Cell#: 732-***-****

Email: adr9o2@r.postjobfree.com

** ************ **

Neshanic Station, NJ 08853

Thomas R. Van Pelt II

Objective:

Director/ Manager/ Production Supervisor.

Experience:

**/***0– 01/2021 Hercon Pharmaceuticals 101 Sinking Springs Lane. Emigsville, PA

Director of Manufacturing- Transdermal Manufacturing

Responsible for Operations of Manufacturing facility including facility/engineering related matters and materials management.

●Responsible for development of Operations strategy which supports the business plan of the company. Liaise with all other department of company including Finance, HR, Quality, and R&D for development and execution of Operations Plan.

●Develop and submits Operations budget and in a timely manner and implement approved budget.

●Work with Finance/Sales organization to develop/execute supply chain management plan.

●Responsible of Operations representative in FDA & DEA inspections of the site.

●Develop the production plan to meet sales demand, and maintain the required levels of finished goods inventory, Cost of Goods information for each product and monitor batch to batch manufacturing cost of goods for each product. Report on any deviations and explanations.

●Target the minimization of cost of goods.

●Responsible for maintaining relationships with equipment manufacturing, raw materials suppliers and other appropriate vendors to ensure timely procurement of materials to help in meeting production plan.

●Responsible for the supervision of Manufacturing, Maintenance, Engineering and Materials Management departments and process improvements.

●Responsible for submitting weekly Operations Report to the CEO identifying critical and non-critical actions of the previous week.

●Oversees the coordination of equipment purchase and equipment, building space allocation and layout, and facility expansion.

●Plans CAPEX budgets and schedule facility modifications, including cost estimates.

●Develop and lead the Company EHS initiatives with support of safety team.

●Participates in the Lean manufacturing program (SLIM), encourage and promote operating in a continuous improvement environment.

●Conduct performance appraisals and provide coaching and guidance to all direct reports.

●Oversee the engineering, maintenance, and facilities departments.

12/2014– 07/2019 Amneal Pharmaceuticals 1 New England Ave. Piscataway, NJ

Senior Manager- Transdermal (Hydrogel, Matrix, Matrix Hormonal) Manufacturing

●Supervise/ Manage the Startup operations of Three Transdermal manufacturing areas.

●Hire and build a team of transdermal manufacturing operators to a 24-hour operation.

●Supervise Up to 40 employees of a 24 hour/ 5- 7-day week operation.

●Manufacture ANDA submission batches.

●Launched 2 Transdermal products in 2019.

●Hydrogel Transdermal fully integrated highspeed line (460 PPM),

●Matrix Transdermal manufacturing suites, (Mixing, Coating, Converting, & Packaging)

●Matrix Hormonal Transdermal Manufacturing Suites. (Mixing, Coating, Converting, & Packaging)

●Assure that operations/ production/ testing are conducted in compliance with cGMPs, Sops, Quality Assurance and EPA, OSHA, DEA, FDA and other Regulatory requirements.

●Perform Lean manufacturing, baseline and Kaizen Improvements with Six Sigma fundamentals.

●Controlled Substance (Class II/ III) Manufacturing.

●Coordinate Production between Planning, Mixing (Compounding) / Coating, Converting, Packaging, Maintenance, and Engineering Departments.

●Troubleshoot product quality and machine issues.

●Daily, monthly, yearly production/ efficiency reports.

●Conduct FDA, Vendor, Client, Executive management facility tours.

●Conduct Monthly Safety inspections.

●Conduct employee GMP/ SOP/ Safety training. Departmental inventory.

●Conduct personnel reviews/ performance evaluations and counseling reports and attendance reports.

● Write/ Review batch records, incident investigations, deviations, CAPA’s and SOPs. Audit Department SOPs. Conduct Monthly Safety audits for department.

●Production & Process Cost Control and Improvements. Safety Committee & First Aid Team.

8/1993– 12/2014 Lohmann Therapy Systems Corp. 21 Henderson Drive West Caldwell, NJ

Manager of Manufacturing (Transdermal & Oral Thin Films)

●Manage the operations of three departments (Mixing/ Compounding, Coating, & Slitting)

●Supervise up to 40 employees of a 24 hour/ 7-day week operation.

●Perform Lean manufacturing, baseline and Kaizen Improvements with Six Sigma fundamentals.

●Controlled Substance (Class II & III Narcotics) Vault Monitor.

●Coordinate production between Production Planning, Mixing (Compounding) / Slitting/ Maintenance and Coating Departments.

●Troubleshoot product quality and machine and coating/ lamination issues with slitting and mixing (Compounding) departments and with customers and vendors.

●Daily, monthly, yearly production/ efficiency reports.

●Accommodate present and future customers. Conduct Monthly Safety inspections.

●Conduct employee GMP/ SOP/ Safety training. Departmental inventory.

●Department purchasing agent and capital investments.

●Conduct personnel reviews/ performance evaluations and counseling reports and attendance reports.

●Write/ Review batch records, incident investigations, deviations, CAPA’s and SOPs. Audit Department SOPs.

●Conduct Monthly Safety audits for department. Production & Process Cost Control and Improvements. Safety Committee & First Aid Team.

●SAP data entry of labor and production reports daily for up to 3 departments.

In Process Controls Supervisor (Coating Dept.)

●Supervise/ Manage the operations of three coating/ laminating lines.

●Assure that operations/ production/ testing are conducted in compliance with cGMPs, Sops, Quality Assurance and EPA, OSHA, DEA, FDA and other Regulatory requirements.

Pharmaceutical Coater/ Mass Preparation Operator II:

●Manufacture Medical and Transdermal pressure sensitive products utilizing coating/ laminating production lines according to cGMP standards. Mix/ Compound various adhesive/ chemical & aqueous/ oral compounds, coatings, and solutions.

In Process Controls Operator:

●Perform appropriate tests and procedures on coated/ laminated products to ensure product quality.

1/1992–8/1993 Betham Corp. Lincoln Blvd. & River Rd. Middlesex, NJ

Lead Man/ Supervisor:

●Supervise the 3rd shift Mixing, Coating, and Slitting Operations of up to 8 Operators.

Coater / Mixing Operator:

●Operate 2 coating/ laminating lines.

●Manufacture Coating trials & specialty products/ tapes/ films/ foams/ & substrates.

●Mixing & custom blending of adhesives & solutions.

Education & Training:

●Bound Brook High School (1989)

●Annual cGMP Trainings.

●OSHA Safety Trainings.

●Haz whopper Trainings.

●Lean Manufacturing and Six Sigma fundamentals.

●(SPC) Statistical Process Capability Overview.

●Controlled Substance (Class II/ III Narcotics) DEAC Training.

●Controlled Substance (Class II/ III Narcotics) Vault/ Room Monitor.

●Confined Space Training.

●Multiple Seminars (Supervisory/ Communications/ Documentation/ Etc.).

●Technical Writing and ISO 9000 overview CECs.

●Equal Employment Law and Workplace Harassment (EANJ)

●First Aid & CPR Training.

●Multiple Microsoft Windows and Office, Lotus Notes, SAP, & PC courses.

Contact this candidate