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 Sr. Associate, Analytical Chemistry will be a member of the Tech Ops team and report into the Head, Analytical Development and Quality Control. In this role, the individual will support development and oversight of testing performed at Rhythm's contract sites for the manufacturing and testing of Drug Substance and Drug Product. This position will support analytical controls and documentation across a) Analytical procedures; b) Specifications; c) Stability and Shelf life; c) Reference Standards; d) GMP Quality Systems.
Responsibilities and Duties - Contribute to the development, optimization, validation, and transfer of analytical procedures for testing drug substance and drug product, key intermediates, raw materials, in-process, release and stability samples.
- Participate in cross-functional task forces to coordinate analytical activities at CMOs/CROs.
- Enhance quality practices and optimize internal processes by contributing to the preparation, review, and approval of standard procedures.
- 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.
- Finalize purchase requisitions and contracts with finance and legal.
- Contribute to fulfilment of pre- and post-approval commitments and annual product reviews.
- Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
Qualifications and Skills - Minimum of Bachelor's degree in chemistry or related discipline with 4+ years' experience or Master's degree with 2+ years' experience.
- Experience with stability studies, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports.
- Awareness of ICH, compendial, cGMP and pharmaceutical best practices.
- Familiarity with analytical and characterization procedures.
- Familiarity with eQMS applications such as Veeva.
- Competent in the use of software applications, including statistical applications, stability trending, task management.
- 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.
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.
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.
