What are the responsibilities and job description for the Director CMC position at Actalent?
Description:
• Must have both drug substance and drug product experience
• Must be comfortable with hands-on work and wearing multiple hats
• Ideally experience working with small molecules
• Looking for someone with experience across all phases but note that early phase is very important as that mirrors VYNE’s current state
• The person needs to be able to manage and maintain dossiers through multiple rounds
• The role is responsible for the overall CMC package
• Experience working across borders and internationally is helpful but not critical
Job Summary/Responsibilities:
- Drives development of program CMC goals in partnership with the CSO that enable on-time filings and delivery of clinical supply for all phases of development. Monitors and reports on progress of the program goals.
- Leads generation, alignment and continual monitoring of an integrated CMC program plan across functional lines involved in the development and delivery of supply.
- Oversee tech transfer and lead optimization activities at external sites.
- Select, qualify, and oversee CDMOs and other vendors supporting development and manufacture of drug substance and drug product, including analytical methods.
- Plan and manage non-GMP and GMP supplies (including packaging and labelling) to support full development programs.
- Troubleshoot problems encountered during manufacturing of drug substance and drug product, including scale-up.
- Assist in due diligence activities for potential products acquisitions.
- Accountable for CMC-related timelines and budgets.
- Identifies and escalates critical issues.
- Acts as a single, authoritative source for CMC-related topics.
- Interfaces with management to ensure company assets are managed effectively.
- Collaborate with and drive external vendors to ensure critical milestones are met.
- Contribute to regulatory documents and interactions.
Additional Skills & Qualifications:
• PhD in biopharmaceutics, chemistry or equivalent
• Minimum of 5 years drug development experience
• Demonstrated success in activities related to lead optimization, clinical and registration batch scale up of small molecules.
• Experience in both topical and oral dose formulation development.
• Experience in preparing CMC components of briefing books, regulatory responses, and IND modules.
• Ability to collaborate/communicate across organizational levels and disciplines.
• Ability to adapt and flex in response to changing priorities and unexpected events.
• Capability to work effectively with little direction.
• Passion for working in a small company environment; self-motivated and proactive.
• Ability to manage multiple projects simultaneously.
Experience Level:
Expert Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $150,000 - $200,000
