Associate Director, Drug Substance

Boston, MA
Full Time
Tech Ops
Experienced
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
As an Associate Director, Drug Substance, you will be responsible for developing and improving small molecule drug substance processes from pre-clinical through validation and commercialization.  These activities will be accomplished by planning and managing technical interfaces with selected contract manufacturers.  This position will report into the Head, Drug Substance.

Responsibilities and Duties
  • Oversee process development, validation and production activities at contract manufacturers of drug substance and intermediates.
  • Work collaboratively with Analytical Development, Regulatory, Quality Assurance and with project teams at the contract manufacturers to ensure that clinical and regulatory timelines are achieved.
  • Provide recommendations for appropriate process controls, specifications and analytical requirements.
  • Review, edit and approve documentation for technical content.
  • Draft and review regulatory documentation.
  • Work closely with Quality Assurance in evaluating and approving manufacturing deviations and change controls.  Work with contract manufacturers to resolve more complex deviations.
  • Advise management of risks including potential process failure, regulatory and quality issues.
  • Ensure compliance with all applicable regulatory requirements and assist in resolution of issues identified.
  • Identify manufacturing efficiency and cost reduction opportunities.

Qualifications and Skills
  • BS in chemistry or related field of study. PhD or MS degree in chemistry or related field of study is preferred.  
  • 8+ years of experience (or equivalent combination of education and experience) working in small molecule drug substance development, validation or manufacturing.  Knowledge of peptide manufacturing a plus.
  • Experience working in compliance with US, EU and ICH GMP requirements.  Experience writing or reviewing regulatory submission documents or responding to regulatory inquiries and inspections desirable.
  • Demonstrated ability to work independently, handle multiple projects, prioritize activities and meet critical timelines.
  • Excellent oral and written communication skills.
  • High sense of accountability to deliver results and meet timelines. 
  • Eager to learn and adapt and contribute to continuous improvement.
  • Strong interpersonal skills to effectively communicate and collaborate with teams, peers, management and external contacts.

Candidates based in the Boston area within commuting distance to our office are preferred, although will consider those based remotely within the Eastern Standard Time zone. 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 in Massachusetts.
 
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