Summit Therapeutics
Senior Manager, Analytical Sciences
Princeton, NJ · Senior
Sponsorship not specified$148k-$188kDetected 3 days ago
Product ManagementProject ManagementStakeholder ManagementRecruitingClinical TrialsFDA RegulatoryScientific WritingAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs
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odds of building a lasting career here
59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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Files H-1B transfers
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About the role
- This role is responsible for advancing robust analytical strategies, overseeing method development, validation, and transfer, and contributing to product characterization, comparability assessments, and regulatory submissions.
Responsibilities
- Lead analytical method development, qualification, validation, and transfer activities for biologic drug substances and drug products.
- Design and oversee extended product characterization studies to establish a comprehensive understanding of product quality attributes.
- Develop analytical strategies and execute comparability assessments supporting process changes, manufacturing changes, formulation changes, technology transfers, and product lifecycle activities.
- Manage contract laboratories, contract development and manufacturing organizations, and other external partners, including defining scope, monitoring timelines and deliverables, reviewing technical work, and resolving issues.
- Partner cross-functionally with Process Development, Formulation, Manufacturing, Quality, Regulatory Affairs, and other CMC functions to deliver integrated development plans.
- The Senior Manager, Analytical Sciences will provide scientific and technical leadership for analytical activities supporting biologic products from clinical development through post-approval support.
- Strong knowledge of relevant ICH guidelines and regulatory expectations for biologics from preclinical development through post-approval support.
- Proven experience managing external laboratories, vendors, or development and manufacturing partners.
- Ability and willingness to work outside standard business hours when needed to support critical activities and global business needs.
- Ability and willingness to travel for business, including visits to external partners and manufacturing or laboratory sites.
Requirements
- Minimum of 5 years of relevant experience in the biotechnology, biopharmaceutical, or pharmaceutical industry.
- Demonstrated experience with analytical method development, validation, and transfer for biologics.
- Experience with extended product characterization and comparability assessments for biologic products.
- 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.
- Bachelor's degree in analytical chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or a related scientific discipline; an advanced degree is preferred.
Nice to have
- an advanced degree is preferred.
- Bachelor's degree in analytical chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or a related scientific discipline
Compensation
- $148,000 - $188,000 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.
- The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Benefits
- Author and critically review analytical sections of regulatory submissions and responses to health authority questions.
- Demonstrate a flexible, collaborative, and can-do attitude while responding effectively to changing priorities and business needs.
Company info
- Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Equal opportunity
- Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.
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This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.