Supervisor, Manufacturing Downstream Drug Product

Responsibilities:

• Produces clinical and commercial material on an annual basis that meets the site strategic objects and is compliant with cGMPs and safety regulations.
• Point person on shift to assign/distribute the work and coordinate emergency situations.
• Leads investigations related to the manufacturing process. Author deviations, non-conformances, and CAPAs as required.
• Partner with Quality to address these issues effectively and compliantly.
• Ensures documentation (batch records and SOPs) are accurate and updated as required.
• Ensures accurate, safe, environmentally responsible, and quality compliant operations of the manufacturing process.
• Demonstrates an appropriate level of understanding of the operations performed in the production unit.
• Identifies and implements continuous improvement opportunities.
• Exhibits safety leadership by example (e.g., utilize proper PPE when performing job functions).
• Leads and mentors staff, writes performance reviews and annual goals, holds one-on-ones, and handles HR related matters.

Requirements:

Bachelor's of Science Degree in Biology, Chemistry, Biotechnology or applicable field with 5 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

Bachelors' degree in Biology, Chemistry, Biotechnology or applicable field with 3 year experience in the manufacture of Novartis Gene Therapies product;
OR
Seven (7) 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.
• Solid knowledge of FDA regulations and GMP systems.
• Excellent oral and written communication skills.
• Strong technical writing ability.
• Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.
• Experience with viral manufacturing and transfection a plus.
• Previous supervisory experience and demonstrated ability to lead a team preferred.
• Must be able to lift over 35lbs.
 

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:

https://www.novartis.com/about/strategy/people-and-culture.

The pay range for this position at commencement of employment is expected to be between $88,000 and $132,000 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. You can find everything you need to know about our benefits and rewards in the Novartis Life

Handbook. https://www.novartis.com/careers/benefits-rewards