About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Skills: Downstream Process Development, Process Validation, Technology Transfer, Control Strategy Development, CMC
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$148k–$175k/yr
Full-time
bachelor degree, postgraduate degree
Bonus, Stock, Benefits
Posted 46d ago
~40 hrs/week
Responsibilities
Provide operational and technical oversight for all downstream-related activities to support drug substance production and achieve company milestones. This includes managing CDMO relationships, driving continuous process improvement, and overseeing technology transfers from development to manufacturing.
Requirements
Requires a degree in chemical engineering, biotechnology, or pharmaceutical science with 3 to 8+ years of experience depending on the degree level. Proven expertise in downstream biologics manufacturing, specifically with mAbs and various chromatography systems, is essential.
Full job description
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Location: Princeton, NJ (ONSITE)
Overview of Role:
The Sr Manager/Assoc Director, MSAT, is an experienced and enthusiastic process development scientist or engineer who will join a dynamic late-stage clinical and commercial environment working with our lead asset, Ivonescimab. The ideal candidate will have proven technical ability, commercial control strategy authorship, and module 3 BLA/MAA authorship experience specifically supporting biologics drug substance. The role involves working with the Summit MSAT group and other CMC, quality, and regulatory stakeholders in drug substance to provide operational, strategic, and technical oversight on predominantly downstream-related activities across the organization 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 Downstream CMC activities, focusing on control strategy development, process validation, continued process verification, and technical troubleshooting to support drug substance and product (as needed)
Support phase-appropriate downstream process development, characterization, validation, and technology transfers to or between external CDMOs for drug substance (DS).
Contribute significant strategic direction and authorship of regulatory documents including clinical IND/IMPD and commercial BLA/MAA
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).
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.
Manage process deviation investigations and change controls.
Travel as needed to support technology transfer, process scale-up, and collaboration with external partners.
Perform all other duties as assigned.
Educational Background:
Degree in chemical engineering, biotechnology, pharmaceutical science, or a related field. Bachelor’s degree with 12+ years of relevant experience; Master’s degree with 10+ years of relevant experience; PhD with 8+ years of relevant experience.
Professional Experience:
Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturing in a biological environment (preferably mAbs) is essential. IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution is critical
Experience with health authority inspection and information request responses highly desired
Proven technical knowledge in various systems (e.g. Unicorn, Delta V, etc) and demonstrated proficiency in all downstream-related operations, including but not limited to Affinity (Protein A), Ion Exchange, Mixed-Mode, and Hydrophobic Interaction Chromatography, Virus Filtration, and Ultrafiltration / Diafiltration
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
Skills and Competencies:
Data Analytics experience including JMP and other data organization (AI-based or not) platforms a strong plus
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.
This is the pay for this position
Pay Transparency
$148,000—$185,000 USD
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 Summit’s Talent Acquisition team at [email protected] to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Related keywords
MSATDownstream ProcessingBiologicsmAbsIvonescimabCMCCDMOBLAMAAINDIMPDContinuous Process VerificationUnicornDelta VProtein AIon Exchange
Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
Industry
Biotechnology Research
Company size
201-500 employees
Founded
2003
Headquarters
Miami, Florida
LinkedIn followers
58,485
Total funding
$1.8B
Summit Mission Statement:
To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate.
We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders.
Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Oxford, UK, and Dublin, Ireland.
Offices: 601 Brickell Key Dr, Suite 1000, Miami, Florida 33131, US · 1000 Page Mill Rd, Palo Alto, California 94304, US · 136a Eastern Avenue, Milton Park, Abingdon, Oxfordshire OX14 4SB, GB · 502 Carnegie Center, Suite 102, Princeton, New Jersey 08540, US · 5 Harcourt Road, Dublin, D02 FW64, IE
OncologyClinical Trialsand Health CareHealth CareMedical DeviceBiotechnologyTherapeutics
Based on 425 listings with disclosed salaries, most healthcare jobs in Princeton, NJ pay between $80k–$238k per year. Individual offers vary with seniority, company size, and specialization.
How many Healthcare jobs are open in Princeton, NJ right now?
There are currently 504 open healthcare positions in Princeton, NJ listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Princeton, NJ?
Companies currently hiring include Bristol Myers Squibb, Otsuka Pharmaceutical Companies (U.S.), Akin Care Senior Services, Integra LifeSciences, Kardigan, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Princeton, NJ?
Yes — 271 of the 504 open healthcare positions offer remote or hybrid work (25 remote, 246 hybrid).
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