Elanco Hiring for Director, TSMS at Charlottetown, PE CA Full Time

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Position Description: The role of Director TS/MS is the care keeping and continuous improvement of the body of technical knowledge that the Elanco site has; including how e products are manufactured and translation of that knowledge into manufacturing instructions.

In direct collaboration with Manufacturing Operation units and other functions (Quality, Engineering, IT, etc) the Director TS/MS provides clear direction and the necessary support to:

Ensure the robustness of manufacturing and packaging processes so that all site products are validated and remain in constant state of validation throughout the product lifecycle. Support and where appropriate lead optimization of biopharmaceutical processes by applying sound scientific reasoning (first principles) and following integrated process and technology strategies. Identify and continuously apply best practices specifically in validation, training, process changes and handling of discrepancy and investigation resolution. Coach and develop TSMS Team members to identify strengths and weaknesses and grow the technical ability at the PEI Site year over year.

Functions, Duties, Task:

• 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 sites 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 sites product portfolio and strategy.
• Advises, guides and coaches TS/MS associates for the purpose of ensuring routine operational support, identifying solutions and improvement, solving problems, decision making and communication including quality of written reports.
• 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).
• Leads major cross functional root cause investigations and delivers clear communication to global ELANCO network.
• Foster proper communication and networking within the TS/MS network of all related divisional sites. Explores and maximizes opportunities to leverage existing programs (e.g. training).
• Committed to knowledge sharing/transfer inside site manufacturing groups as well as to sister sites and Technical R&D (TRD).
• 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.
• Owns and actively manages the Product Improvement Portfolio allowing for prioritization ensuring cross-functional contribution, as necessary.
• Via collaboration with TRD and other functions, ensures that both transfer and new product launches will be executed right first time in terms of correct technology match (equipment, materials) and effective handover to manufacturing operations.
• Responsible for the design and delivery of TS/MS owned technical training programs as well as appropriate technical on-boarding to ensure competency of TS/MS associates with respect to manufacturing and primary packaging processes.
• 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.
• Stays abreast of technological, regulatory and industry developments, e.g. via internal and external benchmarking.
• Reviews and releases regulatory proposals or information required for regulatory filings.

Minimum Qualification (education, experience and/or training, required certifications):

• 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.

Additional Preferences:

• EU GMP manufacturing experience
• Proficiency in applied statistics/Lean Six Sigma methodologies

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status