Manager, Downstream MSAT
Manager, Downstream MSAT
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$ 120000 - 140000
1 Vacancy
Job Description
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:
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. Bachelors degree in chemical engineering biotechnology pharmaceutical science or a related field with 8 years of relevant experience; Masters 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.
The pay range for this role is $120000-$140000 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:
Manager
Employment Type
Full-Time
