Tech Ops Staff Scientist - Process

Tech Ops Staff Scientist - Process

私たちがしていること

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。ケアは私たちの才能です.

Who We Are

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。 私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

Tech Ops Process Science Leader - NA

Location:

North America, United States, New Jersey, Summit

勤務地:

ハイブリッド

あなたがすること

The Technical Operations Staff Scientist is responsible for providing a significant degree of scientific expertise in Technical Operations for a broad range of consumer cosmetics, OTC drug products, and OTC monograph drug products.  This position can work in either our Summit NJ location or our Fort Washington PA location. Primary activities require possessing a solid understanding of principles of manufacturing processes and material interactions with a passion for innovation and continuous improvement.  Working under minimal direction, this individual collaborates cross-functionally to lead and provide technical support in the design, development, and implementation of technical solutions for cost reduction and critical initiatives. This individual is expected to assess, determine and 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 moderate to large 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 . 
• Applies scientific principles to resolve complex technical challenges while being able to articulate complex subject matter in clear, concise terms. 
• 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.).
• Leads the technology transfer process for New Products Introduction, Products Improvements, and new raw material qualification.
• Oversees, writes, reviews, or approves technical documentation.  Reviews and approves reports and confirms conclusions based on scientific analysis and rationale.
• Leads technical aspects for solving critical supply issues, global change control (GCC), root cause analysis, and remediation for technical-related complex issues
• 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.
• Advocates and leads initiatives to drive execution excellence and timely realization. Identify and recommend new agile ways and risk-based approaches to accomplish goals and objectives Provide direction and mentorship to scientists and co-ops

What we are looking for

Required Qualifications

• Bachelor’s Degree is preferred in Pharmacy, Chemistry, Engineering, or related scientific field.
• 6+ 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 required.
• Strong knowledge related to process/product development is required.  Previous experience overseeing complex projects in a matrixed environment is required.

Desired Qualifications

• Strong 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.
• Strong Knowledge of performance requirements of specific products or raw materials and the customer needs.
• Strong Knowledge of product design, characteristics, the procedure (how the product works, anatomy), and competitive products.
• Strong 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), as applicable.
• Strong Understanding of the process equipment and in-process control instruments.
• Strong Knowledge in 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.
• Strong 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.
• Strong 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.
• Strong 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.).
• Strong 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.
• Strong 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.

それは何ですか

$110,500.00 - $156,000.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

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