Lead Analytical Chemist

2 weeks ago

Maryland Heights, Missouri, United States Actalent Full time
Job Title: Lead Analytical Chemist

Job Description

The Lead Analytical Chemist is responsible for providing expert guidance on the scientific aspects of methodologies, analytical evaluations, instrumentation, and the assessment and interpretation of laboratory results. This role also involves assisting with investigations related to out-of-specification (OOS) findings and addressing various quality control (QC) matters as necessary.
  • Conduct both Preventative and Demand Maintenance on QC instruments and apparatus.
  • Develop and implement analytical methodologies, along with equipment/instrument IQ/OQ/PQ protocols.
  • Collaborate with external service providers to ensure proper maintenance and repair of instruments.
  • Create Standard Operating Procedures for new instruments and software.
  • In a cGMP setting, maintain compliance with U.S. and international regulatory bodies (e.g., FDA, NRC, Health Canada, OSHA).
  • Draft Change Controls, Protocols, Corrective and Preventive Action items, and Periodic Reviews.
  • Ensure adherence to departmental training and qualification standards.
  • Safely manage radioactivity and ensure that all team members adhere to ALARA principles while managing their daily tasks to meet quarterly ALARA objectives.
  • Author Change Controls within Quality Management systems.
  • Assist in the training of laboratory staff.
  • Perform routine analyses to support the release of finished products, raw materials, and active pharmaceutical ingredients (API) as required.
Essential Skills
  • Bachelor's Degree in Chemistry or a related discipline is required.
  • A minimum of 5 years of relevant experience in a cGMP environment is essential.
  • Comprehensive knowledge of laboratory instruments and methods, including HPLC, GC, IC, ICP, FTIR, UV, and wet bench techniques.
  • Experience working in a facility that produces radioactive materials, necessitating participation in safety programs to minimize exposure risks.
  • Capability to wear various types of personal protective equipment.
  • Ability to collaborate effectively in a team-oriented environment across different functional areas.
  • Strong attention to detail is crucial, along with good hand-eye coordination.
  • Willingness to work extended hours when necessary.
  • Capacity to remain composed in emergency situations while guiding other personnel.
  • Proficiency in following and enforcing procedural compliance.
  • Physical requirements include the ability to lift up to 70 lbs, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
Interpersonal Skills
  • Ability to enforce procedural compliance effectively.
  • Strong communication skills.
  • Meticulous attention to detail.
  • Competence in crisis management.
Job Type

This is a contract position with a duration of 6 months.
Work Environment

Work is conducted in a plant environment with established safety protocols to minimize exposure risks.
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We assist innovative companies in advancing their engineering and science initiatives by providing access to specialized experts who drive scale, innovation, and speed to market. With a network of nearly 30,000 consultants and over 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many Fortune 500 companies.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are fundamental to the equity and success of our workforce. DE&I principles are woven into our culture through:
  • Recruiting diverse talent.
  • Fostering an inclusive environment through ongoing self-reflection.
  • Building a culture of care, engagement, and recognition with clear outcomes.
  • Providing growth opportunities for our employees.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.

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