Method Transfer Validation Scientist - Group Leader

This role is on-site in Sanford, NC.

• Independently plan and execute laboratory experiments.
• Collaborate with trainers, colleagues and subject matter experts to perform the assays in the laboratories, including the use of computational predictive tools, modeling software, and data visualization tools as necessary.
• Assisting teams in completing the assays required for the validation and transfer of methods.
• 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 as second analyst for the validations, and evaluate new instrumentation and analytical techniques as required.
• Independently analyze experimental data and provide conclusive insights.
• Mentor junior analysts and offer technical guidance when required

Leadership Responsibilities:

• Lead a team of Sample Management Specialists in a regulated facility
• Coordinates, supports, and monitors performance of team through quality metrics while ensuring client deadlines are met
• Coordinates with client contacts to communicate status of deliverables, determine priorities, and set timelines.
• Set individual and team goals to develop the scope of work and responsibilities of the team
• Manage time off and payroll entries of the team
• May participate in new hire interviews
• Supports the on-boarding process of new employees
• Participates in training of other employees.

Minimum Qualifications:

• Bachelors degree in Biology, Chemistry or related scientific concentrration.
• 2+ years of experience in industry, preferrably in a GMP setting
• Experience with cIEF
• Experience with troubleshooting assays and improving method performance.
• Strong technical writing and presentation skills.
• Previous leadership experience

Preferred Qualifications:

• Experience with method validation and method transfer skills to manufacturing site.
• Experience with bio-process downstream development

Position is full-time, Monday-Friday, generally 8 a.m. - 5 p.m., weekend work might be expected. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Yearly goal-based bonus & eligibility for merit-based increases

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.