Specialist, Clinical Manufacturing

Job Description Summary

#LI-Onsite
Location: Durham, NC
Relocation Support: This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible.
NOTE: This role is typically Monday-Friday working standard business hours. However, during active clinical campaigns, working overtime, nights, and weekends will be required.
If you’re energized by seeing new clinical therapies move from idea to execution, this is your opportunity to make a visible impact. As a Specialist, Clinical Manufacturing, you will play a hands-on role at the heart of manufacturing execution, introducing new clinical products into a Good Manufacturing Practice environment. Working closely with Manufacturing, Manufacturing Science and Technology, Engineering, and Technical Research and Development, you’ll translate technical knowledge into compliant, real-world manufacturing outcomes. This role offers a unique blend of shop-floor presence, technical authorship, and project ownership-giving you direct visibility into how your expertise enables safe, timely delivery of medicines that matter.

Job Description

Key Responsibilities

• Responsible for implementation of new clinical products into the facility, ensuring safe, compliant, and timely execution.
• Provide hands-on, front-line manufacturing support during clinical batch execution with shift teams.
• Author and manage master manufacturing documents of assigned products, including Master Batch Record, Standard Operating Procedure, Bill of Material (BOM), and Recipe, Quality Risk Assessment, and Hazard Analysis.
• Support technology transfer projects, including new product change controls.
• Manage projects implementing significant improvements to clinical manufacturing processes.
• Partner cross-functionally with the PMO group, Manufacturing, Manufacturing Science and Technology, Engineering, and Technical Research and Development teams.
• Support deviations, corrective actions, and internal or external audits for group owned processes.

Essential Requirements

• Bachelor’s degree in Engineering or Life Sciences and five years of experience in biopharmaceutical based GMP manufacturing operations.
• Hands-on experience in technology transfer of biotechnology candidate clinical products and/or technology transfer of commercial products from site to site.
• Strong technical writing ability required. Excellent oral and written communication skills.
• In-depth knowledge of Food and Drug Administration regulations and Good Manufacturing Practice systems.
• Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products.
• Ability to travel to other internal sites, vendors, and contract manufacturing organizations, as required, typically less than five percent.

The salary for this position is expected to range between $41.05 and $76.25 per hour. 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 publishedsalary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of therole, eligibility to be considered for annual equity awards.US-based eligible employees will receive a comprehensive benefits package that includes health, life anddisability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Inaddition, employees are eligible for a generous time off package including vacation, personal days,holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.

Salary Range

$85,400.00 – $158,600.00

Skills Desired

Data Analytics, digital skills, General Hse Knowledge, gmp knowledge, process excellence, Resilience
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.