Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.
We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!
Position Summary:
The VP of small molecule drug development and manufacturing will provide strategic direction, technical guidance, and long-range planning for small molecule drug development (API and DP), CDMO evaluation and selection, tech transfer, and GMP manufacturing activities from IND-enabling studies to NDA submission and approval, and commercial launch.
Key Responsibilities:
- Establish and execute a risk-based small molecule drug development and manufacturing strategy (API and DP) to support commercialization of the company's small molecule pipeline assets.
- Lead small molecule drug development and manufacturing efforts from IND enabling to NDA submission and approval, and post-approval lifecycle management.
- Lead the evaluation and selection of CDMOs for small molecule drug development and GMP manufacturing
- Oversee outsourced small molecule drug development and manufacturing activities including process/formulation development/optimization, tech transfer and scale-up, process characterization and process validation at CDMOs, ensuring quality, compliance, and timely execution and delivery.
- Build and lead a small molecule drug development and manufacturing team; hire, mentor, and develop team members aligned with company values and culture.
- Author, review, and approve the relevant CMC sections to enable global regulatory filings (INDs, NDAs, MAAs) and participate in regulatory authority interactions and inspections.
- Collaborate with CDMOs, proactively manage API and DP-related risks and implement mitigation strategies to ensure project success.
Qualifications:
- Degree (BS/MS/PhD) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related fields.
- 18+ years hands-on experience in small molecule drug development from process/formulation development and optimization, process characterization to process validation, CDMO selection and oversight, tech transfer and GMP manufacturing.
- Proven experience leading small molecule drug development and manufacturing from IND enabling to NDA/MAA submission, approval and commercial launch.
- Demonstrated success managing fully outsourced small molecule drug process/formulation development, tech transfer and scale-up, and GMP manufacturing.
- Working experience with FDA and EMA. Strong knowledge of cGMP, ICH guidelines, and global regulatory expectations.
#LI-Hybrid
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $247,200 to $309,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.
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What We Do
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and delivery of immune-based therapies for patients around the world. Zenas is rapidly advancing a deep portfolio of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com
