Analytical Services Supervisor

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 Supervisor will manage a team of analytical scientists supporting internal and external projects. Provide guidance to solve complex Analytical problems. Oversee client projects simultaneously, while managing competing priorities, to effectively meet deadlines and commitments. Be an effective member of various cross-functional teams to drive and process improvements, budgetary decisions, business development initiatives, and other corporate programs. Communicate 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 Manufacturing Operations, Validation, QC, Compliance, Supply Chain Management, Finance, Business Development, and Project Management teams.

Non-Negotiable Requirements:

• Ph.D. in Analytical Chemistry or closely related field with 5-10 years' experience, M.S. in Analytical Chemistry or closely related field with 7-12 years' experience, or a Bachelor's of Science in Chemistry or closely related field with 9-14 years' experience.
• Advanced skills in analytical testing (understanding, use, interpretation, and troubleshooting of HPLC, GC, FTIR, UV, and other laboratory instrumentation).
• Demonstrated proficiency in test method development and test method validation.
• High level of experience in cGXP industry best practices.
• 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.
• Strong scientific reasoning skills. Capable of designing and scheduling experiments through critical examination of data, in order to obtain accurate and reproducible results in the most efficient manner.
• Must have proficient computer skills in Microsoft Word, Excel and Outlook, Chromatographic Data Systems, and Document Management Systems.

Preferred Requirements:

• Equipment qualification/validation experience.
• Pharmaceutical industry work experience.

Responsibilities Include (but are not limited to):

• Provide leadership and guidance to the analytical services team. Assist in hiring, managing, motivating, 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 oversight 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.
• Assist in the development of laboratory analysts, include QC analysts, to solve complex analytical problems.
• Recommend and provide oversight for continuous laboratory improvements.
• Provide expertise in ICH and USP analytical requirements and techniques. Provide support to QC team with lab investigations and troubleshooting as needed.
• Participate in discussions for capital equipment investments for the department.
• Lead team meetings and discussions to achieve goals and deliver on departmental initiatives as needed.
• Communicate effectively in written and oral form across all levels of the organization and with external project teams.
• 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 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.