Website Lachman Consultants
Lachman Consultants is seeking Per Diem Pharmaceutical Consultants who are proficient in both English and one other language (reading, writing, speaking): German, Italian, Mandarin, Portuguese, Spanish, etc. Must have work experience in the Pharmaceutical, Biotechnology, Biologics, Device, and/or Diagnostics industry that includes demonstrable hands-on experience and skill in more than one of the following areas:
- API; Animal/Veterinary; Aseptic/Sterile; Biologic/Biopharmaceuticals; Combination Products; Medical Device; Vaccines, Various dosage forms; et al.
- Batch record reviews
- Computer System Validation
- Design Controls
- Facilities and Equipment; Critical utilities (Air, HVAC, Water, WFI)
- FDA 483 and Warning Letter Remediation / CAPA
- Laboratory: Analytical methods; Change control; Chromatography; Data integrity; GLPs; Instrument qualification; Laboratory control systems; Laboratory GMPs; Method reviews; OOS Investigations; QC; Stability studies; Training programs; Technology Transfer
- Quality Assurance / Quality Control
- Quality Systems
- Regulatory Affairs (DMF’s and ANDA’s for generic APIs and drug products is preferable).
- Stability programs
- Stem Cell
- Minimum of Bachelor’s degree in life sciences, engineering or related field
- 10 years’ related experience, as well as detailed knowledge of current FDA regulations and expectations.
- Strong communication / presentation skills, verbal and written, and the ability to recognize and differentiate importance of issues and prioritize accordingly.
Preferred: Open to international travel (Europe, India, China, etc.) for up to two+ weeks at a time.
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.