Technical Program Coordination Scientist I

Research & Development

Research and Development & Laboratory

 

Technical Program Coordination Scientist 1 (TPC Sc1)

 

Summary/Objective

The primary function of a TPC Scientist is to serve as a technical expert representative across teams and external sources in support of challenges in the development, the validation, and the manufacture of pharmaceutical products.

 

Essential Functions

·        Optimizes and validates analytical methods and provides analytical testing in support of TPC projects.

·        Understands routine risk management processes, inspection practices, sampling techniques, and process qualification procedures for the Cleaning Validation Program.

·        Generates/executes/reviews protocols in support of process development and validation for the Cleaning Validation Program.

·        Offers technical support across teams and external clients and uses their people and technical skills to provide effective transfer (communication) of solutions to resolve routine technological challenges.

·        Understands applicable cGMP, OSHA, and DEA regulations to meet daily TPC functions.

·        Uses the Quality-by-Design systemic approach to design and develop the processes that ensures the predefined product quality is met.

·        Knowledge of the basic concepts of data integrity and statistical treatment of experimental data.

·        Comprehends basic DOE concepts and able to propose conclusion congruent with experimental results.

·        Researches regulatory requirements to resolve routine technical requirement issues due to compendia changes.

·        Uses their technical knowledge and problem solving skills to identify effective solutions for routine technical challenges.

·        Any other duties as required by supervision.

 

Supervisory Responsibility

·        None

 

Work Environment

 

This job operates in a professional office, laboratory, and manufacturing environment. This role routinely uses standard office and laboratory equipment. The employee is occasionally exposed to toxic and/ or caustic chemicals such as sodium hydroxide, hydrochloric acid, acetonitrile, methanol, and other chemical solutions necessary in analytical chemistry.

 

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

The employee must regularly lift and/ or move up to 50 pounds. Specific vision abilities required by this position include close vision, color vision and the ability to adjust focus. While performing the duties of this job, the employee is regularly required to stand, walk, sit and talk or hear. The employee is occasionally required to climb or balance, stoop, kneel, crouch, crawl and smell.

 

Position Type/Expected Hours of Work

 This is a full-time position. Days and hours of work can vary, depending on which shift the employee is assigned.

 

Travel

None.

 

Preferred Experience

·        Bachelor Degree in Science, Chemistry, or technical field with 3 - 5 years of experience in the pharmaceutical industry.

·        Other experience may be considered.

 

Work Authorization/Security Clearance (if applicable)

Must be able to complete and clear DEA background

 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.