TITLE: Technical Process Lead

DEPARTMENT: Innovation, Development and Transfer Services

POSITION REPORTING TO: Technical Operations Manager

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:

3-5 years of related experience
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

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:

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 area. Require the use of PPE to prevent exposure to hazardous materials when in production area.

Critical Process Parameters jobs

Technical Process Lead