BostonRecruiter Since 2001
the smart solution for Boston jobs

Associate Director, Technical Operations

Company: Rhythm Pharmaceuticals
Location: Boston
Posted on: March 20, 2023

Job Description:

Company OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that's passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway 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 OverviewThe Associate Director Technical Operations (Combination Products) will report into the Vice President, Technical Operations. - The candidate will be responsible for injectable combination product development; specifically, characterization testing, design verification, manufacturing process definition and support of device development for the combination product. Experience working in the medical device field or on combination products is a must have. - This individual will work closely with Supply Chain, Quality Assurance, Regulatory Affairs, Finance and various CRO/CMO's to meet objectives. -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. -Responsibilities and Duties

Lead technical interaction with injectable combination product drug product and device suppliers to develop/implement plans to develop/manufacture/package required products, provide required regulatory documents, and gain regulatory approvals and inspectionsAct as drug/device SME on projects and programs as neededWork across disciplines to define, characterize and assess product/device performanceSupport in drafting of IND/IMPD/NDA/MAA and if required Design History Files for Combination products, with changes/data generated from ongoing processes to secure regulatory authority approvals/updates for any change controls.Develop and validate new methods and techniques for testing novel systems including design and validationDesign and coordinate in vivo testing of devices including identifying and qualifying new models as modalities and needs changeDocument and communicate the team's work in written and oral formats for peers and senior leadersGather, develop, and maintain product requirements -Qualifications and Skills
BS in biomedical, mechanical or relevant engineering discipline8+ years in medical devices or similar disciplineProven experience with drug product process development and manufacturing of injectable productsExperience in managing outsourced device/combination product development is preferredCuriosity and passion for novel and off-the-shelf injectable delivery systemsExperience preparing work for a regulatory submission, ideally injectable combination productEnthusiasm and self-motivation to learn within and outside of your expertiseExperience in development of custom methods and equipment used in device testingExperience in verification and validation activities -More about RhythmRhythm is a global, commercial-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of hyperphagia and severe obesity due to rare melanocortin-4 receptor (MC4R) pathway diseases. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm's mission is to improve the understanding of these diseases and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company's clinical development program is currently focused on several rare MC4R pathway diseases. For healthcare professionals, visit -for more information. For those who may be affected or would like to learn more, visit -for more information.Powered by JazzHR

Keywords: Rhythm Pharmaceuticals, Boston , Associate Director, Technical Operations, IT / Software / Systems , Boston, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Boston RSS job feeds