Piramal Enterprises
Technical Services Manager
Piramal Enterprises, Lexington, Kentucky, us, 40598
Business: Pharma SolutionDepartment: Technical Services GroupLocation: Lexington
Job Overview
Responsible for the production process development, scale up, and commercialization of parenteral pharmaceutical products. As a discipline of engineering, this position includes all product and process activities related to the manufacture of new products.
Reporting Structure
Job title of immediate supervisor/manager:
Director, technical operations
Skip level supervisor/manager:
Avp & site head
Education requirements:
Bachelor’s degree in mechanical, biological, chemical engineering; or equivalent years of field experience
Experience
5-7 years of working within pharmaceutical manufacturing/development environment, including development of processes and products
Formal leadership/management experience
Experience working within aseptic or lyophilization manufacturing
Contract manufacturing experience strongly preferred
Functional or technical skills:
Well versed in quality by design and scale up of pharmaceutical products
Knowledge and understanding of the regulatory approval process for us, eu, and jp
Expertise in product scale up
Knowledge and understanding of cgmps; knowledge of cgmp validation requirements and techniques.
Knowledge and experience in cgmp ca/pa, root-cause analysis, risk assessment and investigation tools and techniques
Experience managing direct reports
Seasoned communicator, ability to interface effectively with all levels of the organization and clients
Proficiency using microsoft office applications (word, excel, powerpoint)Ability to effectively lead cross-functional teams
Key Responsibilities
Responsible for design, project management, implementation, enhancement and validation of new and existing systems, processes, and equipment to support the transfer of new products from r&d to clinical and commercial manufacturing
Manage a team of process engineers to tech transfer new products and develop the product for commercial manufacturing including the development and challenging of critical quality parameters and attributes (cpp’s and cqa’s) including qtpp, scale up report, and final product specific technical documentation following qbd q8, q9, and q10
Responsible for the development of robust and repeatable commercial processes
Responsible for the design and fit for purpose equipment, processes and technology selections to ensure reliable and repeatable processes that can be easily followed by the manufacturing operations team
Primary subject matter expert (sme) for all commerical/clinical manufacturing processes
Interface with clients and regulators
Identify and assign continuous improvement projects
Represents technical subject matter expert (sme) in product development, scale up, and optimization of new products.
Supports day-to-day production and maintenance activities as required for product specific attributes, characteristics, and behavior
Provides training support as required
Participates in deviation investigations to identify root causes and define corrective and preventive actions (ca/pa) as related to product chemistry and manufacturing properties
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Job Overview
Responsible for the production process development, scale up, and commercialization of parenteral pharmaceutical products. As a discipline of engineering, this position includes all product and process activities related to the manufacture of new products.
Reporting Structure
Job title of immediate supervisor/manager:
Director, technical operations
Skip level supervisor/manager:
Avp & site head
Education requirements:
Bachelor’s degree in mechanical, biological, chemical engineering; or equivalent years of field experience
Experience
5-7 years of working within pharmaceutical manufacturing/development environment, including development of processes and products
Formal leadership/management experience
Experience working within aseptic or lyophilization manufacturing
Contract manufacturing experience strongly preferred
Functional or technical skills:
Well versed in quality by design and scale up of pharmaceutical products
Knowledge and understanding of the regulatory approval process for us, eu, and jp
Expertise in product scale up
Knowledge and understanding of cgmps; knowledge of cgmp validation requirements and techniques.
Knowledge and experience in cgmp ca/pa, root-cause analysis, risk assessment and investigation tools and techniques
Experience managing direct reports
Seasoned communicator, ability to interface effectively with all levels of the organization and clients
Proficiency using microsoft office applications (word, excel, powerpoint)Ability to effectively lead cross-functional teams
Key Responsibilities
Responsible for design, project management, implementation, enhancement and validation of new and existing systems, processes, and equipment to support the transfer of new products from r&d to clinical and commercial manufacturing
Manage a team of process engineers to tech transfer new products and develop the product for commercial manufacturing including the development and challenging of critical quality parameters and attributes (cpp’s and cqa’s) including qtpp, scale up report, and final product specific technical documentation following qbd q8, q9, and q10
Responsible for the development of robust and repeatable commercial processes
Responsible for the design and fit for purpose equipment, processes and technology selections to ensure reliable and repeatable processes that can be easily followed by the manufacturing operations team
Primary subject matter expert (sme) for all commerical/clinical manufacturing processes
Interface with clients and regulators
Identify and assign continuous improvement projects
Represents technical subject matter expert (sme) in product development, scale up, and optimization of new products.
Supports day-to-day production and maintenance activities as required for product specific attributes, characteristics, and behavior
Provides training support as required
Participates in deviation investigations to identify root causes and define corrective and preventive actions (ca/pa) as related to product chemistry and manufacturing properties
#J-18808-Ljbffr