Research Associate

1 week ago


Oceanside, United States ACL Digital Full time

Title: Research Associate - III

Location: Oceanside, CA

Duration: 06 months


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 enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature.

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.

Must Have 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



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