Guide and drive technical and manufacturing project teams in achieving specific project objectives.
Facilitate client relations, develop project plans, and ensure clear communication.
Track costs and progress against project milestones.
Build and maintain strong, impactful relationships with internal and/or external clients.
Work cross-functionally and collaboratively with technical, operations, quality, and business groups.
Guide, influence, and collaborate using sound leadership skills.
Procure all federal approvals of drug submissions pertaining to chemistry and manufacturing.
Ensure compliance with the Food and Drugs Act and Regulations for new drug or medical device market entrance.
Requirements
A bachelor’s degree in physical or natural sciences, project management, engineering or a directly related field from an accredited institution.
A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
4 years of professional level experience in project management of biomanufacturing, pharmaceutical manufacturing, or equivalent.
CAPM or PMP preferred.
Master’s degree in a related field from an accredited college or university preferred.
Experience in Biomanufacturing, Pharmaceutical, or Device manufacturing, or other highly regulated industry preferred.
Experience working in an academic institution preferred.
Exceptional knowledge of project management process, skills, and tools required.
Strong critical thinking and problem-solving skills required.
Exceptional multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced environment required.
Knowledge of and the ability to work with the MRP System (Microsoft Dynamics/Great Plains) required.
Knowledge of GDP, GLP, GMP, CMC, and classified clean room practices/requirements required.
Basic knowledge of protein production and/or cell therapy processes required.
A strong understanding in drug development processes required.
Knowledge of Food and Drugs Act and Regulations and other important rules and laws related to drugs, with the ability to explain these regulations to team members required.
Benefits
Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of your gross pay