Full-Time Separations SME - Large Molecule

Purpose: Provide leadership and subject matter expertise to the Biochemistry Method Establishment team.

Responsibilities:

• Applies GMP/GLP standards in all areas.
• Maintains highest quality standards.
• Demonstrates and promotes company vision.
• Exhibits strong client service skills, teamwork, and collaboration.
• Proactively plans and multitasks to maximize productivity.
• Meets quality and productivity metrics, demonstrates strong teamwork.
• Ensures regular attendance and punctuality.
• Maintains tracker for ongoing work, ensuring tracker toolkit provides forecasting.
• Contributes to re-evaluating and improving KPIs (quality, performance, cost).
• Maintains and re-evaluates data capture tools to identify KPIs.
• Creates reports for clients summarizing metrics and providing insights.
• Develops tools to estimate project utilization and cost.
• Creates visual KPI presentations for FFS resource monitoring.
• Demonstrates ability to work on multiple projects.
• Communicates effectively with client staff.
• Conducts all activities safely and efficiently.
• Performs other duties as assigned.

Qualifications:

• Education: BSc in Chemistry, Biochemistry, Analytical Sciences, or related field.
• Experience: 7 years industry experience, 5 years in leadership. Experience with Large Molecule separation techniques (HPLC, CE, UV/Vis).
• Experience establishing new and existing GMP methods in FDA-regulated Biotech/Pharmaceutical industry.
• Technical expertise in (Bio)Pharmaceutical Product testing preferred.
• Understanding and application of Lean and/or Six Sigma, and Project Management Methodology.
• Strong skills in process improvement tools and methodologies.
• Computer skills (MS Project, Excel, Windows applications).
• Independent work skills, strong work ethic, and organization skills.

Additional Details:

• Full-time, Monday-Friday, 8:00am-4:00pm; overtime as needed.
• Candidates living within commutable distance to Lancaster, PA encouraged to apply.
• Excellent benefits: medical, dental, vision, life, disability, 401(k) with match, paid time off.
• Equal Opportunity Employer (M/F, Disabled, Veteran).

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