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 -www.RareObesity.com -for more
information. For those who may be affected or would like to learn
more, visit -www.LEADforRareObesity.com -for more
information.Powered by JazzHR
Keywords: Rhythm Pharmaceuticals, Boston , Associate Director, Technical Operations, IT / Software / Systems , Boston, Massachusetts
Didn't find what you're looking for? Search again!
Loading more jobs...
