Senior CMC Project Manager (Biologics)
About The Position
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 eg 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 The Senior CMC Project Manager Biologics is an individual contributor position that will play a critical role driving the success of Summit programs and with prioritized focus in CMC Supply Quality and Business activities This role requires a strong technical foundation in analytical development drug product manufacturing process validation PPQ and supply chain strategy as well as proven experience managing external CDMOs and internal stakeholders in a matrixed environment Role requires flexible execution focused capabilities with the ability to take on additional responsibilities as the departmentcompany grow If you enjoy the excitement and intensity of senior leader engagements where assignments may deeply embed you with targeted functions or teams then this is the role for you
Requirements
- Bachelors degree in life sciences chemistry engineering or related field required; advanced degree MS PharmD PhD MBA desirable
- 8 years in pharmaceuticalbiotech industry with substantial experience in CMC development late stage biologics and regulatory filing preparation BLA MAA
- Proven success leading global matrixed cross functional teams in a regulated environment
- Strong skills in integrated project planning PMP certified risk management resource allocation and budget oversight
- Experience with tools like Smartsheet MS Project Power BI Office Timeline etc is beneficial
- Prior pharmaceutical drug development experience required late stage to commercialization phase experience and biologics preferred
- Proficient user of MS Office suite eg PowerPoint Word Excel Project experience using electronic document management systems document review tools and can quickly build presentations for leadersteams
- Excellent communicator in public speaking meeting facilitation and email communication
- Ability to excel in a fast paced demanding and diverse environment
Nice To Haves
- Prior oncology experience in late stage development and understanding of GMP manufacturing and global regulatory supply chains preferred
- Professional proficiency in Mandarin strongly preferred to facilitate communication with overseas collaborators
Responsibilities
- Cross functional Collaboration and CMC Leadership Orchestrate CMC matrix teams PD AD DP MSAT QAQC RA CMC Supply Chain across functions to deliver integrated project plans timelines and ensure milestone achievement
- Build and maintain critical path roadmaps scenarios and resourceload views; ensure robust change control and decision logs
- Prepare high impact presentations decision memos and status reports for senior management and governance forums
- Can quickly build strong and sustaining relationships with stakeholders at all levels
- Translate technical CMC topics into clear business impacts and options; enable fast informed decisions
- Implement and refine program tools workflows and processes to enhance efficiency transparency and quality of CMC operations
- Ensure alignment of CMC strategy for early stage INDIMPD and late stage biologics suitable for BLA MAA filings including characterization control strategy comparability stability regulatory expectations
- Ensure alignment of CMC deliverables with program milestones and product target profile through data driven and risk based decision making
- Engage in cross functional governance and steering committees to influence and guide program direction
- Drive development execution and oversight of CMC strategies including analytical method development and validation drug substance and drug product process development technology transfer and process performance qualification PPQ
- Actively identify track and mitigate risks to include opportunity creation that may accelerate project success
- Develop implement and maintain CMC plans for assigned activities to include scenario planning dashboards reports and timelines that integrate into overall Project Plans
- Communicate CMC plans to cross functional team and leadership
- Lead assigned internal and external communications outputs CDMOCMO Oversight & External Network Management
- Serve as the primary CMC Quality PM interface for CDMOsCMOs performing drug substance drug product and analytical testing
- Monitor CDMO performance against KPIs batch planning and release deviation closure CAPA effectiveness and escalate risks proactively
- Drive method transfer tech transfer and validation activities at CDMOs to meet regulatory and project timelines
- Support audit readiness and participate in vendor audits as needed
- Limited travel may be required depending on assigned activities or projects plus flexibility for global virtual meetings in different time zones
- Ability to travel globally may be needed including EU and meeting Chinese Visa requirements
- All other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
