Asst. Manager _ADL

Role Purpose
 The role holder needs help build a stability program around the specific requirements of the product,
and can manage every aspect of the stability program at Vapi.
 This role involves managing a team, ensuring the implementation of analytical methods, and
contributing to the development and optimization of pharmaceutical products

Details Supporting Actions
Key Responsibilities  Analytical Method Development: Lead and oversee the development
and validation of analytical methods for drug substances and drug
products
 Collaborate with cross-functional teams to ensure alignment with
project goals
 Team Management: Manage a team of analytical scientists and
technicians
 Provide guidance, mentorship, and training to ensure a high level of
technical expertise
 Instrumentation and Techniques: Evaluate, select, and implement
appropriate analytical instrumentation and techniques
 Stay updated on advancements in analytical technologies
 Project Coordination: Coordinate analytical activities within drug
development projects
 Ensure timelines and milestones are met, collaborating with other
departments
 Quality Control and Assurance: Implement and maintain quality control
measures for analytical processes
 Ensure compliance with regulatory requirements and industry
standards
 Data Analysis and Reporting: Oversee data analysis and interpretation
of analytical results
 Prepare and review analytical reports for internal and regulatory
purposes
 Collaboration:Collaborate with formulation development,
manufacturing, and regulatory affairs teams
 Provide analytical support to troubleshoot and resolve issues
 Continuous Improvement:Identify opportunities for process
improvement and optimization

Job Description

 Implement best practices in analytical development
 Regulatory Compliance:Ensure that analytical methods and processes
comply with regulatory guidelines
 Participate in regulatory submissions and interactions
 Training and Development:Conduct training sessions for the analytical
team
 Support the professional development of team members

Qualification
and
Experiences

a. Bachelor / Masters in Science (Chemistry) ) with minimum 8-13
years of relevant experience in manufacturing API business
b. Added qualification in ADIS (Advance Diploma in Industrial safety)
is desirable.
c. Familiarity with the regulatory landscape related to pharmaceutical
R&D with a focus on process improvement and cost reduction .
Competencies / Skills a. Strong Analytical Method Validation and Development skills

b. Regulatory Affairs knowledge
c. Ability to work under pressure to meet specific timelines & targets
d. Well versed with industry specific products and its application
e. High Emotional Quotient
f. Strong communication and collaboration skill