Job Description

Job Title: Senior Principal Scientist – Analyst

Company Overview:

Pulivarthi Group is a premier global provider of staffing and IT technology solutions, renowned for delivering exceptional services tailored to each client's unique needs. With a steadfast commitment to excellence, we merge expertise with innovation, ensuring cost-effective solutions of the highest quality. Our diverse client base spans healthcare, finance, government, and beyond, reflecting our adaptability and proficiency across industries. Operating in the United States, Canada, and Mexico, we pride ourselves on aligning with clients' cultures, deploying top-tier talent, and utilizing cutting-edge technologies. Pulivarthi Group stands as a beacon of reliability, efficiency, and innovation in the realm of staffing solutions.

Job Overview/Summary:

We are seeking a highly experienced and visionary Senior Principal Scientist – Analyst to lead analytical development and method validation activities for large-molecule biopharmaceutical products. The successful candidate will serve as both an analytical and project leader, ensuring timely development and transfer of analytical methods in compliance with regulatory requirements and organizational standards. This role offers a unique opportunity to guide complex product development projects from preclinical stages through commercial launch, leveraging technical expertise and leadership skills to deliver high-quality results.

Responsibilities:

Analytical Leadership:

• 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.

Project Leadership (as assigned):

• 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.

Primary Skills:

• 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.

Secondary Skills (Good to Have):

• 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.

Qualifications:

• 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.

Benefits/Perks:

• 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.

Equal Opportunity Statement:

Pulivarthi Group is proud to be an equal opportunity employer. We are committed to building a diverse and inclusive culture and celebrate authenticity. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, or any other legally protected characteristics.