Senior Director, Analytical and Pharmaceutical Sciences

The Senior Director, Analytical and Pharmaceutical Sciences will be responsible for managing various API and formulation projects with a focus on analytical R&D, along with oversight of release testing and stability programs via a network of service providers. 

Responsibilities

·      Manage certain API and/or formulation projects for company's key development assets.

·      Oversee the outsourced analytical development, phase-appropriate method validation and transfer to support our development programs.  Analytical methods (chromatographic, spectrometric and physical property methodologies) will span raw materials, intermediates, in-process, and final API, excipients and drug product testing.

·      Manage, review analytical data and reports, specifications, track release, stability, and reference material testing, and lead laboratory investigations along with QA. Analyze stability trends through statistical and scientific tools.

·      Author/ revise phase appropriate SOPs. Maintain ownership and organization of CMC document filing system

·      Write/review various CMC regulatory submission documents.

·      Assess and audit potential new CDMOs and CROs.

·      Interact with a range of team members (including clinical, quality, regulatory and preclinical), and help manage consultants/contractors and contract laboratories.

·      Perform other related duties as required.

Education & Requirements

Graduate degree is required in analytical chemistry, pharmaceutical sciences or closely related discipline. Minimum of 15 years of experience in the pharmaceutical industry, analytical R&D and project management experience is required, while API or Formulation scientists with cross functional DS/DP/Analytical development and management experience will also be considered.

Strong understanding of HPLC/chromatography, along with spectroscopic analyses, solid state (XRPD/particle size) testing and wet methods is required, expertise in dissolution method development is a plus. Experience in API, pre-formulation and/or oral solid project management is strongly desired. A strong understanding of cGMPs, global regulatory requirements, along with demonstrated success in project management is essential.

Other skills necessary for success include: Excellent verbal and written communication skills, superior organization skills with demonstrated technical report writing skills and attention to detail; Ability to work with minimal supervision, to set priorities to meet timelines, to motivate others, and to manage budgets; Superb communication skills and the ability to shape, frame, and present to diverse internal and external audiences are requisite.