MBX Biosciences
Position Summary
MBX Biosciences is seeking an experienced and highly organized Manager, Quality Operations to lead and optimize our batch record review processes and ensure compliance with global regulatory standards. This role is pivotal in driving operational excellence, supporting product release, and strengthening MBX's quality systems. Reporting to the Head of Quality Operations, the Manager will oversee day-to-day quality operations, mentor team members, and collaborate cross-functionally to resolve complex issues and implement continuous improvements.
Key Responsibilities
* Lead and manage the batch record review process, ensuring accuracy, completeness, and compliance with cGMP, internal SOPs, and regulatory requirements
* Mentor staff, providing guidance on documentation practices and compliance standards.
* Approve and release production batch records and associated documentation for timely product disposition.
* Drive resolution of discrepancies, deviations, and documentation errors through root cause analysis and CAPA development.
* Partner cross-functionally with CMC, Manufacturing, and Regulatory teams to ensure alignment and timely issue resolution.
* Own and maintain batch record review templates and documentation standards to meet evolving regulatory expectations.
* Lead readiness efforts for internal audits and external inspections; represent Quality Operations during regulatory agency interactions.
* Oversee GMP training compliance for assigned personnel and support development of training programs.
* Champion continuous improvement initiatives to enhance documentation practices, streamline workflows, and strengthen quality systems.
* Other responsibilities as assigned.
Education & Qualifications
* Bachelor's degree in Life Sciences, Chemistry, or related field.
* 5+ years of experience in a GMP-regulated environment, preferably in batch record review or quality assurance.
* Strong understanding of FDA, EMA, and ICH guidelines related to documentation and manufacturing practices.
* Excellent attention to detail and ability to work independently with minimal supervision.
* Proficient in Microsoft Office and electronic document management systems
Travel
You will be expected to travel periodically based on the needs of the business to the extent requested by the Company including attendance at Together Weeks, Together Days and functional meetings as requested by the Company.
Company Overview
MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs, and large potential market opportunities. The Company's pipeline includes its lead product candidate canvuparatide (MBX 2109), in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); imapextide (MBX 1416), in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, with an IND currently under FDA review, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
EEO Statement:
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
MBX Biosciences is seeking an experienced and highly organized Manager, Quality Operations to lead and optimize our batch record review processes and ensure compliance with global regulatory standards. This role is pivotal in driving operational excellence, supporting product release, and strengthening MBX's quality systems. Reporting to the Head of Quality Operations, the Manager will oversee day-to-day quality operations, mentor team members, and collaborate cross-functionally to resolve complex issues and implement continuous improvements.
Key Responsibilities
* Lead and manage the batch record review process, ensuring accuracy, completeness, and compliance with cGMP, internal SOPs, and regulatory requirements
* Mentor staff, providing guidance on documentation practices and compliance standards.
* Approve and release production batch records and associated documentation for timely product disposition.
* Drive resolution of discrepancies, deviations, and documentation errors through root cause analysis and CAPA development.
* Partner cross-functionally with CMC, Manufacturing, and Regulatory teams to ensure alignment and timely issue resolution.
* Own and maintain batch record review templates and documentation standards to meet evolving regulatory expectations.
* Lead readiness efforts for internal audits and external inspections; represent Quality Operations during regulatory agency interactions.
* Oversee GMP training compliance for assigned personnel and support development of training programs.
* Champion continuous improvement initiatives to enhance documentation practices, streamline workflows, and strengthen quality systems.
* Other responsibilities as assigned.
Education & Qualifications
* Bachelor's degree in Life Sciences, Chemistry, or related field.
* 5+ years of experience in a GMP-regulated environment, preferably in batch record review or quality assurance.
* Strong understanding of FDA, EMA, and ICH guidelines related to documentation and manufacturing practices.
* Excellent attention to detail and ability to work independently with minimal supervision.
* Proficient in Microsoft Office and electronic document management systems
Travel
You will be expected to travel periodically based on the needs of the business to the extent requested by the Company including attendance at Together Weeks, Together Days and functional meetings as requested by the Company.
Company Overview
MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs, and large potential market opportunities. The Company's pipeline includes its lead product candidate canvuparatide (MBX 2109), in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); imapextide (MBX 1416), in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, with an IND currently under FDA review, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
EEO Statement:
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.