Associate Director, Manufacturing

Major accountabilities:

Leads teams who make up upstream manufacturing, whose direct responsibilities include producing product on the manufacturing floor and develops staff, to accommodate needs as a growing organization.

Provides guidance and oversite to the process and production, ensuring material is made in a safe and compliant manner and meeting company targets.

Produces clinical and commercial material on an annual basis that meets the site’s strategic objects and is compliant with cGMPs and safety regulations.

Ensures scheduled operations for manufacturing meet monthly targets. Ensure manpower resources are adequate to complete operations.

Leads critical level investigations as related to the manufacturing process and approve deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.

Ensures batch related documentation (batch records and SOPs) is closed in a timely manner to support batch release.

Maintains robust training program to ensure timely, efficient, and effective training of individuals.

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.

Develops and provide monthly manufacturing metrics and identifies and implements continuous improvement opportunities for process and production related items.

Minimum Requirements:

• High School diploma/GED and 15 years of Operations experience in biopharmaceutical based GMP manufacturing operations cell culture, recovery, purification (TFF, chromatography), aseptic fill/finish preferred; OR Associate’s degree and 12 years ; OR Bachelor’s degree and 10 years; OR Master’s degree and 8 years; OR Doctorate degree and 4 years of experience
• 2 years management experience.
• Solid knowledge of FDA regulations and GMP systems (viral manufacturing and transfection a plus)
• Excellent oral and written communication skills. and strong technical writing ability.
• Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
• Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.

The pay range for this position at commencement of employment is expected to be between $144,000-216,000 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.

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