Senior Method Development Chemist

Senior Method Development Chemist

Cambridge, ON (In-Office)

Full-time Fixed Term (18 Months Contract)

Vacancy will become vacant in May 2026

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 saving initiatives.

Responsibilities

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 required for the role

Analytical Thinking / Problem Solving  – Identify information needed to clarify a situation, seek that information from various sources, and tackle a problem using a logical, systematic, sequential approach. Identify and separate key components of problems and situations, interpret information from a range of sources to spot patterns and trends, and deduce cause and effect.

Creativity and Innovation  – Create, develop and implement a new product, process or service with the aim of improving efficiency, effectiveness or competitive advantage; transcend traditional ideas, rules, patterns, relationships, or the like, and create meaningful new ideas, forms, methods, or interpretations.

Critical Thinking  – Be thoughtful and draw pertinent conclusions after a discussion or meeting; support final outcomes and decisions.

Fostering Collaboration / Teamwork  – Work jointly with others or together especially in an intellectual endeavor; demonstrate the ability and desire to work cooperatively with others on a team, build partnerships for global performance, and respect others.

Effective Communication  – Convey information to another effectively and efficiently, listen, facilitate sharing of information, understand emotional intention behind information, express oneself clearly, confirm understanding, and communicate using data and facts.

Required 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.

Required Education

Minimum

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

Required Technical Skills

HPLC and GC techniques, wet chemistry techniques.

Required Other Skills

Good written and verbal communication skills.

Good organizational and troubleshooting skills.

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.

Desirable Education

Advanced degree (e.g. M.Sc, PhD, Pharm

D) in Chemistry, Analytical Chemistry, Microbiology, Biochemistry, Biology preferred.

Desirable Technical Skills

Advanced knowledge in HPLC and GC techniques; extensive experience with analytical method development. Strong understanding of cGMP guidelines and FDA regulations related to…