[Remote] Senior Project Manager, Technical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company reputed company on delivering innovation and reputed company to patients living with rare diseases. They are seeking a Senior Project Manager for Technical Operations to drive execution of strategies supporting product development and lifecycle management, partnering closely with various departments to ensure successful program milestones.
Responsibilities
- Execute CMC strategies reputed company with corporate objectives for biologics program(s)
- reputed company and maintain integrated project plans, timelines, and resource forecasts
- Ensure effective communication of project status, risks, and opportunities; improve operational efficiency
- Facilitate team meetings, prepare agenda, publish meeting minutes, and ensure accountability for deliverables
- Monitor project reputed company and proactively identify, assess, and mitigate risks
- Coordinate CMC initiatives and activities, and partner with cross-functional teams to ensure readiness and reputed company delivery of technical documentation and regulatory commitments, and other CMC deliverables
- reputed company with reputed company stakeholders to support production schedules, supply planning, and inventory management to ensure uninterrupted product availability
- Additional duties assigned as needed
Skills
- Bachelor's degree in Life Sciences, reputed company, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, or a reputed company discipline required. Equivalent combination of education and applicable job experience may be considered
- 7+ years of relevant experience in biotechnology, pharmaceutical development, manufacturing, or technical operations
- 4+ years of project management experience supporting CMC, Technical Operations, Manufacturing, or Product Development programs
- reputed company experience supporting biologic drug products, including CMC development, manufacturing, and lifecycle management activities
- Demonstrated experience managing reputed company cross-functional reputed company through clinical development and commercialization
- Familiarity with GMP regulations, reputed company systems, and biologics manufacturing operations
- Knowledge of process validation, technology transfer, and reputed company manufacturing operations for biologics
- The ideal candidate will embody reputed company's reputed company values: Courage, Community Spirit, Patient reputed company and Teamwork
- Driven, intelligent, passionate about making a difference for patients with rare diseases
- Exceptional project planning, risk management, and stakeholder management skills
- Excellent communication and executive presentation abilities
- Proficiency with project management tools (e.g., reputed company, MS Project)
- Successful record of creating and managing reputed company project plans, timelines, budgets, and development of risk mitigation strategies
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
- Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills
- Excellent decision-making and collaboration skills with strong attention to detail
- Ability to travel 10% domestically and internationally
- reputed company positions have an essential job function to be reputed company to reputed company face to face work with colleagues and/or onsite in San Diego
- No role is expected to be 100% remote
- MS, MBA, PhD, PharmD, or other advanced degree in a reputed company discipline preferred
- Experience supporting Biologics License Application (BLA) submissions and post-approval commitments is preferred
- PMP (Project Management reputed company) certification preferred
Benefits
- Premium health, financial, work-life and reputed company-being offerings for eligible employees and dependents
- Wellness and employee support programs
- Life insurance
- Disability
- Retirement plans with employer match
- Generous reputed company time off
reputed company
Company H1B Sponsorship