Associate Director/Director, Drug Substance Development
1 month ago
Why join Cardurion Pharma?
At Cardurion, we are advancing the understanding of the cellular mechanisms that regulate heart function and are developing new treatments to address cardiovascular disease. Our programs seek to modulate signaling pathways that regulate heart cell function to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our site to learn more about our Company and how we are advancing the promise of cardiovascular signaling pathways science to improve health and impact lives around the world.
The Role:
Reporting to the Vice President of Manufacturing and CMC, the Associate Director/Director of Drug Substance Development will be responsible for all aspects of drug substance development across multiple Cardurion programs. The Associate Director/Director is recognized as the drug substance subject matter expert and expected to effectively communicate with all levels of the organization and vendors. The incumbent demonstrates strong leadership and capabilities to bring important medicines to patients in alignment with the company’s overall mission. It is a highly independent position that requires a motivated and effective team player who can thrive in a fast-paced environment, balance multiple priorities and operational constraints effectively to cross-functional colleagues.
Here’s What You’ll Do:
· Responsible for managing all aspects of small molecule drug substance development and manufacturing at CDMO’s.
· Responsible for sourcing of starting materials for drug substance manufacturing and ensuring their timely delivery and quality.
· Responsible for planning stage appropriate development activities and working with the CRO/CDMO’s on their timely execution.
· Develop integrated risk mitigation strategies for critical path issues/program risks to ensure timely delivery of program milestones.
· Designs process optimization activities to ensure API processes are robust, cost-effective and fit for purpose.
· Responsible for technical review of the batch records as well as working with Quality Assurance personnel to ensure that manufacturing activities are conducted in compliance with cGMP’s and applicable regulatory requirements.
· Contribute to building and maintaining Quality infrastructure in support of external CMC operations.
· Responsible for authorship of drug substance IND/IMPD/NDA sections.
· Responsible for management of drug substance related documentation, batch records, development reports and stability reports in accordance with internal SOP’s.
· Coordinate periodic meetings with CRO’s/CDMO’s to monitor progress of ongoing work, and provide technical feedback, review reports and meeting minutes.
Here’s What We’ll Bring to the Table:
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), Delta Dental, and vision offered through VSP
- Fully funded HSA for high-deductible PPO Plan
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 4 weeks Paid Time Off annually
- 401k (traditional and Roth offered) with 50% match on first 4% deferred. Match is vested immediately
- A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability
- 10 company paid holidays and Year-End shut down
Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Requirements:Here’s What You’ll Bring to the Table:
· Ph.D. in Organic Chemistry with 8+ years of small molecule process chemistry experience in biotech, pharma or CDMO industries.
· Technical depth and a broad understanding of chemical process and analytical development.
· Familiarity with cGMP and ICH guidelines for drug substance for late-stage clinical trials.
· Experience with managing CDMO’s.
· Experience with process development for small molecule drug substance, scale up, and process transfer between CRO’s/CDMO’s.
· Experience with analytical method development and validation for drug substance and starting materials
· Proficient in technical report writing.
· Outstanding communication skills (verbal and written).
· Ability to manage multiple projects in a fast-paced environment.
· Ability to effectively collaborate effectively in a dynamic, cross-functional environment.
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