Senior Manager, Analytical Chemistry

Rhythm Pharmaceuticals, Inc; Boston, Northern (MA, KY); Hybrid; USD 135,000 - 215,000; Full time

Job summary

Rhythm Pharmaceuticals, Inc. seeks an Analytical Chemistry Manager to oversee testing at contract sites, guide CMOs/CROs, and serve as SME on cross-functional teams.

The role focuses on analytical methods for excipients, raw materials, and process-related impurities, with strong emphasis on regulatory readiness and method lifecycle management. The ideal candidate has 7+ years in analytical method development or 5+ years with a Master’s, and is proficient in HPLC/GC/MS with ICH and cGMP

Qualifications

• Bachelor’s degree with 7+ years in analytical method development or Master’s with 5+ years in pharmaceutical analytics.
• Experience in analytical techniques for monitoring yield and purity.
• Knowledge of testing raw materials, excipients and components.
• Familiarity with characterization and impurity standards management.
• Authorship/review of analytical method development, validation and transfer documents.
• Knowledge of ICH, compendial, cGMP and pharmaceutical best practices.
• Experience with trace impurities, extractables, leachables and nitrosamines.
• Hands-on use of HPLC, GC, MS, elemental impurities and moisture analyses.
• Competent in software including LC chromatographic analyses, statistics, and QMS.
• Strong interpersonal, organizational and problem-solving skills.

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 CRO/CMOs, solicit quotes and finalize contracts with finance and legal.
• Contribute to fulfilment of pre- and post-approval commitments and annual product reviews.

Skills

Analytical method development

Quality control

ICH and cGMP

HPLC

GC

MS

Trace impurities

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry or related field

Master’s degree in analytical chemistry

Tools

HPLC software

LC-MS software

Quality management systems (QMS)

Job description

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview

The Analytical Chemistry Manager is responsible for oversight of testing performed at Rhythm’s contract sites to support manufacturing. The qualified candidate will provide directions to CMO analytical laboratories and serve as subject matter expert on cross functional project teams (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 and Duties

• 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 CRO/CMOs, solicit quotes and finalize contracts with finance and legal.
• Contribute to fulfilment of pre- and post-approval commitments and annual product reviews.

Qualifications and Skills

• Minimum of Bachelor’s degree with over 7 years’ experience or 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 the testing of raw materials, excipients and components.
• Familiarity in procedures for characterization, qualification and management of intermediate and impurity standards.
• 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 in qualification of trace impurities, including extractables, leachables and nitrosamines.
• Well versed in analytical and characterization procedures, for example, HPLC, GC, MS, elemental impurities and moisture analyses.
• Competent in the use of 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 a high level of scientific quality and compliance.

Location & Work Arrangement

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involvesome travel.

Salary & Benefits

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 be eligible for benefits and other compensation such as restricted stock units.

More About Rhythm

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

Core Values

• We are committed to advancing scientific understanding to improve patients’ lives
• We are inspired to tackle tough challenges and have the courage to ask bold questions
• We are eager to learn and adapt
• We believe collaboration and ownership are foundational for our success
• We value the unique contribution each individual brings to furthering our mission

Inherent in our core values is the commitment to act ethically and with integrity in all we do.

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.