Director, Technical Services Manufacturing Science

PUB307254

About this role

About this role

We’re hiring a Director of Technical Services / Manufacturing Science for our client, a large pharmaceutical company producing medicines and vaccinations for pets and livestock. The Director or TS/MS is the care keeping and continuous improvement of the body of technical knowledge the site; including how products are manufactured and translation of that knowledge into manufacturing instructions. This permanent opportunity is based out of Charlottetown, PEI.

  • Key member of plant leadership team (PLT) and expected to play a full part in driving continuous improvements and supporting strategic developments.
  • Ensure that the technical competencies/knowledge for the site’s chemical/biological processes, raw materials, sterile processes, and primary packaging components are in place (as applicable)
  • Functional ownership for TS/MS; lead and motivate team, institute development plans for the organization, address forward looking resource plans to adequately meet the needs of the site’s product portfolio and strategy.
  • Owns and promotes robust end-to-end product stewardship, ensuring single point of contact for products within the site and across sites for multi-site products. Assesses APRs/PQRs.
  • Owns the overall Validation Master plan and coordinates all related activities.
  • Ensures adherence to cGMP requirements, guidelines, SOPs, as well as compliance to local laws, the Elanco Red Book, company policies and Health Safety & Environment (HSE) requirements. Particular attention is given to the protection of employees, patients, company assets and the environment.
  • Promotes excellence in Packaging and Pharmaceutical Processing in the plant. Ensures that the site has set and rigorously applies appropriate technical standards for processing, packaging and materials where applicable, employing new/modern processes and technologies like Quality by Design (QbD), Design of Experiment (DOE) and Process Analytical Technologies (PAT).
  • Drives the product control strategy including development and application of KPIs to enable meaningful CPP/CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues.
  • Supports TS/MS staff during the execution of process improvements, scale-ups, and justification/verification projects. Oversees that the process justification/verification batches generate sufficient process knowledge by thoroughly testing critical variables.
  • Provide meaningful and up to date scientific/technical input into User Requirement specifications, in accordance with Elanco manufacturing/packaging standards and strategy.
  • Reviews and releases regulatory proposals or information required for regulatory filings.

Requirements

Requirements

  • MSc in Science, Pharmacy, Mechanical or Chemical Engineering, Pharmaceutical Technology, or equivalent experience.
  • 5+ years’ experience in technical management position.
  • 5+ years’ experience in pharmaceutical formulation, process development, or manufacturing technology.
  • Experience in the packaging technology for pharmaceutical products.
  • Ability to lead and develop a Team.
  • Fundamental understanding of pharmaceutical analytical testing.
  • Demonstrated understanding of Q culture and regulatory regulations.
  • Experience with applied statistics/ Lean Six Sigma methodologies is an asset

Benefits

Benefits

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Join the Brunel Family

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Start applying immediately

Start applying immediately

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  • Job references (optional)
  • Motivation Letter (optional)
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Any questions remaining?

Your consultant, Chris Kapusta is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB307254

Account manager

Chris Kapusta
Brunel Canada - Calgary
c.kapusta@brunel.net

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