Job Description

About our client:
Our client is an American multinational healthcare company. For over a century now, they have delivered on their commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world. At the intersection of progress and purpose, they are redefining what it means to be a global medtech leader. Their forward-looking leadership team is a driving force in ensuring we meet the needs of all our stakeholders--every day and everywhere. They strive to create lasting value by empowering their patients, protecting the planet, and championing people and communities.
Role Description:

• The Manager -ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.
• This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.

Responsibilities

• Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.
• Troubleshoot and resolve challenges during method validation and method transfer of new products from R&D to manufacturing sites.
• Support regulatory filings and respond to analytical function queries.
• Ensure compliance with cGLP within the ADL GMP function.
• Provide support during quality inspections by regulatory agencies at manufacturing plants.
• Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.
• Ensure timely compliance with Pharmacopoeia updates.
• Mentor, coach, and develop team members for task execution and personal growth.
• Collaborate with external partners (CRO/CMO) for analytical testing execution.
• Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.

Requirements:

• Education: Ph.D. OR MPharm.
• Experience: 3-4 years of team handling experience.

Skills Required:

• Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.
• Sound understanding of analytical techniques with good learning agility.
• Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.
• Strong coordination, relationship management, and ability to work in multicultural teams.
• Effective communication and team management skills.
• Knowledge of latest quality and regulatory requirements.
• Ability to delegate effectively and take autonomous decisions.
• Critical thinking skills for problem-solving and decision making.

Skills Required