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- Tasks: Lead upstream production processes and ensure smooth drug development at Summit Therapeutics.
- Company: Summit Therapeutics is pioneering innovative therapies for serious diseases, focusing on cutting-edge biologics.
- Benefits: Enjoy a vibrant work culture, competitive salary, and opportunities for professional growth.
- Why this job: Be part of groundbreaking research that could change lives and make a real impact in healthcare.
- Qualifications: Bachelor's degree with 8+ years experience in biotech or related fields; advanced degrees preferred.
- Other info: Join a passionate team dedicated to advancing novel therapies and improving patient outcomes.
The predicted salary is between 36000 - 60000 £ per year.
Join to apply for the Manager, Upstream MSAT role at Summit Therapeutics, Inc.
Join to apply for the Manager, Upstream MSAT role at Summit Therapeutics, Inc.
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.
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 Summit’s 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 Manager, Upstream MSAT, is an enthusiastic process engineer who will work within a vibrant development environment as we approach the commercialization of our lead asset, Ivonescimab. The ideal candidate will have proven technical ability in the upstream production of biologics. The role involves working with the Summit MSAT group and other CMC, quality, and regulatory stakeholders in drug substance and product development to provide operational and technical oversight on all upstream-related activities across the organization and support the supply of required material/information to achieve Summit milestones. This position will require building operational relationships with Summit CDMOs and working in close collaboration internally and externally to ensure successful CMC deliverables.
Role And Responsibilities
- Contribute to and have accountability for all Summit CMC activities, focusing on the design of new or improved upstream processes and technical troubleshooting to support drug substance (DS) and product (DP) development, control strategies, specifications, etc.
- Support phase-appropriate upstream process development, characterization, validation, and technology transfers to or between external CDMOs for drug substance (DS)
- Assist in planning and execution of upstream activities
- Assess and manage process risks arising from manufacturing or process changes
- Develop effective working relationships with Summit project team members and external Contract Manufacturing Organizations (CMOs)
- Assist in the generation, update, and/or review of regulatory filings
- Support MSAT team objectives while providing clear and concise updates of results and reports to the project team leaders, including the Head of CMC
- Work in close partnership with process scientists & engineers, QA, RA, supply chain, consultants, and cross-functionally
- Support CMC sub-teams and programs
- Facilitate problem-solving, contingency planning, and decision-making
- Provide technical support to manufacturing operations, addressing and resolving any issues that arise during upstream processing
- Drive continuous improvement to enhance process robustness, efficiency, and scalability.
- Oversee tech transfer activities to ensure a seamless transition from development to manufacturing
- Perform risk assessments to identify and mitigate potential issues in upstream processes.
- Manage process deviation investigations and change controls
- Travel as needed to support technology transfer, process scale-up, and collaboration with external partners
- All other duties as assigned
Experience, Education And Specialized Knowledge And Skills
- Bachelor’s degree in chemical engineering, biotechnology, pharmaceutical science, or a related field with 8+ years of relevant experience; Master’s degree in chemical engineering, biotechnology, pharmaceutical science, or a related field with 6+ years of relevant experience; PhD in chemical engineering, biotechnology, pharmaceutical science, or a related field with 5+ years of relevant experience.
- Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturing in a biological environment (preferably mAbs)
- Proven technical knowledge in various bioreactor systems (e.g., Ambr15/250, Applikon, Hyperforma, DynaDrive & XDR) and demonstrated proficiency in all upstream-related operations, including but not limited to cell banking, seed expansion, production, harvest, and clarification
- Proven track record with process scale-up and technology transfer, moving from bench scale to pilot and production plant
- Experience with technology transfer across different systems, scales, and sites is highly valued
- Experience in late-stage process development, characterization and validation is highly valued
- Experience in IND and BLA, validation planning, and execution is highly valued
- Experience in commercial lifecycle management (commercial process optimizations, comparability, control charting and process capability)
- Strong communication, management, and interpersonal skills to effectively influence across the organization and with CDMOs/CMOs
- Excellent attention to detail and organizational skills, with a focus on quality and technical excellence
- Good information management and data organization skills
- Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
- A track record of working under pressure and delivering high-quality results to tight deadlines
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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
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Manager, Upstream MSAT employer: Summit Therapeutics, Inc.
Contact Detail:
Summit Therapeutics, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Upstream MSAT
✨Tip Number 1
Familiarise yourself with the latest advancements in upstream bioprocessing, especially related to monoclonal antibodies. Being well-versed in current technologies and methodologies will help you stand out during discussions with the hiring team.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, particularly those who have experience in MSAT roles. Engaging in conversations can provide valuable insights and potentially lead to referrals that could enhance your application.
✨Tip Number 3
Prepare to discuss specific examples of your experience with process scale-up and technology transfer. Highlighting your hands-on experience with bioreactor systems will demonstrate your technical expertise and readiness for the role.
✨Tip Number 4
Showcase your problem-solving skills by preparing to discuss how you've addressed challenges in previous roles. This will illustrate your ability to contribute to continuous improvement and operational excellence at Summit.
We think you need these skills to ace Manager, Upstream MSAT
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in upstream production and process development. Use specific examples that demonstrate your technical skills and achievements in the biotechnology field.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for Summit Therapeutics and the Manager, Upstream MSAT role. Mention how your background aligns with their focus on drug substance and product development.
Highlight Relevant Experience: In your application, emphasise your experience with bioreactor systems and any previous roles involving technology transfer or process scale-up. This will show that you have the hands-on experience needed for the position.
Showcase Soft Skills: Summit values strong communication and interpersonal skills. Include examples of how you've successfully collaborated with cross-functional teams or managed relationships with external partners in your previous roles.
How to prepare for a job interview at Summit Therapeutics, Inc.
✨Know Your Biologics
Make sure you have a solid understanding of biologics, especially in the context of upstream production. Familiarise yourself with the specific processes and technologies mentioned in the job description, such as bioreactor systems and cell banking.
✨Demonstrate Technical Expertise
Be prepared to discuss your technical experience in detail. Highlight any relevant projects you've worked on, particularly those involving process development, scale-up, and technology transfer in a biological environment.
✨Showcase Problem-Solving Skills
Expect questions that assess your ability to troubleshoot and resolve issues during upstream processing. Prepare examples of past challenges you've faced and how you successfully addressed them.
✨Build Relationships
Emphasise your interpersonal skills and ability to work collaboratively with cross-functional teams and external partners. Share experiences where you've built effective working relationships to achieve project goals.
