FSP Scientist-Formulation & Process Development

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
As a Scientist, your role will be to perform advanced diagnostic testing and analysis, ensure the accuracy and reliability of laboratory results, troubleshoot complex technical issues, and contribute to the continuous improvement of lab procedures and quality standards.

What You’ll Do:

To utilise technical skills and expertise to develop drug product formulations and associated manufacturing processes as part of a matrix Technical Team. Conduct duties as listed below, plus any other tasks as requested by team leader or departmental director.

Knowledge, Skills and Abilities:

•Work as part of a multi-disciplinary development team, liaising efficiently with Formulators, Modellers, Process Analytical Technology (PAT) Scientists, automation experts, data scientists and device engineers, to plan and Execute preformulation, formulation and process development activities

•Assists in the manufacture of batches of product as required, e.g. for process development, stability studies or clinical trials

•Coordinates his/her activities within Pharmaceutical Development and with analytical and manufacturing representatives to meet project deliverables

•Works with the matrix technical team to align and execute preformulation, formulation and process development activities including authoring or contributing to manufacturing batch records

•Identify and interpret any problems in the execution of experimental processes and/or in results and communicates them to his/her supervisor

•Proactively engage and seek assistance from other scientists to solve problems

•Maintains cleanliness in own work area and in communal work areas

•Anticipates/recognizes potential problems with equipment and/or supplies, and proposes/initiates action to solve or prevent problems

•Operates equipment for which he/she is trained independently with due regard for GMP and Safety

•Works to GMP/GLP as appropriate

•Demonstrates timely & reliable recording of laboratory data in Labware and other suitable systems in accordance with company policy and legal requirements.

•Performs data management tasks including recording results effectively and in compliance with departmental guidelines in a laboratory notebook or computer with minimal supervision (e.g. tabulating and graphing results)

•Consults with supervisor when difficulties arise that cannot be readily resolved

•Prepares oral or written summaries of results with interpretation for project work

• Writes specific technical sections of internal and external reports with supervision

• Attends regular safety training and is fully aware of safety requirements for his/her laboratory/working environment

• Follows safe Laboratory and Manufacturing Practices

• Maintains accurate and complete safety records consistent with company policy and legal requirements

• Recognizes potential safety problems and takes action to rectify them

Education and Experience:

MS degree in Chemical Engineering, Pharmaceutical Sciences or related field with 1-3 years of protein formulation, process development and drug delivery development experience; or bachelor’s degree in chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with a minimum of 2+ years of previous experience that provides the knowledge, skills, and abilities to perform the job.

• Is technically competent in a number of formulation/process development techniques

• Demonstrates competence and experience in proper handling, recording and analyzing scientific experimental data

• Has good knowledge of GMP requirements, SOPs and policies

• Has operational knowledge of routine laboratory/plant equipment

• Understands the basic principles, concepts and methodology governing the work performed

Preferred Requirements:

• Can perform literature searches independently and understands scientific literature directly related to his/her experiments

• Can learn and apply new experimental techniques

Has basic knowledge about regulatory requirements for sterile and oral solid dosage forms

Working Conditions and Environment:
• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations, occasional domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
• Occasional mobility needed.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.