Upstream Manager, Manufacturing

Novartis • Durham, CA

1d • Onsite

About The Position

Step onto the manufacturing floor where every batch matters—your leadership in upstream operations will directly support the delivery of gene therapy medicines. As an Upstream Manager, Manufacturing, you will lead and develop a team of Manufacturing Associates producing clinical and commercial material while serving as the first point of contact for process and equipment deviations. You’ll set clear direction for your area, establish leader standard work that enables consistent execution across shifts, and partner closely with cross‑functional teams to mitigate risk and drive continuous improvement. This is a hands‑on leadership role for someone energized by operational excellence, accountability, and building strong teams in a regulated manufacturing environment.

Requirements

• Bachelor’s degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
• Minimum 5 years of experience in biopharmaceutical current Good Manufacturing Practice manufacturing operations.
• Prior people management experience with demonstrated ability to lead, mentor, and develop manufacturing teams.
• Strong working knowledge of health authority regulations and current Good Manufacturing Practice systems.
• Proven ability to manage deviations, ensure accurate documentation, and maintain inspection‑ready operations.
• Hands‑on experience supporting upstream manufacturing operations, including cell culture processes in a regulated environment.
• Excellent written and verbal communication skills, including strong technical writing capability.
• 5-10% travel as needed

Nice To Haves

• Demonstrated success driving continuous improvement initiatives within manufacturing operations.
• Current Gene Therapy Manufacturing experience strongly preferred.

Responsibilities

• Lead and develop Manufacturing Associates to safely execute upstream manufacturing operations across all shifts.
• Serve as first point of contact for upstream process and equipment deviations, ensuring timely and compliant resolution.
• Execute manufacturing activities in compliance with current Good Manufacturing Practice and site safety requirements.
• Set clear vision, strategy, and performance goals aligned with site and business objectives.
• Establish leader standard work to support consistent execution within normal scheduled work hours.
• Proactively identify operational risks and implement mitigation plans to protect supply and quality.
• Partner with Engineering, Quality, and other support teams to resolve issues safely and effectively.
• Ensure batch records, standard operating procedures, and documentation remain accurate and inspection ready.
• Support internal and external audits, inspections, and tours; respond to observations per procedure.
• Drive continuous improvement initiatives and support technology transfer of new products and processes.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager