Location
Newton, MA | United States
Job description
STC Biologics is a boutique CDMO within the hub of biotechnology in MA that provides integrated biopharmaceutical CMC services. Our high flexibility combined with technical and regulatory sciences expertise provides unique advantage to clients for bringing their products from preclinical phase to global approvals.
We are seeking a talented mass spectrometrist. With us, you have the opportunity to learn a diverse range of CMC activities and regulatory sciences while contributing to advancing complex therapeutic products through clinical development.
Key Responsibilities
- Develop and execute detailed analytical plans in an agile manner with minimal re-work.
- Provide routine client updates and deliver high quality work timely. Specific analytical activities include:
- Develop robust analytical methods for release and stability testing
- In close collaboration with Quality, design and execute protocols for phase-appropriate validation of analytical methods, troubleshoot assay performance issues, contribute to addressing Investigations and Deviations
- In close collaboration with Process development and Quality, develop in-process and raw materials tests; support in-process testing and contribute to batch records
- Biophysical and biochemical characterization of proteins, nanoparticles, and impurities. Characterize structural properties (e.g. glycans, sequence variants, charge variants) and impurity profile using orthogonal and high resolution analytical technologies
- Support writing proposals with swift response to client. Then drive efficient execution of diverse projects that necessitates working with manager to maneuver resources in a matrixed and fast paced environment
- Track budgeted activities and communicate timely project invoicing per STC procedures
- Write/review technical reports and documents
- Train and mentor technical staff
- Be current on analytical technologies, publications, instrumentation, providing recommendations to management.
Credentials and Experience
- PhD degree in protein analytical sciences or related field with 5 years of industry experience in a regulated biopharmaceutical environment.
- Specific expertise in mass spectrometry modalities, intact mass analysis, peptide map/MS/MS, disulfide linkage analysis, glycosylation characterization; hands-on experience with Thermo’s QE mass spectrometer highly desirable.
- Demonstrated experience with the development of a broad range of analytical methodologies for characterization of biotherapeutics. Experience with biophysical methods, and analysis of complex mixtures and nanoparticles highly desirable
- Knowledge of GMP requirements and ICH guidelines desirable
Competencies
- Drive and flexibility to meet objectives efficiently in a fast pace environment
- Critical thinking and creativity to integrate information and devise solutions for complex technical problems
- Excellent written and oral communication skills with clear writing of technical reports, client updates, and regulatory submissions
- Effective teamwork, people management through influence and accountability
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