Formulation Scientist

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Job description

Kelly Services is currently seeking a Formulation Scientist for a Direct Hire role in Fremont.

Job Title: Formulation Scientist

We are looking for a knowledgeable and highly motivated individual to join our Formulation Development group as Scientist I/II. 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.

Key Responsibilities Include:

• 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.

Qualifications:

• 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.

About the company

The company was founded by a group of biopharmaceutical specialists and is located in Fremont, CA. This biologics company presents world-class expert CDMO services including cell line development, commercial process development and process characterization studies, formulation development, analytical method development, qualification and validation, cGMP biopharmaceutical manufacturing (250L, 500L, 1kL and 2kL), and Quality Control services.

#TJP2021_SPEC

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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