FSP Scientist-Formulation & Process Development

Thermo Fisher Scientific•Collegeville, PA

6d•Onsite

About The Position

At Thermo Fisher Scientific, the FSP Scientist-Formulation & Process Development contributes to the company’s mission of enabling customers to make the world healthier, cleaner and safer. The role uses technical skills to develop drug product formulations and associated manufacturing processes as part of a matrix Technical Team. The scientist works with multidisciplinary colleagues to plan and carry out preformulation, formulation and process development activities, and coordinates work across Pharmaceutical Development, analytical teams and manufacturing representatives to meet project deliverables. The position includes assisting with product batch manufacture for process development, stability studies or clinical trials; preparing and recording laboratory data; interpreting results; contributing to reports and manufacturing batch records; and operating trained equipment in accordance with GMP and safety requirements. The scientist also maintains safe, clean work areas, identifies and addresses potential equipment, supply and safety problems, and consults a supervisor when issues cannot be readily resolved. Work is performed in a laboratory and/or clinical environment, with exposure to office equipment and potential exposure to biological fluids and infectious organisms. Occasional travel to site locations and occasional domestic travel are noted. Personal protective equipment, including protective eyewear, garments and gloves, is required. The work schedule is standard Monday through Friday.

Requirements

Master’s degree in Chemical Engineering, Pharmaceutical Sciences or a related field, with 1–3 years of protein formulation, process development and drug delivery development experience; or a bachelor’s degree in chemistry, Chemical Engineering, Pharmaceutical Sciences or a related field, with at least 2 years of relevant experience.
Technical competence in a number of formulation or process development techniques.
Competence and experience in proper handling, recording and analysis of scientific experimental data.
Good knowledge of GMP requirements, SOPs and policies.
Operational knowledge of routine laboratory or plant equipment.
Understanding of the basic principles, concepts and methodology governing the work performed.
Ability to work with multidisciplinary colleagues, including formulators, modellers, PAT scientists, automation experts, data scientists and device engineers.
Ability to work in an upright and/or stationary position for 6–8 hours per day.
Ability to perform repetitive hand movements to operate laboratory equipment.
Ability to lift and carry objects weighing up to 15–20 pounds.
Ability to use a variety of in-house and off-the-shelf computer software.
Ability to communicate and understand information conveyed through spoken words and sentences.
Ability to work independently, plan work schedules, manage multiple tasks and periods of intense concentration, and perform under stress.
Regular and consistent attendance.

Nice To Haves

Ability to perform literature searches independently and understand scientific literature related to experiments.
Ability to learn and apply new experimental techniques.
Basic knowledge of regulatory requirements for sterile and oral solid dosage forms.

Responsibilities

Plan and execute preformulation, formulation and process development activities as part of a multidisciplinary development team.
Coordinate activities within Pharmaceutical Development and with analytical and manufacturing representatives to meet project deliverables.
Assist with manufacturing product batches for process development, stability studies or clinical trials.
Align and execute development activities with the matrix Technical Team, including authoring or contributing to manufacturing batch records.
Identify and interpret problems in experimental execution or results and communicate them to a supervisor.
Seek assistance from other scientists to solve problems and consult a supervisor when difficulties cannot be readily resolved.
Maintain cleanliness in personal and communal work areas.
Anticipate or recognize equipment and supply problems and propose or initiate corrective or preventive action.
Independently operate equipment for which trained, with due regard for GMP and safety.
Work to GMP and GLP requirements as appropriate.
Record laboratory data promptly and reliably in Labware and other suitable systems in accordance with company policy and legal requirements.
Perform data management tasks, including recording, tabulating and graphing results in a laboratory notebook or computer with minimal supervision.
Prepare oral or written summaries of results, including interpretation, for project work.
Write specific technical sections of internal and external reports with supervision.
Attend safety training, follow safe Laboratory and Manufacturing Practices, and maintain accurate safety records.
Recognize potential safety problems and take action to rectify them.