Biologics Drug Product Development

1 month ago

Oceanside, United States Fladger Associates Full time

Responsibilities:

  • Excellent employment opportunity for a Senior Research Associate - Biologics Drug Product Development (BDPD) in the Oceanside, CA area. 100% onsite
  • BDPD is responsible to develop and characterize formulations and processes for all biologic drug products in pivotal (P3) and commercial stages; also responsible for short / long term stability assessments, technology transfers to clinical and commercial sites, manufacturing support, in-use, and compatibility to support clinical studies.
  • Seeking motivated, team-oriented individuals with scientific experience in laboratory work related to biologics.
  • Perform experiments pertaining to:
  • Protein formulation/stability of various dosage forms (liquid/lyophilized) and configurations (vial/syringe), employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods.
  • Scale-down/-up of biologics drug product processes.
  • In-use stability and administration
  • Author protocols, technical summary reports/memos and tech transfer documentation defining the manufacturing process and parameters.
  • Review Master Batch Records for accuracy and trend process data supporting process development or fill/finish manufacturing operations.
  • Execute studies in support of drug product technology transfers to clinical and commercial manufacturing sites.
  • Be an effective communicator of ideas, project goals and results at departments/meetings in both written and presentation format.
  • Be self-motivated, organized, thrive in team settings, and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature.

Experience:

  • A minimum of 5+ years of experience with BS degree or 3+ years of experience with MS degree in Pharmaceutical Sciences, Biology, Biochemistry, Biochemical Engineering, or a related Scientific discipline.
  • Degree in Chemical/Biochemical Engineering (or a related Engineering discipline) or Pharmaceutical Sciences, and relevant industry experience that demonstrates expertise in drug product development as well as sustained excellence in performance and accomplishments that align to company goals.
  • Excellent communication (both verbal and technical) and interpersonal skills are required.
  • Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy.
  • A basic understanding of formulation and drug product process development for biologics (antibodies, fusion proteins, bi-specifics, vaccines, antibody drug conjugates, etc.).
  • Previous experience interfacing with Biologics Drug Product Manufacturing sites and providing technical support during engineering runs/GMP operations is a plus.

Requirements Skills:

  • Experience working with Biologics molecules (proteins, mAbs); experience working with ADC is a plus.
  • Protein formulation/stability of various dosage forms (liquid/lyophilized) employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods, analytical data analysis.
  • Experience with some scale-down/-up of biologics drug product process development activities; buffer preparations, testing using compendial methods (Osmo, protein conc., pH, etc.) and UF/DF is a plus.

Desired Skills:

  • Presentation and Documentations (ELNs, technical reports, MEMO, etc.)
  • Good understanding / experience in biologics drug product process (freeze-thaw, filtration, mixing, filling, lyophilization)
  • Some understanding of in-use stability and drug administration process and associated challenges (IV bags, subcutaneous injections)

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