Process Specialist Supervisor @ ArmorLine Corporation
Sr. Technical Operations Consultant @ Sandoz
Jeff is a highly experienced and accomplished pharmaceutical scientist/engineer with 30+ continuous years of pharmaceutical technology experience. He has developed robust and scaleable immediate and modified release solid oral dosage forms of generic and branded OTC, Rx and Nutraceutical products. He managed and executed successful process development, scale-up and technology transfer activities for many key products to
Jeff is a highly experienced and accomplished pharmaceutical scientist/engineer with 30+ continuous years of pharmaceutical technology experience. He has developed robust and scaleable immediate and modified release solid oral dosage forms of generic and branded OTC, Rx and Nutraceutical products. He managed and executed successful process development, scale-up and technology transfer activities for many key products to multiple manufacturing facilities. He also provided technical guidance to operations for marketed products. Jeff is professional, gregarious and has a self-confident personality that interacts well with both customers and colleagues, creating genuine rapport and long-term relationships. Key strengths include outstanding technical writing and communication skills used to effectively handle multiple projects simultaneously. He is very resourceful and has an instinctive desire to succeed within the company. He has the ability to think independently and perform within a team.
Specialties: Jeff is a very detail oriented professional. The challenge he enjoys the most is discovering a process or ingredient change that may be key to a more rugged formulation or one that may be more efficiently produced. Jeff is also mindful to be conservative with company resources during the development and manufacturing phase of a new product. He thrives on reducing costs, increasing profitability and enhancing product quality.
Sr. Process Engineer ll @ • Responsible for projects during Technology Transfer, Bio/Submission, Scale up/down and Process Validation, trouble shooting of commercial products and Cleaning Validation activities
• Provide support to Formulators regarding design & execution of DOEs that challenge the robustness of formulations on commercial scale equipment
• SME in granulation, blending, compression, encapsulation & coating
• Collect, summarize and analyze Technology Transfer, Submission Batch and Process Validation data including In-process manufacturing testing, In-process QC testing and Finished Product QC testing for the preparation of associated reports
• Ensure that equipment and processes transferred from Product Development to Manufacturing are production ready From July 2015 to Present (6 months) Greater Philadelphia AreaProcess Specialist Supervisor @ • Recruited to design, set-up and operate a class 100K clean room for manufacture of propriety powders used for military,defense and aerospace applications
• Streamlined production processes using Lean Manufacturing principles by more than 75% reducing labor costs, increased throughput and Total Quality of finished goods
• Supervised technicians and managed the daily production activities
• Validated manufacturing equipment and processes
• Performed quality checks using analytical instrumentation
• Author manufacturing batch records, SOP’s, quality documents and performed employee training
• Worked with third party manufacturers to develop processes to meet raw material specifications From October 2010 to Present (5 years 3 months) Sr. Technical Operations Consultant @ • Facilitate Technical Transfer and Validation activities From January 2009 to October 2010 (1 year 10 months) Manager, Technical Services @ • Participated on a project team that was instrumental in lifting the consent decree by ensuring all production processes, facilities and controls were brought into compliance with FDA.
• Managed the Technical Services Department for high volume multi-product facilities located in Charlotte, NC and Huntsville, AL. Provide technical support to mfg, QA, QC, validation and RA.
• Led process optimization trials, scale-up, technology transfer activities, and trouble shooting of new approved and existing marketed products.
• Regulatory support for the CMC section of NDA & ANDA filings.
• Significant experience with SUPAC and Schedule CII-IV Narcotics.
• Optimized manufacturing processes to achieve cost reductions and quality improvements.
• Qualified alternate raw materials and API's to reduce costs.
• Monitor pilot batches, post approval scale-up batches and process validation activities.
• Develop and conduct engineering studies to determine root causes and implement corrective action / preventive action plans (CAPA).
• Prepared master batch records, pilot batch records, reports and other critical documents.
• Hands-on experience with various pharmaceutical processes including controlled and modified release drug delivery, tableting (single and multi-layer), film & sugar coating (functional and non-functional), wet granulation (high shear and fluidbed), blenders, milling machines, planetary mixers, tablet printers, roller compaction, packaging machinery and more.
• Products include tablets, capsules, liquids, suspensions, suppositories, creams, and ointments. The company’s prescription and over-the-counter products are used to treat various therapeutic categories, including anti-hypertensions, analgesics, antibiotics, cough/cold, antidepressants, and antipsychotics. From February 1999 to January 2009 (10 years) Group Leader, Technical Services @ • Managed scientists in the development of OTC pharmaceutical products.
• Participated on a project team to facilitate sight transfers of Rx products from Toronto to NC.
• Support manufacturing processes and resolved technical issues that arose during plant start-up and technology transfer activities. From September 1996 to February 1999 (2 years 6 months) Manager, Research & Development @ • Direct, coordinate and schedule departmental personnel and activities.
• Provided technical support and led optimization trials, scale-up, technology transfer, and trouble shooting of new developed and marketed products.
• Research new technologies and processes adapting their use to meet specific project requirements.
• Strong understanding of sustained release formulations and functional enteric tablet coatings.
• Design and develop over 130 private label OTC pharmaceutical products as directed by marketing.
• Activities include conceptual formulation prototype design, feasibility experimentation, formula “fine tuning”, scale-up trials and transfer of technology to production.
• Streamline manufacturing processes to improve efficiency and reduce costs.
• Improved existing marketed products via changes in process equipment and formulation.
• Managed manufacturing personnel for 3-shift/24 hour day operation, including up to 36 people in the combined areas.
• Coordinate all aspects of the plant’s operation to facilitate efficient product flow between departments.
• Evaluated, sourced and purchased new equipment for the plant.
• Directly supervised 18-25 manufacturing employees.
• Maintained daily production schedules ensuring production schedules were met.
• Trained and coached production personnel to consistently perform operational tasks by complying with cGMP requirements and following proper SOP's. From July 1985 to September 1996 (11 years 3 months) Supervisor, Tablet Coating @ • Served as Coating Supervisor with responsibility for operation of 60” Vector coating pans.
• Gained extensive experience in both organic and aqueous tablet coatings.
• Operated tablet printing equipment. From April 1984 to June 1985 (1 year 3 months) Manager, Process Development @ • Responsible for the set up and operation of a new product development laboratory.
• Moving to R&D, learned skills from basic formulation through commercial production.
• Gained extensive experience in operation of Glatt WSG 300 fluidbed granulators, high speed tablet presses, moisture determination units, tablet disintegration and dissolution apparatus, tablet hardness & thickness testers, friabulators, analytical balances, sieve analysis equipment, micrometers and titration units. From June 1981 to April 1984 (2 years 11 months) Feasibility Lab Technician @ • Conducted experiments to determine if equipment manufactured by Glatt would be feasible to manufacture customers products.
• Disassembled, cleaned and set-up pilot scale equipment manufactured by Glatt, such as: fluidbed granulators, wurster columns, tablet coating equipment, quick sieves etc.
• Operated a Glatt WSG 300 fluidbed granulator and processed food and pharmaceutical products. From June 1979 to June 1981 (2 years 1 month)
Licensed North Carolina Real Estate Broker @ Allen Tate School of Real EstateBarton College Jeff Phykitt is skilled in: Formulation, GMP, Validation, Sop, FDA, Technology Transfer, Pharmaceutical Industry, V&V, Technical Transfers, Manufacturing, Dissolution, Quality Assurance, CAPA, Drug Delivery, Cross-functional Team Leadership
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