Job Summary

The primary function of this position involves the physical chemical characterization of lead compounds and design and development of dosage forms for Preclinical and clinical studies and tech-transfer to manufacturing with particular emphasis on lyophilization. This position will also provide training and supervision for less experiences staff chemists.

Responsibilities/Duties

Support the full range of drug formulation development activities from early stage discovery through a protein scale-up; development and execution of all studies including preclinical supplies, stability, compatibility studies, comparability and forced decomposition studies; optimization from laboratory scale to pilot scale; apply statistical approaches in the design and analysis of experiments.  Serve as an expert on lyophilization.

Analysis on a variety of dosage forms including solids, topical, gels and parenterals. Techniques commonly employed include: HPLC, GC, IR, pH, Viscosity, Karl Fisher.  Provide troubleshooting support to manufacturing operations; develop junior laboratory personnel and interact with clients

Qualifications

5+ years experience in a GMP laboratory with a degree in analytical chemistry, chemistry, pharmaceutical sciences or related field. Experience form the pharmaceutical or biotech industry is preferred.  Must have significant experience in lyophilization.  Experience in HPLC, GC and other pharmaceutical analysis including dissolution, IR, viscosity, density, purity and content is desired.

Job Summary

The primary function of this position involves the physical chemical characterization of lead compounds and design and development of dosage forms for Preclinical and clinical studies and tech-transfer to manufacturing with particular emphasis on lyophilization. This position will also provide training and supervision for less experiences staff chemists.

Responsibilities/Duties

Support the full range of drug formulation development activities from early stage discovery through a protein scale-up; development and execution of all studies including preclinical supplies, stability, compatibility studies, comparability and forced decomposition studies; optimization from laboratory scale to pilot scale; apply statistical approaches in the design and analysis of experiments.  Serve as an expert on lyophilization.

Analysis on a variety of dosage forms including solids, topical, gels and parenterals. Techniques commonly employed include: HPLC, GC, IR, pH, Viscosity, Karl Fisher.  Provide troubleshooting support to manufacturing operations; develop junior laboratory personnel and interact with clients

Qualifications

5+ years experience in a GMP laboratory with a degree in analytical chemistry, chemistry, pharmaceutical sciences or related field. Experience form the pharmaceutical or biotech industry is preferred.  Must have significant experience in lyophilization.  Experience in HPLC, GC and other pharmaceutical analysis including dissolution, IR, viscosity, density, purity and content is desired.