Director, Analytical 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 analytical method development and proven leadership skills
The successful candidate will have an established record in analytical method development, qualification, and validation related to recombinant proteins and 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 both the in-house and external development of analytical and bioanalytical methods to support process and formulation development, pre-clinical pharmacology, Tox/ADME, and cGMP manufacture of recombinant therapeutic drug product. An in-depth understanding of the regulatory requirements for development and cGMP manufacturing for protein therapeutics is essential as is direct experience in authoring and submitting CMC regulatory documents to support clinical development. This position requires strong leadership and problem solving skills as well as excellent communication skills, particularly with respect to the analyses required for therapeutic protein drug development and manufacuturing. This person must have an in-depth understanding of protein structure and chemistry with detailed knowledge of the analytical methods used to support recombinant protein process development and manufacturing, stability testing, and product characterization in both a development and cGMP manufacturing setting. An established reputation of expert knowledge in at least one analytical subject area related to proteins is preferred.
This person will assist in evaluation, selection, and management of CRO/CMO organizations and make recommendations as to their suitability for analytical development and/or contract manufacturing. This person must be comfortable working independently in a small company environment and balancing internal work with outside contractors to complete drug development and manufacturing projects.
In-depth knowledge of protein structure and chemistry and hands-on experience executing analytical methods related to development and characterization of protein therapeutics (e.g. HPLC, electrophoretic and spectroscopic techniques, immunologic-based assays, mass spectrometry, calorimetry, protein derivatization, peptide mapping, etc.) with an in-depth understanding of the technical and regulatory issues relevant to analytical method development, qualification, and validation for cGMP manufacturing
Ability to work independently in a small company and to effectively manage external contract organizations
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
||Boston, MA |
THIS JOB HAS EXPIRED