Leo Levin

Background

About Leo Levin

Accomplished professional with more than 30 years of global experience within the FDA regulated biopharmaceutical and medical device corporations, especially in the area of aseptic processing and facilities. Subject matter expert (SME) in Compliance, Quality, Validation, Engineering, Technical / Manufacturing Operations, 3rd Party cGMP audit and implementation of Consent Decree programs. Recognized for maturity, responsibility, and the ability to earn the trust and respect of clients. Extensive experience in quality and compliance for drug products, vaccines, and medical devices has established a reputation as a sought-after expert in the field. Experienced with all phases of product life cycle from product development through facility start-up, product launch, and commercial supply. Strong analytical skills, able to operate with large amounts of information. Comparative analysis and interpretation skills. Strong interpersonal communication skills, able to collaborate successfully and efficiently with internal and external groups. AIM: Flexible in terms of location and duration and I am very interested in being involved in North American & international bio-pharmaceutical projects, especially for 3rd Party cGMP audit and remediation. EXPERTISE & SKILLS FDA 483s, FDA Warning Letters and FDA Consent Decree remediation projects. Global cGMP audits, gap analyses and technical reports preparation and support. 3rd party oversight in support of FDA Remediation Activities. Coaching and mentoring. Deviation investigation and management. Strengthening Quality Oversight programs Airflow Visualization [Smoke Study] programs Critical thinking skills. Regulatory inspection support and response writing. Biopharmaceutical processing – aseptic (bulk and final formulations), oral solid dosage forms and API. Extensive project management and hands-on experience in process and building system retrofits, facility expansions, etc. Strong analytical skills, able to operate with large amounts of information. Comparative analysis and interpretation skills. Strong interpersonal communication skills, able to collaborate successfully and efficiently with internal and external groups. PROCESSES: Cell culture and Purification, Small and Large Volume / Parenteral (Vials, IV bags, Prefilled dual chamber syringes); Inhalation Solutions and Suspensions (Vials & Form/Fill/Seal ampoules); Ophthalmic Solutions; Oral Solutions and Suspensions; Nasal Solutions and Suspensions; Topical Solutions and API products.