Senior Manager, Analytical Chemistry

About the Role

Rhythm is seeking an Analytical Chemistry Manager to oversee testing performed at contract sites supporting manufacturing. This role provides direction to CMO analytical laboratories and serves as a subject matter expert on cross-functional project teams, both internal and external. The ideal candidate will be knowledgeable in analytical techniques used for testing excipients, raw materials, components, in-process reactions, and purifications.

Responsibilities

• Direct the development, optimization, validation, and transfer of analytical procedures for testing and control of in-process yield, purity, key intermediates, and impurities.
• Participate in cross-functional task forces to coordinate analytical activities at CMOs/CROs.
• Contribute to remediation of deviations and investigations, implementation of corrective/preventive actions, and change controls.
• Author and review regulatory CMC submissions, including analytical procedures, method validations, reference standards, batch analyses, characterization, stability, and specification sections.
• Identify, review, and organize analytical documents to support robust analytical method life-cycle management.
• Assess and select CROs/CMOs, solicit quotes, and finalize contracts with finance and legal.
• Contribute to fulfillment of pre- and post-approval commitments and annual product reviews.

Requirements

• Minimum of a Bachelor’s degree with over 7 years’ experience or a Master’s degree with over 5 years’ experience in analytical method development or quality control in the pharmaceutical industry.
• Experience in analytical techniques for monitoring yield and purity during organic synthesis.
• Knowledgeable in testing raw materials, excipients, and components.
• Familiarity with procedures for characterization, qualification, and management of intermediate and impurity standards.
• Experience in authorship and/or review of analytical method development, validation, and transfer documents.
• Demonstrated knowledge and experience in the interpretation and application of ICH, compendial, cGMP, and pharmaceutical best practices.
• Familiarity with qualification of trace impurities, including extractables, leachables, and nitrosamines.
• Proficiency in analytical and characterization procedures, such as HPLC, GC, MS, elemental impurities, and moisture analyses.
• Competence in using software applications, including LC chromatographic analyses, statistical applications, and quality management systems.
• Excellent interpersonal, organizational, problem-solving, customer service, and communication skills.
• Self-motivated, flexible, and able to prioritize work and handle multiple assignments in a fast-paced environment while maintaining high scientific quality and compliance.

Location & Schedule

This role is based at our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model, requiring in-office coordination with department and business needs. Some travel may be involved.

Pay

The expected salary range for this position is $135,000 - $215,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may also be eligible for benefits and other compensation, such as restricted stock units.

About Rhythm

Rhythm is a dynamic and growing global team spanning more than a dozen countries, dedicated to transforming the lives of patients living with rare neuroendocrine diseases. We rapidly advance care and precision medicines that address the root cause of these conditions. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.

Our core values include a commitment to advancing scientific understanding, tackling tough challenges, continuous learning and adaptation, collaboration, and ownership. We value the unique contributions each individual brings to furthering our mission and operate with a commitment to ethics and integrity.