Scientist, Formulations

Thermo Fisher Scientific•Collegeville, PA

9d•Onsite

About The Position

The Scientist, Formulations develops drug product formulations and associated manufacturing processes as part of a matrix Technical Team. The role conducts pre-formulation, formulation, and process development activities under established protocols and procedures; supports manufacture of product batches for process development, stability studies, or clinical trials; and coordinates with Pharmaceutical Development, analytical, and manufacturing colleagues to meet project deliverables. The Scientist contributes to manufacturing batch records, identifies and communicates problems, records and manages laboratory data, prepares summaries and report sections, and performs work in accordance with applicable GMP/GLP, safety, and company requirements. This is a fully onsite role at a customer site in Collegeville, Pennsylvania. The laboratory setting may include exposure to potentially hazardous elements, including infectious agents. Applicants must be legally authorized to work in the United States without sponsorship and must pass a comprehensive background check, including drug screening. Relocation assistance is not provided.

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 1 or more years.
An equivalency consisting of an appropriate combination of education, training, and/or directly related experience may be considered.
Technical competence in 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.
Legally authorized to work in the United States without sponsorship.
Able to pass a comprehensive background check, including drug screening.
Able to communicate and understand information and ideas with diverse groups of people.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to use and learn standard office equipment and technology proficiently.
Able to perform under pressure while prioritizing and handling multiple projects or activities.

Nice To Haves

Honours degree or equivalent in an appropriate discipline, or working toward a relevant qualification.
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 based on established protocols and procedures.
Assist in manufacturing product batches for process development, stability studies, or clinical trials.
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 interpreting problems in experimental processes 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 potential equipment and supply problems and propose or initiate actions to resolve or prevent them.
Operate trained equipment independently while observing GMP and safety requirements.
Work in accordance with GMP/GLP, as appropriate.
Record laboratory data in Labware and other suitable systems accurately and promptly in accordance with company policy and legal requirements.
Manage data, record results, and tabulate or graph results in a laboratory notebook or computer with minimal supervision and in accordance with departmental guidelines.
Prepare oral or written summaries of project results, including interpretation.
Write specific technical sections of internal and external reports with supervision.
Attend safety training, understand laboratory and workplace safety requirements, follow safe Laboratory and Manufacturing Practices, and maintain accurate safety records.
Recognize potential safety problems and take action to address them.
May assist in training others in the area of responsibility.