Formulation Scientist I

3 days ago

Fremont, California, United States Bionova Scientific Llc Full time


Company Summary:

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.

Job Description
 We are looking for a knowledgeable and highly motivated individual to join our Formulation Development group as Scientist I/II at Bionova Scientific. The candidate will lead the study design in the development of stable formulations for biologicals to support clinical trial and product commercialization. In this role, the candidate will be a strong team member working in a fast-growing CDMO collaborating closely with scientists from multiple functional areas including Process Development, Analytical Science, Manufacturing Science and Technology, and Quality Control.

Duties & Responsibilities

  • Perform formulation development and stability assessment activities for biological drug candidates, including monoclonal antibodies (mAb), antibody drug conjugates (ADC), bispecific antibodies, and fusion proteins, to enable clinical study and product commercialization.
  • Design and execute studies evaluating chemical & physical stability of biologics in various formulation buffers (pH, ionic strength, stabilizing additives) under proper study conditions (accelerated temperature, mechanical stress, etc.) for product shelf-life stability; Address manufacturing process related product stability (freeze thaw, mixing, filtration and filling, etc.).
  • Apply combined theoretical models and utilize experimental results to aid development of robust drug product manufacturing control strategy.
  • Draft SOPs for laboratory and assay procedures; Prepare concise, sound scientific presentations of study results to the management team; Co-author scientific technical reports.
  • Demonstrate scientific leadership with the ability to drive innovation; Lead projects and teams, resolve technical problems; Work both independently and across functional teams.
  • Perform general laboratory duties associated with equipment maintenance and good housekeeping.

Requirements

  • BS or MS in Pharmaceutical Sciences, Chemistry, Biophysics or Biochemistry and typically 5+ (BS) or 2+ (MS) years of relevant industrial experience.
  • Extensive hands-on experience using analytical equipment (UV-vis, HPLC, UPLC, CE-SDS, icIEF, Plate reader, etc.) for chemical and structural characterization of protein pharmaceuticals, and other biophysical techniques (MFI, DLS, DSC, etc.) a must.
  • Solid understanding of the structure & function relation for mAb, ADC, bispecific antibodies, and fusion proteins and their modes of degradation a plus.
  • Knowledge for the systematic scientific approaches to developing commercially viable protein formulation a must.
  • Knowledge of unit operations in aseptic manufacturing for liquid and lyophilized dosage forms a plus (bulk freeze thaw, compounding/mixing, filtration, filling, and lyophilization etc.).
  • Extensive hands-on laboratory skills for the preparation of protein formulation (buffer preparation, protein concentration, buffer exchange, etc.) and stability set up (stability protocol, sampling pulling strategy, etc.) a must.
  • Detail oriented and excellent skills in record keeping/documentation a must.
  • Strong scientific leadership, critical thinking, ability to aid study design, organizing and presenting complex data sets a must.
  • Flexible and timeline driven mentality a must.
  • Strong interpersonal communication skills both verbally and in written formats a must.
  • Prior managerial experience a plus.

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