Technical Operations Senior Scientist
Tech Ops Regional Cluster Leader Location:
North America, United States, Pennsylvania, Fort Washington Work Location:
Fully Onsite What you will do The Technical Operations Senior Scientist is responsible for providing support in Technical Operations for a broad range of consumer cosmetics, OTC drug products, and OTC monograph drug products while developing deeper knowledge and benchmarking with other sites. The Senior Scientist possesses a passion for innovation and continuous improvement. Working under minimal direction, this individual collaborates cross-functionally as needed to provide technical support in the design, development, and implementation of technical solutions for cost reduction and critical initiatives. This individual is expected to implement technical aspects of projects, and interact with multi-functional teams to implement projects. This position plays a role in ensuring robust product development, process optimization, and adherence to quality standards. The ideal candidate will have a strong background in biopharmaceutical process development and cross-functional collaboration. Key Responsibilities
- Lead small to moderately sized project per established timeline, including but not limited to the technology transfer process for New Products Introduction, Product Improvements, and new raw material qualification . Support large complex project tasks.
- Uses scientific principles to resolve sophisticated technical challenges while being able to articulate complex subject matter in clear, concise terms. Seeks guidance on more complex technical challenges.
- Designs, coordinates, and implements project tasks per established timeline including the execution of planned experiments (i.e., sample collection, in-process testing, sample management, etc.).
- Prepares or may approve technical memos, reports, analyzes and summarizes data, and recommends conclusions based on scientific rationale.
- Leads technical aspects for solving supply issues, global change control, root cause analysis, and remediation for technical-related issues.
- Effectively execute technical transfer and life cycle management initiatives and identify new agile ways and risk-based approaches to accomplish goals and objectives
- Collaborate and work closely with Supply Chain, R&D, Quality Assurance, Regulatory Affairs, and other departments to ensure seamless transitions through new product and project development lifecycle.
- Provide direction and mentorship to scientists and co-ops
- Bachelor's Degree is preferred in Pharmacy, Chemistry, Engineering, or related scientific field.
- 4+ years of industry experience related to process development is required.
- Experience within the Consumer, OTC, or Pharmaceutical industry is preferred. GMP experience is preferred. Experience in a highly regulated environment is preferred.
- Strong process knowledge related to process/product development is required.
- Solid 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.
- Solid understanding 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), as applicable.
- Understanding of the process equipment and in-process control instruments.
- Strong 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.
- 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.
- Knowledge and ability to apply selected lean tools to a situation. Tools include- 5S, Visual Management, Mistake proofing, kanbans/ rhythm wheels, and other Lean principles.
- 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.).
- Solid 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.
- 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.
- 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
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