Analytical Development Chemist II

1 week ago


Cambridge, Canada Septodont North America Full time

Join to apply for the Analytical Development Chemist II role at Septodont North America Company Details Novocol Pharma is a growing contract development and manufacturing organization (CDMO) specializing in sterile injectable cartridges and combination product manufacturing. With over 40 years in operation and 600 employees, our facility in Cambridge, Ontario serves as a significant manufacturing site within the Septodont group, producing high-volume dental anesthetic products. We are focused on serving strategic partners and patients with quality, integrity, and value. Job Summary The Analytical Development Chemist II is accountable to the Pharmaceutical Development Manager and has a primary focus on analytical development, validation, and support for Novocol Pharma CDMO projects, as well as Septodont dental projects. As a technical expert, the Analytical Development Chemist II is knowledgeable of all development and validation activities performed in the laboratory and is responsible for training, problem solving and documentation of analytical methods. Responsibilities Develops, validates, transfers, and verifies analytical methods for testing of raw materials, bulk and finished products using a variety of equipment such as UV, GC, HPLC, UPLC, LC/HRMS, LC/MS etc. Supports the generation of method development, validation, verification, and transfer related protocols and reports. Develops specifications for release and stability (when applicable) testing of raw materials, packaged components, bulk, and finished product. Performs analytical testing and evaluation of raw materials, finished products, and stability samples of development batches including samples from R&D experimental formulation development trials. Records and reports all lab data as per approved procedures and regulatory requirements. Ensures all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health & safety requirements. Maintains a clean and safe work environment in the laboratory. Serves as the SME for selected equipment in the Pharmaceutical Development laboratory. Observes and supports all safety guidelines and regulations. Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices. Performs other related tasks/duties as required. Qualifications Education B.Sc., MSc or PhD degree in analytical chemistry, biochemistry or related area. Experience A minimum 3 years of experience developing GC and HPLC/UPLC analytical methods is required. Experience testing for biological products such as peptides, proteins, and vaccines are preferred. Good working knowledge of LC/MS and a minimum of 1 year of experience in the use and/or development of methods for LC/MS analysis. Proven analytical and problem-solving skills to resolve routine and non-routine problems. Proficient understanding of regulatory requirements. Laboratory data recording skills required. Strong organizational, interpersonal and communication skills, both written and verbal. What We Offer Excellent compensation/benefits package. Bonus and reward programs. Discounted gym memberships. Programs supporting work-life balance. Employee recognition program. Professional and personal development programs. Social events and spirit days. We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview. In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process. Recruitment Fraud – please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. If you are contacted without submitting an application, please delete the message and advise your e‑mail provider. Location: North America, Canada, Cambridge – 25 Wolseley Court N1R 6X3 Cambridge. #J-18808-Ljbffr



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