Analytical Scientist (FTC)

Bora Pharmaceuticals•Mississauga, ON

4d•Onsite

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. This is a 14 months fixed term contract (FTC) position. Responsible for analytical method development and validation, analytical testing of drug substances and drug products, cleaning validation studies in support of the new development projects. Make detailed observations, review documents, and communicate test results.

Requirements

3 years’ experience in the pharmaceutical industry.
Capable of operating analytical lab equipment (i.e., HPLC, Dissolution, GC) relevant to job.
Good understanding of analytical method development and validation.
Excellent oral and written communication.
Excellent computer skills.
Proven ability to manage tasks and meet timelines.
Good working knowledge of cGMPs, ICH and regulatory requirements for highly regulated markets.
Is a team player and can work across all levels and functions.
Well-developed multitasking abilities and strong collaborative skills.

Nice To Haves

MSc in Chemistry or equivalent with 3 years’ experience in the pharmaceutical industry.

Responsibilities

Perform routine analytical testing, method transfer, method validation and test stability batches of drug products and drug substances.
Responsible for timely execution of method development and validation to support Client’s needs.
Author protocols and technical reports related to method development, method validation, method transfer and analytical cleaning validation.
Ensure all analytical results and documentation are of high quality, generated in a timely fashion and comply with cGMP.
Conduct analytical data and reports review in a timely manner.
Provide technical expertise in support of OOS/OOT deviations.
Actively participating and/or leading RCA to resolve/trouble shoot technical problems.
Maintain extensive lateral contacts within and outside Bora.