Description

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 Manager, Drug Product will support ongoing activities for the formulation and manufacturing of small molecule, oral solid dose drug products, managing outsourced development activities and overseeing 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 to the Associate Director, Drug Product 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.
Oversee manufacturing and release of clinical drug products. Experience in oral solid dosage forms.
Review and approve drug product development protocols, Master Batch Records, production records, and testing results.
Manage change controls, CAPAs and manufacturing batch record development
Develop effective and efficient working relationships with both internal and external partners to ensure drug supply, adequate inventory and delivery.
Facilitate activities related to drug product technology transfer, validation and process improvements to manufacturing partners. Oversees cGMP manufacturing operation including person in plant support
Review relevant drug product CMC sections for global regulatory submissions (IND/CTA, NDA, MAA etc).

Qualifications and Skills

BS/MS with 5+ years’ experience in Pharmaceutical Sciences, Chemical Engineering or related field, or PhD with 1-2 years of experience in the pharmaceutical or biotech industry.
Experience in oral solid dosage formulation development. Experience with pediatric formulations is a plus.
Early formulation development (animal studies) to support discovery and preclinical stages of drug development is a plus
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 a plus.
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 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.

The expected salary range for this position is $110,000 - $165,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.

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.

Manager, Drug Product

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