Validation Scientist

Title: Senior Scientist - Microbiology

• Method Transfer and Validation Scientist

Location: Sanford, NC

Pay Range: 45-65/hr - potential for flexibility

Responsibilities

• The Scientist will support the Quality Control Method Transfer and Validation team by performing method validation activities including drafting protocols and reports, executing validation assays, and conducting data analysis
• This role also involves procedural updates, reviewing various reports, and ensuring compliance with cGMP and data integrity principles
• Independently conceptualize, plan, and execute laboratory experiments
• Collaborate with colleagues and subject matter experts to determine the most suitable analytical methodologies to support project initiatives, including the use of computational predictive tools, modeling software, and data visualization tools
• Lead and manage multiple projects, assisting teams in developing effective strategies for analytical needs and controls
• Engage with the method development team and participate in both in-process and final product sample analyses
• Author relevant sections of technical reports to support interdepartmental technology and method validation and transfer processes
• Prepare technical reports, critically review data, and evaluate new instrumentation and analytical techniques/approaches as required
• Independently analyze experimental data and provide conclusive insights
• Mentor junior scientists and offer technical guidance
• The position follows a 1st shift schedule from Monday to Friday, 8 AM to 5 PM, with occasional weekend work on a rotating basis

Qualifications

• Bachelor's degree with 10 years of industry experience, preferably in GMP; Master's degree with 8 years of industry experience, preferably in GMP; or PhD with 4 years of industry experience
• Experience with assay development, method validation, method development, and method transfer
• Experience working in a pharmaceutical environment.
• Extensive hands-on experience in pharmaceutical method transfer, validation, and development of relevant assays
• Strong experience in troubleshooting assays and improving methods
• Proficiency in technical writing and presentation skills
• Experience with bioburden, endotoxin, and molecular biology
• Experience with assay development, method validation, method development, and method transfer
• Familiarity with Waters HPLC, Maurice, PA 800, and chemistry plate-based assays

Compensation:

$45/hr to $65/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.