Zenasbio
VP, Small Molecule Drug Development and Manufacturing New Waltham, MA
Zenasbio, Waltham, Massachusetts, United States, 02254
VP, Small Molecule Drug Development and Manufacturing
Waltham, MA
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.
Compensation: base salary $247,200 to $309,000, plus annual performance bonus, equity, full range of benefits and other incentive compensation plans.
Zenas BioPharma is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.
Apply for this job.
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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.
Compensation: base salary $247,200 to $309,000, plus annual performance bonus, equity, full range of benefits and other incentive compensation plans.
Zenas BioPharma is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.
Apply for this job.
#J-18808-Ljbffr