Director, Formulation Development Promedior
THIS JOB HAS EXPIRED Reports to: V.P, Biopharmaceutical Development
Education: Ph. D. in Analytical Chemistry, Pharmaceutical Chemistry, or Biochemistry
Experience: Minimum of 10 years experience with Ph.D., or equivalent experience. Established reputation in protein formulation development and proven leadership skills
The successful candidate will have an established record in formulation development of recombinant protein therapeutics. The candidate must be results driven, and make independent decisions on the basis of data using sound scientific methods in order to keep projects on track and on time. This person will lead formulation projects internally as well as externally to support preclinical and clinical development of Promedior?s products. This position requires strong leadership and problem solving skills, particularly with respect to formulating proteins for various delivery routes including IV, intraocular, subcutaneous, pulmonary, and sustained-release. Experience with drug-device development (inhaled dosage forms, pre-filled syringes) would be beneficial for this position. An in-depth understanding of the regulatory requirements for therapeutic protein formulations is required.
This person will assist in evaluation and management of CRO/CMO organizations and make recommendations as to their suitability for formulation development and/or contract manufacturing. This person must be comfortable working independently in a small company environment and capable of balancing internal work with external contractors to complete drug development and manufacturing projects.
In-depth knowledge of protein formulation technologies with hands-on experience developing formulations for clinical and commercial stage products.
Experience developing formuations for multiple routes of administration of protein therapeutics with an in-depth understanding of regulatory issues relevant to protein formulations.
Ability to execute and manage formulation development activities internally, as well as ability to evaluate, select, and manage external contract organizations to achieve formulation objectives.
Demonstrated experience in authoring and submitting CMC regulatory documents with a strong working knowledge of relevant US and European regulations
Demonstrated capability of proficient written and oral communication skills
Ability to work in a small company
||Boston, MA |
THIS JOB HAS EXPIRED