Job Information
Rhythm Pharmaceuticals Quality Control Manager in Boston, Massachusetts
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
The Quality Control Manager is responsible for oversight of testing performed at Rhythm’s contract sites to support the manufacturing and testing of Drug Substance and Drug Product. The qualified candidate will review testing conducted at CMO analytical laboratories and have internal responsibility in stability monitoring, documentation best practices and quality control activities. This position reports into the Head, Analytical Chemistry and QC and is based in our Boston office.
Responsibilities and Duties
Contribute to the development, optimization, validation, and transfer of analytical procedures for testing drug substance and drug product, key intermediates, in-process, release and stability samples.
Participate in cross-functional task forces coordinating analytical activities at CMOs/CROs, setting of specifications and design of stability studies
Support production, certification, inventory, and distribution of reference materials.
Complete remediation of deviations and investigations, implementation of corrective / preventive actions and change controls.
Enhance quality practices and optimize internal processes by contributing to the preparation, review, and approval of standard procedures.
Author and review regulatory CMC submissions including analytical procedures, method validations, reference standards, batch analyses, product characterization, stability, and specification sections.
Identify, review, and organize analytical documents to support robust analytical method life-cycle management.
Qualifications and Skills
Bachelor’s degree in a scientific discipline, Master’s a plus.
5+ years’ experience in analytical method development or quality control in the pharmaceutical industry.
Experience authoring and/or reviewing of documents such as stability and analytical studies.
Experience with interpretation and application of ICH, compendial, cGMP and pharmaceutical best practices.
Ability to perform stability trending, document management and quality control functions such as change control, corrective actions and investigations is a plus.
Familiar with analytical method and product characterization procedures.
Competent in the use of software applications, such as stability trending 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 and highly collaborative environment, while maintaining a high level of scientific quality and compliance.
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.
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 (https://www.bostonglobe.com/magazine/top-places-work/2023/) in Massachusetts.
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