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 Services Manager is responsible for managing a team of highly trained analytical scientists supporting internal and external projects. This position provides expert guidance to solve complex analytical problems, oversees client projects, all while managing competing priorities and effectively meeting deadlines and commitments. Works with cross-functional teams to drive and process improvements, budgetary decisions, business development initiatives, and other corporate programs. Communicates effectively across all levels of the organization and with external project teams. Serve as an Analytical SME during site audits with clients, FDA, or other regulatory bodies. This position works closely with all levels of the Management, Manufacturing Operations, Validation, QC, Compliance, Supply Chain Management, Finance, Business Development, and Project Management teams.

Non-Negotiable Requirements:

• Ph.D. in Analytical Chemistry with 5-10 years' experience, or M.S. in Analytical Chemistry with 7-12 years' experience. Bachelor's Degree with equivalent experience may be considered.
• Previous managerial experience required, preferably in an analytical laboratory setting.
• High level of experience in cGXP industry best practices; Working knowledge of FDA, ICH, EMA, and other regulatory requirements for pharmaceutical industry standards.
• Direct work experience in laboratory management and analytical chemistry.
• Demonstrated proficiency in analytical laboratory instrumentation, test method development, and validation required.
• Extensive knowledge and hands-on experience with drug substances and drug product formulations.
• Highly experienced in the development and validation of analytical test methods used to test various types of pharmaceutical grade materials including: drug substances, excipients, and drug product formulations.

Preferred Requirements:

• Advanced skills in analytical testing (understanding, use, interpretation, and troubleshooting of HPLC, GC, FTIR, UV, and other laboratory instrumentation).

Responsibilities Include (but are not limited to):

• Provide leadership and guidance to the analytical services team. Responsible for hiring, managing, motivating, developing, coaching, and mentoring analytical scientists.
• Review and approve analytical documentation and procedures including material specifications, test methods, validation protocols, reports, standard operating procedures, and client work orders.
• Provide expertise and leadership in test method feasibility, development, and validation campaigns for client projects. This may also include the authorship and approval of inter-and intra-lab method transfers to and from GRAM ARD/QC laboratories.
• Ensure that all laboratory work is maintained to cGXP standards.
• Work with EHS, safety officers, and other teams as necessary to implement safety best practices to ensure that the laboratory is a safe work environment. Recognize potential safety issues, discusses with EHS and management, and takes action to rectify them.
• Oversee analytical laboratory equipment, ensure equipment is properly maintained and service in prescribed intervals.
• Work closely with all levels of the Management, Manufacturing Operations, Validation, QC, Compliance, Supply Chain Management, Finance, Business Development, and Project Management teams on a daily basis.

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.