and in-process testing, along with method development, validation, and tech transfer
- Considerable working knowledge of the methods, materials, and techniques used in laboratory work
- Ability to manage and schedule the work of others
Senior Analytical Laboratory Manager - PharmaToronto, ON, Canada
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SENIOR ANALYTICAL LABORATORY MANAGER - PHARMA
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001459
Date Posted: 08/11/2019