Summary
The Quality Controls Laboratory group conducts routine testing for manufactured products. Perform chemistry laboratory procedures in compliance with Standard Operating Procedures and Standard Test Procedures used to support testing and release of product. Skills of interest include chemistry assay validation and troubleshooting, training team members, project management, and report writing.
Position Responsibilities (Senior Chemist)
- Provide process leadership for key chemistry quality programs (e.g., AMTE, Cleaning Validation, Empower, and LES) by contributing to program strategy and driving execution of KPIs, governance, and continuous improvement plans aligned with site Quality objectives.
- Lead daily chemistry decision-making, including go/no-go calls, prioritization, and stakeholder communications.
- Lead root cause analyses and CAPA; review and approve data, reports, and material dispositions.
- Coordinate daily lab execution via scheduling, inventory planning, and workload forecasting; identify constraints and propose priority trade-offs.
- Define training curricula and competency standards; authorize training sign-offs and method qualifications.
- Independently manage ordering and inventory of materials and supplies.
- Represent chemistry in cross-functional forums; influence plans and negotiate priorities.
Education and Experience
- B.S. or M.S. (or equivalent) in Chemistry or Biochemistry; 9+ years of chemistry laboratory experience.
- Experience performing/troubleshooting/developing chemistry assays.
- Exceptional organizational, communication, and interpersonal skills.
Required Technical Skills and Competencies
- Strong analytical skills including chemistry, HPLC, PA800, Maurice, Biomek i5, GC, AA, UV/Vis; proficient in Empower.
- Proficient in Microsoft Word and PowerPoint; advanced Excel for data analysis.
Minimum Qualifications
- Understanding of biological and chemical processes common to Quality Control Testing.
- Understanding of chemical regulatory requirements and licensure process.
- Self-starter; prioritize work efficiently with minimal supervision.
- Complete calculations using basic math; understand metric system and basic statistics.
- Ability to solve practical problems with concrete variables.
- Ability to make logical laboratory/team/department decisions, including in absence of supervision.
- Ability to recognize product quality issues based on company guidelines.
- Ability to train colleagues in fundamental and technical aspects of chemistry assays.
- Excellent verbal/written communication, organizational and interpersonal.
Preferred Qualifications
- Advanced understanding of chemistry and biochemistry.
- Experience with facility start-up and analytical method transfer.
- Experience with equipment qualification.
- Knowledge of FDA, USDA, EMA, and compendial requirements for QC assay development/testing.
- Proven project and time management experience; technical writing of protocols and reports.
Physical Position Requirements
- Manual dexterity using hands and fingers.
- Sit or stand at a laboratory bench or desk; close vision required.
- Occasional need to sit and reach with hands/arms.
- Ability to work flexible hours, weekends, and overtime.