Formulation Scientist

4 weeks ago

Philadelphia, United States Apex Systems Full time

Job Description:

(30%) Support formulation development of gene therapy (adeno-associated virus, lipid nanoparticles). Use forced-degradation and stability studies to improve the storage strategy in frozen, lyophilized, and liquid storage forms.


(30%) Support development of drug-product processes for pipeline programs. Collaborate with Drug-product team members to design and support key IND and BLA enabling studies, including stability, administration (in-use), container closure, manufacturing optimization, and related.


(20%) Maintain and operate key analytics for biophysical characterization to assess changes in AAV titer, high molecular weight, and other quality attributes. Including HPLC, particulate measurement (HIAC, HALO), electrophoresis (Labchip).


(10%) Work with drug-product team members to maintain a clean and efficient laboratory compliant with good laboratory and safety practices.


(10%) Maintain electronic lab notebooks and comply with good documentation and EHS practices



Requirements:


  • BS or MS in biochemistry, biochemical engineering, biology, or related field with 2+ years of directly relevant experience is required.
  • Experience in a drug product development, formulation development, or analytical development of large molecules (vaccines, mAbs, related) is required. Experience with gene therapies is preferred.
  • Familiarity with good laboratory techniques and aseptic techniques in biosafety cabinets and similar is required. Biophysical/bioanalytical experience is preferred. Especially experience using HPLC (Agilent, Waters), Caliper/LabChip, particulate detection (HALO, MFI, HIAC). Knowledge of DoE is preferred.
  • Should be a quick learner, and capable of working both independently and with a team

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