Drug Product Manager, Manufacturing

Novartis • Durham, NC

8d • Onsite

About The Position

The Drug Product Manager, Manufacturing, is responsible for organizing, managing, and continuously improving the manufacturing operations and process at a manufacturing site. Location: This position will be located in Durham, NC and will be an On-Site role. Produces clinical and commercial material on an annual basis that meets the site’s strategic objects and is compliant with cGMPs and safety regulations. Accountable for performance in their area Sets vision, strategy and goals for their area. Accountable to have leader standard work for Supervisors and ensure activities are manageable within normal scheduled work hours. Proactively identifies risks to achieving goals and mitigates them. Creates environment where org can successfully achieve their goals, equally on all shifts. Partners with support groups to address issues safely, compliantly and effectively. Participates in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure. Provides monthly manufacturing metrics as determined by management. Leads areas of tech transfer of new products and processes into the manufacturing area. Provide manufacturing feedback on engineering related projects. Identifies and implements continuous improvement opportunities. Other related duties as assigned.

Requirements

• B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
• Prior management experience.
• 5 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification (TFF, chromatography), aseptic fill/finish with:
• Solid knowledge of FDA regulations and GMP systems
• Excellent oral and written communication skills.
• Strong technical writing ability.
• Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
• Demonstrated leadership skills.
• Experience in strategic/tactical planning, team building, and meeting budgets.

Responsibilities

• Leads a team of Manufacturing Associates whose direct responsibilities include producing product on the manufacturing floor.
• First line of contact to handle process and equipment deviations on the floor.
• Areas of responsibility could include upstream (cell culture), downstream (Purification), and/or fill/finish activities as well as media and buffers.
• Ensures documentation (batch records and SOPs) are accurate and updated as required.
• Leads and mentors staff.
• Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters.

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
• Number of Employees: 5,001-10,000 employees