Project Manager - Pharmaceutical R&D Department

URL/Mutual is an expanding Philadelphia based distributor and manufacturer of generic pharmaceuticals, poised to roll out an exciting, innovative array of new products and drug delivery technologies.The position will require Project Management of multiple ANDA/NDA development projects. This will involve working with the R&D management to develop appropriate project management systems for an organization undergoing considerable growth. This will include developing project plans and cross- functional project teams. Development efficiency is critical and the project manager will be responsible to alert R&D management early on of obstacles that jeopardize the project timeline as well as provide status updates. Key interactions will include but are not limited to the following functions: Formulation Development, Analytical Development, Regulatory Affairs, Legal, QA/Compliance, Portfolio, Biopharmaceutics, API Purchasing, Operations, and Quality Control. The position will require building positive working relationships that span all levels and functions of the organization.ESSENTIAL DUTIES AND RESPONSIBILITIES:Along with R&D management develop appropriate project management systems.
Develop project plans from the authorization of a project through technical transfer.
Overlay project plans within the portfolio.
Manage cross-functional project teams.
Proactively identify resource conflicts across functions to facilitate project flow.
Facilitate communication across all functions that impact the product development timeline.
Assist R&D management with removing obstacles to development.
Coordinate document flow for the compilation of the CMC section of ANDA’s.
Familiarity with key FDA Guidances that impact development.
May require occasional travel.Performs other duties as assigned.
REQUIREMENTS
EDUCATION AND/OR EXPERTISE:
BS or advanced degree in Chemical Engineering, Chemistry, or Biology coupled with 2 to 5 years of project management experience in the pharmaceutical or related industry commensurate with degree level. Project Management certification desirable.We offer a competitive compensation package that includes medical, dental and life insurance, Short term and long term disability insurance, 401K savings plan, stock options and tuition assistance.Please submit your resume and provide salary requirements.URL/Mutual is an Equal Opportunity Employer M/F/V/D.