Robert Vail Email & Phone Number

Malvern, Pa, Us

Malvern, Pa

Large molecule API. Team leader, responsible for process development for early and late phase upstream and downstream process platform development and technology transfer for biologic molecules. lab scale to 15 K. Process performance validation, IND and BLA document preparation.

Malvern, Pa

Large molecule API. Responsible for downstream platform process development of therapeutic recombinant monoclonal antibodies, including chromatography, ultrafiltration, viral inactivation, analysis and bispecific Mab synthesis.

Rahway, Nj

Purpose and Scope: Played a leading role planning and managing key research projects aligned to ongoing pharmaceutical development efforts. Assigned and supervised research and support personnel. Documented and presented findings during team meetings to ensure clear communication for upper management and stakeholders, and resolved issues in a timely manner. Managed resources and ensured full compliance with internal and external guidelines. • Developed, implemented, and managed novel… Show more Purpose and Scope: Played a leading role planning and managing key research projects aligned to ongoing pharmaceutical development efforts. Assigned and supervised research and support personnel. Documented and presented findings during team meetings to ensure clear communication for upper management and stakeholders, and resolved issues in a timely manner. Managed resources and ensured full compliance with internal and external guidelines. • Developed, implemented, and managed novel approaches for medium to large scale purification of complex inhibitory RNA oligos in a GMP environment, • Managed technology transfer and directed off site, large-scale expression (100 L) of recombinant mammalian proteins.• Directed synthesis and purification of key simvastatin metabolites that fully met Japanese regulatory requirements. Show less

Union, New Jersey

Purpose and Scope: Consistently delivered strong and effective leadership planning and guiding research-initiatives focused on drug metabolites to facilitate the development of pharmaceutical products already in the pipeline. Ensured FDA MIST (Metabolites in Safety Testing) guidelines met. Mentored and supervised lab personnel. Monitored activities to meet deadlines and budget restrictions. Managed resources effectively to lower costs and improve outcomes. Organizational Impact |… Show more Purpose and Scope: Consistently delivered strong and effective leadership planning and guiding research-initiatives focused on drug metabolites to facilitate the development of pharmaceutical products already in the pipeline. Ensured FDA MIST (Metabolites in Safety Testing) guidelines met. Mentored and supervised lab personnel. Monitored activities to meet deadlines and budget restrictions. Managed resources effectively to lower costs and improve outcomes. Organizational Impact | Selected Contributions:• 30 L fermentor scale production of recombinant human proteins.• Synthesized and purified critical drug metabolites using a variety of chemical and biocatalytic approaches: human P450 enzymes, isolated enzymes, recombinant BM3, and microbial transformation. • Championed and managed the successful departmental chromatography software migration from PC based to a network resident version of Empower, cutting costs and creating a secure departmental database. • Ownership of departmental Empower database management and training.• Supported compound development by synthesizing and purifying modified lead candidate compounds using biocatalytic and preparative chromatographic approaches (chiral/non-chiral). Show less

Union, Nj

Purpose and Scope: Managed routine and special laboratory management functions. Scheduled technicians and scientists, evaluated budgets, and maintained fiscal prudency while meeting goals. Managed vendor relations, purchasing, and inventory requirements. Provided reports to upper management to make sound business-decisions and to determine short- and long-term scientific and administrative strategies. Managed HPLC/UPLC, LCMS maintenance, and developed and optimized HPLC/HPLC and LCMS… Show more Purpose and Scope: Managed routine and special laboratory management functions. Scheduled technicians and scientists, evaluated budgets, and maintained fiscal prudency while meeting goals. Managed vendor relations, purchasing, and inventory requirements. Provided reports to upper management to make sound business-decisions and to determine short- and long-term scientific and administrative strategies. Managed HPLC/UPLC, LCMS maintenance, and developed and optimized HPLC/HPLC and LCMS methodology. Organizational Impact | Selected Contributions:• Implemented and developed a metabolite synthesis program based on recombinant expression of human P450s expressed in E. coli. • Led efforts cloning and co-expressing 11 human cytochrome P450 enzymes and human oxidoreductase in a heterologus E. coli expression system. • Established key relationships with academia resulting in acquisition of critical technology which sharply reduced timelines for the delivery of pipeline drug metabolites Show less

Phd, Microbiology And Molecular Genetics

Dissertation research: Coordinate regulation of lipid biosynthesis in Saccharomyces cerevisiae: Isolation and characterization of mutants.

Bachelor Of Science

Ms, Microbiology And Molecular Genetics

Dissertation research: Regulation of fatty acid desaturation in Aspergillus nidulans.