Similar posts
Senior Scientist, Vaccines Formulation Development
- Permanent
- Senior/Director & VP, Molecular Biology, Pharmacology
- United States
Proclinical is currently recruiting for a Senior Scientist of Vaccines Formulation Development with a leading biotechnology company located in Gaithersburg, MD. As the Senior Scientist, you will be responsible for the design, execution, and management of scientific studies in the development of both liquid and /or lyophilized drug product formulation to support product development from initial candidate identification through commercialization.
Job Responsibilities:
- Design, definition, and execution of scientific formulation activities for preclinical and early clinical studies for the formulation development of solid and liquid drug product presentations.
- Design and execute Quality by Design (QbD) and Design of Experiment (DOE) principles in drug product and process development experimentation.
- Assay method development and validation including: AUC, CD, Fluorescence spectroscopy, DSC, ITC, UV/Vis spectroscopy, FTIR, SLS and HPLC.
- Develop SOP documentation for new processes and equipment.
- Participate in all scientific development and scale-up activities of drug product processes from bench top to pilot scale and technology transfers.
- Review all formulation developed methods and protocols.
- Support in activities and documentation for technology transfer to CMC facilities.
- Lead scientific discussion and investigations for all drug substances and drug products being developed.
- Project management of research associates in support of the larger drug development project.
- Support Regulatory Affairs in IND and BLA submission.
Skills and Requirements:
- PhD in relevant field or a minimum of 10 years relevant experience with a Master's degree required.
- Experience in vaccines formulation product development, Quality by Design (QbD), Design of Experiment (DOE) processes.
- Direct experience and expertise in protein drug substance synthesis, characterization, evaluations and formulation development.
- Direct experience and expertise in biologics, and/or vaccine drug product development.
- Direct experience and expertise in lyophilization cycle design, operations, and evaluation for freeze-drying drug products.
- Direct experience in project leadership and grant management.
- Significant experience in designing and initiating research projects.
- Knowledge of aseptic manufacturing and fill/finish process related to liquid and solid formulation products.
- Knowledge and experience in GLP and GMP requirements.
- Demonstrated expertise with bio/analytical and physicochemical characterizations of proteins, including protein synthesis, structure, stability, aggregation, and solubility is highly desirable.
If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 617-903-7746 or m.robinson@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-MR3
Related jobs
Highly Competitive Salary
Norton, USA
Proclinical is currently recruiting for an Administrator with a pharmaceutical company located in Norton, MA.
Highly Competitive Salary
Philadelphia, USA
Proclinical is currently recruiting for a Process Development Scientist with a pharmaceutical company located in Philadelphia, PA..
Highly Competitive Salary
North Chicago, USA
Proclinical is currently recruiting for a Chemist with a biopharmaceutical company located in North Chicago, IL.
Highly Competitive Salary
Rockville, USA
Proclinical is currently recruiting for a QC Microbiologist with a pharmaceutical company located in Rockville, MD.
Highly Competitive Salary
Rockville, USA
Proclinical is currently recruiting for a Biopharmaceutical Associate with a pharmaceutical company located in Rockville, MD.
Highly Competitive Salary
Waltham, USA
As the Companion Diagnostics Director, you will be accountable for ensuring that diagnostic tests or equivalent segmentation tools are delivered to drug products.
Highly Competitive Salary
Gaithersburg, USA
Proclinical is currently recruiting for a Diagnostics Project Manager with a global pharmaceutical company located in Gaithersburg, MD; Waltham, MA; Cambridge, UK; Gothenburg, Sweden; Shanghai, China.
Highly Competitive Salary
North Chicago, USA
Proclinical is currently recruiting for a Pharmacy Technician with a biopharmaceutical company located in North Chicago, IL.
Highly Competitive Salary
Buffalo, USA
Proclinical is currently recruiting for a Research Scientist with a pharmaceutical company located in Buffalo, NY.
Highly Competitive Salary
Worcester, USA
Proclinical is currently recruiting for a Sample Management Associate Scientist with a biopharmaceutical company located in Worcester, MA.