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VACANCY REFERENCE NUMBER 116101
Senior Associate, GMP Manufacturing
Location : Burnaby, BC
Legal Entity : Evonik Canada Inc.
Business Line : Health Care
Evonik stands for attractive business and innovative prowess. Our corporate culture is geared toward results, profitable growth, and increasing the value of the company.
Operating in over 100 countries, we benefit from close customer relationships and leading market positions. Over 36,000 employees are united by the understanding that no product is so perfect that you can't make it better.
Evonik Vancouver Laboratories is a contract development and manufacturing organization (CDMO) that offers Chemistry, Manufacturing and Control (CMC) services to customers conducting pharmaceutical research and development.
With proven success in moving drug candidates from the bench into clinical trials, the site focuses on lipid nanoparticle (LNP) drug delivery systems from pre-
formulation R&D services through GMP clinical trial manufacturing and commercial process development. Evonik Vancouver Laboratories is the leader for advanced lipid nanoparticle drug delivery with significant expertise in siRNA, mRNA, peptides and high potency APIs.
Participates and leads aseptic manufacturing of Drug Products compounding, preparation, filtration and filling activities.
Provides technical expertise and supports all aspects of the manufacture of Drug Products in cleanroom environment according to appropriate GMP regulations and legal requirements (FDA, USP, EP, Health Canada).
Serves as a key representative on multidisciplinary project teams to help define processes, equipment requirements, and quality attributes.
Seeks and identifies opportunities for continuous improvement and optimization of GMP activities, and intra-departmental workflow.
Provides training and mentorship to other Department members on the usage and maintenance of equipment, sterile manufacturing techniques, tools and methodologies.
Contributes actively to increase GMP process understandings and transfer of knowledge.
Samples raw materials, Active Pharmaceutical Ingredients (APIs), In-process Control Samples, Test Articles and Drug Products.
Participates in the inspection, labeling, packaging and storing of Drug Products vials.
Documents GMP Manufacturing activities by completing forms, reports, logs, and records of equipment and batches.
B.Sc. or College diploma in Chemical or Industrial Engineering, Pharmaceutical Sciences, Biochemistry, Chemistry or equivalent.
5-7 years of industry experience working in a sterile product manufacturing facility under current Good Manufacturing Practices (GMPs).
Knowledgeable on lean manufacturing, quality systems and industry standards a definite asset.
Strict adherence to GMP Regulations and the ability to learn new techniques quickly and skillfully.
Ability to work as an effective team member is an indispensable asset. Team leadership qualifications are essential.
Strong communication abilities, problem-solving skills, and capability to show flexibility within the workplace.
Ability to perform the physical tasks associated with manufacturing operations.