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Pharmaceutical manufacturing manager

Location:
Flemington, NJ
Salary:
130000
Posted:
October 22, 2019

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Resume:

Cell#: 732-***-****. Email: adanjh@r.postjobfree.com

** ************ **. *** ***** Palm Springs Terrace

Neshanic Station, N.J. 08853. Crystal River, Fl. 34429

Thomas R. Van Pelt II

Experience:

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.



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