Scientist

About the role

The DDS-AD-EC(US) is well equipped with modern instrumentation for structural characterization of pharmaceuticals including various mass spectrometers, biophysical and analytical tools. This position will be in the DDS-AD-EC(US) Structural Analysis and Characterization (SA&C) group and will provide an opportunity to lead key activities required for progression of small and large molecule assets.

Responsibilities

• Provide structural characterization of various API and protein therapeutics using vibrational spectroscopy.
• Characterize and identify foreign particulates by optical and digital microscopy, vibrational spectroscopy, and SEM-EDX.
• Characterize sub-visible and visible particulates by flow-imaging and LS techniques.
• Develop and implement various methods for structural characterization of coformulations and long-acting injectables (LAIs).
• Develop and implement various methods for sizing of various APIs in coformulations and LAIs.
• Develop and implement various methods for 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.
• Represent line function in project teams and/or sub teams.

Requirements

• A BS or MS degree in protein biochemistry, biophysics, pharmaceutical sciences or related fields.
• 4-6 years of experience with an BS degree; 1-3 years with an MS degree.

Preferred Qualifications

• API characterization using vibrational spectroscopy (VCD, IR and Raman).
• 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, Micro-Flow Imaging, and HIAC).
• Elemental analysis using SEM-EDX.
• Proficient in and demonstrates highly effective oral and written communication skills.
• Team player and ability to work in a matrix environment.

Keys to Success

• Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance.
• Ability to utilize Microsoft Excel and Word to perform tasks.

Physical Requirements / Work Environment

• 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 successfully under pressure while prioritizing and handling multiple projects or activities.

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!