Manufacturing Science and Technology (MSAT) Product and Process Support Specialist
Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? 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!

NON-NEGOTIABLE REQUIREMENTS:

• Bachelor’s degree in Life Sciences or related field
• A minimum of 2-4 years’ related work experience in a pharmaceutical, bio pharmaceutical, and/or biotechnology 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:

• Knowledge of project management techniques and tools.
• Minimum of 2 years in an aseptic pharmaceutical manufacturing and/or finishing environment.
• Minimum of 1 year work experience in the capacity of MSAT or Technical Services preferred.

Responsibilities Include (but are not limited to):

• Conduct the identification and transfer of manufacturing processes from early-stage development through transition to commercial manufacturing.
• Conduct the identification and transfer of finishing processes (Terminal Sterilization, Inspection, Labeling and Packaging) from engineering through commercial finishing.
• Conduct new equipment and materials identification, evaluation, and procurement in support of new products, product scale up, and process improvements.
• Create and/or revise documentation in support of deviations, quality investigation and corrective actions.
• Work with Manufacturing, Finishing, Engineering, and Quality personnel to solve difficult technical problems, with Subject Matter Expertise (SME) in aspects of manufacturing and/or finishing environment.
• Recommend materials and component applications for new products (i.e. product contact material, filters, tubing, vials, stoppers, caps, cartons, labels, shippers, etc.).
• Directly support production with subject matter expertise to increase efficiency, solve problems, and troubleshoot issues.
• Prepare and conduct unassisted training of Manufacturing and Quality personnel for new product introduction, protocol execution and unique manufacturing processes.

Full job description available during formal interview process.

PAY: DEPENDS ON EXPERIENCE AND IS DISCUSSED DURING THE INTERVIEW PROCESS.

If you meet the required criteria listed above, GRAM welcomes you to apply today

• Conduct the identification and transfer of manufacturing processes from early-stage development through transition to commercial manufacturing.
• Conduct the identification and transfer of finishing processes (Terminal Sterilization, Inspection, Labeling and Packaging) from engineering through commercial finishing.
• Conduct new equipment and materials identification, evaluation, and procurement in support of new products, product scale up, and process improvements.
• Create and/or revise documentation in support of deviations, quality investigation and corrective actions.
• Work with Manufacturing, Finishing, Engineering, and Quality personnel to solve difficult technical problems, with Subject Matter Expertise (SME) in aspects of manufacturing and/or finishing environment.
• Recommend materials and component applications for new products (i.e. product contact material, filters, tubing, vials, stoppers, caps, cartons, labels, shippers, etc.).
• Directly support production with subject matter expertise to increase efficiency, solve problems, and troubleshoot issues.
• Prepare and conduct unassisted training of Manufacturing and Quality personnel for new product introduction, protocol execution and unique manufacturing processes