KBI: US - Project Manager
KBI Biopharma
Summary
The Senior (Sr.) Project Manager will report to the Site Head of KBI’s Commercial Manufacturing Facility (CMF) or designee in North Carolina. The Sr. Project Manager will oversee the project portfolio associated with GxP operations of the facility. They will track progress of all major projects, provide direct project management (PM) assistance as required, and create efficiencies through training and standardization of best PM practices.
Job description
Job Responsibilities
Oversee, track, and ensure the proper management of all major projects within the facility. These include
- Process and system improvements
- Facility and equipment capital projects
- Functional area GxP projects
- Technology Transfer/New Product Info/Ops Readiness
Provide direct PM leadership or assistance for specific projects as required.
Manage key strategic projects aligned with site strategic objectives. Participate in site Project Portfolio Governance meetings.
Improve PM capability of the site through coaching, training, and standardization of best PM practices.
Responsibility
Oversee, track, and ensure the proper management of all major projects. Provide direct PM leadership or assistance for specific projects as required.
Collaborate with OpEx and other site leaders in effective Project Portfolio Governance.
Improve PM capability of the site through coaching, training, and standardization of best PM practices.
Minimum Requirements
Knowledge, Skills, Abilities
- Minimum of B.S./B.A. degree.
- 10+ years’ experience to include minimum of
- 4 years project management
- 4 years GxP operations (MSAT, Mfg., or Eng)
- 2 years biomanufacturing
- 2 years in supervisory role with direct report(s)
- Experience required
- Tech Transfer, NPI, Ops Readiness
- Process improvement
- Business systems implementation
- Experience preferred
- CapEx
- PMP certification
- Budget development and management
- LEAN certification
- Expertise with MS Project
- Strong problem-solving capacity & conflict resolution
- Results driven
- Strong communication and presentation skills
Requirements
- Minimum of B.S./B.A. degree
- 10+ years’ experience
- 4 years project management
- 4 years GxP operations (MSAT, Mfg., or Eng)
- 2 years biomanufacturing
- 2 years in supervisory role with direct report(s)
- Tech Transfer, NPI, Ops Readiness
- Process improvement
- Business systems implementation
- CapEx
- PMP certification
- Budget development and management
- LEAN certification
- Expertise with MS Project
- Strong problem-solving capacity & conflict resolution
- Results driven
- Strong communication and presentation skills
Company overview
KBI Biopharma is an award-winning global contract development and manufacturing organization (CDMO) that provides fully integrated, accelerated drug development and biologics manufacturing services to pharmaceutical and biotechnology companies worldwide. Founded in 1996 and now part of JSR Life Sciences, KBI has established itself as a next-generation CDMO specializing in complex biologics. The company serves over 500 client partners and has supported the advancement of more than 160 drug candidates from preclinical stages to market, including the manufacture of ten commercial products. KBI's comprehensive service portfolio includes cell line development, process development, analytical services, formulation development, and clinical and commercial cGMP manufacturing for both mammalian and microbial programs. With strategically located facilities across the United States and Europe, KBI leverages world-class analytical capabilities and proprietary platforms like SUREtechnology™ and PUREplatform™ to deliver personalized, accelerated solutions for biopharmaceutical development. The company is recognized for its scientific excellence, quality manufacturing, and commitment to helping clients bring innovative medicines to patients faster.