Global RD Self Care Stability Principal Scientist
4 weeks ago
We are currently recruiting for a Principal Scientist Global RD Self Care Stability to join our team.
This position reports into Manager RD and is based at our office.
Our Company
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.
Job DescriptionThe Principal Scientist Global RD Self Care Stability is responsible for providing guidance and support for the global developmental stability programs for technical transfers, newly developed products, and changes to commercialized/marketed products in EMEA markets.
Key Responsibilities
- Work independently to ensure regional stability requirements are met.
- Partner with cross-functional peer groups and manage the planning and execution of stability project tasks within established timelines.
- Develop stability strategies based on global regulatory requirements, internal procedures, technical information, and historical stability data.
- Facilitate the implementation of the established stability strategy across functional areas and across internal and external sites, including stability study initiation, stability sample management, stability storage, and stability testing.
- Document stability assessments, technical justifications, stability protocols, stability reports, and perform statistical analysis of stability data.
- Present and discuss stability strategies and report stability results to project teams, management, and governance boards.
- Participate in and lead initiatives to improve cross-functional collaboration, process efficiency, cycle times, and productivity.
- Maintain training proficiency on SOPs, work instructions, and data analysis.
Requirements
- 6 years of experience with a BS or equivalent.
- 4 years of experience with an MS.
- 2 years of experience with a PhD.
- Experience must be in the area(s) of stability, quality, and/or laboratory within a drug, device, or biologics environment.
Desired Qualifications
- Experience preparing/reviewing stability protocols/reports, including performing statistical analysis of stability data.
- Previous experience managing or mentoring others.
- Knowledge and understanding of GMPs, ICH, CFR, stability guidance documents, latest regulatory trends, and global Health Authority regulations.
- Excellent oral and written communication skills.
- Strong project management, coordination, and multitasking skills.
What's In It For You
- Competitive Benefit Package.
- Paid Company Holidays.
- Paid Vacation.
- Volunteer Time.
- Summer Fridays.
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