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!

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).

• 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.