New Brunswick, New Jersey · Biotech/Pharmaceutical
ProStaff Solutions is looking for Scientist I to work with a pharmaceutical company in New Brunswick, NJ.
Scientist performs process development studies and process validation activities. This position also prepares technical documentation to support development and validation program. This position provides technical support to Manufacturing and Quality department.
Area of Responsibility
Design and execution of DOE’s, process optimization studies, and process qualification batches, Process data compilation and analysis using statistical tools.
Develop a strong documentation package, involving from conceptual study to various phases of product development like process study, characterization, process qualification and cleaning validation.
Responsibility for preparation of Master batch records, Exhibit Batch protocols, pre-validation and process validation documentation and reports.
Provide troubleshooting support to manufacturing operations.
Champion compliance investigations, commitments (CAPA), and change controls.
Participate on cross-functional team that address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.
Other responsibilities may be assigned as deemed necessary.
Office Environment located within a Manufacturing/Production facility.
Environmental related to manufacturing/production environments:
Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
Odors: Unpleasant smells.
Gases: Examples include carbon monoxide and ozone.
Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock. Corporate office environment.
Moderate physical effort equal to frequent lifting or moving of lightweight materials up to 10lbs.
Ability to navigate office and plant floor working environments, stands, ambulates, and reaches.
Ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education, Qualifications and Experience
Minimum B.S. in relevant science field, Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines. M.S. preferred.
Proficient in MS office applications such as MS word; MS-excel; MS-projects; MS-power point
Minimum 3 years’ experience in Solid oral Manufacturing. Experience in Solid oral dosage development is desirable.
Good oral communication and technical report writing skills.
Excellent interpersonal written and oral communication skills