Manager/Sr. Manager, Analytical Method Development - Radiopharmaceuticals

The Manager/Sr. Manager, Analytical Method Development for Radiopharmaceuticals, is responsible for the development, optimization, validation, and transfer of analytical methods supporting radiopharmaceutical products across early- and late-stage development. This role requires strong technical expertise in analytical chemistry and a solid understanding of the unique challenges associated with radiopharmaceuticals, including short half-life materials, radioactive impurities, and time-critical testing. The position sits within CMC organization and works closely with Quality, Manufacturing, and external partners to ensure robust, compliant, and transferable analytical methods.

Responsibilities Analytical Method Development

• Working with CDMOs, develop, optimize, and qualify analytical methods to support radiopharmaceutical drug substance and drug product development
• Design methods suitable for radioactive materials, accounting for decay, sensitivity, speed, and radiation safety considerations
• Apply a range of analytical techniques, including but not limited to HPLC/UPLC, radio-HPLC, GC, TLC, radio-TLC, spectroscopy, and wet chemistry methods

Method Validation & Transfer

• Author and execute method qualification, validation, and verification protocols in accordance with ICH and regulatory expectations
• Lead or support analytical method transfer to internal QC laboratories, CDMOs, and external testing sites
• Troubleshoot method performance issues during transfer and routine testing, ensuring method robustness and reproducibility

Radiopharmaceutical-Specific Testing

• Support testing of precursors and radiolabeled finished drug products, including identity, purity, potency, and impurity profiling
• Collaborate with Radiation Safety Officers (RSO) to ensure compliant handling and testing of radioactive materials
• Develop rapid and fit-for-purpose methods suitable for short half-life products and just-in-time manufacturing models

Documentation & Regulatory Support

• Prepare and review technical reports, method SOPs, validation reports, and specifications
• Contribute to CMC sections of regulatory submissions (IND, CTA, IMPD, NDA/BLA) related to analytical methods
• Support regulatory interactions, audits, and inspections by providing analytical expertise and documentation

Cross-Functional Collaboration & Continuous Improvement

• Partner with CMC, Process Development, Manufacturing, Quality, and Clinical teams to align analytical strategies with development timelines
• Support investigation of OOS/OOT results and implement corrective actions as needed
• Drive continuous improvement initiatives in analytical efficiency, data integrity, and method lifecycle management

Required Qualifications

• Bachelor’s degree in Chemistry, Biology, Life Sciences, or a related discipline
• Minimum of 7 years of experience in the pharmaceutical or biotechnology industry
• 2–3 years of direct experience working with radiopharmaceutical products
• Strong hands-on experience in analytical method development and characterization
• Demonstrated experience with analytical method transfer to internal or external laboratories

Preferred

• Advanced degree (Master’s or Ph.D.) in Chemistry, Pharmaceutical Sciences, or a related field
• Experience supporting regulatory submissions involving radiopharmaceuticals
• Familiarity with GMP environments and data integrity requirements (e.g., ALCOA+)

Key Competencies

• Strong analytical and problem-solving skills with attention to detail
• Ability to work effectively in fast-paced, time-sensitive environments
• Excellent technical writing and documentation skills
• Strong collaboration and communication skills across cross-functional teams
• Commitment to quality, compliance, and scientific rigor

Compensation & Benefits The anticipated salary range for this position is $120,000 to $140,000. Actual compensation may vary based on factors including experience, qualifications, skills, and business needs.

In addition to base salary, SK Life Science offers a competitive benefits package, including a 401(k) plan with company match and medical, dental, and vision coverage. Benefits are subject to eligibility requirements and may be modified at the Company's discretion.