Senior Method Development Chemist

Bimeda•Cambridge, ON

13d•CA$60,000 - CA$85,000•Onsite

About The Position

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.

Requirements

At least 5 years of drug experience developing microbiological methods in a GMP environment
Minimum B.Sc in technical field or scientific discipline (Biology, Biochemistry, Chemistry) is required.
HPLC and GC techniques, wet chemistry techniques.
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.

Nice To Haves

Experience with the requirements of ANDA, ANADA, IND, and INAD submissions is desirable.
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.
Advanced degree (e.g. M.Sc, PhD,) Microbiology, Biochemistry, Biology or PharmD is preferred.
Advanced knowledge in HPLC and GC, techniques; extensive experience with analytical method development.
Strong understanding of cGMP guidelines and FDA regulations related to the pharmaceutical industry.
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.

Responsibilities

Develops 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 validation protocols and 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.
Writes necessary documents and reports in a clear and concise manner.
Prepares product registration documentation and product chemistry packages to meet regulatory requirements.
Participates in team driven activities to new product development projects.
Other duties as assigned.