Summit Therapeutics

Senior Principal Engineer/Associate Director, Drug Product MSAT

Princeton, NJ · Director

Sponsorship not specified$180k-$195kDetected 58 days ago

Data AnalysisProduct ManagementSupply ChainRecruitingClinical TrialsGMPCommunicationCollaborationOrganizational Skills

About the role

The ideal candidate will bring significant experience in biologics manufacturing, sterile drug product operations, and regulatory expectations.

Assess and manage process risks arising from manufacturing or process changes.
Lead or significantly contribute to implementation of process, product, and site changes across the product lifecycle.
Support and guide execution of clinical and commercial batch manufacturing activities to meet development and supply timelines.
Collaborate closely with Regulatory, Quality, Supply Chain, and other CMC functions to ensure integrated planning and execution.
Support audits, inspections, and continuous improvement initiatives.
Manage process deviation investigations and change controls.
Travel as needed to support technology transfer, process scale-up, and collaboration with external partners.
Lead PPQ execution and manufacturing oversight in alignment with GMP and quality system requirements through person in plant.

Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Minimum of 10+ years of relevant experience within the life sciences industry
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
IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution highly preferred
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
A track record of working under pressure and delivering high-quality results to tight deadlines.
This is the pay for this position
Pay Transparency
$180,000 - $195,000 USD

$180,000 - $195,000 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 recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Experience, Education and Specialized Knowledge and
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.
Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.

This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.