• Provide strategic and scientific guidance on integrating new Biologics drug product-related technologies (such as new delivery technologies, new formulation approaches, and new development approaches, e.g., modeling approaches) into CMC projects in collaboration with key stakeholders. 

• Promote a comprehensive approach to drug product development that focuses on the needs of patients and payers while integrating new technologies (pharmaceutical / in-silico) in line with Health Authorities expectations.  

• Engage in industry consortia to shape regulatory environment and influence Health Authorities. 

• Liaise with key stakeholders, including Biomedical Research, Global Program Teams, Devices and Primary Packaging, Regulatory CMC, Quality, and Commercial Manufacturing sites, to encourage them to integrate new technologies into our Biologics product while ensuring their needs for a patient-centric product are met. 

• Support / drive interactions with health authorities through participation on briefing packages 

• Proactively identify, lead/propose solution-oriented plans to resolve scientific drug product development challenges/barriers.  

• Lead innovation programs as needed  

Minimum requirements 

• 10+ years experience in the biopharmaceutical industry 

• Experience in Biologics development, and specifically DP process development, understanding of drug product manufacturing process operations such as mixing, sterile filtration, and aseptic fill/finish.  

• Experience in DP manufacturing of sterile dosage forms including frozen, liquid, and lyophilized formulations in vials and pre-filled syringes and other presentations 

• Experience in writing regulatory modules including INDs and BLAs 

• Relevant experience of developing and implementing strategies of patient-centered science related work 

• Deep understanding of regulatory guidance from the FDA and EMA for development of biologic drug products, knowledge of USP and Ph. Eur. as it relates to biologics development 

• Learning agility towards new delivery, DP process and other innovative technologies 

• Experience of cross-functional collaboration and leading within a matrix organisation 

• Outstanding influencing skills, leading without authority, excellent presentation and communication skills towards different internal and external stakeholders (senior management, health authorities), outstanding ability to deal with ambiguity, combined with demonstrating strong business acumen 

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.