Website Lachman Consultants
Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking API Pharmaceutical Chemists, either former FDA or pharmaceutical industry QC senior level supervisors / managers with demonstrated regulatory compliance expertise as it relates to the testing of active pharmaceutical ingredients, or secondarily drug products.
- Analytical / Quality Control laboratory experience
- Development of analytical methods and analyses
- GMP / GLP audits covering laboratory procedures and practices
- Good Documentation practices
- Analytical methods development, validation and transfer
- Instrument qualification
- Training programs
- Stability studies
- Assist in project management
- Electronic data reviews
- Troubleshooting analytical problems
- Remediation of laboratory control systems
- Laboratory investigations including OOS and mitigation, deviations, and change control records.
- Quality Assurance or Regulatory Agency experience a plus.
- S. / M.S. / Ph.D. in Chemistry
- Minimum of 10 years’ laboratory experience in a Quality Control setting with demonstrated laboratory supervisory / managerial experience.
- Detailed knowledge of current FDA, ICH, and USP regulations / guidances and expectations
- Strong communication / presentation skills, verbal and written, are required for interaction with clients and coworkers
- Ability to recognize and differentiate importance of issues and prioritize accordingly
- Verifiable and recent “hands on” experience, including demonstrated remediation skills in the pharmaceutical industry
- Domestic and international travel required
For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.