Senior/Principal Scientist - Analytical Method Development

Job highlights

• Deep experience in writing clear and precise analytical protocols for newly-developed methods,and keeping said protocols updated as methods are further developed
• Experience writing testing protocols for newly-developed methods for inclusion in regulatory submissions,as well as discussing and defending the appropriateness of these protocols in regulatory consultations and audits

We are seeking a Senior/Principal Scientist - Analytical Method Development to join our team in Hyderabad (note: in-person only, we do not offer remote work) to play a key role across our programs. This role involves:

• Leading the analytical team in the development and optimization of analytical methods for nucleic acid vaccines and lipid nanoparticles, including but not limited to HPLC, LC-MS, GC-MS, capillary electrophoresis, agarose gel electrophoresis, and spectroscopy techniques.
• Working with our R&D teams to rapidly adapt analytical methods to accommodate changes in product as they go through their fast-paced iterative development processes.
• Driving innovation in new analytical technologies and methodologies to enhance and accelerate vaccine characterization and quality control.
• Collaborating closely with R&D, manufacturing, and QC teams to ensure analytical methods are aligned with product development, production, and quality needs.
• Mentoring and developing the analytical method development team, fostering a culture of excellence, collaboration, and continuous improvement.
• Managing the analytical laboratory, including coordinating equipment maintenance, inventory management, and team training.
• Participating in regulatory submissions and audits, including proproviding expert insights and data to support product approvals.

Candidates must have:

• MS (or PhD) in Analytical Chemistry, Biochemistry, or a related field with a minimum of 10 (or 5 for PhD) years of experience in analytical method development, preferably related to biologics.
• A deep understanding of HPLC-based techniques and method development, with a proven track record of developing and optimizing HPLC methods for the characterization of novel biomolecules.
• Deep experience in writing clear and precise analytical protocols for newly-developed methods, and keeping said protocols updated as methods are further developed.
• A history of ethical leadership and team management in a fast-paced, innovative environment.
• Excellent problem-solving, organizational, and communication skills.
• A demonstrated ability to collaborate effectively across departments and with external partners.

The ideal candidate will have:

• Extensive experience in the development and validation of analytical methods for nucleic acids in particular mRNA & pDNA or related cell & gene therapy (CGT) materials using techniques including but not limited to HPLC, capillary electrophoresis, and gel electrophoresis.
• Some knowledge of molecular biology, particularly as relates to the design of probes and primers for the characterization of nucleic acid products.
• Experience in the development and validation of analytical methods for lipids and lipid nanoparticles, in particular the use of HPLC-CAD.
• Experience writing testing protocols for newly-developed methods for inclusion in regulatory submissions, as well as discussing and defending the appropriateness of these protocols in regulatory consultations and audits.
• Experience developing completely novel analytical methods, as demonstrated by high-quality academic publications.
• A deep understanding of quality standards for biopharmaceuticals, including knowledge of the relevant regulatory requirements for QC assay validation