Scientist I/II, Formulation Development (Biologics) - Simply BiotechOverviewLooking for a chance to join a world class, cutting edge genomics company who has dominated their space for more than 50 years? In this role, youll work locally near Shrewsbury MA being responsible for assisting in the development of project strategies, and the independent execution of preformulation and formulation development (liquid/ lyophilized) tasks for different biomolecules including peptides, therapeutic proteins, monoclonal antibodies (mAb), vaccines and oligonucleotides! Our client offers top market compensation, generous bonus, very progressive career opportunity (this role is open because person was promoted up), and first-class team to learn and growth with! Let's connect ASAP! Immediate direct hire opportunity for a Scientist I/II, Formulation Development (Biologics) near Shrewsbury MA who possesses:M.S. in Biochemistry or related (Ph.D. strongly preferred)1-3 years of biologic formulation development experience in pharma or contract research environment (specifically protein/large molecule) Versatile in common biochemical and biophysical characterization techniques for biologics and must have a thorough understanding of the degradation pathways for protein therapeutics in liquid and lyophilized formulations. Must have experience and knowledge in common analytical and formulation practices and procedures including design-of-experiments (DOE), HPLC/UPLC, MS, CE, DSC, MFI, CD, FT-IR and light scattering methods. Solid knowledge of regulatory agencies like FDA and ICH guidelines associated with drug product development, along with drug substance and drug product stability assessment is necessary. Some familiarity in container/closure systems is required. Email your resume to ...@simplybiotech.com and call (858) ###-####Key Responsibilities IncludeProviding scientific support in identifying novel formulations, and delivery technologies that can advance the current standard of care and lead larger programs which may include multiple projects. Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepare technical reports. Hands on experience in liquid and lyophilized bioformulation development, formulation optimization and robustness studies. Serves as a technical resource for junior staff and leverages expertise in laboratory technology as a functional resource/ trainer. With the aid/supervision of senior staff, generate protocols for different stability study types, including development stability studies, IND-enabling stability studies, long-term stability studies, etc. Execute statistical data analysis for prediction of drug substance retest date and drug product shelf-life. Assist senior staff in the interaction with clients in support of formulation needs. Generate preformulation and formulation technical reports, as well as technology transfer reports. Participate in formulation process transfer to Sponsors manufacturing and other CMOs in support of fill-finish of drug product. Remain current with the scientific knowledge and practices in the development and formulation of biological products. Incorporate new technologies into the formulation practices within the Company.For immediate consideration, please email your resume to ...@simplybiotech.com and call (858) ###-####Simply Biotech specializes in recruiting exclusively for the biotech community. Associated topics: aseptic, bioengineering, biostatistics, biotechnology, genome, life science, metabolism, neurobiology, physiology, protein
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