Advance Biologics Characterization: Senior Analytical Scientist
Drive Analytical Innovation for Global Biologic Drug Development
Lambda Therapeutic Research Ltd. is expanding its integrated Contract Development & Manufacturing Organization (CDMO) capabilities to provide end-to-end solutions for biologics. With flexible, scalable platforms and a collaborative approach, we accelerate the journey from pilot batch to clinical manufacturing and First-in-Human trials. We are seeking an experienced Analytical Scientist to strengthen our Physicochemical Characterization team, delivering robust, regulatory-ready analytical methods for monoclonal antibodies and novel biologics.
Key Responsibilities
Method Development & Validation Leadership
- Provide expert technical input for developing and validating physicochemical analytical methods for monoclonal antibodies (mAbs) and other complex biologics.
- Deliver robust, fit-for-purpose analytical methods that are easily validated and transferred.
- Author and review analytical method development and validation protocols and reports.
Technology & Laboratory Stewardship
- Demonstrate strong operational and troubleshooting knowledge of analytical platforms, including:
- Chromatography: NP-HPLC, RP-HPLC, SEC-HPLC, CEX
- Electrophoresis: CE-SDS (Sciex), capillary isoelectric focusing (cIEF)
- Advanced Techniques: SoloVPE, Mass Spectrometry, Dynamic Light Scattering (DLS), Differential Scanning Calorimetry (DSC), Circular Dichroism (CD)
- Maintain analytical laboratories and ensure complete documentation of equipment performance and calibration.
Quality Systems & Compliance
- Utilize electronic Laboratory Notebook (eLN) and adhere to Quality Management System (QMS) requirements.
- Apply knowledge of regulatory guidance (USP, ICH) and GLP/GMP standards to all analytical activities.
- Support GMP investigations to resolve deviations related to physicochemical method outcomes.
Cross-Functional Collaboration & Regulatory Support
- Provide in-process analytical support to upstream/downstream process development teams.
- Lead analytical method transfer to the Quality Control laboratory.
- Author and review technical reports and regulatory submission sections to support IND-enabling data packages for early-phase clinical trials.
Qualifications & Experience
Essential Requirements:
- MSc or M.Tech. in Biochemistry, Biotechnology, or a closely related field.
- 4 to 8 years of hands-on experience developing and validating physicochemical methods for monoclonal antibodies within a biopharma, biotech, or relevant CRO/CDMO.
- Demonstrated expertise in HPLC (various modes), CE-SDS, cIEF, and protein characterization techniques.
- Working knowledge of eLN, QMS, and regulatory guidelines (USP, ICH Q2(R2)).
- Experience in analytical method transfer and GMP/GLP environments.
- Strong technical writing skills for protocols, reports, and regulatory documents.
Preferred Attributes:
- Prior experience in a biopharma organization focused on the physicochemical characterization of mAbs.
- Hands-on experience with advanced techniques such as Mass Spectrometry, DLS, DSC, or CD.
- Proven ability to troubleshoot analytical methods and instrumentation.
- Experience contributing to regulatory filings (e.g., IND, CTA) for biologics.
Why Join Lambda's CDMO Analytical Team?
- End-to-End Impact: Your methods support the entire development pathway—from candidate selection through GMP manufacturing and regulatory submission.
- Technical Leadership: Work with state-of-the-art instrumentation in a dedicated analytical development lab.
- Regulatory Influence: Play a key role in generating high-quality, submission-ready data for global clinical trials.
- Career Growth: Clear path to Principal Scientist or Analytical Team Lead within a growing, integrated CDMO.
- Collaborative Science: Partner closely with Process Development, Manufacturing, and Quality teams in a seamless, project-driven environment.
Ready to develop the analytical science that underpins tomorrow's biologic therapies?
Apply now for the Senior Analytical Scientist position.
Lambda Therapeutic Research is an equal opportunity employer. We champion scientific rigor and are dedicated to building an inclusive team that advances the development of life-changing biologics.
