Job Description

Summary 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.
Key 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.
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.
Ensures documentation (batch records and SOPs) are accurate and updated as required.
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.
Leads and mentors staff. Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters.
Other related duties as assigned.
Essential 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.

Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $103,600 and $192,400 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, 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 $103,600.00 - $192,400.00
Skills Desired Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Efficiency, General Hse Knowledge , Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Process Control, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure), Team Work, Technology Transfer, Web Methods Flow

Skills Required