Provides guidance and mentorship to project team members and ensures that the project team is working efficiently according to project objectives, goals, specifications, deliverables, and timelines.
Manages the Statement of Work (SOW) creation and approval process for assigned projects.
Generates project plans including but not limited to milestones, hours, schedules, communications, risk analysis.
Prepares and leads kick-off and regular project team meetings internally and with clients.
Ensures the required manufacturing, quality, and regulatory documents, labels, and sampling plans are identified, resourced, created, and completed according to schedule.
Leads project teams in prioritization of tasks, and technical and logistical problem-solving issues affecting schedule, cost, and quality.
Initiates and maintains client information in the ERP system and RFP and SOW tools.
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.
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications: CAPM or PMP
Master’s degree in a related field from an accredited college or university.
Experience in Biomanufacturing, Pharmaceutical, or Device manufacturing, or other highly regulated industry.
Experience working in an academic institution.
Exceptional knowledge of project management process, skills, and tools.
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.
Knowledge of and the ability to work with the MRP System (Microsoft Dynamics/Great Plains).
Knowledge of GDP, GLP, GMP, CMC, and classified clean room practices/requirements.
Basic knowledge of protein production and/or cell therapy processes
A strong understanding in drug development processes.
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.
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