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 Analytical Scientist will serve as a Subject Matter Expert to assist internal and external project teams with current client projects, as well as the onboarding of new clients and/or client projects. Develop and validate test methods and specifications with the guidance of senior team members and through independent research. Serve as an SME for analyst training and development and various laboratory instrumentation. This position works closely with various levels of the Manufacturing Operations, Validation, QC, Compliance, Supply Chain Management, and Project Management teams.

Non-Negotiable Requirements:

• Master of Science degree or closely related field with appropriate level of experience, or
• Bachelor of Science degree or closely related field with 2-3 years' experience.
• Knowledge and hands-on experience with analytical test method development and test method validation.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Knowledge of analytical test method development, validation, and compendial method verification.
• Experience with various types of laboratory instruments including: HPLC, UHPLC, UPLC, GC, UV-Vis, FTIR, etc.
• Experience in raw materials and/or finished product testing.
• Candidate should understand and have experience with pharmaceutical manufacturing and analytical laboratories in regulated environments under FDA, ICH, and EMA guidelines.

Responsibilities Include (but are not limited to):

• Solve complex analytical problems, as well as recommending and implementing continuous laboratory improvements.
• Provide documentation support for analytical services (i.e. Test Methods, Specifications, Validation Protocols, and Summary Reports).
• Capable of executing test method feasibility, development, and validation campaigns for client projects with guidance for senior staff members.
• Perform compendial method verifications as necessary.
• Provide support to QC laboratory analysts as needed.
• Provide thorough and timely updates to cross functional team meetings to meet deadlines.
• Work effectively in a team to achieve goals and deliver on departmental initiatives through innovation, proper planning, and efficiency.
• Communicate effectively in written and oral form. With minimal guidance from senior staff, write detailed scientific reports with full experimental details and present the information in a clear and concise manner.
• Maintain clear, detailed, and up-to-date laboratory notebooks according to internal policies.
• Comply with cGXP standards in all work performed.
• Follow safe laboratory practices and comply with EHS, safety officers, and delegates to
• ensure that the laboratory is a safe environment. Recognizes potential safety issues, discusses them with EHS and management, and takes action to rectify them.

Full job description available during formal interview process.

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 17 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: We offer all employees one (1) paid day of Wellness Time Off (WTO) per quarter to invest in self-care, take some downtime, or whatever 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.