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 troubleshooting skills are required. Self‑motivated and committed to a team approach. Strong interpersonal and organizational skills. Desirable Experience 5 years pharmaceutical industry experience. Strong working knowledge of FDA regulations and requirements with the ability to integrate into projects. Strong technical writing and editing skills. Education Advanced degree (e.g. M.Sc, PhD) Microbiology, Biochemistry, Biology or PharmD is preferred. Advanced knowledge in microbiological testing techniques; extensive experience with analytical method development. Strong understanding of cGMP guidelines and FDA regulations related to the pharmaceutical industry. Other Should possess a well‑defined sense of diplomacy, including solid negotiation, conflict resolution, and people skills. Able to build and maintain lasting relationships with corporate departments and key business partners. Compensation & Benefits Competitive vacation policy effective upon hire. 13 paid holidays. 5 paid personal care days. Medical, dental, vision, STD & LTD benefits. Defined Contribution Pension plan with employer matching 5%. Employee Assistance Program. Expected Salary Range: $65,000 - $90,000 per year. About Bimeda Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science‑driven solutions to optimize the health, wellbeing and productivity of the world’s animals. Bimeda’s global innovation program sees eight state‑of‑the‑art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever‑evolving needs of the animal health industry. Bimeda’s ten manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water‑soluble powders, pastes and non‑sterile liquids. Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda‑branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry. More info at Equal Opportunity & Accessibility At Bimeda we are committed to fostering an inclusive, barrier‑free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs. We are committed to an inclusive and accessible recruitment process. We are an equal‑opportunity employer and assess candidates based on skills and experience. Canadian experience is not required. Recruitment records are retained in accordance with Ontario law. #J-18808-Ljbffr