This is a hands-on, non-supervisory, non-laboratory role in the India Biologics department. The incumbent will support the reference standard development program within the Global Biologics department, participating in the development of replacement and new reference standards/ARMs.
Responsibilities
Works with key stakeholders to develop reference standards for biotechnology pharmaceutical products including proteins, peptides, heparins, antibiotics, and advanced therapies.
Oversee and facilitates the development of reference standards and solutions to address analytical challenges associated with biological medicines.
Supports day-to-day operations of the Stability program covering the USP Biologics RS catalog inventory.
Reviews testing history and drafts test protocols for lab submission based on designated testing requirements and schedules.
Assists laboratories to ensure testing is completed accurately and in timely manner.
Requirements
Ph.D. degree in Biochemistry, Analytical Chemistry or Biological Sciences
Pay Range Minimum: $99,444.00 annual
Pay Range Maximum: $122,124.00 annual
Responsibilities
20% Structure-based and machine-learning immunogen design for protein subunit and mRNA vaccines based on viral surface glycoproteins (construct design, recombinant expression in mammalian cells, purification, and stability assays)
20% Characterize protein antigenicity (binding assays using ELISAs, SPR and biolayer interferometry to evaluate binding kinetics and affinity of antibodies or designed proteins)
15% Perform structural studies (high-throughput cryo-electron microscopy of subunit vaccines as well as of complexes between viral glycoproteins and monoclonal and polyclonal antibodies as well as X-ray crystallography)
10% Design and execution of virology assays
10% Analysis of the data to help determining the research strategy
Serve as a formulation and drug product process development lead for a growing portfolio of protein biologics, providing technical formulation and drug product expertise across the development lifecycle.
Compensation
Salary Range: $159,000.00 to $207,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience.
Responsibilities
Independently drive formulation and drug product development activities for large molecule biotherapeutics
Design and execute formulation development studies to identify clinical and commercial formulation & dosage form, establish shelf life of DS & DP, assess in-use compatibility, and support comparability assessments
Develop stress comparability strategies to support process changes and scale-up
Oversee drug product process development activities as well as DP process characterization and process validation activities to support clinical and commercial manufacturing
Perform biophysical and biochemical characterization of protein therapeutics in the laboratory using chromatography-, capillary-, spectroscopy-based analytical methods
Requirements
PhD in Chemical Engineering
PhD in Pharmaceutical Sciences
PhD in Biophysics
PhD in Analytical Chemistry
BS or MS with commensurately greater directly relevant experience
Lead scientist responsible for analytical and functional characterization of biopharmaceutical products, including monoclonal antibodies and antibody-like biologics.
Responsibilities
Develop and execute SPR assays to generate selection criteria for antibody panels
Evaluate and integrate protein–protein interaction technologies to support therapeutic candidate selection
Implement high-throughput epitope binning for large antibody panels
Perform antibody Fc characterization studies for regulatory submissions
Solve technical problems and develop new approaches to advance characterization and screening technologies
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