Formulation Specialist - Mississauga, Canada - Bora Pharmaceutical Services
Description
Location:
***- Mississauga, ON
Date Posted:***- 5/2/2023
Job Number:***- JO
TITLE: IDTS - Formulation Specialist
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DEPARTMENT: Innovation, Development and Transformational Services (IDTS)
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CURRENT
GRADE: 7
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POSITION REPORTING TO: IDTS
- Tech Transfer Manager
General Description
Be responsible for ensuring all technical aspects of the formulation for a client are put in place, this is a client facing role.
Responsibilities
- Assessment of information from the client on the potential new product to identify high level process issues, or equipment needed
- Assessment of new product formulation by leveraging previous knowledge and process/equipment on site.
- Accountable for key documents in formulation development and attention to detail while writing up accurate and detailed lab work.
- Establish process understanding for product, while establishing knowledge to define critical parameters of the new process relating to product CQAs.
- Provide technical input and lead root cause analyses to support investigations that may arise during the development process.
- Ensures a robust and well understood process and product control strategy are transferred to technical operations team and into Production as required.
- Provides leadership and establishes key relationships within IDTS team including Analytical Science, Tech Transfer leads, Project Managers and QA
- Provides technical input during Client and regulatory audits.
Qualifications
Experience and Skills
- Detailed knowledge of relevant dosage forms including, unit operation understanding, functionality and critically of formulation materials, plant equipment and analytical testing.
- Experienced in the product development process. with an understanding of technology transfer
- Ability to effectively communicate and build working relationships with internal teams/clients.
- Thorough knowledge of GMP and EHS requirements.
- Able to assess/evaluate statistical data e.g., process capability, control charts, DoE, MVA.
- Working knowledge of key statistical software (e.g JMP), is an asset.
Education
Required:
- BSc or equivalent
- A scientific discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical sciences
Preferred: - MSc or Ph.
WORKING CONDITIONS
Mainly office environment with regular visits to production areas. Require the use of PPE to prevent exposure to hazardous materials when in production area.
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