Pharmaceutical Technology Scientist

Company: Purdue Pharma L.P.
Location: Wilson
Posted on: October 12, 2020

Job Description:

Pharmaceutical Technology Scientist Purdue Pharmaceuticals L.P. Technical Operations, 4701 Purdue Drive, Wilson, North Carolina, United States of America Req #27 Tuesday, October 6, 2020 Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships. Job Summary The Pharmaceutical Technology Scientist is primarily responsible for new product development, clinical activities, scale-up / manufacturing development, product transfer, optimization, and validation of new products/ processes into operations. The major objective is to assure successful new products to production and proper training of production personnel in any new product, process and/or equipment. Key objectives include clinical / manufacturing support, transfer of new products to the North Carolina as well as our external third-party partner sites and alternative API qualification. Additional responsibilities include troubleshooting and reformulation of problem products, product lifecycle development, product portfolio enhancement, and providing technical expertise and support to Production Investigations. Other key objectives include generation, execution, and reporting of development, DOE's, product, cleaning, and equipment validation protocols, new production / equipment selection and evaluation, rework evaluation of rejected batches and new/existing raw material evaluation. Primary Responsibilities * Primary responsibility is to coordinate the development, clinical, manufacturing, product transfer, and scale-up batches of new products and processes at the Purdue Pharmaceutical L.P. site in Wilson, NC as well as at third-party partner sites. This includes such tasks as batch record preparation, protocol generation, scheduling, raw material acquisition, and travel for on-site supervision of batch manufacture. * Responsible for identifying potential product/process improvements of existing commercial dosage forms. Will present proposals to optimize formula and product flow. Will implement changes after management approval. * Responsible for development of potential product/process activities for new products. Will present proposals to optimize formula and product flow. * Will provide technical assistance to alternate departments, as needed, to solve problems as they occur with the product. This responsibility includes both troubleshooting of active products on the shop floor and potential rework procedures for failed batches. * Responsible for new equipment evaluation. Additionally, will interface with engineering and equipment manufacturer to ensure proper installation and operation of the new equipment. Will be responsible for coordination of all activities to transfer new equipment to production, including training as required of both supervisors and operators. * Responsible for new product evaluation. Additionally, will interface with clinical, regulatory, R & D, operations and quality to ensure proper development of new products. Will be responsible for coordination of all activities within pilot plant /operations and laboratory areas. * Responsible for evaluating and qualifying sources of raw materials. * Responsible for compliance with Controlled Substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities. * Coordinate, develop and prepare protocols for process / product development, validation studies, including cleaning and equipment validation. * Prepare reports, including data analysis, conclusions and recommendations. * Coordinate the execution of validation studies with Production Scheduling. This may also include review and execution of protocols developed by other individuals. * Has a functional understanding of the operation of production equipment involved in the manufacturing process (such as high shear granulators, fluid bed processors, solution prep systems, weighing systems, milling systems, blending systems, tablet compression machines/encapsulators, etc.) following all applicable SOP's, safety standards and procedures Education and Experience Requirements A degree in a science or engineering and possess a minimum of 6-9 years' experience in the fields of Pharmaceutical Product Development and/or Process Development . May also hold a MS degree with 4-7 relevant experience. Necessary Knowledge, Skills, and Abilities * In-depth knowledge of process development techniques, formulation, cGMP regulations, FDA and DEA regulations, and recent trends in validation concepts. * The individual must have a functional, working knowledge of pharmaceutical manufacturing equipment, and be able to supervise batch manufacture and instruct production operators. * A thorough knowledge of Pharmaceutical unit operations is required, primarily as it relates to solid dosage forms. Scientist is capable of competent scientific judgments. Decisions must be made by this individual without delay during development, DOE, and batch manufacture. This may require some innovation on very short notice. 'Thinking on your feet' is often required. * Original solutions will be required to optimize formulas/processes. * Coordination of scale-up is a complex process that differs with each individual product. It is critical that problems be eliminated at this stage to obtain 'right first time' commercial products * The development of protocols requires an understanding of the formula/process/system to be studied. An approach must then be chosen which will demonstrate that the product performs in a consistent and acceptable manner. This involves original thinking and independent research, as well as the ability to effectively interact with other departments and utilize available resources. Effective time management is also essential. * The preparation of reports involves the analysis and evaluation of data regarding specifications and acceptance criteria and the presentation of all information in conformance with cGMPs, FDA guidelines/regulations, clinical and current validation industry practices. All process variations, deviations or discrepancies must be investigated and fully explained and justified. * Periodically, the Scientist may encounter unexpected production problems as well as process deviations during the execution of studies. Examples of problems typically experienced are: * Equipment changes/modifications * Equipment malfunction/breakage * Process control system disruptions * MES (SAP) system disruptions * If the Scientist experiences a production problem, they are expected to troubleshoot and call on additional resources (experienced operator, process engineers, maintenance, quality specialist) as needed to resolve issues. Supervisor Responsibilities (if applicable) - The Pharm Tech Scientist reports administratively to the Senior Manager or Assistant Director, Pharmaceutical Technology. - The Pharm Tech Scientist, from time to time, be responsible for supervision of production supervisors, production operators, and other personnel in completion of the required batch manufacture functions. - The individual will, at times, perform some duties of the department manager, as required, in his/her absence. Purdue Pharma L.P. & its Subsidiaries are an Equal Opportunity (EEO) and Affirmative Action Employer encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, national origin, religion, age, sex, sexual orientation, marital status, gender identity, genetic information, disability, military, protected veteran status, or any other characteristic protected by local, state, or federal law. Protected veterans and qualified individuals with a disability may request a reasonable accommodation by emailing: . For more information about your rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement EEO is the Law Poster Supplement OFCCP Pay Transparency Other details * Job Family Engineering & Sciences * Pay Type Salary * Purdue Pharmaceuticals L.P. Technical Operations, 4701 Purdue Drive, Wilson, North Carolina, United States of America

Keywords: Purdue Pharma L.P., Wilson , Pharmaceutical Technology Scientist, Healthcare , Wilson, North Carolina