Job Description:
Client is in need of a PURE PROJECT MANAGER to oversee all GMP/CMC drug product technology transfer activities.
- Lean Six Sigma practices and aseptic technology transfer for drug product.
- PMP – cert. is a must
- This is for a new aseptic manufacturing facility and this PM will be supporting a medium sized group.
- The PM should to be self-motivated, well organized, have strong technical and communication skills, and a solid understanding and hands-on experience of drug product manufacturing and quality/compliance requirements.
- Support drafting, review and approval of aseptic tech transfer and manufacturing documentation such as risk assessments, gap analyses, batch records, standard operating procedures and sample plans.
- Participate in internal team meetings.
- Ability to work in a new, complex, dynamic, environment with an emphasis on results-oriented, strong planning and project execution skills
- Minimum 5-7 years GMP & Lean Six Sigma experience with Aseptic Technology Transfer and Validation Execution experience.
- Must be able to manage priorities and projects – prioritizing effectively and must communicate clearly with all levels of management.
Phoenix AZ: Project Manager – Aseptic Technology Transfer (232493)