Director, Drug Product, Technical Operations (Princeton, NJ or Oxford, UK )
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Job Location:
Princeton, NJ - USA
Yearly Salary:
$ 184000 - 230000
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Location: Princeton NJ or Oxford UK onsite
About Summit:
Ivonescimab known as SMT112 is a novel potential first-in-class investigational
bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.
Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC) with three active Phase III trials:
HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g. osimertinib).
HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.
Overview of Role:
We are seeking a highly experienced and strategic Director of Drug Product Technical Operations to lead late-phase clinical and commercial manufacturing activities for our bispecific antibody sterile drug product. This role is critical in supporting BLA readiness overseeing clinical/commercial batch production and driving process and site changes in collaboration with MSAT. The ideal candidate will bring deep expertise in biologics manufacturing sterile drug product operations and regulatory expectations.
Role and Responsibilities:
Partner with MSAT to implement product process and site changes ensuring robust technical oversight and documentation.
Lead end-to-end manufacturing operations for sterile drug product including oversight of CMOs and internal teams.
Ensure successful execution of clinical batch manufacturing in alignment with development timelines and quality standards.
Drive readiness for BLA filing and commercial launch including validation and PPQ strategy.
Ensure successful execution of commercial batch manufacturing in alignment with supply plan and quality standards.
Lead investigations and root cause analyses for manufacturing deviations and implement corrective actions.
Develop and execute manufacturing strategies aligned with program milestones and regulatory requirements.
Collaborate cross-functionally with Regulatory Quality Supply Chain and CMC teams to ensure integrated planning and execution.
Manage budgets timelines and resources for manufacturing operations.
Ensure GMP compliance across all manufacturing activities.
Support audits and inspections.
Maintain strong documentation practices and contribute to regulatory submissions.
All other duties as assigned
Experience Education and Specialized Knowledge and Skills:
Bachelors degree in Engineering Biochemistry Pharmaceutical Sciences or related field; PhD or MS preferred.
Minimum of 12 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.
Experience managing external manufacturing partners and internal cross-functional teams.
Excellent leadership communication and project management skills.
The pay range for this role is $184000-$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.
Required Experience:
Director
Key Skills
- Employee Relations
- Employee Evaluation
- Management Experience
- Profit & Loss
- Conflict Management
- Operations Management
- Project Management
- Budgeting
- Leadership Experience
- Supervising Experience
- Leadership management
- Financial Planning
About Company
Summit is committed to leadership in resolving serious, unmet medical needs in oncology for the betterment of overall HUMAN HEALTH. Stifel Fireside Chat Patients & Caregivers Summit Latest News Committed to Optimizing Human Health Summit Therapeutics Inc. is a biopharmaceutical oncolo ... View more
