Technical Services/Pharmaceutical Technology S

Job Description

Job Summary

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 ensure 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 Quality investigations. Other key objectives include generation, execution, and reporting of products, 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 Responsibilities

• Coordinate the scale-up batches of new products and processes including such tasks as batch record preparation, scheduling, raw material acquisition, supervising batch manufacture, etc.
• Identify potential product/process improvements of existing commercial dosage forms. Present proposals to optimize formula and product flow and 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.
• 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 manufacturers 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.
• Evaluate and qualify alternate sources of raw materials.
• Maintain 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.
• Perform other related assignments and duties as required and assigned.

Education and Experience

BS degree in Chemistry, Biology or Engineering with a minimum of 5-7 years’ experience in the fields of Pharmaceutical Product Development and/or Process Development; Master’s degree and 4 years of experience.

Necessary Knowledge, Skills, and Abilities

• Advanced knowledge of process development methodologies, including current validation concepts, with a strong working understanding of cGMP requirements and FDA and DEA regulations.
• Demonstrated expertise in the operation and oversight of pharmaceutical production equipment, including high‑shear granulators, fluid bed processors, solution preparation systems, weighing and dispensing systems, milling and blending equipment, tablet compression machines, and encapsulators. Ability to direct batch manufacturing activities, ensure compliance with SOPs and safety standards, and provide hands‑on guidance to production operators.
• Comprehensive knowledge of pharmaceutical unit operations, particularly as they relate to solid oral dosage forms. Proven capability to apply sound scientific judgment and make timely decisions during process development, design of experiments (DOE), and batch manufacturing activities.
• Demonstrated ability to develop original, data‑driven solutions to optimize formulations and manufacturing processes.
• Proven experience coordinating and executing process scale‑up activities, recognizing that scale‑up strategies vary by product and require customized technical and operational approaches.
• Strong capability in protocol development, including selection of appropriate study designs to demonstrate process consistency and product acceptability. This requires independent research, technical originality, cross‑functional collaboration, effective use of internal resources, and strong time‑management skills.
• Proficient in the preparation of technical reports, including analysis and interpretation of data against specifications and acceptance criteria. All documentation must comply with cGMPs, FDA regulations, clinical requirements, and current validation practices. Responsible for investigating, documenting, and justifying all process deviations, discrepancies, and variations

• Periodically, the Scientist may encounter unexpected production problems as well as process deviations during the execution of studies. Examples of problems typically experienced are:

o Equipment changes/modifications

o Equipment malfunction/breakage

o Process control system disruptions

o MES (SAP) system disruptions