Senior Scientist, Formulation Development

ROLE SUMMARY

This position will be part of Pharmaceutical Research and Development which has developed formulations for advancing vaccines for deadly adolescent and adult infections including Meningococcal disease, Staphylococcus aureus and Clostridium difficile. The candidate will lead the formulation development, scale-up and transfer of vaccine modalities. This is a project-based position performing formulation and process development activities for vaccines from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization

ROLE RESPONSIBILITIES

The Senior Scientist, Biotherapeutics Pharmaceutical Research and Development is responsible for developing parenteral formulations, and tech transfer manufacturing processes to enable the successful development of novel antigen presenting technologies and adjuvant vaccine drug products. The position will involve leading a technical project team inside and outside the lab that will apply characterization and stability information to develop an appropriate dosage form to meet vaccine clinical and commercial needs. The position is responsible for leading the formulation and development activities from pre-clinical and Ph I clinical trials through commercialization.

The candidate is also responsible for executing new technologies and procedures to accelerate the biotherapeutic development vaccine processes across projects.

BASIC QUALIFICATIONS

Minimum:

B.S. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering and at least 9 years industry or equivalent experience.
M.S. in Pharmaceutics, Chemistry, Chemical/Biochemical, Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering and at least 7 years industry or equivalent experience.
PhD. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering.
PREFERRED QUALIFICATIONS

B.S. with 9 or more years of industry experience in parenteral formulation and process development of biotherapeutics.
M.S. with 7 or more years of industry experience in parenteral formulation and process development of biotherapeutics.
PhD. with 1 to 3 years of industry experience in gene therapy formulation and process development of biotherapeutics.
PREFERRED QUALIFICATIONS

Excellent leadership skills.
Expert understanding and leadership of technical area necessary for biotherapeutic molecule formulation development.
Experience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities.
Solid understanding of thermodynamics and kinetics.
Working knowledge of GLP/GMP requirements.
Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA).
Solid understanding of QbD concept in design, execution, and interpretation of formulation and process development experiments.
Ability to demonstrate autonomy in representing functional area.
Communicates well in written form and verbally across functional areas and large groups