Formulation Specialist - Mississauga, Canada - Bora Pharmaceutical Services

Sophia Lee

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Sophia Lee

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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
Working as part of a team, deliver necessary formulation and formulation trials to client as discussed.

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.
D
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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