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Description

Kenvue is currently recruiting for:

Sr Manager MQSA New Product Introduction/New Process Development (NPI/NPD) & Platform Technology

This position reports to Head of Microbiological Quality & Sterility Assurance (MQSA) and is based at Skillman, NJ USA (relocating to Summit NJ, starting Q2-25).

Who we are

At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson's and BAND-AID Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here .

Role reports to: Head of Microbiological Quality & Sterility Assurance (MQSA)

Location: Kenvue's corporate headquarter is currently located in Skillman NJ, but is scheduled to move to Summit, NJ in or around early 2025.

Travel %: 15

Pay: In the US this position ranges from $119,000 - $205,850

What you will do

The Senior Manager of Microbiological Quality and Sterility Assurance leading the New Product Introduction/New Process Development (NPI/NPD) processes for Product Platforms (Liquids, Solids, Semi-Solids or Commodities) supporting the business segments (Self-Care, Skin Health and Essential Health) will be responsible for supporting the R&D and QHS teams in the development of new products and processes. They will lead the characterization efforts to ensure successful scale-up from lab-scale/pilot plant to commercial manufacturing. Responsibilities will include, but not be limited to, championing proactive quality through formula design in alignment with design for microbiological controlled manufacturing principles, approval of transfers from lab-scale to pilot stages, approval of MQSA technical documents, lead root cause analysis and CAPA investigations associated with product design, will be involved in the identification and qualification of direct material suppliers, lead MRAS as part of supplier qualification, approval of material microbiological risk classification(MRC)/qualification and material source changes, definition of microbiological critical process parameters and approval of technical reports generated from compliance programs (e.g. regulatory inspections, regulatory commitments, and global non-conformances and CAPAs among others). Where appropriate will work with the brand development teams in advancing our product portfolio/pipeline.

The MQSA Senior Manager will also serve as the global process and/or program owner for Kenvue's microbial contamination control programs associated with continued product and portfolio reliability, associated with infection prevention and introduction of rapid technology.

Key Responsibilities

MQSA representative in the NPI/NPD process in the identification and qualification of suppliers to meet product design

Develop microbial control critical process parameters to meet product CQAs

Microbially control process design including cleaning and sanitization to support manufacturing requirements (e.g., campaign manufacturing)

Develop sterilization and microbial reduction technologies

Root cause analysis and CAPA determination associated with technical product investigations, including accountability to proactively identify and deploy CAPAs proven effective

Identification of proactive projects and activities to improve technical attributes of product performance, compliance, and reliability enabling rapid technologies and process analytical technologies

Global program and/or process ownership of one or more assigned Kenvue programs associated with continued product and portfolio reliability, compliance, and/or performance

Support the validation and maintenance of the aseptic and/or sterilization processes from R&D to Pilot Plant followed by handing over to the regions as part of the manufacturing technology transfer. Will assist in the preparation of protocols and technical reports.

Conduct training for manufacturing, laboratory, and management personnel, as needed, to support the implementation of microbiological quality and sterility assurance practices.

Support internal and external manufacturing audit assessments to include suppliers (e.g., manufacturing of raw materials/components, contract labs, contract sterilization and manufacturing sites).

Provide support during due diligence for acquisitions and integrations.

Liaison to global industry, trade and standards organizations.

What we are looking for

Required Qualifications

Bachelor's Degree in Microbiology, Biochemistry, Biotechnology or related scientific field.

Minimum of 8-10 years of experience with evidence of progressive increase in responsibility in product development, quality, manufacturing, technical operations, or technical quality functions for regulated consumer products.

Demonstrated ability to lead global programs with positive impact on product reliability, compliance, and/or performance through the creation of resilient programs for microbiological controlled products and processes.

Technical understanding of Consumer technologies, product design, process controls and organizational capabilities in the areas of: Product...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity