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  • ID
    #13069245
  • Job type
    Permanent
  • Salary
    Depends on Experience
  • Source
    AgreeYa Solutions
  • Date
    2021-04-23
  • Deadline
    2021-06-22

Vacancy expired!

The role is remote until COVID restrictions are lifted.
  • 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, DOEs, 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 ceutical 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 SOPs, safety standards and procedures.

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.

About Us:AgreeYa is a global systems integrator delivering competitive advantage for its customers through software, solutions, and services. Established in 1999, AgreeYa is headquartered in Folsom, California, with a global footprint and a team of more than 1,850 staff across offices. AgreeYa works with 500+ organizations ranging from Fortune 100 firms to small and large businesses across industries such as Telecom, Banking, Financial Services & Insurance, Healthcare, Utility & Energy, Technology, Public sector, Pharma & Biotech, and others. Please visit us at www.agreeya.com for more information. AgreeYa is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender identity, sexual orientation, national origin, disability, veteran status or other protected characteristics. Visit our website to learn about our Career & Culture.

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