Senior Manager, Analytical Sciences

Senior Manager, Analytical Sciences Location: Princeton, New Jersey Position Summary The Senior Manager, Analytical Sciences will provide scientific and technical leadership for analytical activities supporting biologic products from clinical development through post-approval support. 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. The successful candidate will combine strong technical expertise with effective external partner management, sound judgment, and a flexible, hands-on approach in a dynamic development environment. Key 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. • Author and critically review analytical sections of regulatory submissions and responses to health authority questions. • Ensure analytical programs align with relevant ICH guidelines and global regulatory expectations across preclinical, clinical, registration, and post-approval stages. • Provide scientific interpretation of analytical data, identify risks, and recommend practical, phase-appropriate solutions. • 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. • Contribute to continuous improvement of analytical capabilities, technical standards, workflows, and documentation practices. • Demonstrate a flexible, collaborative, and can-do attitude while responding effectively to changing priorities and business needs. Required Qualifications • Bachelor's degree in analytical chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or a related scientific discipline; an advanced degree is preferred. • 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. • 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. Work Expectations • This position is based at the company's Princeton, New Jersey site. • 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. This is the pay for this position Pay Transparency $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. 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 [redacted] to obtain prior written authorization before referring any candidates to Summit.