What are the responsibilities and job description for the Research Associate - III position at Peer Consulting Resources Inc.?
Contact Details : 1.Sandeep Bisane
Email : Cell : (732)
2.Saravanan Ganesan
Email : Cell : (732)
Job Title : Research Associate III
Location : Oceanside CA
Duration : Long Term
Years of Experience : 5 Yrs.
Required Hours / Week : 40hrs. / Week
Notes :
Relocation is fine
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 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 a BS degree or 3 years of experience with an 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)
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