R&D Microbiologist, Product Development

Position: R&D Microbiologist, New Product Development
Job Title:

R&D Microbiologist, New Product Development

Location:

Cambridge, ON (In-Office)
Position Type:
Full-time
Vacancy Status:
This position will become vacant in March 2026
AI Disclosure in Hiring:
We do not use artificial intelligence to screen, assess, or select applicants

Job Summary
The R&D Microbiologist is responsible for developing and validating robust methods for the microbiological analysis of new products in support of new product registrations for global markets. The R&D Microbiologist serves as a technical expert who supports new product application submissions, new product method improvements and cost savings initiatives.

Role Specific Requirements

Develop microbiological analytical procedures and methods for raw material and/or finished product using up-to-date knowledge in various analytical techniques and ICH/VICH guidelines.

Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).

Creates Project Timelines in accordance with marketing priorities, sets milestones/critical path and ensures on time project completion.

Writes suitability protocols and development reports.

Is able to think critically and respond to issues in a timely manner with little supervision.

Responsible for executing stability studies on new products under development and analyzing/reporting stability trends.

Establishes specifications for new and/or reformulated products.

Writes necessary documents and reports in a clear and concise manner.

Prepares product registration documentation and product microbiology packages to meet regulatory requirements.

Participates in team driven activities to new product development projects.

Other duties as assigned.

Competencies required for the role
ANALYTICAL THINKING/PROBLEM SOLVING
is the ability to identify the information needed to clarify a situation,

seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this

CREATIVITY AND INNOVATION
is the ability to create, develop and implement a new product, process or service with the aim of improving efficiency, effectiveness or competitive advantage. Also, the ability to transcend traditional ideas, rules, patterns, relationships, or the like, and to create meaningful new ideas, forms, methods, or interpretations.

CRITICAL THINKING
– is the ability to be thoughtful and draw pertinent conclusions after a discussion or meeting; can eventually support the final outcomes and decisions.

FOSTERING COLLABORATION/TEAMWORK
is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

EFFECTIVE COMMUNICATION
Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others.

Requirements
Experience

At least 5 years of drug experience developing microbiological methods in a GMP environment,

Experience with the requirements of ANDA, ANADA, IND, and INAD submissions is desirable.

Education

Minimum

B.Sc in technical field or scientific discipline (Biology, Biochemistry) is required.

Technical

BET, AET, Sterility Bioburden, and microbial enumeration testing. Thorough understanding of microbiological method development and suitability testing (NIC, IET, MVD, MVC etc.)

Other

Good written and verbal communication skills are required.

Good organizational and…