Senior Associate – Technology Transfer
ROLE OVERVIEW
Pfizer's Vizag site is one of the company's flagship manufacturing and technology-transfer hubs, supplying sterile and solid oral products to regulated markets worldwide. The Senior Associate – Technology Transfer position sits at the intersection of technical operations, validation science and regulatory compliance, making it one of the most consequential roles in the product lifecycle: nothing moves from development to commercial scale without it. You will own the transfer of new molecules from R&D into commercial manufacturing, design and execute exhibit batches, defend process validation packages during US FDA and multi-market inspections, and troubleshoot deviations that could otherwise delay launch. For a pharma professional with 2–5 years of experience, this is a rare chance to build a global transfer portfolio with a top-tier innovator, gaining exposure to steriles, medical devices and advanced quality systems.
ROLE DEFINITION & RESPONSIBILITIES
- •Execute end-to-end technology transfers of new molecules from R&D into commercial manufacturing, covering scale-up strategy, process design and engineering batch planning.
- •Design, monitor and evaluate developmental exhibit batches, documenting critical process parameters to establish proven acceptable ranges.
- •Author, review and approve validation master plans, protocols, reports and technical documents in line with Pfizer Quality Standards and ICH expectations.
- •Perform statistical analysis of batch results and process anomalies, translating data trends into corrective actions and Quality Investigation support.
- •Troubleshoot equipment, utility and process performance validation issues, coordinating resolution with engineering and manufacturing teams.
- •Manage routine quality systems — change control, quality agreements, documentation and deviation investigations — with full data-integrity compliance.
- •Maintain the Site Validation Master Plan and represent engineering validation during regulatory audits and network-level transfer forums.
- •Support cleaning validation, cost improvement projects and regulatory query responses, integrating validation schedules into live production plans.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- BA/BS in Pharmacy, Chemical Engineering, Biotechnology or a related science with 2+ years of relevant experience; MS/MBA candidates with transferable validation exposure are also considered.
- Demonstrated experience in technology transfer scale-ups, exhibit batch execution and process validation inside a GMP-regulated pharmaceutical plant.
- Working knowledge of multi-market FDA regulations, including US FDA, EU GMP and other international submission requirements.
- Proven expertise in Good Manufacturing Practices and applied understanding of quality systems such as change control and investigations.
- Familiarity with electronic systems including Global Document Management Systems, SAP and quality tracking platforms.
- Excellent written and verbal communication skills, with the ability to work independently and within cross-functional teams.
PREFERRED QUALIFICATIONS
- •Sterile products and medical device manufacturing knowledge
- •Experience hosting US FDA and international regulatory audits
- •Mentoring and coaching junior validation associates
- •Generative AI tools (ChatGPT, Microsoft Copilot) for problem solving and productivity
- •Responsible AI practices, risk management and ethical use awareness
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation. It is dedicated to the discovery, development, manufacturing, marketing, and sale of medicines and vaccines worldwide. The company focuses on breakthrough science to deliver innovative treatments across various therapeutic areas to improve health outcomes.
EXPECTED CAREER ROADMAP
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