Description

　　Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.

　　Overview of this Position:

　　The Process and Product Support Supervisor is responsible for leading the Manufacturing Science and Technology (MSAT) specialists that are assigned to formulation and filling activities related to new projects and technical transfer, finishing activities, or commercial production support and technical services. This position's primary responsibility is to manage new equipment implementation and the technical responsibilities of the client manufacturing processes at GRAM. This includes the interpretation of client supplied documentation (i.e. batch records, product inserts, product proposal, work orders, etc.) and translating manufacturing and finishing requirements into GRAM specific batch records, specifications and procedures. Leads and/or works within cross-functional teams to support product scale-up, development and technical transfer to support Project Management, Manufacturing, Finishing, Quality Assurance, Quality Control, Business Development, and Validation. Experience level will determine candidacy for supervisor or manager level.

　　Non-Negotiable Requirements:

　　Bachelor's degree in Life Sciences or related field.

　　Knowledge of project management techniques and tools.

　　Minimum of 3-5 years' related work experience in a pharma, biopharma, and/or biotech manufacturing environment.

　　Experience and expertise in manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards.

　　Proficient computer skills in Microsoft Word, Excel, and Outlook.

　　Preferred Requirements:

　　Engineering skills (e.g. mechanical, electrical, controls) are strongly desired.

　　Minimum of 5 years in an aseptic environment preferred.

　　Minimum of three (3) years' work experience in the capacity of a Process and Product Support Specialist type of role is preferred.

　　Responsibilities Include (but are not limited to):

　　Manage and assign MSAT responsibilities for project work related to filling equipment, finishing equipment, and/or client technical transfer projects.

　　Lead regular scheduled MSAT filling, finishing, and/or commercial project meetings to obtain project updates, risks, and process improvement initiatives.

　　Report MSAT related updates to the MSAT Manager.

　　Support and monitor the training of new employees in MSAT related to filling and/or finishing activities for technical transfer projects.

　　Conduct the identification and transfer of manufacturing and/or finishing processes from early-stage development through transition to commercial manufacturing.

　　Conduct new equipment and materials identification, evaluation, and procurement in support of product scale up, process improvements, and commercial support projects.

　　Proficiency to create and/or revise Master Batch Records, including, but not limited to all supporting systems and documentation (i.e. specifications, change control, procedures, etc.).

　　Function as the MSAT representative within client and cross-functional teams to identify manufacturing processes and address product transfer requirements. Translate all manufacturing requirements into draft MBRs and conduct peer-review activities.

　　Prepare GRAM sample plans from client documentation, GRAM protocols or other support doc