MSAT Director Drug Product

About Summit:

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life increasing potential duration of life and resolving serious unmet medical needs. At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality. Summits core values include integrity passion for excellence purposeful urgency collaboration andour commitmentto people. Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence.

Summits team is inspired to touch and help change lives through Summits clinical studies in the field of has multiple global Phase 3 clinical studies including:

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluateivonescimabcombined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locallyadvancedor metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

• HARMONi-3: Phase 3 clinical study which is intended to evaluateivonescimabcombined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7: Phase 3 clinical study which is intended to evaluateivonescimabmonotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluateivonescimabin combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimabis an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and hasadditionaloffices in California New Jersey the UK and Ireland.

Overview of Role:

We are seeking a highly experienced and strategic Director of MSAT - Drug Product to join the CMC team and lead ongoing process development technology transfer process validation BLA/IND/IMPD authoring and readiness and agency interaction activities in preparation for commercialization and incremental clinical/commercial batch production of our main asset. This role will focus on leading a small DP team DP Tech transfer(s) and on co-authoring the CMC chapters of regulatorysubmitteddocuments ensuring all required data integrity and technical compliance standards are met. The ideal candidate will bring deepexpertiseinbiologicsmanufacturing sterile drug product operations and regulatory expectations. This role will also contribute strategically and technically to future improvements scale-up / scale-out decisions etc.

Role and Responsibilities:

• Lead process development/characterization techtransferand process validation for sterile drugproduct including oversight of external CDMOs and internal teams.
• Partner with the broader CMC team to implement process product and site changes
• Support with the team successful execution of clinical and commercial batch manufacturing in alignment with the development and supplytimelines.
• Be accountable with the team to successfully deliver CMC chapters to regulatory documents
• Actively support dialogue/interaction with regulatory agencies
• Support PLI/PAI preparation and delivery
• Responsible for all stages of Process Validation including CPV (Continuous Process Verification)in accordance withgoverning quality system requirements.
• Prioritizepost-approval opportunities and develop business cases for further investment/development
• Foster effective communication and collaboration with internal and external stakeholders including other CMC functions Regulatory Affairs Quality Assurance and CROs/CDMOs
• Collaboratively work across the broader CMC regulatory and quality departments to deliver desired outcomes
• Collaborate cross-functionally with Regulatory Quality Supply Chain and CMC teams to ensure integrated planning and execution.
• Ensure GMP compliance across all activities.
• Support audits and inspections.
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• MSc degree in Engineering Biochemistry Pharmaceutical Sciences or related field; PhD preferred.
• Minimum of 10 years of experience inbiologicsmanufacturing with a focus on sterile drugproductand late-phase development.
• Proventrack recordin BLA preparation PPQ and commercial launch.
• Strong knowledge of regulatory expectations (FDA EMA) for biologics and sterile drugproduct(s).
• A strong teamplayer and promotor of inclusion and collaboration
• Able to handle multiple projects simultaneously whilemaintaininghigh-quality results
• Capable of providing and implementing innovative solutions to unique and pressing situations
• Experience managing CDMO partners and internal cross-functional teams.
• Excellent leadership communication and project management skills.

The pay range for this role is 100000.00 - 120000annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stockbenefitsand/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agenciesare required tocontact Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.