Chemistry Manufacturing & Controls (CMC) Manager

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.

YOU WILL BE RESPONSIBLE FOR

• Manage external manufacturing and analytical activities at contract development and manufacturing organizations (CDMOs) to support commercial supply and clinical programs, ensuring collaboration, communication and scientific expertise.
• Manage GMP production of drug substance/drug product at CDMOs intended for nasal administration.
• Manage and support outsourced analytical development, validation and testing activities.
• Manage stability programs and trending.
• Provide technical expertise to support the development of new processes and formulations, scale-up, technology transfer and validation.
• Review batch production records, certificate of analysis, stability reports, validation protocols and reports to ensure technical and cGMP compliance.
• Review and approve deviations, investigations, CAPAs and change controls as technical subject matter expert and make recommendations to Quality Assurance.
• Review technical drug substance and drug product documents in a timely matter for regulatory submissions.

EDUCATION AND RESPONSIBILITIES

• BSc or MSc in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry or related field.
• 5+ years of experience in the biotech or pharmaceutical industry with at least 3+ years in cGMP environment.
• Hands-on experience with one or more of the following: drug substance/drug product GMP manufacturing, tech transfer, process scale-up and validation, analytical development and validation, formulation development, experience working with CDMOs or contract testing laboratories.
• Knowledge of GMP, FDA and EU regulations, ICH guidelines, as well as CMC content of regulatory submissions.
• Proficiency with Word, Excel, PowerPoint, SharePoint, Teams and Acrobat.

KEY ATTRIBUTES

• Superior interpersonal abilities - including working in a multi-cultural, multi-lingual environment.
• Exceptional communication skills, with both written and oral presentation abilities.
• Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining positive working relationships.
• Attention to details, strong organization and troubleshooting skills.
• Able to travel approximately 15% of the time, including international travel when appropriate.

EEOC STATEMENT: Milestone believes in a diverse environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Milestone will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.