
Senior Engineer, MS&T - Technology Transfer
Required skills
- drug substance manufacturing
- biopharmaceutical production
- technology transfer
- process transfer
- commercialization
- GMP/cGMP
- manufacturing compliance
- process monitoring
- data analysis
- continuous improvement
Nice to have
- Applied Statistics
- Change Controls
- Cleaning Validations
- Data Analytics
- Good Documentation Practices
- HSE Policy
Role summary
Novartis is seeking a Senior Engineer for their MSAT team in Durham, NC, to lead technology transfer of drug substance manufacturing processes. This onsite role involves supporting process scale-up, commercialization, and GMP readiness, acting as a technical lead for investigations and troubleshooting. The engineer will analyze process data, implement improvements for reliability and quality, and collaborate with Manufacturing, Quality, and Supply Chain. Responsibilities also include driving continuous improvement and supporting new equipment and process qualifications. A Bachelor's degree with 6+ years of relevant experience is required, along with hands-on experience in technology transfer within a biopharmaceutical setting and strong knowledge of GMP.
Band
Level 4Job Description Summary
Join Novartis and help bring innovative therapies to patients through successful technology transfer of drug substance manufacturing processes. As a Senior Engineer within MSAT, you will lead technology transfer activities, support process scale-up and commercialization efforts, and partner across Manufacturing, Quality, and Supply Chain to ensure reliable GMP production. This role offers the opportunity to drive process performance, continuous improvement, and the successful introduction of new products at our Durham site.Job Description
Location:
- This position will be located in Durham, NC and will be an onsite role.
- Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Key Responsibilities:
- Lead technology transfer activities for new drug substance products and manufacturing processes.
- Support process scale-up, commercialization, and GMP readiness for transferred products.
- Serve as the technical lead for process investigations, troubleshooting, and operational challenges.
- Analyze process performance data and implement improvements to enhance reliability and product quality.
- Monitor CQAs and CPPs to maintain process control and reduce variability.
- Partner with Manufacturing, Quality, and Supply Chain to support production goals and product supply.
- Drive continuous improvement initiatives and support implementation of process changes.
- Support startup and qualification activities for new equipment, systems, and manufacturing processes.
Essential Requirements:
- Bachelor's degree with 6+ years, Master's degree with 4+ years, or PhD with 2+ years of relevant experience.
- Experience supporting drug substance manufacturing within a biopharmaceutical production environment.
- Hands-on experience leading or supporting technology transfer, process transfer, or commercialization activities.
- Strong knowledge of GMP/cGMP requirements and manufacturing compliance standards.
- Experience with process monitoring, data analysis, and continuous improvement initiatives.
- Ability to troubleshoot manufacturing processes and lead technical investigations.
- Experience collaborating with cross-functional teams including Manufacturing, Quality, and Supply Chain.
- Strong written and verbal communication skills with the ability to influence technical outcomes.
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $114,100 and $211,900 annually
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
#LI-Onsite
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings
Salary Range
$114,100.00 - $211,900.00Skills Desired
Applied Statistics, Change Controls, Cleaning Validations, Data Analytics, Emotional Resilience, Good Documentation Practices, Health, Safety, and Environment (HSE) Policy, Manufacturing Processes, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Process Validation, Quality Compliance, Regulatory Compliance, Risk Management, Technical Leadership, Technology TransferSample Novartis interview questions
- 1
Merge a New Interval Merge a new interval into a list of non-overlapping intervals. Input: intervals = [[1,2],[3,5],[6,7],[8,10],[12,16]], newInterval = [4,8] Output: [[1,2],[3,10],[12,16]] Explanation: The new interval overlaps with [3,5], [6,7], and [8,10], merging them all into the unified block [3,10].
codingmedium - 2
Sort a String by Frequency Sort a string by the frequency of its characters. Input: s = "cccaaa" Output: "cccaaa" or "aaaccc" Explanation: Both 'c' and 'a' appear three times, so sorting them by descending frequency keeps them grouped equally.
codingmedium - 3
Diameter of a Binary Tree Find the diameter of a binary tree. Input: root = [1,2] Output: 1 Explanation: The longest path is simply the single edge connecting the root node to its only child.
codingmedium - 4
Iterator over a Binary Search Tree Implement an iterator over a binary search tree. Input: root = [7,3,15,null,null,9,20], calls: next(), hasNext(), next() Output: 3, TRUE, 7 Explanation: The iterator yields the smallest value (3), confirms more nodes exist, then properly yields the next in-order value (7).
codingmedium - 5
Minimum Path Sum Find the minimum path sum from top-left to bottom-right in a grid. Input: grid = [[1,2,3],[4,5,6]] Output: 12 Explanation: The optimal path moves along 1 -> 2 -> 3 -> 6, resulting in a minimum accumulated sum of 12.
codingmedium
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