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Research Associate
1 week ago
Job Title: Research Associate - III
Location: Oceanside, CA
Duration: 6 Months+ (Possible extension)
Pay Range: $44.67/hour on W2
Job Description:
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.
Essential Duties and Job Functions:
• Perform experiments pertaining to:
o 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
o Scale-down/-up of biologics drug product processes
o 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 enProduct scientific investigation and thinking, as well as be familiar with the relevant technical literature.
Knowledge, Experience and Skills:
• 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.
Minimum Qualifications:
• 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.
• 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.
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