Senior Research Associate - Biologics Drug Product Development
Senior Research Associate - Biologics Drug Product Development
Posted on :
11-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-01-2025
Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.
Position: Senior Research Associate Biologics Drug Product Development
Location: Oceanside CA 92056
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
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 inuse and compatibility to support clinical studies.
- Seeking motivated teamoriented individuals with scientific experience in laboratory work related to biologics.
Essential Duties and Job Functions:
- 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
- Scaledown/up of biologics drug product processes
- Inuse 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 selfmotivated 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.
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 bispecifics 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 scaledown/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 (freezethaw filtration mixing filling lyophilization)
- Some understanding of inuse stability and drug administration process and associated challenges (IV bags subcutaneous injections)
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Employment Type
Full Time
Key Skills
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