Lachman Consultants is in need of Per Diem Biopharmaceutical Consultants with expertise in the development, manufacture, and quality management of biopharmaceuticals, vaccines, peptides, and antibodies. Must have demonstrable hands-on experience in the Biotechnology / Biologics industry that includes experience and skill in one or more of the following areas:
• Bioformulation / bioprocess development, or research & development.
• Therapeutic strategies for the treatment of Infectious, Genetic, Allergic, Metabolic and CNS Diseases
• Biologics production, cell culture, upstream and downstream processes, including filling and packaging.
• CMC and regulatory submission support, including NDAs, ANDAs, and INDs, FDA/regulatory agency preparedness
• Manufacturing operations, sterility assurance, supply chain management, facilities, contract manufacturing management, quality assurance / quality control, validation, materials management, metrology, method development, and stability testing programs
• Biotech manufacturing facility design and qualification; process validation of facilities and processes
• Clinical trials
Consultants must have a minimum of a Bachelor’s degree in life sciences, engineering or related field and 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. If you meet all of the qualifications, please submit your full chronological resume via the Lachman website or to email@example.com. No phone calls please. Thank you.