R&D Microbiologist, New Product Development in Cambridge

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

• Develops 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: 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.
• CREATIVITY AND INNOVATION: Ability to create, develop and implement a new product, process or service with the aim of improving efficiency, effectiveness or competitive advantage.
• CRITICAL THINKING: Ability to be thoughtful and draw pertinent conclusions after a discussion or meeting; can eventually support the final outcomes and decisions.
• FOSTERING COLLABORATION/TEAMWORK: 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.
• EFFECTIVE COMMUNICATION: Ability to convey information to another effectively and efficiently, to listen; help facilitate sharing of information between people.

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. 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): Advanced degree (e.g. M.Sc, PhD) in 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 (Benefits): 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. Competitive vacation policy effective upon hire. 13 paid holidays. 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.

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.