Analytical Scientist

Globus Medical•Audubon, PA

11d•Onsite

About The Position

The Analytical Scientist will be joining a growing Regenerative Biologics group working on Process and Analytical Development for our developing recombinant protein projects. This role will be responsible for developing, optimizing, and validating analytical methods to characterize recombinant proteins, ensuring product quality and regulatory compliance. This role will also serve as technical contact for outside CDMOs and CROs for assay development, transfer, and validations.

Requirements

Ph.D. in Analytical Chemistry, Biochemistry, Biotechnology, or a related field (or M.S. with 5+ years of experience in protein analytical development).
Previous experience in biopharmaceutical or CDMO setting preferred.
Strong expertise in chromatographic (HPLC/UPLC), electrophoretic, and mass spectrometry-based methods for protein characterization.
Hands-on experience in method development, qualification, and validation under GMP/GLP environments.
In-depth knowledge of protein chemistry, post-translational modifications, aggregation, and degradation mechanisms.
Familiarity with regulatory guidelines (ICH, FDA, EMA) and CMC requirements for biologics.
Proficiency in data analysis software (e.g., Empower, MassLynx, Genedata, Origin, JMP).
Excellent problem-solving skills and ability to work independently in a fast-paced environment.
Strong communication, technical writing, and cross-functional collaboration skills.

Responsibilities

Develop and optimize analytical methods for the characterization of recombinant proteins, including purity, identity, potency, and structural integrity.
Perform and troubleshoot advanced analytical techniques, such as HPLC/UPLC (SEC, RP, IEX), capillary electrophoresis (CE-SDS, icIEF), mass spectrometry (LC-MS), and spectroscopic techniques (UV-Vis, CD, FTIR).
Support formulation development, process development, and stability studies by providing analytical insights into protein structure and degradation pathways.
Conduct assay transfer and validation activities in compliance with regulatory guidelines (ICH, FDA, EMA) and prepare method qualification/validation reports.
Collaborate cross-functionally with upstream/downstream process development, formulation, and quality teams to support CMC development.
Analyze and interpret complex data, provide scientific conclusions, and present findings in technical reports and meetings.
Author and review technical documents, including SOPs, protocols, regulatory submissions (IND, BLA), and scientific publications.
Stay updated on emerging trends and technologies in protein analytics and contribute to innovation within the analytical development group.
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.