Microbiologist R&D and Method Optimization
1 month ago
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
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Under the direction of the Supervisor R&D and Method Optimization, the Microbiologist QS6 will participate in projects for developing suitable test methods and continuous improvement in methods or method execution.
The Microbiologist QS6 will support projects for Formulation Development, Research and Development and contract manufacturing partners within the worldwide Apotex microbiology network.
Job Responsibilities- Displays strong technical skills and proficiency in microbiological method development.
- Assists with projects in support of the global microbiology network.
- Assists in the drafting of protocols. Executes protocols.
- Plans individual projects to ensure timely completion.
- Serves as technical resource within the global microbiology team.
- Offers assistance to team members with microbiological analysis.
- Good understanding of microbiology, compendial/regulatory requirements on a global scale.
- Works collaboratively with microbiologists and the supervisor. Offers resolution to problems.
- Demonstrates thorough working knowledge of LIMS and shares LIMS expertise.
- Assists laboratory management in the development of all levels of microbiologists.
- As a qualified trainer, participates in the training of microbiologists in microbiological techniques.
- Assists in the technical development of junior microbiologists for performance of job requirements.
- Provides technical guidance to junior microbiologists on a daily basis.
- With a keen eye for detail, reviews work for accuracy and alignment with procedures.
- Excellent verbal and written communication skills; clear and concise technical writer.
- Assists with projects for Formulation Development/ Research and Development business partners.
- Provides assistance during audits/ inspections.
- Coordinates and monitors the availability of laboratory supplies and equipment.
- Understands regulatory requirements and standards (FDA, EU, ICH, ISO, USP).
- Develops reviews and revises laboratory methods and Standard Operating Procedures.
- Works within cross-functional teams; communicates progress effectively to other team members.
- Promotes a positive work environment, motivating peers.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
- Education
- Sc. in Microbiology, or similar qualification in related field.
- Knowledge, Skills and Abilities
- Computer skills; good understanding of LIMS would be an advantage.
- Able to interpret results and perform work with minimal supervision.
- Good interpersonal and communication skills.
- Detail oriented with excellent problem solving skills.
- Knowledge of compendia, regulatory requirements and Good Laboratory Practices.
- Proven organizational and time management skills, as demonstrated through previous work and/or educational experience.
- Experience
- 2 years' experience in a pharmaceutical microbiology laboratory.
- Experience working with microbial cultures and developing microbiological methods.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
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