Technical Process Lead at Bora Pharmaceuticals

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.

From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.

At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

Why join Bora?

• Competitive salary
• A modern and state-of-the-art facility
• An on-site cafeteria with dedicated chefs
• On-site gym and basketball court

Click here for a video tour of our Mississauga facility: https://lnkd.in/evhPktDN

POSITION DESCRIPTION

Job Title: Technical Process Lead

Department: Pharmaceutical Development Solutions

Position Reporting To: Technical Manager

Direct Reports: None

Location: Mississauga, ON (Hybrid Schedule)

Employment Type: Full-time, Permanent

General Description:

• Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for all commercial products including Technical Risk Assessment, Product Control Strategy, trending, and maintenance of changes to ensure that the product is delivered and maintained to the highest levels of quality and robustness.

Responsibilities:

• Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), including knowledge of packaging, performance, and end to end process, including critical quality attributes (CQAs)and critical process parameters (CPPs).
• Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs
• Maintain accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approach for the product.
• Establish process understanding using statistical tools to develop models/design spaces and identify patterns and relationships between CPPs and CQAs.
• Participate in technical transfer activities from clients.
• Responsible for reviewing and approving master production batch records.
• Provide impact assessment on excipient changes that can impact CQAs/CPPs .
• Provide technical input and lead root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.
• Ensures a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialization of new products.
• Provides leadership and establishes key relationships within site across Operations, Technical, Quality and Engineering for the new or established product(s).
• Provides technical input to Periodic Product Reviews, and internal and external audits.

Qualifications:

Experience and Skills

• Minimum 5 years of combined experience working in the pharmaceutical industry.
• Detailed knowledge of relevant dosage forms including unit operation understanding, functionality and critically of formulation materials, plant equipment and analytical testing.
• Experienced in technology transfer, with an understanding of the product development process.
• 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.
• Knowledge with statistical software (e.g., Statistics, JMP, SIMCA etc.) is an asset.

Education

Required:

• Bachelors of Science or equivalent- A scientific discipline such as chemical engineering, chemistry, pharmacy, Process Engineer or pharmaceutical sciences.

Preferred:

• Masters of Science or Ph.D

Working Conditions

• Hybrid schedule (Standard Office and Remote).
• Mainly office environment with regular visits to production area. Require the use of PPE to prevent exposure to hazardous materials when in production area.

Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. Bora is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected].

Please do not send resumes to this email and instead apply through the online application process of this posting.