Associate Director, Chemistry Manufacturing & Controls

at  Milestone Pharmaceuticals

WHY JOIN MILESTONE

At Milestone, we aspire to advance and implement paradigm shifts for cardiac therapy. We are currently focused on developing anti‐arrhythmia treatments for self‐administration outside of the emergency department or hospital setting for patients with acute episodes of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation (AFib), as well as other episodic cardiovascular conditions.
In addition to our science and innovation, we are a team guided and driven by our core values. Patient needs and empowerments are continually upheld as central to our mission. Our teamwork is strengthened in an environment in which we support and challenge each other while enjoying and celebrating our achievements. We maintain an entrepreneurial, proactive, and action‐oriented mindset that places high value on grit, courage, and resolve. Decision‐making is based on evaluating information and an idea’s merits; data‐driven proposals are both supported and sought. We act individually and as a team with humility, candor, empathy, and unwavering integrity.
We have been successful in attracting and empowering best‐in‐class talent, and we seek those with passion to join on our journey to develop treatments and to motivate change. We are excited about the possibilities of this team and what we can accomplish together.

• Management of the pharmaceutical development of drug substance and drug products at contract manufacturing organizations (CMOs) intended for nasal and sublingual administration
• Collaborate with internal teams, consultants, CMOs and suppliers, providing project management oversight for CMC, and in accordance with development plans
• Execute external development and manufacturing activities at CMOs, ensuring collaboration, communication, scientific expertise, and attention to detail
• Manage formulation and analytical development activities for current and future CMC projects, Act as a subject matter expert on reformulation of existing products and development of new formulations and delivery systems
• Review essential elements of scale-up and technology transfer
• Manage the technical oversight and timeline of outsourced activities
• Apply technical expertise to support the development of new formulations, and manufacturing processes for nasal, sublingual, and transdermal dosage forms
• Review batch production records and development protocols to ensure cGMP compliance
• Review and approve drug substance and drug product documents for regulatory submissions (NDA, MAA etc)