Pharmaceutical Technology Scientist
A Pharmaceutical Technology Specialist is primarily responsible for transfer and validation of new products/ processes into production, scale-up/manufacturing development, product transfer, and optimization. The major objective is to assure successful new product transfer to production and proper training of production personnel in any new process and/or equipment. Key objectives include troubleshooting and reformulation of problem products, providing technical expertise and support to Production Investigations. Other key objectives include generation, execution, and reporting of product, cleaning, and equipment validation protocols. Additional objectives include new production equipment selection and evaluation, rework evaluation of rejected batches and new/existing raw material evaluation.
- Primary responsibility is to coordinate the scale-up batches of new products and processes at Purdue Pharmaceutical L.P. This includes such tasks as batch record preparation, scheduling, raw material acquisition, supervising batch manufacture, etc.
- 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 Production, as needed, to solve problems as they occur on the shop floor. This responsibility includes both troubleshooting of active products on the shop floor and potential rework procedures for failed batches.
- Responsible for new equipment evaluation. 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 for both supervisors and operators.
- Responsible for evaluating and qualifying alternate sources of raw materials.
- Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high level to diversion and theft possibilities.
- Coordinate, develop and prepare protocols for process / product validation studies, including cleaning and equipment validation.
- Prepare validation 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.
- Performs other related assignments and duties as required and assigned.
BS degree in Chemistry, Biology or Engineering with a minimum of 5 years’ experience in the fields of Pharmaceutical Product Development and/or Process Development.
Necessary Knowledge, Skills, and Abilities
- In-depth knowledge of process development techniques, 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. Must be capable of competent scientific judgments. Decisions must be made by this individual without delay during development, DOE, and batch manufacture.
- Original solutions will be required to optimize formulas/processes.
- Coordination of scale-up is a complex process that differs with each individual product.
- 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 in regard to 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
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: email@example.com.
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