Sr Scientist, Protein Formulations

Work Schedule

Environmental Conditions

Job Description

Join us as Senior Scientist!

Role: Sr. Scientist Protein Formulations

This is a fully onsite role based at our customers site in Wilmington DE. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States withoutsponsorship.

Must be able to pass a comprehensive background check whichincludes a drug screening.

Thermo Fishers clinical research business is a leading global contract research organization and world leader in serving science. We are passionate deliberate and driven by our mission to enable our customers to make the world healthier safer and cleaner.

Within our Analytical Services team we have a functional service provider solution which is a unique partnership that allows our customers to leverage the experience of our staff whileallowing you the employee to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company all while maintaining full-time benefits.

Summarized Purpose

We are seeking a highly motivated Scientist to join our Drug Product Technologies team. This role will support the development of formulations and drug product processes for monoclonal antibodies and related biologics from early development through commercialization.

Essential Functions

• Design and execute subcutaneous formulation development studies for monoclonal antibodies (e.g. buffer screening excipient selection stability assessment device compatibility in-vitro bioavailability assessment)
• Perform biophysical characterization (e.g. DLS DSC DSF) to investigate protein
• aggregation and degradation pathways
• Execute drug product development activities including fill-finish container closure selection (e.g. vials PFS autoinjectors) compatibility studies and support pilot batch manufacturing scale-up and technology transfer into GMP manufacturing
• Design and execute in-use compatibility studies to evaluate product quality under dilution storage and administration conditions
• Provide support for regulatory filings (e.g. IND BLA MAA) through assisting with CMC documentation and data compilation for submissions to global health authorities
• Coordinate and communicate with CROs and CMOs to support external studies manufacturing activities and project timelines
• Collaborate cross-functionally with analytical process development regulatory and quality teams

Education and Experience

• PhD in Pharmaceutical Sciences Chemistry Biochemistry Chemical Engineering or related field
• 0 2 years of relevant experience in biologics formulation or drug product development (including graduate research)
• Hands-on experience with protein/antibody formulation development
• Understanding of protein aggregation/degradation mechanisms and stabilization strategies
• Experience with analytical techniques for biologics (e.g. SEC IEX CE DSC particle analysis)
• Experience with statistical analysis approaches (e.g. DOE multivariate analysis)
• Strong problem-solving skills and ability to work independently and manage tasks effectively
• Highly organized with the ability to manage multiple tasks and priorities

In somecasesan equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities

• Experience with high-concentration protein subcutaneous product development
• Experience with prefilled syringes (PFS) or other container closure systems
• Experience with lipid-based nanoparticle formulations and delivery technologies
• Familiarity with ICH guidelines and regulatory requirements for biologics is a plus

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 is 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. Youll 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 tomorrows breakthrough.