The QC Chemistry Analyst role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of the new strategic Drug Substance facility. This tremendous opportunity will be responsible for qualifying the Chemistry analytical lab and in the transfer of Chemistry analytical methods. This person will be key in the layout of the lab testing to ensure the process is streamlined and in line with the companies lean methodologies.
Additional development opportunities within the micro and chemistry lab will be strongly considered to recognize the tremendous value of knowledge/experience gained by the candidate during the project phases. To maximize the development opportunity, the candidate will be the key talent in analytical Chemistry techniques and in Pharmacopeia methods.
The facility will utilize the latest innovations in technology and automation and the latest in analytical technics. The candidate will work with a high performing cross-functional team of talent sourced from across the company and the biotechnology industry.
The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise. The full analytical scope will incorporate micro, chemistry, bioassay, raw materials, stability, and in-process). Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc) will allow the candidate to challenge current thinking in designing for the future. The candidate will have responsibilities in analytical transfer and qualification of methods.
• The motivation to be an inspiring member of a high performing team.
• The desire to continuously learn, improve, and develop.
• Perform supportive activities for general lab readiness, laboratory equipment qualification, and method transfers.
• Perform and carry out a variety of routine analytical techniques including but not limited to HPLC, HIC, CE, IEX, HP-SEC, UV, pH, Colour, Osmolality, Degree of Coloration, and Appearance in compliance with GMP requirements.
• Follow up-to-date analytical practices with reference to pharmacopeias, specifications, regulations, and industry standards.
• Support the laboratory testing schedule to achieve an efficient QC system.
• Receive and manage samples that come into the lab for stability, in-process, and release testing.
• Solution preparation, cleaning, routine equipment maintenance, and system set-up.
• Writing and update of SOPs.
• Maintain good housekeeping and hygiene within the laboratory.
• Calibrate and maintain all designated laboratory instruments.
• Participate in risk assessments, inspections, audits, incident investigations, etc., and implement and follow-up on corrective/preventative measures.
• Ensure training is current for all job functions performed.
• Assist in training new QC Analysts on routine procedures and practices.
• Order, stock, and receive laboratory supplies.
• Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
• Ensure that cGMP standards are always maintained.
• Delivery of area performance to meet or exceed performance or quality goals.
• Promote and participate in the implementation and maintenance of the relevant safety programmes.
• Participate and Comply with the the company’s Quality Management System requirements.
• Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools.
• This position will be on days with the possibility of shift work when required.
• Degree qualification (Science/Quality/Technical).
• Graduate entry-level with 6-12 months experience desired. Prior experience working in a GMP Chemistry lab unit preferred.
• Ability to respond to changing priorities.
• Strong organizational skills
• Good verbal and written communication skills
• Good attention to detail
• Ability to think critically, logically, and be proactive.
• Ability to work as part of a team and on own initiative in a constructive manner
• Flexible and self-motivated
• Experience in High-Performance Liquid Chromatography with Empower 3, Capillary Electrophoresis, Osmolality, pH, Appearance testing, UV, preferable.
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