Robert Perry Email & Phone Number

Tucson, Arizona, United States

San Antonio, Texas Area

• Plan, execute, and oversee the work of the team to achieve client communicated goals in support of ANDA and NDA filings.
• Provide leadership, evaluate performance, and oversee employee development within the group to minimize risk to the business and maximize value.
• Oversee the assignment of work to assure accuracy in the data generated so that reliable testing procedures and specifications are developed and followed.
• Work with Operations personnel (i.e. New Product Launch, Stability, QC Finished Products) to transfer analytical technology and to support commercialization of new products.
• Maintain knowledge of compendial changes and other regulatory guidance documents provided through ICH and FDA.
• Especially experienced with development and validation of in vitro testing methodology for semi solid drug products with respect to current FDA initiatives regarding complex drug products.

• Plan, execute, and oversee the work of the group to achieve goals for the annual required number of ANDA filings as determined by the Vice President of Scientific Affairs.
• Provide leadership, evaluate performance, and oversee employee development within the group to minimize risk to the business and maximize value.
• Oversee the assignment of work to assure accuracy in the data generated so that reliable testing procedures and specifications are developed.
• Work with Operations personnel (i.e. New Product Launch, Stability, QC Finished Products) to transfer analytical technology and to support the launch of new products.
• Maintain knowledge of compendial changes and other regulatory guidances provided through ICH and FDA.
• Participate in analytical patent defense preparations and deliverables to support Paragraph IV challenges to maximize product value.

• Supervised and coordinated the activities of twenty-three laboratory personnel engaged in pharmaceutical methods development, validation and testing conducted for our clients. Directed laboratory work to ensure highest.
• Developed and wrote sponsor specific test protocols. Identified testing need for sponsors.
• Planned and directed laboratory activities on multiple projects to meet sponsor needs.
• Interfaced directly with business development and product development.
• Developed comprehensive testing procedures for pharmaceutical products, bulk drug substances and intermediates.
• Managed group resources to accomplish multiple projects in an effective manner.

• Built and managed two analytical research and development groups with responsibilities for method development from the phase 1 development stage through the technology transfer to quality control at phase 3. The focus.
• Duties included training analysts in developmental theory, validation, and cGMP. Also responsible for maintaining laboratory records of this training with monthly review of updated procedures.
• Responsible for writing, reviewing, and updating laboratory procedures for testing by the Analytical Services and Analytical Development Laboratories. This includes reviewing changes and determining their impact on the.
• Set-up new facilities for a state-of-the-art analytical laboratory for analysis of transdermally and orally delivered drug dosage forms. Included design, costing, and budgeting for increased laboratory space with new.
• Involved in PAI discussions with the FDA and defense of the chemistry sections for ANDA and NDA submissions.
• Supervised multidisciplinary teams of scientists totaling up to 12 scientists in performance of various testing, including stability testing, routine QC release testing, raw materials testing, analytical method.

• Developed, validated, and performed experiments designed to determine the pharmaceutical properties of new and existing drug candidates in accordance with current GMPs and GLPs.
• Experiments involved the testing of raw materials and finished dosage forms using the techniques of atomic absorption, UV, HPLC, GC and derivation.
• Involved in inter-laboratory method transfer to and from the stability laboratory.
• Supervised 3-6 chemists and technicians in the performance of accepted experimental procedures for analysis of existing drugs.

Phd, Chemistry

Bs, Chemistry