Job Description Summary

-Shift Lead I -The Shift Leader is responsible for managing his team to carry out the manufacturing operations according to schedule in compliance with HSE and GMP rules. -Process Specialist / Equipment Specialist -Execute assigned manufacturing tasks and activities according to production schedule to enable the timely production of product with the quality and quantity in compliance with the relevant GMP, safety and environmental guidelines. -Documentation Specialist GMP -The Documentation Specialist GMP reviews and consolidate the Batch records after production in order to deliver them to Quality Assurance acc. to set timelines And in right quality. The Documentation Specialist GMP performs entries and verifies transactions/declarations in the ERP system.

Job Description

#LI-Onsite

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.

Shift: 2-2-3 day shift position

At Novartis, we are reimagining medicine to improve and extend peoples lives. As part of our manufacturing team, you will support commercial and clinical operations in a highly regulated environment, helping ensure that products are produced safely, reliably, and in compliance with quality standards. This role offers the opportunity to build hands-on experience across manufacturing processes while contributing to work that ultimately supports patients and their families.

Key Responsibilities:

• Execute hands-on drug product manufacturing across fill-finish, inspection, packaging, and media and buffer preparation.
• Operate, monitor, and adjust manufacturing equipment to ensure safe, efficient, and compliant production.
• Troubleshoot equipment and process issues, escalating and collaborating to minimize production impact.
• Apply and maintain strong aseptic techniques in controlled manufacturing environments.
• Support manufacturing-led deviations, contributing to root cause analysis and corrective actions.
• Complete batch records and manufacturing documentation accurately and in real time.
• Partner with Quality and Operations to maintain inspection-ready, compliant production areas.

Essential Requirements:

• Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 2 years experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment;
• OR four (4) years experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree

Benefits & Rewards

The salary for this position is expected to range between: Bioprocess Engineer II $32.11 and $59.61, 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 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.

At Novartis, were committed to reimagining medicine together and rewarding the people who make it happen. We offer a competitive rewards package designed to support your personal and professional well-being, including health and wellness resources, retirement programs, paid time off, recognition programs, and opportunities for learning and career growth. Benefits and compensation may vary by country and are subject to local legal requirements and Novartis policies.

Salary Range

$66,800.00 - $124,000.00

Skills Desired