About this opportunity
SK Life Science lists this Manager/Sr. Manager, Analytical Method Development - Radiopharmaceuticals opportunity in paramus, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Manager/Sr. Manager, Analytical Method Development - Radiopharmaceuticals
Job Locations
US-NJ-Paramus
ID
Category
CMC
Type
Regular Full-Time
Overview
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
Qualifications
Required
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.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.