Biotech Drug Product Manager Job at Novartis, Apply Online
Biotech Drug Product Manager Job at Novartis, Apply Online. Novartis Jobs. Novartis Technical Manager – Drug Product Job. Interested and eligible candidates may check out all the details on the same below:
Possible Interview Questions for the role of Technical Manager – Drug Product at Novartis are posted below
Technical Manager – Drug Product
370465BR
Job Description
28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
Your key responsibilities:
Your responsibilities include, but are not limited to
Your key responsibilities:
- Represent the technical Interface to external suppliers to ensure robust product process capability.
- Responsible for validation oversight at the external supplier.
- Ensure successful and well-documented transfers and launches of products with external manufacturing involvement.
- Assess the impact of technical changes, technical feasibility and scope/design of technical batches.
- Lead or support root cause investigation of product and process failures.
- Contribute to the registration strategy and ensure alignment of (regulatory) timelines. MS&T support for technical development of biopharmaceuticals.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities
we serve.Minimum requirements
What you’ll bring to the role:
- University Degree in Pharmacy, Biotechnology, Chemistry or equivalent.
- Fluent in English, intermediate command of German beneficial.
- Minimum of 5 years in pharmaceutical manufacturing, a solid understanding of biotechnology.
- Demonstrated leadership and accomplishments in a global/matrix environment, strong project management experience and problem-solving skills.
- Technical expertise in manufacturing process science and drug development as well as experience with shipping verification studies.
Why Novartis?
236 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division: Operations
Business Unit: SUPPLY CHAIN
Country: India
Work Location: Hyderabad, AP
Company/Legal Entity: Nov Hltcr Shared Services Ind
Functional Area: Technical Operations
Job Type: Full Time
Employment Type: Regular
Shift Work: No
Early Talent: No
Possible Interview Questions for the role of Technical Manager – Drug Product at Novartis:
- Can you describe your experience in pharmaceutical manufacturing and your understanding of biotechnology? How have you applied this knowledge in your previous roles?
- Answer: In my previous role as a Technical Manager, I have worked in pharmaceutical manufacturing for over five years, gaining a solid understanding of biotechnology. I have successfully managed manufacturing processes and ensured compliance with regulatory requirements. For example, I have overseen the validation of manufacturing processes and led the transfer and launch of products with external manufacturing involvement.
- How do you approach assessing the impact of technical changes and ensuring technical feasibility in the manufacturing process? Can you provide an example?
- Answer: When assessing the impact of technical changes, I consider the potential risks and benefits they may bring to the manufacturing process. I evaluate the feasibility by conducting thorough technical feasibility studies and engaging in cross-functional discussions. An example of this is when we implemented a new manufacturing technology in my previous role. I led a team to assess its impact, conducted risk assessments, and ensured that the process modifications were well-documented and aligned with regulatory requirements.
- Tell us about a time when you faced a product or process failure. How did you lead or support the root cause investigation, and what steps did you take to prevent similar failures in the future?
- Answer: In one instance, we encountered a process failure that resulted in product quality issues. I took the lead in investigating the root cause by gathering relevant data, conducting thorough analyses, and engaging cross-functional teams. We identified the root cause, implemented corrective actions, and developed preventive measures to avoid similar failures. This included enhancing process controls, providing additional training, and implementing stricter quality assurance protocols.
- How have you contributed to the registration strategy and alignment of regulatory timelines in your previous role? Can you provide an example of a project where you played a significant role in this aspect?
- Answer: In my previous role, I actively contributed to the registration strategy by collaborating with regulatory affairs teams and providing technical expertise on manufacturing processes. For example, during the registration of a biopharmaceutical product, I worked closely with regulatory colleagues to ensure alignment of timelines for technical data submission. By providing comprehensive technical documentation and actively participating in regulatory discussions, we achieved successful registration within the expected timeline.
- How do you stay updated on the latest trends and advancements in manufacturing process science and drug development? Can you provide an example of how you have applied this knowledge to improve processes or overcome challenges?
- Answer: I believe in continuous learning and staying abreast of industry trends and advancements. I regularly attend conferences, seminars, and workshops related to manufacturing process science and drug development. Additionally, I actively engage in professional networks and read scientific literature. An example of applying this knowledge is when I implemented a new manufacturing technique based on emerging industry research. By incorporating this innovation, we improved process efficiency, reduced costs, and enhanced product quality in my previous role.
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Seeking a job interview after pursuing Medical biotechnology and completing Computer Aided Drug Discovery Targeting HER2 protein for Breast cancer successfully.