Evonik Industries, its Burnaby, B.C. site, specializes in parenteral formulation development and manufacturing process design and implementation at small, intermediate, and large/commercial scales. This enables manufacturing of complex lipid-based formulations of therapeutic agents for preclinical and clinical testing in its state-of-the-art R&D and manufacturing facilities and transfer of drug product manufacturing to commercial facilities. Core manufacturing technologies include liposome extrusion, micro-mixing, tangential flow filtration (TFF) and sterile filtration with availability of small to large-scale equipment.
The site currently has an opening for a Research Associate - Process Development position, responsible for the development and scale-up manufacturing of lipid nanoparticle-based drug formulations and technology transfer to GMP production.
- Scale up and evaluate manufacturing processes at the 100 mL to 100 L scale;
- Perform quantitative analyses on formulations and processes and analyze data;
- Transfer manufacturing processes from R&D to Process Development and from Process Development to GMP production;
- Support all aspects of the manufacture of Test Articles for use in GLP toxicology studies as well as Drug Products prepared in the GMP suite;
- Closely work with the in-house Research, Analytical and GMP manufacturing groups;
- Perform equipment DQ/IQ/OQ/PQ;
- Prepare process equipment and buffer solutions (including large volumes);
- Assist with inventory control and supply chain activities;
- Prepare protocols, technical reports, data summaries and presentations.
- Effectively communicate in oral and/or written form to internal and external audiences;
- Prepare, review and update laboratory procedures as required
- Perform other duties as assigned
- BSc or MSc degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Engineering or related field with a minimum of 3 years of work experience related to formulation development, process development, manufacturing or a related relevant field (industry experience preferred).
- Experience with general laboratory instrumentation and techniques including aseptic methods;
- Understanding of experimental design;
- Mechanically inclined; adept at troubleshooting plumbing and electrical issues;
- Work involves some heavy lifting (up to 50 kg) and maneuver large heavy equipment on wheels;
- Basic knowledge of GMP and CMC regulatory requirements;
- Must possess strong problem solving, organizational, and documentation skills with a focus on details and results;
- Ability to work independently as well as in a team;
- The candidate should be self-motivated and possess good interpersonal, collaborative, and communication skills.
Posted: February 16, 2019
Closes: April 17, 2019