Job Title: Senior Expert, Science & Technology (EPM Specialist)
Job ID: REQ-10037171
Location: Hyderabad, India
Company: Novartis Healthcare Private Limited
About the Role:
The Senior Expert, Science & Technology (EPM Specialist) position is integral to the Global Drug Development (GDD) team at Novartis. This role focuses on ensuring the development of high-quality small molecule drug substances required to support clinical trials. You will lead and manage key aspects of externalized process R&D, including managing vendor relationships, data management, and documentation related to the externalized activities.
Key Responsibilities:
Process Improvement: Lead and manage process improvement activities related to externalized process R&D.
Documentation Management: Support workflows and documentation for externalized business processes (non-GMP/GMP).
Data Management: Oversee data compilation, key performance indicators (KPIs), and evaluations with external partners.
Regulatory Support: Contribute to the preparation of CMC documents and regulatory submissions.
External Partner Evaluation: Assist in the selection and onboarding process for new external partners.
Collaboration Management: Actively manage interactions with both internal and external partners to ensure productive collaborations.
Technical Exchange: Participate in scientific/technical discussions with stakeholders and external partners.
GMP Oversight: Supervise GMP activities including deviation handling, change control, and batch record management.
External Manufacturing Support: Ensure timely delivery of drug substances from external manufacturers.
Continuous Improvement: Identify and support continuous improvement initiatives with external partners and internal processes.
Data/Document Flow: Lead the creation and management of SharePoint sites and document flow processes within the EPM unit.
Qualifications:
Education: PhD/MSc in Chemistry, Chemical Engineering, or a related field.
Experience: Minimum of 3 years of experience in the pharmaceutical industry, specifically in chemical development or commercial roles.
GMP Experience: Proven experience in a GMP environment (handling equipment, manufacturing, deviation handling, change control, documentation, etc.).
Technical Expertise: Demonstrated expertise in a specific scientific or technical area.
Language: Fluent in English (oral and written).
Skills:
Strong communication and coordination skills.
Self-driven with a collaborative spirit and high learning agility.
Proficient in data management and software/tools such as Office (Excel, SharePoint, MS Teams), SAP, and planning tools.
A personal inclination toward IT solutions and data management is a plus.
Experience with Six Sigma or Operational Excellence is advantageous.
Familiarity with procurement of API, intermediates, raw materials, and services (management of RFPs and RFIs) is a plus.
Why Novartis?
At Novartis, we are reimagining medicine to improve and extend people’s lives. We believe in the power of people to make a difference. If you are passionate about contributing to groundbreaking science, this is the place to grow. Join us and be part of a dynamic and innovative team.
Purpose: We are dedicated to improving patient lives and making breakthroughs that will change the future of medicine.
Diversity & Inclusion: Novartis fosters a diverse and inclusive work environment, ensuring every team member feels valued and empowered.
How to Apply
If you are interested in this role, apply through the Novartis Career Portal.
Additional Information
Benefits & Rewards: Discover the benefits of working at Novartis here.
Accessibility: Novartis is committed to providing reasonable accommodations for individuals with disabilities during the recruitment process. For assistance, please contact diversityandincl.india@novartis.com.
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