MSAT - Finishing - Product and Process Support Specialist or Associate Specialist

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 Finishing Process and Product Support Specialist or Associate Specialist leads/supports production and finishing technology transfer activities and manages new equipment implementation at GRAM. The Specialist role serves as a Subject Matter Expert (SME) in assigned technical areas and is responsible for translating client requirements into robust, compliant and scalable manufacturing process. The Associate Specialist role works under guidance to contribute to assigned technical areas and supports the translation of client requirements into robust, compliant, and scalable manufacturing processes. Represents/supports MSAT on cross-functional and client-facing teams and is accountable for/assists with technical decision-making throughout product lifecycle activities.

Non-Negotiable Requirements:

Specialist Level:

• Bachelor's degree in Life Sciences or related field.
• A minimum of 3-5 years' related work experience in a pharmaceutical, bio pharmaceutical, and/or biotechnology manufacturing environment.
• Minimum of 5 years in an aseptic pharmaceutical manufacturing and/or finishing environment.
• Experience and expertise in visual inspection, labeling and packaging of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Knowledge of project management techniques and tools.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Associate Specialist Level:

• Working knowledge of tools and equipment to support new projects and production.
• Knowledge of project management techniques and tools.
• Demonstrated ability to learn technical processes, documentation systems, and cross-functional collaboration.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

Specialist Level:

• Knowledge of project management techniques and tools.
• Strong technical expertise in regulated pharmaceutical processes related to visual inspection, labeling and packaging of parenterals.
• Minimum of 3 years' work experience in the capacity of MSAT or Technical Services preferred.

Associate Specialist Level:

• Entry-level role intended for development of technical proficiency in manufacturing science and technology functions. 0-2 years of manufacturing experience in pharmaceuticals, biopharmaceutical, biotech, or regulated manufacturing environment
• No previous experience required. Related work experience in a pharma, biopharma, and/or biotech manufacturing environment is preferred.
• Working knowledge in visual inspection, labeling and packaging of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is a plus.
• Completion of a bachelor's degree in Life Sciences or related field is desired but not required. Equivalent experience in related pharma, biopharma, and/or biotech manufacturing may be a substitute for a bachelor's degree.

Responsibilities Include (but are not limited to):

Specialist Level:

• Lead and execute finishing technology transfers for early development through commercial manufacturing.
• Own the technical interpretation of client documentation and translate requirements into GRAM-compliant batch records, specifications and procedures.
• Serve as the MSAT technical representative on cross-functional and client-facing teams.
• Provide direct production support to troubleshoot complex technical issues and improve process efficiency.
• Represent MSAT on cross-functional and client-facing teams and provide technical recommendations.
• Act as SME in one of more technical areas (e.g., Manual, Semi-Auto, and Automatic Inspection, Labeling, Packaging).
• Independently solve complex technical problems and provide defensible technical recommendations.
• Independently author, review, and approve Master Batch Records and support documentation.

Associate Specialist Level:

• Support finishing technology transfer activities from development through commercial operations under supervision.
• Assist in translating client documentation into GRAM-compliant manufacturing requirements.
• Support feasibility studies, data collection, and process justification activities.
• Provide production- floor support during new product introduction and scale-up activities.
• Provide hands-on support during equipment trials and process optimization efforts.
• Create, revise, and maintain Master Batch Records and support documentation under guidance.
• Support training activities for Finishing personnel related to new processes, equipment, and protocol execution.
• Demonstrates growing independence, accountability, and technical proficiency.

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.