Pulivarthi Group (PG) Healthcare Staffing · 3 months ago
Senior Principal Scientist – Analyst
Delaware City, DE
Full-time
Onsite
Senior Level, Lead/StaffPulivarthi Group is a premier global provider of staffing and IT technology solutions, renowned for delivering exceptional services tailored to each client's unique needs. They are seeking a highly experienced and visionary Senior Principal Scientist – Analyst to lead analytical development and method validation activities for large-molecule biopharmaceutical products, ensuring compliance with regulatory requirements and organizational standards.
Artificial Intelligence (AI)Data ManagementInformation TechnologyRobotic Process Automation (RPA)Robotics
Responsibilities
Develop, validate, and transfer analytical methods supporting animal drug applications for a broad range of biotherapeutic products
Lead analytical activities from preclinical development through clinical supplies, registration studies, and commercial launch
Apply in-depth knowledge of regulations to design analytical strategies supporting new product development
Anticipate project needs and ensure analytical method development aligns with timelines and registration goals
Provide technical leadership in analytical method development related to formulation, manufacturing, packaging, and stability studies (including VICH compliance)
Maintain awareness of technological advances and incorporate innovations into development strategies
Develop and oversee Chemistry, Manufacturing and Control (CMC) project plans, ensuring deliverables meet program needs and timelines
Communicate resource requirements, project progress, and risks to stakeholders and project leads
Evaluate the viability of analytical strategies and define mitigation plans
Author and critically review technical protocols, reports, batch records, and regulatory filings (CMC sections, responses to deficiencies, CLOQs)
Collaborate with CROs, CDMOs, patent advisors, and external scientific experts to drive innovation and compliance
Provide technical support during product handover and launch
Lead cross-functional project teams to ensure alignment and successful product registration and launch
Coordinate CMC activities with other work streams (clinical, safety, efficacy, labeling)
Inspire and guide team members, tailoring support to individual and project needs
Manage timelines, budgets, and scope, escalating issues when necessary
Prepare and implement research and development plans, status reports, and cost analyses
Present updates to senior executives regarding timelines, costs, and risks
Work closely with Regulatory Affairs to support interactions with agencies such as FDA, EMA, and USDA
Qualification
Required
Bachelor's, Master's, or Ph.D. in Chemistry, Pharmaceutical Sciences, Biotechnology, Protein Chemistry, or a related field
Pharmaceutical product development experience with increasing leadership responsibilities
Proven track record in developing and transferring analytical assays for large-molecule biopharmaceuticals
In-depth knowledge of method validation, stability testing, and regulatory compliance
Strong organizational and problem-solving skills
Demonstrated ability to lead teams and manage complex projects across multiple stakeholders
Proven leadership in analytical method development, validation, and transfer for biopharmaceutical products
Deep understanding of biopharmaceutical products including antibodies, proteins, and fusion molecules
Knowledge of regulatory requirements (FDA, EMA, USDA, VICH/ICH) and CMC project management
Ability to develop and execute complex project plans, ensuring alignment with organizational and regulatory goals
Strong communication and collaboration skills across multidisciplinary teams
Preferred
Experience working with CROs, CDMOs, and external scientific partners
Familiarity with stability testing, process validation, and quality assurance
Exposure to patent strategy and intellectual property considerations
Ability to anticipate and mitigate technical and regulatory risks
Benefits
Competitive executive-level compensation package.
Comprehensive health, dental, and vision benefits.
Paid time off, holidays, and sick leave.
Opportunities for professional development, conferences, and leadership training.
Collaborative environment with exposure to cutting-edge biopharmaceutical projects.
Occasional domestic and international travel opportunities.
Company
Pulivarthi Group (PG) Healthcare Staffing
Pulivarthi Group | Experts in Permanent & Specialized Staffing for Healthcare Welcome to Pulivarthi Group, your strategic staffing and recruiting partner across the United States and Canada.
Founded in 2017
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase