Remote Sr Project Manager, Production Readiness
2380 Conejo Spectrum St Suite 200, ION Thousand Oaks, CA 91320 US
Job Description
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.Â
Primary Responsibilities:
- 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
Qualifications:
- 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
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