Senior Director, Manufacturing, Science and Technology
About Edgewise Therapeutics:
At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the Position:
This position oversees late phase through commercialization drug product and drug substance manufacturing at partner Contract Development and Manufacturing Organizations (CDMOs) and ensures high-quality products are delivered on time and within budget. Serve as a technical expert who leads the transfer of manufacturing processes to commercial scale. Manage processes, systems and infrastructure that meet safety, cGMP manufacturing, and regulatory compliance. Provide technical expertise and oversight for process validation, lifecycle management, and continuous improvement. Anticipate and solve complex manufacturing issues. Work in collaboration with internal and external stakeholders including CMC, Quality and Regulatory, as well as CDMOs.
Essential Job Duties and Functions:
- Lead the scale-up, and validation of manufacturing processes for both drug substance and drug product as well as finished goods packaging.
- Facilitate technology transfers, ensuring successful scale-up to commercial-scale production environments.
- Oversee CDMO qualification, contracting, and performance.
- Analyze existing processes, identify areas for improvement, and implement innovative technologies and strategies to optimize yield, reduce costs, and enhance efficiency.
- Provide technical expertise and actively troubleshoot and solve complex technical problems that arise during production.
- Manage and support manufacturing processes throughout their lifecycle, from validation through commercial operation.
- Work in collaboration with other teams to resolve technical challenges and meet program expectations, including RCMC, Quality Assurance, and Regulatory Affairs.
- Ensure that all manufacturing processes comply with relevant regulations and guidelines, including cGMP.
- Provide strategic leadership by directing and mentoring staff and fostering a culture of quality and innovation.
- Drive continuous improvement, implement best practices, and optimize manufacturing for efficiency and cost-effectiveness.
- Participate in the preparation of CMC sections for regulatory submissions, including for INDs and NDAs.
- Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
- Perform other duties as assigned by supervisor.
Required Education, Experience and Skills:
- B.S. or M.S. in chemical engineering, pharmaceutical sciences or related field with an exceptional understanding of drug product development and manufacturing for solid oral dosage forms
- 20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment
- 8+ years of management and oversight of CDMOs for cGMP activities
- Ability to navigate and craft global regulatory CMC documents
- Familiarity with safe and efficient laboratory practices
- General and scientific computer and software application proficiency
This is a full-time position (40 hours/week) that has been designated a hybrid position. Up to 30% travel.
Salary range: $225,000 - $280,000, title and salary commensurate with experience
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis.
Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
