Bioequivalence Expert Pharmaceutical Consultants

Lachman Consultant Services, Inc; Chicago (IL); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking Bioequivalence experts to join their team in Chicago. This role involves providing consultation and remediation services across the pharmaceutical and biotechnology sectors. The ideal candidate will possess extensive experience in bioavailability, regulatory science, and project leadership. You will engage in innovative problem-solving and work closely with a talented team to ensure the successful development of high-quality medical products. If you are passionate about making a difference in the industry and have a proven track record in bioequivalence, this opportunity is perfect for you.

Qualifications

• 10 years of relevant experience in bioequivalence and biopharmaceutics.
• Strong background in regulatory science and GCP/GLP audits.

Responsibilities

• Lead bioequivalence studies and develop study protocols.
• Conduct statistical analyses and ensure compliance with US FDA regulations.

Skills

Bioavailability expertise

Bioequivalence strategies

Biopharmaceutics

Regulatory science

GCP and GLP audits

Formulation development

Statistical data analyses

Project leadership

Communication skills

Problem-solving techniques

Education

B.S. in life sciences

Job description

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 accomplished Bioequivalence experts for pharmaceutical, biotechnology, and medical device products. The Bioequivalence professional must have a strong background and demonstrable hands-on experience and skills.

Qualifications / Responsibilities include:

• Bioavailability / bioequivalence expertise
• Bioequivalence strategies for diverse dosage forms
• Biopharmaceutics and Regulatory science
• GCP and GLP audits
• Formulation development; dissolution methods/reviews; interpretation of dissolution data
• Study design and protocol development
• Bioequivalence studies
• Pharmacokinetic, pharmacodynamic, and clinical endpoint studies
• Bioanalytical method validation
• Statistical data analyses
• US and global regulatory requirements
• US FDA / global applications / submissions
• Due diligence reviews of bioequivalence reports
• Ability to lead projects and meet crucial timelines
• Superb written and oral communication skills
• Excellent interpersonal and soft skills
• Ability to solve problems using innovative techniques

Educational / Experience Requirements include:

• B.S. life sciences and 10 years’ relevant experience.

Apply to: http://www.lachmanconsultants.com/career-opportunities/

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.