Role reports to:
Tech Ops Senior Manager Process Science

Location:
North America, United States, Pennsylvania, Lititz

Work Location:
Fully Onsite

What you will do

The Scientist supports Technical Operations R&D Pilot Plant for a broad range of pilot scale consumer cosmetics, OTC drug products, and OTC monograph drug products. Primary activities require the use of basic scientific knowledge while developing a solid understanding of the principles of manufacturing processes and a passion for innovation and continuous improvement. This individual is expected to implement technical aspects of projects, report metrics, and interact with multi-functional teams to implement projects.

Additionally, the Scientist will ensure quality and compliance through GMP training, adhere to strict compliance with procedures and GDP, exercise the highest level of integrity in tasks performed, identify, report, and seek corrections for deviations noted in the workplace and embrace a behavior of employee involvement and commitment to doing the job right the first time.

Key Responsibilities:

• Ensure quality and compliance in all actions by:
  • Attending GMP / EHS&S (Environmental, Health, Safety & Sustainability) training
  • Adhering to strict compliance with procedures applicable to the role.
  • Exercising the highest level of integrity in the tasks that they perform.
  • In a timely and prompt manner, identifying, reporting, and seeking correction for deviations noted in the workplace.
  • Accepting the behavior of employee involvement and commitment to doing the job right the first time.
• Uses scientific principles to resolve moderately sophisticated technical challenges while being able to articulate complex subject matter in clear, concise terms.
• Support execution of or lead small to moderately sized project tasks per established timeline, including any activities associated with production of Pilot scale batches and Clinical Supplies operations.
• Work with project teams to manage and execute batch requests in the pilot plant
• Responsible for Clinical Supplies Project Execution and Coordination including repacking and labeling operations for clinical supplies
• Support the execution of the planned experimental design (i.e., sample collection, in-process testing, sample management, etc.).
• Support with report preparation by compiling and analyzing and summarizing data using appropriate analysis techniques.
• Support change control deliverables/documentation, investigations, and corrective/preventative actions.
• Support or lead conducting investigations related to product out of specification or process deviation, stability deviation, consumer complaints, and other investigations as applicable.
• Conduct laboratory experimentation as needed related to investigations and root cause analysis.
• Support or lead in conducting troubleshooting of scale-up issues, root cause analysis, and remediation for technical-related issues. Corrective Action and Preventative Action (CAPA) implementation and follow up to ensure CAPA effectiveness to address investigation and the root causes related to process deviation, stability, out of specification, out of trend, out of expectation, complaints, and others as applicable.
• Support or lead in manufacturing process improvements through data analysis, identification of critical process parameters, the proposal of alternate process modifications, assistance in conducting DOE to determine the best processes.
• Support in writing technical documentation including but not limited to Manufacturing Work Instructions, Fill Records, Cleaning Procedures, Technical Justifications, and INV reports.
• Works with general/moderate direction. Provide direction and mentorship to contractors.
• Decisions made at this level are limited in scope and authority.
• Support and execute End to End Pilot Tasks including material management, cleaning and sanitization of small-scale equipment, labeling, shipping, document control/closure, etc.
• May assist in process or equipment validation.

Qualifications:

• Bachelor's Degree is preferred in Pharmacy, Chemistry, Engineering, or related scientific field.
• 2+ years of industry experience is required
• Experience within the Consumer, OTC, or Pharmaceutical industry is preferred. GMP experience is preferred.
• Process knowledge related to process/product development is required.
• General knowledge of product characteristics and their correlation with product/raw material performance and performance requirements of specific products or raw materials and the customer needs.
• General knowledge of scientific principles for liquid/semi-solid formulation development (i.e., solution, suspension, semi-solid), solid dosage development (i.e., immediate and delayed-release), and other formulation development (i.e., Nasal Spray, Eye drops, Lozenges, and sterile products), engineered products and devices as applicable.
• General understanding of the process equipment and in-process control instruments.
• General process knowledge in a few of the processes such as Mixing, Filling, Liquid dosage, Solid dosage, Liquid Packaging, Scale-up, Technology Transfer, Continued Process Verification, Process Development, as applicable.
• General knowledge and understanding of equipment design, cleaning procedures, analytical methods, sampling requirements, and in the collection and evaluation of data, from the process design stage through commercial production.
• General knowledge and ability to apply selected lean tools to a situation. Tools include- 5S, Visual Management, Mistake proofing, kanban's/ rhythm wheels, and other Lean principles.
• General knowledge of statistical methods such as Six Sigma, statistical tools for data analysis. (i.e., CpK, Probability of failure), and risk management tools (FMEA, etc.).
• General knowledge and understanding of the Root Cause Analysis tools such as brainstorming, cause and effect analysis, fishbone diagrams, 5 why's, failure mode, effect analysis, RATIO, and others as applicable.
• General knowledge of regulatory requirements in the development, validation, and manufacture of consumer cosmetic and OTC monograph drug products (regulatory agencies such as, FDA, MHRA, Health Canada, AIFA etc.).
• Strong analytical skills are required. Excellent technical writing skills are required. Experience with MS Word, Excel and Project software packages is required. Excellent interpersonal, influencing, communication, listening, negotiating and problem-solving/decision-making skills are preferred.

What's in it for you

Annual base salary for new hires in this position ranges:

$72,675.00 - $102,600.00

This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.

• Competitive Benefit Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Kenvuer Impact Networks
• This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.