Analytical Project Coordinator, Quality Control

RiseMe; Milford (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Rentschler Biopharma SE in Milford, MA seeks an Analytical Project Coordinator to be the primary QC contact for analytical methods across client projects, coordinating with global teams and labs. You will ensure QC standards, support method development, validation, and lifecycle management in a GMP environment.

Ideal candidates have 5+ years in Analytical Process Sciences or related fields, with strong knowledge of GMP analytics and excellent communication skills.

Qualifications

• Masters degree with 5+ years in Analytical Process Sciences, Analytical Development, and/or project management
• Bachelor's degree with 7+ years in Analytical Process Sciences, Analytical Development, and/or project management
• Solid experience in common biological and protein chemical analytical methods
• Knowledge of GMP-compliant analytics
• Strong understanding of GMPs in a commercial GMP environment
• Excellent verbal and written communication; ability to author SOPs and reports
• Advanced knowledge of development, approval, manufacturing and testing of biopharmaceuticals
• Proficiency in Microsoft Office: Outlook, Word, Excel, PowerPoint, and Project

Responsibilities

• Serve as the primary QC contact for the analytical methods portfolio and liaison between project teams, international customers, and internal/external labs
• Represent QC labs and uphold Rentschler quality standards across client projects; collaborate with AD, Microbiology, Raw Materials, and Release
• Determine client needs for work packages and coordinate with internal teams on capabilities and capacity
• Prepare for client meetings by consulting SMEs and reviewing data; generate presentations as needed
• Plan analytical work packages including method development, qualifications, validations, and sampling
• Coordinate analytical support and timelines between development, production, and QC
• Initiate and own change controls related to SOPs, specifications, and scope of analytical methods
• Compile and document inter-lab data; contribute to lifecycle management of analytical methods
• Assist with SOP authoring, lab investigations, OOS investigations, and deviations
• Escalate quality-critical issues within the Rentschler Quality Unit
• Review/develop ICH USP compliant analytical methods; support audits by internal/external authorities
• Pursue new methods/techniques; organize laboratory testing
• Maintain readiness for audits and act as contact for labs during inspections

Education

Master's Degree in Biochemistry/Biotechnology or comparable field

Bachelor's Degree in Biochemistry/Biotechnology or comparable field

Job description

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions –together with our clients.

Rentschler Biopharma hasapproximately1,400 employees and is headquartered in Laupheim, Germany,with asite in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

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.

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