FSP Senior Scientist

Thermo Fisher Scientific • King of Prussia, PA

14h

About The Position

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. Location/Division Specific Information Thermo Fisher's 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 clients to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Discover Impactful Work The MDS-AD-SFC are well equipped with modern instrumentation for structural characterization pharmaceuticals including various mass spectrometers, biophysical and analytical tools. This position will be in the MDS-AD-SFC mass spectrometry and characterization (MSC) group and will provide an opportunity to lead key activities required for progression of small and large molecule assets. A day in the Life Characterize and identify API and foreign particulates by vibrational spectroscopy and SEM-EDX. Characterize sub-visible and visible particulates by LO, Microflow-imaging, LS techniques. Provide structural characterization of various API and protein therapeutics. Develop and implement various methods for structural characterization of formulations and long acting injectables (LAIs). Develop and implement various methods for sizing of various APIs in co formulations and LAIs. Analysis and characterization of aggregate and particle formation in protein therapeutics. Provide high quality data and aid in drafting of sections for characterization reports and regulatory submissions.

Requirements

• A BS (4-6 years of experience) or MS degree (2-4 years of experience) in protein biochemistry, biophysics, pharmaceutical sciences or related fields
• In some cases an 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.
• Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
• Ability to apply Microsoft Excel and Word to perform tasks.
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• 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 work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform optimally under pressure while prioritizing and handling multiple projects or activities.

Nice To Haves

• API characterization using vibrational spectroscopy (IR, Raman and VCD).
• Elemental analysis using SEM-EDX.
• Experience in protein structure analysis such as secondary and tertiary structure, protein folding-unfolding, aggregates, and particles characterization and quantification using various spectroscopic and biophysical techniques including FTIR, CD, VCD, DSC, AUC, Fluorescence, SEC-MALS, particle analysis technologies (DLS, FlowCam, MFI, and HIAC).
• Proficient in and demonstrates highly effective oral and written communication skills.
• Great teammate and ability to work in a matrix environment.

Responsibilities

• Characterize and identify API and foreign particulates by vibrational spectroscopy and SEM-EDX.
• Characterize sub-visible and visible particulates by LO, Microflow-imaging, LS techniques.
• Provide structural characterization of various API and protein therapeutics.
• Develop and implement various methods for structural characterization of formulations and long acting injectables (LAIs).
• Develop and implement various methods for sizing of various APIs in co formulations and LAIs.
• Analysis and characterization of aggregate and particle formation in protein therapeutics.
• Provide high quality data and aid in drafting of sections for characterization reports and regulatory submissions.

Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
• We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees