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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

Rhythm seeks an experienced and highly motivated individual to join its team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product small molecule drug product development, manage outsourced development activities, and handle cGMP manufacturing campaigns. This individual will collaborate with partners in Supply Chain, Quality Assurance, Regulatory Affairs, Finance and various CRO/CMO’s to achieve Rhythm’s objectives. The role will report into the Vice President, Technical Operations and is based in our Boston office.

Responsibilities and Duties

+ Ensures development and validation of all drug product processes meets regulatory requirements including FDA, EU, ICH requirements as required.

+ Ensures contract manufacturers comply with appropriate manufacturing procedures including any investigations and changes required via Change Controls.

+ Provides technical leadership, planning and oversees implementation of plans for developing, validating and if required transferring processes or changes required within/between Rhythm contract manufacturing partners.

+ Drug Product formulation development, process development, and cGMP manufacturing of solid oral dosage forms.

+ Evaluates external vendors to ensure the successful execution of drug product supply plans, creates Requests for Proposals (RFPs).

+ Collaborates with internal stakeholders, including CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs.

+ Manages and executes activities related to drug product technology transfer, validation and process improvements to manufacturing partners. Oversees cGMP manufacturing operation including person in plant support

+ Collaborates with the internal and external manufacturing scientist and cross functional teams to assist with troubleshooting or investigations related to the manufacturing processes. Works directly with manufacturing and quality teams to author deviations, non-conformances, and CAPAs as required.

+ Authors and reviews relevant drug product CMC sections for global regulatory submissions (IND/CTA, NDA, MAA etc).

Qualifications and Skills

+ MS or PhD in Pharmaceutical sciences, Chemical Engineering or related field

+ Minimum of 8+ years of experience in the pharmaceutical or biotech industry.

+ Demonstrated knowledge/experience with development of solid oral dosage forms. Experience in pediatric formulation development (liquid, Chewable, and ODT) is a plus

+ Early formulation development (animal studies) to support discovery and preclinical stages of drug development

+ Excellent knowledge of GMP and ICH guidelines related to clinical and commercial labeling, and packaging operations and the overall drug development process.

+ Demonstrated experience with process validation and regulatory requirements. NDA / MAA/ ANDA filing experience is preferred.

+ Demonstrated experience with scale-up and optimization of lab procedures up to commercial scale under GMP conditions.

+ Demonstrated knowledge and application of Pharmaceutical Quality by Design (QbD) principles.

+ Experience overseeing/managing CDMOs conducting clinical and commercial manufacturing.

+ Demonstrated expertise in the development of project plans for manufacturing transfers, including the ability to manage multiple projects.

+ Experience working with both domestic and international CMOs.

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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