Remote Sr Project Manager, Production Readiness
2380 Conejo Spectrum St Suite 200, ION Thousand Oaks, CA 91320 US
The Sr Project Manager, Production Readiness – Contract will be responsible developing and managing project schedules and tracking project schedules, resources, materials and budgets to ensure production readiness across the external manufacturing network.
- Provides Project Management services as needed to support to External Manufacturing related initiatives
- Facilitates functional project meetings and sub-teams by preparing meeting schedules, agenda, minutes, action items list, Gantt charts and timelines
- Tracks material requirements for production, ensures material change controls are in place and in proper state, and drives cross-functional team to completion to ensure timely resolution for manufacturing
- Works with External Manufacturing site leads on production readiness assessments for reagents, intermediates, and materials (orders, inventory, testing and release) to support both short-term projects and long range planning
- Partner with program teams to ensure effective communication and alignment regarding manufacturing related issues
- Work with the project leads and teams to identify and mitigate risks to meeting project schedules and escalates when necessary
- Conduct lessons learned sessions to identify areas for improvement and maintain tracker for implementation of short and longer-term corrective and improvement measures into standard project management practices
- 6+ years experience in the biopharma industry, with an understanding of the lifecycle of a biopharmaceutical product development
- BA/BS degree in life sciences or business required, advanced degree is preferred
- Experienced in project and/or program management
- Basic knowledge of preclinical, clinical, regulatory, CMC, medical affairs, and commercial functions
- Experience synthesizing, organizing, and communicating deliverables and timelines
- Proficiency with MS Project, MS Excel, and other tracking tools
- Knowledge of GxPs, FDA guidelines, and other relevant international and domestic regulations
- Flexible, with positive attitude, and highly self-motivated. Can work independently, able to prioritize, and works effectively under pressure
- Excellent written and verbal communication skills
- Strong customer focus and interpersonal skills
- Ability to effectively manage multiple projects simultaneously and in a timely manner.
- Self-motivated with a "can do" attitude
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.