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Senior Research Associate

2 months ago

Oceanside, United States Rose International Full time

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.

Nice to Have Requirements/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).

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 enjoy 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.

  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Benefits:

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).