Senior Scientist

Company Name:
Koch Davis
This position will be part of pharmaceutical research and development. The incumbent will participate in the development, scale-up and transfer of parenteral formulations and manufacturing processes for biologics modalities such as monoclonal antibodies, antibody drug conjugates proteins and vaccines. This is a laboratory based position performing formulation and process development activities for biologic products from pre-clinical and clinical trials through manufacturing process validation, license application and commercialization. The Senior Scientist, Bio-therapeutics Pharmaceutical R&D, is performing formulation and manufacturing process development activities of therapeutic biologic drug products including prophylactic and therapeutic vaccines and therapeutic protein-based modalities from pre-clinical and clinical trials through commercialization. The position will involve use of innovative and modern techniques to develop and characterize dosage forms with appropriate stability profiles and develop associated manufacturing processes to meet project needs. Data generated by the incumbent will utilized to nominate dosage forms, support clinical trial applications, scale-up and support transfer of manufacturing processes and to support product licensure related activities in accordance with ICH guidance Q8 and Q9. The incumbent will author written documentation and regulatory filings associated with work and will participate in technology transfer activities to manufacturing sites. The Senior Scientist, Bio-therapeutics Pharmaceutical R&D, must be able to interact effectively with a multi-disciplinary team of scientists and engineers for formulation and process optimization and overall product development. Effective communication skills are essential for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.
Requirements
This position required PhD with 1+ years, MS with 7+ years, or BS with more than 10 years of industrial experience in Pharmacy, Pharmaceutics, Chemical Eng, Biochemistry, Biotechnology or equivalent. Experience in biologics or vaccines drug product development desired. Experience in bio-therapeutic parenteral drug product formulation or process development of protein/peptide, vaccines or oligonucleotide therapeutics. Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA). Experience in application of QbD concept in design, execution, and interpretation of formulation and process development experiments. Knowledge of ICH Q8 and Q9 guidance and protein, vaccine oligonucleotide chemistry, degradation pathways and stabilization techniques. Knowledge of drug development processes for progression of a biological candidate. Experience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities and vaccines formulation and process development. Excellent oral and written communication skills and ability to mentor junior staff and peers across matrix teams.
Education
MS or BS in Pharmacy, Pharmaceutics, Chemical Eng, Biochemistry, Biotechnology or equivalent. PhD preferred.
Client
This multinational pharmaceutical corporation develops and produces medicines and vaccines for a wide range of medical disciplines.

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