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Associate Director, Chemistry Manufacturing & Controls

Remote:

Full Remote

Contract:

Full time

Experience:

Expert & Leadership (>10 years)

Work from:

Canada

Offer summary

Qualifications:

MS or PhD in Pharmaceutics, Pharmaceutical Chemistry, or Chemical Engineering, Approximately ten years of pharmaceutical industry experience, Experience with Investigational Medicinal Products (IMP), Knowledge of FDA, EU, and ICH regulations, Proficient in project management tools.

Key responsabilities:

Manage pharmaceutical development at contract manufacturing organizations
Collaborate with internal teams and external partners for CMC projects
Oversee formulation and analytical development activities
Ensure cGMP compliance through review of production records
Approve documents for regulatory submissions such as NDA and MAA

Milestone Pharmaceuticals, Inc. Biotech: Biology + Technology TPE https://www.milestonepharma.com/

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Job description

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

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)

ABOUT YOU

MS or PhD in Pharmaceutics, Pharmaceutical Chemistry, or Chemical Engineering
Approximately Ten years of experience in the pharmaceutical industry or CMO’s including virtual pharmaceutical development with direct CMC experience
Experience with the management of an Investigational Medicinal Product (IMP)
Experience working with drug substance, and drug product contract manufacturers in the US, EU and Asia
Experience with intranasal and sublingual drug delivery systems for formulation and manufacturing is preferred, as is experience with drug/device combinations.
Knowledge of formulation development, analytical development, technology transfer, GXPs, FDA, EU, and ICH regulation/guidelines, as well as CMC content of regulatory submissions; and
Experience with project management tools including Excel, PowerPoint, Project, Teams and Adobe.
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.
Able to travel approximately15% of the time, including international travel when appropriate.
Located in or willing to relocate to Montreal or Charlotte; or located in the Raleigh or New Jersey area.

COVID-19 VACCINATION POLICY: All Milestone employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

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.