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- Tasks: Lead downstream process development and ensure smooth tech transfers in a dynamic biotech environment.
- Company: Join Summit Therapeutics, a pioneering company focused on innovative cancer therapies.
- Benefits: Enjoy a collaborative culture, opportunities for growth, and the chance to impact patient lives.
- Why this job: Be part of groundbreaking clinical trials and contribute to life-changing therapies.
- Qualifications: Degree in relevant fields with significant experience in biologics and process development required.
- Other info: Remote work options may be available; travel required for tech transfers.
The predicted salary is between 60000 - 84000 £ per year.
Career Opportunities with Summit Therapeutics Sub, Inc.
A great place to work.
Careers At Summit Therapeutics Sub, Inc.
Current job opportunities are posted here as they become available.
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, Downstream 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 downstream 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 downstream-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 downstream processes and technical troubleshooting to support drug substance (DS) and product (DP) development, control strategies, specifications, etc.
Support phase-appropriate downstream process development, characterization, validation, and technology transfers to or between external CDMOs for drug substance (DS)
Assist in planning and execution of downstream 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 downstream 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 downstream 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:
Degree in chemical engineering, biotechnology, pharmaceutical science, or a related field. 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 systems (e.g. Deta V, Unicorn) and demonstrated proficiency in all downstream-related (development and scale-up) operations, including but not limited to Protein A and Ion-Exchange Chromatography, Virus Filtration, UF/ DF.
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, Downstream MSAT employer: Summit Therapeutics Sub, Inc.
Contact Detail:
Summit Therapeutics Sub, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Downstream MSAT
✨Tip Number 1
Familiarise yourself with the latest advancements in biologics and downstream processing. Understanding the nuances of technologies like Protein A and Ion-Exchange Chromatography will give you an edge during discussions with our team.
✨Tip Number 2
Network with professionals in the field of MSAT and biologics. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends, which can be beneficial when discussing your insights during interviews.
✨Tip Number 3
Prepare to discuss your experience with technology transfer and process scale-up. Be ready to share specific examples of challenges you've faced and how you overcame them, as this is crucial for the role at Summit.
✨Tip Number 4
Showcase your problem-solving skills by preparing case studies or scenarios related to downstream processes. This will demonstrate your analytical thinking and ability to handle real-world challenges that may arise in the role.
We think you need these skills to ace Manager, Downstream MSAT
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in downstream process development and MSAT. Use specific examples from your past roles that demonstrate your technical skills and achievements related to biologics production.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role at Summit Therapeutics. Mention how your background aligns with their focus on Ivonescimab and the importance of collaboration in drug development.
Highlight Relevant Skills: In your application, emphasise your experience with technologies like Deta V and Unicorn, as well as your proficiency in downstream operations such as Protein A and Ion-Exchange Chromatography. This will show that you have the technical expertise they are looking for.
Showcase Problem-Solving Abilities: Include examples of how you've successfully managed process risks or resolved issues during downstream processing in your previous roles. This will demonstrate your capability to drive continuous improvement and handle challenges effectively.
How to prepare for a job interview at Summit Therapeutics Sub, Inc.
✨Know Your Technical Stuff
Make sure you brush up on your knowledge of downstream processes and the specific technologies mentioned in the job description, like Protein A and Ion-Exchange Chromatography. Being able to discuss these topics confidently will show that you're well-prepared and knowledgeable.
✨Demonstrate Problem-Solving Skills
Prepare examples of how you've tackled challenges in previous roles, especially related to process development or technology transfer. This will highlight your ability to think critically and adapt in a fast-paced environment.
✨Build Rapport with Interviewers
Since this role involves collaboration with various teams, focus on building a connection with your interviewers. Show enthusiasm for teamwork and share experiences where you've successfully worked with cross-functional teams or external partners.
✨Ask Insightful Questions
Prepare thoughtful questions about Summit's current projects, particularly regarding ivonescimab and its clinical trials. This demonstrates your genuine interest in the company and the role, as well as your proactive approach to understanding their goals.
