Analytical Project Coordinator, Quality Control

Rentschler Biopharma•Milford, MA

1d•Onsite

About The Position

The Analytical Project Coordinator serves as the primary point of QC contact as it relates to client project delivery, client support, analytical work packages and implementation of activities from the QC team. Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.

Requirements

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

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