Sr Project Manager, Chemistry Manufacturing & Controls
Montreal, QC, Canada
Full Time
Experienced
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.
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.
duties and responsibilities
- Develop and manage detailed project plans for manufacturing activities and track project timelines, critical items, and deliverables across internal teams, consultants and external suppliers and CMOs
- Proactively coordinate cross-functional project meetings to align project activities and ensure clear communication of priorities and decisions
- Support review and tracking of key documentation, including batch records, validation protocols, deviations, and CAPAs (in collaboration with QA)
- Creation of reports, Gantt charts, and dashboards tracking ongoing and planned manufacturing and development activities
- Creation of budgets for CMC and CMC related operations departments
- Collaborates with finance and internal team to track budget vs actuals
- Generates and tracks purchase orders, vendor contracts, and invoices
- Provide CMC / QA integration support, document management and tracking
- Creation of a positive work environment by sharing and demonstrating functional/technical knowledge
Education, background, knowledge and skills
- B.Sc., or M.Sc. in Life sciences, Chemistry or a related field
- 5+ years of experience in the biotech, pharmaceutical or CDMO industry with at least 3+ years in cGMP manufacturing
- Hands-on experience with one or more of the following: Drug Substance/Drug Product manufacturing, Tech transfer, regulatory submissions (e.g IMPD, IND), working with CDMOs or CMOs.
- PMP certification not required but preferred
- Fluent in budgeting and financial planning
- Extensive experience with project management tools including Excel, PowerPoint, Teams, Acrobat, and PM tools such as MS Project, Smartsheet.
key attributes
- Highly organized, detailed oriented personality
- Strong interpersonal and communication skills, both written and verbal. Ability to liaise with others to ensure plans remain on schedule.
- Influential and effective member of cross-functional teams or projects.
- Self-motivated taking personal pride in delivering high quality output by closely monitoring every process.
- Able to travel approximately 15% of the time, including international travel when appropriate.
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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