Senior Manager, Analytical Sciences (Biopharma)

Location: Princeton, New Jersey; based at the company’s Princeton site. Requires willingness to work outside standard business hours when needed and travel to external partner, manufacturing, and laboratory sites.

Salary: $148,000–$188,000 USD annually, with potential bonus, stock, benefits, and other variable compensation.

Company

hirify.global is a biopharmaceutical oncology company developing investigational therapies and conducting global Phase 3 clinical studies in non-small cell lung cancer and colorectal cancer.

What you will do

• Lead analytical method development, qualification, validation, and transfer for biologic drug substances and drug products.
• Design and oversee extended product characterization studies and develop analytical strategies for comparability assessments related to process, manufacturing, formulation, technology transfer, and lifecycle changes.
• Author and critically review analytical sections of regulatory submissions and responses to health authority questions.
• Align analytical programs with ICH guidelines and global regulatory expectations across preclinical, clinical, registration, and post-approval stages.
• Interpret analytical data, identify risks, and recommend phase-appropriate solutions.
• Manage contract laboratories, contract development and manufacturing organizations, and other external partners while collaborating with Process Development, Formulation, Manufacturing, Quality, Regulatory Affairs, and other CMC functions.

Requirements

• Bachelor’s degree in analytical chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or a related scientific discipline.
• At least 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.
• Hands-on experience authoring and reviewing analytical content for regulatory submissions.
• 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.
• Strong scientific writing, data interpretation, problem-solving, project management, and stakeholder communication skills.
• Ability and willingness to work outside standard business hours when needed and travel for business.

Nice to have

• Advanced degree in a relevant scientific discipline.

Culture & Benefits

• Collaborative, flexible, hands-on work environment focused on integrity, excellence, purposeful urgency, and commitment to people.
• Opportunity to support oncology clinical development and serious unmet medical needs.
• Compensation may include bonus, stock, benefits, and other applicable variable compensation.
• Equal opportunity workplace committed to maintaining a diverse environment.