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Animal Health Manufacturing Science & Technology (MS&T) Manager

Prince Edward Island BioAlliance

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Location: Charlottetown, CANADA - PRINCE EDWARD ISLAND Posted Date: 4/24/2013 Position Type: Full time Job Code: MS&T Required Education: Masters Degree

Description

Job Purpose
The role of site MS&T is the care keeping and continuous improvement of the body of technical knowledge that the Novartis site has. It includes how we manufacture our products and transmitting that knowledge into manufacturing instructions.
In direct collaboration with Manufacturing Operation/PU units and other functions like Engineering, IT,
the site MS&T head provides clear direction and the necessary support to:
1. 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.
2. Support and were appropriate lead optimization of pharmaceutical processes by applying sound
scientific reasoning (first principles) and following integrated process and technology strategies.
3. Identify and continuously apply best practises specifically in validation, training, process
changes and handling of discrepancy and investigation resolution.

Major Accountabilities
• Key member of site leadership team 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/galenical processes, raw materials and primary packaging components are in place (as applicable)
• Functional ownership for MS&T, lead and motivate team, institute development plans for the broader MS&T organization, address forward looking resource plans to adequately meet the needs of the site’s product portfolio and strategy
• Advises, guides and coaches MS&T associates for the purpose of ensuring routine operational support, identifying solutions and improvement, solving problems and decision making
• 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 Novartis Code of Conduct, company policies and Health Safety & Environment (HSE) requirements. Particular attention is to 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)
• Fosters proper communication and networking within the MS&T community 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/ Process Units (Pus) as well as to sister sites and TRD
• Develop and apply 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 (PIP) allowing for prioritization and 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 the manufacturing operations/PU
• Responsible for the design and delivery of MS&T owned technical training programs as well as appropriate technical on-boarding to ensure proper technical competency of operators and MS&T associates with respect to manufacturing and primary packaging processes
• Supports MS&T 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 Novartis division 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

Requirements

Ideal Background
Education (minimum/desirable):
• MSc. In Science, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent experience. Ph.D. preferred
Languages
• English

Relevant Experience
• Minimum 5 years experience in pharmaceutical formulation, process development, or manufacturing technology
• Preferred IQP Silver certification or Green Belt or equivalent
proficiency in applied statistics. Experience in DoE and Gage R&R
• Experience in the packaging technology for pharmaceutical
products
• Fundamental understanding of standard pharmaceutical
analytical testing
• Demonstrated understanding of Q culture and regulatory
regulations

Other Dimensions:
HSE
• Encourage and maintain safe work environment
• Ensuring HSE compliance, participate in 6S housekeeping, participate in HSE training and activities.
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