IDT is a 100% owned subsidiary of IDT Biologika GmbH, a German contract developer and manufacturer of vaccines and biologics for the global protection of human and animal health. IDT’s facility located in Rockville, MD is engaged in the development of manufacturing processes and the production of vaccines for clinical phase 1 and 2 projects.
IDT is recruiting for a proactive, dynamic, and critical-thinking Associate Director, Project Management to lead and support IDT’s CMO contracts. This position requires a “hands-on” approach with a combination of project management, staff supervision, and business development skills; plus the ability to work with a mix of clients, client-site staff, and corporate colleagues.
- Oversees and manages process development, assay development, and Phase I/II current Good Manufacturing Project (cGMP) manufacturing projects from US and EU based clients.
- Manages project management team, assessing performance and ensuring that all projects are executed based on the terms of the contract and within stated deadlines.
- Evaluates and assigns newly executed contracts to the project management team based on contract scope, work load, and experience.
- Manages the resolution of client escalations including scope creep, deliverable disputes, and change order requests. Reports and escalates as needed.
- Tracks cGMP manufacturing activities to determine percent utilization and future availability for forecasting and scheduling purposes.
- Forecasts and tracks project performance tasks and invoices related to executed contract deliverables. Monitors all project work packages for on time and in-full delivery of contract specified deliverables.
- Serves as a project’s primary point of contact while organizing and leading inter- & intra-departmental communication between cross functional teams.
- Reviews master service agreements to ensure contract terms adequately reflect performance realities to successfully execute the contract work and meet contract deliverables.
- Generates detailed project plans and schedules based on resources and facility capacity, availability, contract scope of work, task interdependency, client risk profile, and information obtained during technical transfer.
- Communicates with prospective clients during contract negotiation to better understand the customers’ goals and manage expectations from a scope and timing perspective.
- Organizes, leads, and monitors re-occurring project meetings, critical action items, project documents, and meeting minutes.
- Performs risk management to minimize project risks.
- Bachelor’s in Biological Sciences (Chemistry, Biology, Biotechnology, etc.) required. A degree in Business and/or Master’s highly desired.
- Project Management Professional (PMP) Certification is an asset but not required.
- 3+ years of project management experience in a CMO, pharmaceutical or biotechnology environment required.
- 2+ years of technical background in process development and cGMP manufacturing required.
- Minimum of 2 years’ experience managing project teams required.
- Experience in managing and coordinating projects, and securing delivery of tasks from planning to reporting.
- Ability to work independently and take accountability for ensuring delivery.
- Prior hands-on experience in a cGMP and/or process development environment a plus.
- Ability to handle stringent documentation requirements.
- Strong working knowledge of Microsoft Office including project management software (MS Project) and other relevant business related software packages.
- Excellent oral and written communications skills required including the ability to communicate with internal and external clients.
- Strong organizational skills including attention to detail and multi-tasking skills.
IDT offers a competitive compensation package to include major medical/dental/vision, group life insurance, STD/LTD plans, 401K plan with company match, and paid vacation, sick and holidays. If interested in being part of a dynamic and growing company, please email your resume and cover letter. Include the position for which you are applying in the subject line.
IDT Biologika Corporation is an Equal Opportunity Employer: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Job Type: Full-time
Salary: $120,000.00 to $125,000.00 /year
- project management in biotech industry: 3 years (Preferred)
- technical process development & cGMP: 2 years (Required)
- PMP Certification (Preferred)