Analytical Project Coordinator, Quality Control

Duties and Responsibilities

• Primary QC contact for the complete analytical methods portfolio and link between project team, international customers as well as internal and external laboratories
• Representative of the QC labs as well as Rentschler quality standards in assigned client projects; working in collaboration with all QC departments (AD, Microbiology, Raw Materials, and Release) and potentially Process Development Analytics to gather information to present to client and providing client feedback and requests back to the appropriate departments
• Determines client needs for requested work packages and collaborate internally to assess capabilities/capacity
• Prepare for client facing meetings by consulting SMEs, reviewing work package data, and generating presentations as appropriate
• Project planning of analytical work packages including method developments, qualifications, validations, specification development, sampling plans
• Assess new projects as it relates to QC activities and capabilities
• Coordination of analytical support and timelines between development, production, and QC departments
• Organizational and technical support of analytical method developments in the context of projects Initiate and own change controls related to client request for SOPs, Specification Documents, Scope of Analytical Methods
• Inter-laboratory compilation, evaluation and documentation of various analytical data as well as collaboration in the lifecycle management of analytical methods as it relates to assigned projects
• Provide collaboration and potential authoring SOP’s, lab investigations, OOS Investigations, and deviations as it relates to assigned projects
• Escalation of quality critical issues in customer projects within the Rentschler Quality Unit
• Review/Collaboration of development, validation, and Qualification of analytical methods per ICH USP guidelines
• Continuous research for new methods/techniques as well as initiation and organization of laboratory testing
• Ensure department readiness for audits by both internal and external authorities; potential contact person for analytical laboratories during both internal and external inspections

Qualifications

• Masters Degree in field of biochemistry, biotechnology or comparable field with at least 5+ years of experience in Analytical Process Sciences, Analytical Development, and/or project management in a Pharmaceutical, Biotechnology, CDMO, or other healthcare related field.
• OR
• Bachelors Degree with 7+ years of experience in Analytical Process Sciences, Analytical Development, and/or project management in a Pharmaceutical, Biotechnology, CDMO, or other healthcare related field
• Solid experience in common biological and protein chemical analytical methods
• Knowledge of GMP-compliant analytics
• Strong Understanding of GMP’s with expectations of a commercial GMP environment
• Must communicate effectively (verbal and written) with director and peers; written communicate skills require full competence in following detailed written instructions, creating/revising SOP’s and reports
• Advanced knowledge development, approval, manufacturing and testing of biopharmaceuticals
• Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint and Project

Working Conditions

• May require working in laboratory environment including using chemical reagents and analytical equipment
• Personal Protective Equipment must be worn as required
• Normal office working conditions: computer, phone, files, fax, copier
• Will interact with other people and clients
• Pace may be fast and job completion demands may be high

Physical Requirements

• Frequent lifting up to 10 lbs
• Frequent standing/walking to work in lab environment for extended periods
• Frequent sitting for extended periods to use computer