The qualified individual will have at least 3-5 years of relevant industry working experience in developing parenteral formulation, solid and liquid oral dosage forms for use in first-in-human studies.

The Formulation Scientist in the

Large Molecule Drug Product Development

will be a lab-based role, responsible for experimental studies in the pre-formulation, formulation, characterization, and analytical development of therapeutic proteins including monoclonal antibodies, virus-like particles, RNA therapeutics, and subunit-based vaccines. Since most of our clients are based out of USA and Europe, we expect candidates to have some exposure working on international projects.

Major Duties and Responsibilities:

Develop formulations for parenteral/ injectable and oral drug products.
Develop parenteral formulations for biotherapeutic modalities such as monoclonal antibodies, antibody-drug conjugates, proteins, and vaccines.
Perform rapid, comprehensive characterization of candidate molecules to determine the stability profile and apply this information to develop an appropriate dosage form to meet clinical needs. This will be achieved by applying various biophysical and biochemical techniques such as HPLC (SE-HPLC, IEX, RP-HPLC), SDS-PAGE, Capillary Gel electrophoresis (CGE), and imaged Capillary Electrophoresis (iCE).
Evaluates feasibility of analytical methods to support product characterization, formulation stability, and compatibility testing.
Rational formulation design/selection and characterization studies relevant to the stage of development.
Development and optimization of liquid and lyophilized biologics formulations.
Design and execute compatibility studies to support the administration of large molecules
Design and manage stability studies on target and experimental formulations
Perform her/his duties consistent with good laboratory practices

Preferred qualifications:

Knowledge of protein science, including biochemical, immunological, and biophysical characterization.
Knowledge and experience in the development of large molecule formulation.
Familiarity with biochemical, biophysical, and/or analytical methodologies for characterization of proteins and peptides. Hands-on experience and trouble-shooting proficiency with column chromatography (SEC, IEX, RP, HIC), biophysical characterization (DLS, DSC, DSF, fluorescence, EM), capillary electrophoresis (CE-SDS, cIEF, iCE), charge variant analysis, oxidation analysis, and peptide mapping for protein characterization are highly desirable.

Required qualifications:

Ph.D. + > 3 years experience, M.S. + > 5 years experience, or B.S. + > 8 years experience in an appropriate scientific discipline is required.
Strong scientific understanding and extensive research experience is necessary. Experiences in the areas of formulation/drug product development, biophysical/biochemical characterization, analytical method development for mAb or recombinant protein-based biotherapeutics and pharmaceutical development are desirable
Ability to interpret and analyze data from biophysical assays and design appropriate experiments.
Demonstrated experience delivering high quality and timely data while adhering to compliance and data integrity requirements
Self-motivated, attention to details, excellent teamwork, organization, oral/written communication skills are highly desirable

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Formulation Scientist