Job ID 111794BR
Posting Title Manager, Manufacturing (Support Viral Pilot Plant)
Division Vaccines & Diagnostics
Business Unit Vaccines & Diagnostics - Global Technical Operations
Work Location Holly Springs, NC
Company/Legal Entity NOVARTIS VACCINES & DIGNOSTICS
Functional Area Production
Employment Type Regular
Job Description • The incumbent will be a key leader within the TD-Viral Pilot Plant team, responsible for GMP production of Phase I/II/III clinical trial materials and new product introductions of novel viral vaccine candidates from TD-Viral pipeline. The incumbent will own the TD Operations Support team to consistently deliver high quality products in a compliant and efficient manner.
• GMP compliance expert for TD Operations, fully aligned with expectations of Development QA function – senior compliance and manufacturing resource for entire TD Pilot Plant Operations team
• Own TD Operations deviation investigations, CAPA implementations, Batch record reviews / issuance, change control implementations and commitments, and major SOP revisions
• Own key business processes in TD Pilot Plant including New Product Introduction (NPI), materials onboarding, GMP release, Tox release, SAP and Maximo utilization, and area changeover as required per campaign.
• Drive material onboarding process for all new product introductions in TD Pilot Plant and implement improvements to overall business process to enable fast and flexible operation.
• TD lead for Operations Support team ensuring right first time GMP execution of media/buffer and small equipment preparations that support Phase I/II/III clinical trial material production.
• Facility owner for all media/buffer, equipment prep, and support manufacturing suites ensuring GMP compliance including all SOPs, BPRs, and manufacturing records. Coordinate maintenance and validation activities as needed.
• Support New Product Introductions for TD Pilot Plant by managing operational readiness deliverables, and supporting design/procurement/commissioning/validation of GMP process equipment. Ensure adequate support and oversight for area qualification and validation activities.
• Support recruiting, hiring, onboarding, and training of TD operations team
• Development and performance management of TD operations staff in support of a high performance environment
• Drive department objectives, direction & priorities
• Drive technical problem solving, coordinate and facilitate team decision making, and drive continuous process improvements
• Own standards and manpower requirements to meet production needs.
Minimum requirements . BS Degree, preferrably in Chemical, Biological, or Mechanical Engineering, Biological Sciences or related field of study.
. Minimum 7 years of solid GMP industry experience in biopharmaceutical processes
. Minimum 5 years of production management / leadership experience preferred
. Demonstrated superior knowledge of cGMPs and FDA requirements required
. Demonstrated ability to lead and develop a high performing workforce.
. Previous new product introductions / operational readiness /startup experience
. Excellent organizational and time management skills required.
. Proven ability to manage complexity and interdependencies of multiple systems (Quality and Business).
. Strong oral, written and communication skills required.
. Must be self starter, able to work with minimal supervision.