Scientist - Client Support en Grand River Aseptic Manufacturing, Inc.

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 Scientist serves as a project lead for internal and external project teams with current client projects, as well as the onboarding of new clients and/or client projects. Author test methods and specifications with the guidance of senior team members and through independent research. This position works closely with various levels of the Manufacturing Operations, Validation, QC, Compliance, Supply Chain Management, and Project Management teams.

Non-Negotiable Requirements:

• Bachelor of Science degree or closely related field with more than 3-4 years’ experience.
• Working knowledge of GMP and GDP standards required.
• Knowledge of analytical test method validation, and compendial method verification required.
• Experience with various types of laboratory instruments including: HPLC, UHPLC, UPLC, GC, UV-Vis, FTIR, etc. preferred.
• Understand and have experience with analytical laboratories in regulated environments under FDA, ICH, and EMA guidelines.
• Must have experience with Microsoft Word, Excel, and Outlook.
• Must be able to communicate in a professional manner with colleagues, clients, and regulatory agencies.

Preferred Requirements:

• Experience with Chromatographic Data Systems (Empower, Openlab, Chromeleon, etc.) is a plus.
• Master of Science or Ph.D. degree in Analytical Chemistry or closely related field with an appropriate level of experience. 

Responsibilities Include (but are not limited to):

• Manage a minimum of two active clients with support.
• Create Specifications and Analytical Method Evaluation (AME) with guidance.
• Author test methods with guidance.
• Create Compendial Method Verifications (CMV) protocols, waivers and reports with guidance.
• Collaborate with clients and additional members of the Analytical Services team to author method transfers and execution protocols. Author reports with guidance.
• Author client facing non-conformance reports (NCR’s) with support. 
• Recommend and implement laboratory continuous improvement initiatives with assistance.
• Capable of executing test method feasibility, development, and validation/verifications for client projects with minimal guidance. 
• Author risk assessment, Chemical Review Forms, and change controls for specifications and SOP’s with guidance.
• Perform periodic reviews, and review supplier/vendor change notifications with guidance.
• Material/Excipient Sourcing with assistance.
• Work effectively in a team and independently to achieve goals and deliver on departmental initiatives through innovation, proper planning, and efficiency.
• Communicate effectively in written and oral form. With guidance from senior staff, write detailed scientific reports with full experimental details and present the information in a clear and concise manner. Ability to communicate effectively with clients, management, and colleagues by exhibiting excellent interpersonal skills. 

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% 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!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of 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.