Scientist, Formulations

Thermo Fisher Scientific•Collegeville, PA

7d•Onsite

About The Position

The Scientist, Formulations develops drug product formulations and associated manufacturing processes as part of a matrix Technical Team. The role supports pre-formulation, formulation, and process development, and may assist in manufacturing batches for process development, stability studies, or clinical trials. The position is fully onsite at a customer site in Collegeville, Pennsylvania. Applicants from anywhere in the United States are welcome, but relocation assistance is not provided. Candidates must be legally authorized to work in the United States without sponsorship and must pass a comprehensive background check, including drug screening. The Scientist works with Pharmaceutical Development and analytical and manufacturing representatives to meet project deliverables. The role includes following established protocols and procedures, recording and managing laboratory data, contributing to reports and batch records, and operating trained equipment in accordance with GMP and safety requirements. The Scientist also identifies and communicates experimental or equipment issues, maintains a clean work area, and follows laboratory and manufacturing safety practices. The role requires a bachelor's degree in a relevant laboratory science and comparable experience of 2–4 years, or a master's degree and comparable experience of at least 1 year. An equivalent combination of education, training, and directly related experience may be considered. Preferred qualifications include independent literature searches, the ability to learn and apply new techniques, and basic knowledge of regulatory requirements for sterile and oral solid dosage forms.

Requirements

Bachelor's degree in a laboratory science such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology, or a similar discipline, plus comparable experience of 2–4 years; or a master's degree plus comparable experience of at least 1 year.
An equivalent combination of appropriate education, training, and directly related experience may be considered.
Honours degree or equivalent in an appropriate discipline, or working toward a relevant qualification.
Technical competence in a number of formulation and 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.
Legal authorization to work in the United States without sponsorship.
Ability to pass a comprehensive background check, including drug screening.
Ability to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Ability to work upright and stationary and/or standing for typical working hours.
Ability to lift and move objects up to 25 pounds.
Ability to work in non-traditional work environments and use and learn standard office equipment and technology proficiently.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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

Execute pre-formulation, formulation, and process development activities using established protocols and procedures.
Assist in manufacturing product batches for process development, stability studies, or clinical trials as required.
Coordinate activities within Pharmaceutical Development and with analytical and manufacturing representatives to meet project deliverables.
Work with the matrix technical team to align and execute development activities, including authoring or contributing to manufacturing batch records.
Identify and begin to interpret problems in experimental processes or results, and communicate them to a supervisor.
Seek assistance from other scientists to solve problems.
Maintain cleanliness in personal and communal work areas.
Anticipate or recognize potential equipment and supply problems and propose or initiate corrective or preventive actions.
Independently operate equipment for which trained, with due regard for GMP and safety.
Work in accordance with GMP and GLP, 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, including recording, tabulating, and graphing results in a laboratory notebook or computer, with minimal supervision and in compliance with departmental guidelines.
Consult a supervisor when difficulties cannot be readily resolved.
Prepare oral or written summaries of results, including interpretations for project work.
Write specific technical sections of internal and external reports with supervision.
Attend regular safety training and understand the safety requirements of the laboratory and working environment.
Follow safe Laboratory and Manufacturing Practices and maintain accurate, complete safety records.
Recognize potential safety problems and take action to rectify them.
May assist in training others in the area of responsibility.