Robert Strack Email & Phone Number

Proven leader with strong record of achievement and diverse experience in analytical, quality, and process development activities. Extensive management experience from overseeing activities of a large number of scientific and non-scientific staff with excellent skills in leading high performing cross-functional teams. Demonstrated flexibility and willingness to take on additional responsibilities to support changing business needs, skilled in identifying issues, and developing plans to improve efficiency and compliance posture of the laboratory. Experience in:● Analytical Development including impurity characterization, setup of stability testing of the active pharmaceutical ingredient (API, drug substance) and chemical intermediates● Authoring and approving Test Methods● Quality Control testing (raw materials, chemical intermediates, in-process testing)● Laboratory Audit programs● Method Validation● Method Transfer● Pre-Approval Inspections (PAI)● Regulatory Submissions (e.g., IND and NDA)● Good Manufacturing Procedure (GMP) programs● Standard Operating Procedures (SOP) management● Consent Decree remediation

Listed skills include Gmp, Pharmaceutical Industry, Hplc, Validation, and 14 others.

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  Montclair State University

  Chemistry