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 Manager, reporting to the Director of Quality, will be responsible for day-to day management of the Microbiology Laboratory and all microbiology testing at Dalton to ensure compliance with cGMP regulations, following internal, client and compendial methodologies. The incumbent will provide guidance for method development and validation, propose and implement improvements, and perform investigations for product and environmental monitoring excursions, while coordinating and prioritizing the laboratory workload to meet client requirements and turn-around time.

The successful candidate should meet the following qualifications and requirements.

Qualifications:

Strong knowledge of regulatory requirements (Health Canada, FDA and EU) for microbiology testing related to the manufacturing of sterile and non-sterile pharmaceutical products.Knowledge of the recently implemented Annex 1 and ability to perform a comprehensive gap analysis and implement actions to meet requirements.
Experience writing microbiological Standard Operating Procedures, method/equipment qualification protocols and method transfers.
Extensive experience performing testing for the enumeration and identification of microorganisms from raw materials, products, environment and utilities.
Extensive experience in conducting and/or reviewing microbial and/or endotoxin OOS investigations and the implementation of corrective actions and preventive actions (CAPAs) via change controls.
Responsibility for a Microbiology Laboratory to ensure timely completion of raw materials, in process testing and Drug Substance/Product release.
Performing routine record review and data analysis to identify trends. Update management on trends and implement corrective action plans when necessary.
Representing the company as an SME during GMP regulatory inspections and client audits to address microbiology issues and develop solutions.
Experience in coaching, mentoring, and training not only microbiologists but cross-functional team members in microbial principles and behaviour in environmentally controlled clean rooms.
Establishing a strong Microbiology presence in the organization by working closely with and assisting other teams to solve microbiology related issues.
Managing a team of professional(s) including performance management, succession planning (coach and develop employees) and distribution of workload.

Requirements :

A minimum Bachelor's university degree in Microbiology. Preference will be given to candidates with an advanced degree.
5+ years of experience as a Microbiology Manager, responsible for leading a team of microbiologists within a biotechnology/pharmaceutical aseptic manufacturing environment facility.
10+ years of practical and progressive experience in a microbiology related role in the pharmaceutical industry for commercial and clinical drug products.
Demonstrated experience in microbial and endotoxin testing of in-process & finished product, aseptic process simulations, environmental monitoring and testing of utilities (water, steam, etc).
Thorough knowledge of GMP, FDA, Health Canada and EU regulations and guidances, combined with the ability to adopt best practices by responding quickly to a changing regulatory environment.
Excellent organizational skills and multi-tasking ability.
Excellent leadership, communication (written and verbal) and influencing skills.
Demonstrated ability to work in a team environment and build high-performing teams.
Proficient in the use of Microsoft software and Trackwise.

_While we appreciate all applications received, only those selected for an interview will be contacted_

Job Types: Full-time, Permanent

Pay: From $80,000.00 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 Manager: 5 years (required)
microbiology (commercial & clinical drug products): 10 years (required)

Work Location: In person