Senior Method Development Chemist

Job Title: Senior Method Development Chemist

Location: Cambridge, ON (In Office)

Position Type: Full time Fixed Term (18 Months Contract)

Vacancy Status: This contract position will become vacant in May 2026

AI Disclosure: We do not use artificial intelligence to screen, assess, or select applicants.

Job Summary

The Senior Method Development Chemist is responsible for developing and validating robust methods for the analysis of new products in support of new product registrations for global markets. The Senior Method Development Chemist serves as a technical expert who supports new product application submissions, new product method improvements and cost savings initiatives.

Role Specific Requirements

• Develop analytical procedures and methods for raw material and/or finished product using up to date knowledge in various analytical techniques and ICH/VICH guidelines.
• Ensure that all work is carried out in compliance with company safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
• Create project timelines in accordance with marketing priorities, set milestones/critical path and ensure on time project completion.
• Write validation protocols and reports.
• Think critically and respond to issues in a timely manner with little supervision.
• Execute stability studies on new products under development and analyze/report stability trends.
• Establish specifications for new and/or reformulated products.
• Write necessary documents and reports in a clear and concise manner.
• Prepare product registration documentation and product chemistry packages to meet regulatory requirements.
• Participate in team driven activities for new product development projects.
• Other duties as assigned.

Competencies

Analytical Thinking / Problem Solving - Identify necessary information, seek it from various sources, tackle problems with a logical, systematic approach and deduce cause and effect.

Creativity and Innovation - Create and implement new product, process or service to improve efficiency, effectiveness or competitive advantage.

Critical Thinking - Draw pertinent conclusions after discussion and support final outcomes and decisions.

Collaboration / Teamwork - Work jointly with others, build partnerships for global performance, and respect others.

Effective Communication - Convey information clearly and efficiently, listen, confirm understanding, communicate using data and facts, and show respect.

Other 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 a technical field or scientific discipline (Biology, Biochemistry, Chemistry) is required.
• Advanced degree (e.g. M.Sc, Ph.D., Microbiology, Biochemistry, Biology or PharmD) is preferred.

Technical Skills

• Proficiency in HPLC and GC techniques, wet chemistry techniques.
• Advanced knowledge in HPLC and GC techniques, extensive experience with analytical method development, and strong understanding of cGMP guidelines and FDA regulations related to the pharmaceutical industry.

Other

• Good written and verbal communication skills.
• Good organizational and troubleshooting skills.
• 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.
• Strong technical writing and editing skills.
• 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.
• 13 paid holidays.
• Employee Assistance Program.
• Expected Salary Range: $60,000 - $85,000 per year.

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 an equal opportunity employer and assess candidates based on skills and experience. Recruitment records are retained in accordance with Ontario law.