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 and our commitment to 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 oncology. Summit has multiple global Phase 3 clinical studies including:

Non-small Cell Lung Cancer (NSCLC)

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

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

Colorectal Cancer (CRC)

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

Ivonescimab is 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 has additional offices 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 regulatory submitted documents ensuring all required data integrity and technical compliance standards are met. The ideal candidate will bring deep expertise in biologics manufacturing sterile drug product operations and regulatory expectations. This role will also contribute strategically and technically to future lifecycle considerations e.g. productivity improvements scale-up / scale-out decisions etc.

Role and Responsibilities:

• Lead process development/characterization tech transfer and process validation for sterile drug product 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 supply timelines.
• 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 with governing quality system requirements.
• Prioritize post-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 in biologics manufacturing with a focus on sterile drug product and late-phase development.
• Proven track record in BLA preparation PPQ and commercial launch.
• Strong knowledge of regulatory expectations (FDA EMA) for biologics and sterile drug product(s).
• A strong team player and promotor of inclusion and collaboration
• Able to handle multiple projects simultaneously while maintaining high-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 $190000.00 - $230000 annually. 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 stock benefits and/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/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.