Senior Director, Analytical Development & Quality Control

Job Description

Job Description

Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. 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
As the Senior Director, Analytical Development and Quality Control , you will provide strategic and technical leadership for analytical development and quality control across Rhythm’s portfolio, spanning discovery through commercialization and lifecycle management. This role is accountable for defining and executing phase-appropriate analytical control strategies, enabling robust product characterization, and ensuring compliant, timely delivery of analytical data to support regulatory submissions and commercial supply.

You will lead and develop a high-performing organization while overseeing external partners, including CDMOs, CROs, and contract laboratories, to deliver analytical development and QC activities across drug substance and drug product. As a key member of the Technical Operations leadership team, you will drive cross-functional alignment, influence organizational strategy, and represent Analytical Development and QC in regulatory and governance interactions.

Responsibilities and Duties
Strategic Leadership & Analytical Development

• Define and execute end-to-end analytical strategies across the product lifecycle, including method development, validation, transfer, and lifecycle management from raw materials through drug substance and drug product.
• Establish phase-appropriate control strategies, specifications, and analytical approaches aligned with regulatory expectations and commercial readiness.
• Drive innovation in analytical technologies and methodologies, translating new approaches into robust, scalable platforms for development and commercial testing.
• Lead product characterization strategies, including identification and control of critical quality attributes (CQAs), impurity profiling, comparability, and stability programs.

Quality Control & GMP Oversight

• Act as Head of Quality Control for analytical testing supporting US and EU market authorization holders (MAHs), ensuring compliant release and support of clinical and commercial products.
• Oversee QC testing activities, including in-process, release, stability, reference standards, and impurity monitoring programs for drug substance and drug product.
• Ensure laboratories (internal and external) operate in compliance with cGMP, data integrity, and global regulatory requirements.
• Provide oversight for investigations, deviations, OOS/OOT results, complaints, and root cause analyses, ensuring timely and compliant resolution.

External Partner & Operational Management

• Lead and manage analytical development and QC activities executed by CDMOs, CROs, and contract laboratories, ensuring quality, timelines, and cost objectives are met.
• Oversee analytical method transfer activities, including protocol design, execution, and performance monitoring across internal and external sites.
• Establish and manage budgets, resource plans, timelines, and risk mitigation strategies across programs.
• Build and maintain strong supplier relationships and oversee regulatory inspections and audit readiness of external laboratories.

Regulatory & CMC Contribution

• Provide strategic leadership for regulatory submission activities, including authoring, reviewing, and approving Module 3 analytical sections for INDs, IMPDs, NDAs, MAAs, and lifecycle filings.
• Lead analytical responses to health authority queries and represent the function during regulatory interactions and inspections.
• Ensure analytical development activities are aligned with ICH guidelines and global regulatory expectations.

Cross-Functional Leadership

• Partner with Drug Substance, Drug Product, Regulatory Affairs, Quality Assurance, Manufacturing, Project Management, and Research functions to advance development programs.
• Serve as analytical subject matter expert on cross-functional CMC and Product Development Teams.
• Influence strategic decision-making and drive alignment across internal stakeholders and senior leadership.

People Leadership

• Build, lead, and develop a high-performing analytical development and QC organization, including hiring, coaching, mentoring, and succession planning.
• Foster a culture of scientific excellence, innovation, accountability, and continuous improvement.

Qualifications and Skills
Education & Experience

• PhD (preferred) or MS in Analytical Chemistry, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline.
• 12+ years (PhD) or equivalent experience in analytical development within the pharmaceutical or biotechnology industry, including significant leadership experience.
• Demonstrated experience leading analytical development and QC organizations supporting small molecule and/or peptide drug development across the lifecycle (discovery through commercialization).

Technical Expertise

• Deep expertise in analytical method development, validation, transfer, and lifecycle management.
• Strong knowledge of small molecule and/or peptide analytical techniques, including chromatography (HPLC/UPLC), mass spectrometry, impurity analysis, stability, and characterization.
• Extensive experience with control strategy development, specification setting, comparability, and regulatory-ready analytical packages.
• Proven experience overseeing stability programs, impurity tracking, and reference standard programs.
• Familiarity with quality management systems and procedures for change management, investigations, deviations, and document control.

Regulatory & Compliance

• Strong understanding of cGMP, data integrity principles, and ICH guidelines.
• Demonstrated experience supporting global regulatory submissions (IND, IMPD, NDA, MAA) and regulatory inspections.

Leadership & Execution

• Proven ability to lead cross-functional teams and influence decision-making in a matrixed organization.
• Strong external vendor management experience, including CDMOs and CRO oversight in a virtual environment.
• Track record of managing complex programs, solving technical and regulatory challenges, and delivering under aggressive timelines.

Professional Skills

• Excellent communication and presentation skills, with the ability to convey complex technical information to diverse stakeholders.
• Strong strategic thinking, problem-solving, and risk management capabilities.
• Ability to manage multiple priorities in a fast-paced, dynamic, and highly collaborative environment.

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 involve some travel.

The expected salary range for this position is $210,000 - $370,000. 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.  

At Rhythm our core values are:

• 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

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.

 

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