BHAVESH SHAH

• Establishing Quality protocols and hands-on experience of shop-floor processes and equipment for Creams, Lotions, Ointments, Gels, Solutions and Aerosol equipment.
• Managed laboratory scale to scale up projects for commercial manufacturing.
• Responsible for seamless technical transfer of projects from Formulation Development to Process/Product Development to Commercial Manufacturing.
• Customer Interactions:.
• Direct interaction with customers on project status and scientific discussion.
• Written the PDR section of CMCs in ANDAs.
• Other: Inventor on US Patents for formulation and processes.
• 503(b) start-up.
• Engaged in drafting documentation for Validation of facility and equipment including IQ/OQ/PQ, VMP, and SOPs.
• Engaged in drafting documentation of Quality systems and identifying vendors for QMS and ERP.
• Engaged in drafting SOPs / WIs of Operational equipment and implementation.
• Engaged in assigning aseptic equipment in specific suites for processing.
• Engaged in establishing and qualifying suppliers via virtual audits (Covid restrictions for on-site).
• Working on feasibility of 6 concept products presented by Marketing.
• Working on developing processes for one sterile and one non-sterile product.

• Part-time consulting for a 503(b) startup Compounding Pharmacy – setting up SOPs and IOQ documentation.

• Commissioned the production – pilot and full-scale manufacturing of the company’s oxygenated olive oil line of products in a record 6-month time period.
• Saved the company about $40,000 in contract negotiations.
• Established the manufacturing process and developed 7 new products in the span of two months.
• Established Quality procedures and assisted in writing the SOPs and IQ and OQ protocols.
• Commissioned the tube-filling operations of the company’s products.
• Established vendors and raw material specifications.
• Established manufacturing SOPs.
• Commissioned the warehouse and logistics operations.
• Established rack / bin storage system in the warehouse to sync with the ERP system.
• Liaised with freight forwarders, truck lines to facilitate receiving products and materials and shipping products.
• Was part of the Senior Leadership team.

QuVa Pharma (previously Unique Pharmaceuticals,) Temple, Texas

• Managed the identification, specification, and recommendation of special application pumps to enable accurate dosing of injectable products in IV bags and syringes. Managed the Validation and Qualification of pumps and trained personnel on operation.

• Designed single-use compounding assembly to enable increased productivity of the sterile products manufactured at QuVa. This would result in annual savings of $250,000.

• Established and commissioned R&D department in the company that included drafting and implementing SOPs in the system.

• Introduced systems to implement sourcing and specification procedures of new raw materials and components in the system.

• Established Raw Material and Component Specifications for Quality. Improvised processing of injectable drugs by reducing the number of unit operations and help achieve efficiency and reduce costs.

• Managed the identification, specification, and recommendation of special application pumps to enable accurate dosing of injectable products in IV bags and syringes.
• Managed the Validation and Qualification of pumps and trained personnel on operation.
• Designed single-use compounding assembly to enable increased productivity of the sterile products manufactured at QuVa.
• This would result in annual savings of $250,000.
• Established and commissioned R&D department in the company that included drafting and implementing SOPs in the system.
• Introduced systems to implement sourcing and specification procedures of new raw materials and components in the system.
• Established Raw Material and Component Specifications for Quality.
• Improvised processing of injectable drugs by reducing the number of unit operations and help achieve efficiency and reduce costs., for Scale-up.
• Actively interacted with Project Management, Analytical, Pre-formulation, Technical Liaison, Quality and Sales and Marketing groups to work on projects from concept to commercialization.
• Guided and mentored scientists in professional and personal development.
• Administrative and professional Management of Formulations Personnel.
• Oversaw development of Company’s base of formulary to offer clientele.
• Responsible for administrative Management of Laboratory.
• Prepared department budgets and responsible for identifying capital equipment for the department.

• Optimizing processes for scale manufacturing.
• Resulted in expediting the ANDA approval of the two topical drugs worth $2.5 MM projected sales in the first year.
• Project management of Commercial Validation and Bio-batch manufacturing.
• Supervision of bio-batch / commercial validation manufacturing.
• Participate in preparing ANDA documentation for submission to FDA – CMC section including PDRs, review of regulatory document for manufacturing labeling, etc., review and establishing bulk and finished product specifications and setting Quality standards.
• Participate in vendor audits.

November 2004 – December 2011 Group Leader – Formulation Development.

DPT Labs, San Antonio, Texas

• Project Management of Contract and House Formulations and Technical Transfer for Scale-up.

• Actively interacted with Project Management, Analytical, Pre-formulation, Technical Liaison, Quality and Sales and Marketing groups to work on projects from concept to commercialization.

• Guided and mentored scientists in professional and personal development.

• Administrative and professional Management of Formulations Personnel.

• Oversaw development of Company’s base of formulary to offer clientele.

• Responsible for administrative Management of Laboratory.

• Prepared department budgets and responsible for identifying capital equipment for the department.

• Converted certain topical formulations to aerosol formulations for enhanced drug delivery.
• Developed formulations and processes for topical drug substances that include dosage forms of creams, lotions, liquids, gels, solutions and serums.
• Developed formulation base for polyclonal anti-body biologic drug substance that was then a part of clinical trial study.
• Review Quality standards / specifications of packaging components for each product.
• Assist in defining go- no-go standards.
• New Formulation Development for OTC / Drugs.
• Authorized to handle DEA Controlled Substances Conceptualize and develop formulations for ANDAs from reverse engineered formulations.

New Product development and product and process improvisation.

• Work experience available upon request.
• This experience has been outside of the US and hence not included.