Dalton Pharma Services is a leading provider of integrated pharmaceutical discovery, development and manufacturing services to the biotechnology and pharmaceutical industries. We develop and manufacture innovative new products on a contract basis for our customers that bring enhanced therapeutic value and impact the lives of the patients that use them. Our customers range from the largest global pharmaceutical companies in the world to the smallest startup company. Dalton offers industry leading expertise in chemical synthesis, API production, formulation development and the manufacturing of sterile injectable products, all supported by extensive in-house analytical and quality support.

The Microbiology Supervisor will be responsible in performing microbial testing, using a variety of techniques, methods and instrumentation, to ensure products are safe for human use and meet the pre-determined quality specifications. The Microbiology Supervisor ensures that the Dalton Pharma Services facility meets pre-established criteria by conducting environmental monitoring, utilities testing and trending. The Microbiology Supervisor will also conduct microbiological method development and validation to meet client needs and regulatory requirements.

Responsibilities:

• Prepare schedule, assign daily tasks and provide guidance to the microbiologists.
• Conduct microbial testing of raw materials, in-process samples, finished products, utilities and EM of facilities using various techniques.
• Perform all microbiology testing in compliance with cGMP regulations, following internal, client and compendial methodologies.
• Review data generated by microbiologists for accuracy and compliance.
• Write and/or approve SOP revisions.
• Write/execute method and validation protocols, and sign-off reports.
• Perform investigations for product and environmental monitoring excursions, identify root cause and make CAPA recommendations.
• Review processes in the microbiology department to identify opportunities and make recommendations for improvement.
• Participate in client and regulatory audits and assist with responses/CAPA generation, as needed
• Act as back-up to the Microbiology Manager.

Requirements:

• Knowledge of regulatory requirements (Health Canada, FDA and EU) for microbiology testing related to the manufacturing of sterile and non-sterile pharmaceutical products.

• B.Sc. or higher degree in Microbiology
• 2 or more years of experience as a Microbiology Supervisor, responsible for a team of microbiologists
• Supported by 5 or more years of microbiology laboratory experience within a biotechnology/pharmaceutical aseptic manufacturing environment facility.

OR

• B.Sc. or higher degree in Microbiology
• 5 or more years of experience as a Senior Microbiologist/Team Lead
• Supported by 10 or more years of microbiology laboratory experience within a biotechnology/pharmaceutical aseptic manufacturing environment facility.

• Experience in aseptic techniques and microbiology testing, including validation, related to the manufacturing of sterile and non-sterile pharmaceutical products. Testing includes, but is not limited to: environmental monitoring, microbial enumeration, microbial identification, growth promotion, endotoxin testing, disinfectant qualification, bacterial retention/filter validation, ingress testing, media fill processing.
• Knowledgeable in the gowning qualification process and MUST be able to be gown qualified and work in an aseptic environment.
• Experience in good laboratory documentation practices and regulatory guidelines e.g. SOPs, Pharmacopeias
• Knowledge of Annex 1 guidelines is a definite asset.
• Strong oral/written communication and interpersonal/leadership skills.
• Strong investigative and problem-solving abilities, and report writing skills
• Proficient in the use of Microsoft software and EQMS software such as Trackwise or Dot Compliance.

While we appreciate all applications received, only those selected for an interview will be contacted

Job Types: Full-time, Permanent

Pay: From $70,000.00 per year

Benefits:

• Casual dress
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Flexible schedule
• Life insurance
• On-site parking
• RRSP match
• Tuition reimbursement
• Vision care
• Wellness program

Application question(s):

• Are you comfortable with fully on-site work arrangement at our North York location?
• Do you have experience with Annex 1 compliance & gap analysis?

Education:

• Bachelor's Degree (preferred)

Experience:

• Microbiology Supervisor : 2 years (required)
• microbiology (biotechnology/pharmaceutical ): 10 years (required)

Work Location: In person