Opportunity OverviewRhythm 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.
