Quality Control Chemist

Biovire, Inc.; Brighton Charter Township (MI); Sur place; USD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

Résumé du poste

Biovire, Inc. in Brighton, Michigan is seeking a Quality Control Chemist to join our GMP-regulated laboratory.

You will perform analytical testing to support release of excipients, APIs, raw materials, and finished products, with focus on HPLC and cGMP compliance. This role demands strong data analysis, detailed documentation, and collaboration with cross-functional teams to maintain quality and regulatory standards in a fast-paced setting.

Qualifications

• Bachelor's degree in Chemistry, Biology, or related Life Science.
• 2+ years of pharmaceutical/industrial laboratory experience.
• Familiarity with cGMP, USP/NF, FDA, ICH, and regulatory expectations.

Responsabilités

• Perform analytical testing of excipients, APIs, raw materials, and finished products using wet chemistry and analytical instrumentation (HPLC).
• Document results per cGMP and internal procedures.
• Coordinate testing with contract labs and manage sample preparation/shipment.
• Author and revise SOPs, test methods, and specifications.
• Support maintenance and calibration of laboratory instrumentation.
• Assist method validation activities and contribute to lab operations and housekeeping.

Connaissances

Attention to detail

Data analysis

Communication skills

Time management

Formation

Bachelor's degree in Chemistry, Biology, or Life Science

Outils

HPLC

Agilent OpenLab CDS

Agilent ChemStation

Microsoft Office

Description du poste

Quality Control Chemist

Brighton, Michigan

Biovire is advancing toward commercialization with a focus on quality, precision, and operational excellence in a GMP-regulated environment. We are seeking a Quality Control Chemist to join our Quality Control team and support laboratory testing and release activities for materials and products manufactured at our Brighton facility.

The Role

The Quality Control Chemist performs analytical laboratory testing to support the release of excipients, active pharmaceutical ingredients (APIs), raw materials, and finished drug products. This role works within a cGMP-regulated laboratory environment and is responsible for accurate testing, documentation, sample coordination, and laboratory support activities that help ensure products meet established quality and regulatory requirements.

Key Responsibilities

• Perform testing of incoming components, excipients, APIs, and finished drug products using wet chemistry, dimensional analysis, analytical instrumentation with an emphasis on HPLC, and applicable microbiological techniques.
• Perform testing according to internal procedures and USP requirements in compliance with cGMP and applicable regulatory expectations.
• Accurately document laboratory testing and results in accordance with cGMP documentation practices.
• Coordinate testing performed by contract laboratories, including sample preparation and shipment.
• Author and revise SOPs, test methods, specifications, and other controlled laboratory documents.
• Support maintenance, troubleshooting, calibration, and onboarding of laboratory analytical instrumentation.
• Assist Analytical Services with mentored method validation activities as needed.
• Support laboratory operations including consumables inventory, housekeeping, glassware management, and maintenance of a clean and organized laboratory environment.
• Perform work safely using appropriate procedures and personal protective equipment.
• Partner with colleagues across Quality and other functions to support testing priorities and production schedules without compromising product quality.

What You Bring

• Bachelor's degree in Chemistry, Biology, or a related Life Science.
• 2+ years of pharmaceutical industry or equivalent relevant laboratory experience.
• Familiarity with cGMP and regulatory principles, including deviations and CAPAs.
• Familiarity with USP/NF, FDA, ICH guidance, and cGMP requirements.
• 1-2 years of HPLC experience preferred.
• Working knowledge of chromatography data systems and Microsoft Office.
• Experience with Agilent OpenLab CDS or Agilent ChemStation is a plus.
• Strong mathematical, organizational, and data-analysis skills with excellent attention to detail.
• Ability to prioritize work effectively in a fast-paced laboratory environment.
• Strong written and verbal communication skills and the ability to work effectively as part of a cross-functional team.

Physical Requirements

• Ability to perform frequent lifting, bending, stooping, squatting, pushing, and pulling.
• Ability to sit, stand, and walk for extended periods.
• Ability to perform extended computer and data-entry work as required.

Why Join Biovire

• Collaborative, mission-driven GMP-regulated pharmaceutical manufacturing environment
• Hands-on analytical experience supporting sterile pharmaceutical manufacturing and product release
• Opportunity to develop technical expertise in HPLC, analytical instrumentation, method validation, and cGMP laboratory operations
• Cross-functional exposure within a growing organization advancing toward commercialization
• Comprehensive employee benefits including medical, dental, vision, and life insurance
• Competitive Paid Time Off supporting work-life balance
• Company-sponsored events and team activities

Biovire is an equal opportunity employer and is committed to fostering a respectful and inclusive workplace grounded in Quality, Safety, and Teamwork. Our mission is to deliver specialized sterile manufacturing solutions that support life-saving treatments for patients.