FSP Scientist-Formulation & Process Development

Thermo Fisher Scientific•Collegeville, PA

7d•Onsite

About The Position

At Thermo Fisher Scientific, the FSP Scientist supports the company’s mission to enable customers to make the world healthier, cleaner and safer. The role is part of PPD Laboratory Services, whose scientists and laboratory professionals contribute to patient health through accurate, high-quality work. The Scientist uses technical skills and expertise to develop drug product formulations and associated manufacturing processes as part of a matrix technical team. The work includes planning and executing preformulation, formulation and process development activities; supporting manufacturing batches for process development, stability studies or clinical trials; coordinating with Pharmaceutical Development and analytical and manufacturing representatives; and contributing to manufacturing batch records. The Scientist troubleshoots experimental and equipment issues, records and interprets data, prepares project summaries and report sections, and follows GMP/GLP, safety and quality requirements. Work is performed in a laboratory and/or clinical environment, with occasional drives to site locations and occasional domestic travel. Conditions may include exposure to biological fluids and potentially infectious organisms, rare exposure to irritants, radiation, toxic materials and hazardous waste, and rare exposure to fluctuating or extreme temperatures. Personal protective equipment, including protective eyewear, garments and gloves, is required. The role involves extended periods upright or stationary, repetitive hand movements, occasional mobility, frequent upper-body and neck bending or twisting, and light to moderate lifting of objects weighing up to 15–20 lbs.

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 and process development techniques.
Experience and competence in properly handling, recording and analyzing 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 minimal guidance, plan work schedules to meet goals, concentrate for multiple periods, multitask and perform under stress.
Ability to use a variety of in-house and off-the-shelf computer software.
Ability to communicate and understand information presented verbally and interact with others to obtain or relate information.
Regular and consistent attendance.

Nice To Haves

Ability to perform literature searches independently and understand scientific literature directly 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.
Liaise with formulators, modellers, Process Analytical Technology (PAT) scientists, automation experts, data scientists and device engineers.
Assist with manufacturing product batches for process development, stability studies or clinical trials as needed.
Coordinate activities within Pharmaceutical Development and with analytical and manufacturing representatives to meet project deliverables.
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.
Engage other scientists to help solve problems and consult a supervisor about difficulties that cannot readily be resolved.
Maintain cleanliness in personal and communal work areas.
Anticipate or recognize potential 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 in accordance with GMP/GLP, company policy, legal requirements and departmental guidelines.
Record laboratory data reliably and on time in Labware and other suitable systems.
Manage data, record results, and tabulate or graph findings 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 regular safety training, follow safe Laboratory and Manufacturing Practices, and maintain accurate safety records.
Recognize potential safety problems and take action to rectify them.