Associate Director/Director, Chemistry Manufacturing and Control
Montreal, QC, Canada
Full Time
Senior Manager/Supervisor
| Position title | Associate Director/director, Chemistry manufacturing and controls |
| reports to | Vp, Chemistry Manufacturing and Controls |
| manages | GMP pharmaceuticals Production |
| Location | montreal, QC or Charlotte, NC (possibility of remote position) |
duties and responsibilities
- Management of the GMP Production of drug substance and drug products at contract manufacturing organizations (CMOs) intended for nasal and sublingual administration
- Compliance against applicable cGMPs, regulatory requirements and company’s SOPs and policies
- 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
- Creation of a positive work environment by sharing and demonstrating functional/technical knowledge
- 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 deviations, investigations and CAPAs and make recommendations to Quality Assurance
- Review and approve technical drug substance and drug product documents for regulatory submissions, ensuring all documentation is approved and processed within budget and timeline
Education, background, knowledge and skills
- MS or PhD in Pharmaceutics, Pharmaceutical Chemistry, Medical Chemistry or Chemical Engineering
- Approximately Ten years of experience in the pharmaceutical industry or CMO’s including virtual pharmaceutical development with direct GMP manufacturing experience
- 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 required, as is experience with drug/device combinations.
- Knowledge of formulation development, analytical development, technology transfer, cGMP, FDA, EU, and ICH regulation/guidelines, as well as requirements for CMC content of regulatory submissions; and
- Experience with project management tools including Excel, PowerPoint, Project Team 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.
- Able to travel approximately 15% of the time, including international travel when appropriate.
Disclaimer: The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, but rather are intended only to describe the general nature of the position.
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.
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