MSAT Supervisor, Tech Transfer

Description

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!

Overview of this Position:

The MSAT Supervisor is responsible for leading the MSAT specialists that are assigned to formulation and filling activities related to new projects and technical transfer. This includes new project evaluation, process fit to plant analysis, formulation and filling operations. Manages new equipment implementation and the technical responsibilities of client manufacturing processes at GRAM related to filling activities as directed by immediate manager. This includes the interpretation of client supplied documentation (i.e. batch records, product inserts, product proposal, work orders, etc.) and translating manufacturing requirements into GRAM specific batch records, specifications and procedures. Lead and/or works within cross-functional teams to support product scale-up, development and technical transfer to support Project Management, Finishing, Quality Assurance, Quality Control, Business Development, and Validation.

Non-Negotiable Requirements:

• Knowledge of project management techniques and tools.
• Completion of a bachelor's degree in Life Sciences or related field is required.
• A minimum of 3-5 years' related work experience in a pharma, biopharma, and/or biotech manufacturing environment, preferably an aseptic environment.
• Experience and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is a must.
• Minimum of 5 years in an aseptic pharmaceutical manufacturing and/or finishing environment. Minimum of three (3) years' work experience in the capacity of MSAT or Technical Services preferred.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Minimum of 5 years in an aseptic pharmaceutical manufacturing and/or finishing environment. Minimum of three (3) years' work experience in the capacity of MSAT or Technical Services preferred. Knowledge of project management techniques and tools.

Responsibilities Include (but are not limited to):

• Manage and assign MSAT responsibilities for project work related to filling equipment, and client technical transfer projects.
• Lead regular scheduled MSAT filling meetings to obtain project updates, risks, and process improvement initiatives.
• Report MSAT filling and client technical transfer related updates to the MSAT Manager.
• Support and monitor the training of new employees in MSAT related to filling activities for technical transfer projects.
• Conduct the identification and transfer of manufacturing processes from early-stage development through transition to commercial manufacturing.
• Conduct the identification and transfer of filling processes (formulation, filtration, filling) from engineering through transition to commercial production.
• Conduct new equipment and materials identification, evaluation, and procurement in support of new products, product scale up, and process improvements.
• 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.).
• Under limited supervision create, revise, and archive material and component specifications using the electronic document management system (MasterControl). Develop proficiency to operate within the MasterControl application.
• Create and/or revise documentation in support of deviations, quality investigation and corrective actions.
• Subject Matter Expertise (SME) in one or more of the many areas associated with Tech. Services support (i.e. compounding, filtration, filling, component specifications, etc.).
• Recommend materials and component applications for new products (i.e. fluid paths materials, primary components, etc.).
• Work with Manufacturing, Finishing, Engineering, and Quality personnel to solve difficult technical problems, with Subject Matter Expertise (SME) in aspects of product filling environment.
• 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 documents. In support of sample plans, prepare all associated labels and forms, conduct personnel training, and work cross functionally with the MSAT finishing team for batch requirements for end-to-end coverage.
• Prepare and execute feasibility study documentation to support data gathering and process justification activities.
• Prepare/Review risk assessments and FMEA documentation related to products and/or processes.
• Directly support production in the area of expertise to increase efficiency, solve problems, and troubleshoot issues.
• Assist with the development of requirements and procurement of equipment and materials in support of new products, product scale up, and process improvements.
• Assist with training for operations staff related to new equipment, processes, resolutions of technical problems and study protocol execution.
• Prepare and conduct unassisted training of Manufacturing and Quality personnel for new product introduction, protocol execution and unique manufacturing processes.

What Sets GRAM Apart from Other Employers:

BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness time off for every 30 hours worked, to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.