Senior Process Scientist

  Medical Writing

Job title: Senior Process Scientist

Company: Johnson & Johnson

Job description: Job Description:

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science — bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Our Consumer Business touches a billion lives around the world and works with the vision of ‘Bringing science to the art of healthy living’. In India, the company touches the lives of consumers through businesses spanning baby care, women’s health, beauty, oral & wound care and over-the-counter-products which are endorsed by healthcare professionals around the world. In India, the company touches the lives of consumers through Baby Care, Women’s Health, Beauty, Oral & Wound Care and OTC. Some of our key brands include Johnson’s® Baby, Stayfree®, Clean & Clear™, Band-Aid®, Listerine®, ORSL and Benadryl®.

The Process Scientist supports Manufacturing Science and Technology for a broad range of OTC Drug Products, OTC drug products, Dietary Supplements, Foods, Consumer and Cosmetic products. Primary activities require the use of basic scientific knowledge on principles of manufacturing processes and a passion for innovation and continuous improvement. Working under moderate direction, this individual will collaborate cross-functionally with Operations, Marketing, Quality Assurance, Research and Development (R&D), and other function as needed to provide technical support in the design, development, and implementation of technical solutions for cost reduction and critical initiatives. This individual is encouraged to implement technical aspects of projects, report metrics, and get along with multi-functional teams to implement projects.

The Process Scientist should ensure quality and compliance through GMP training, enforce to strict compliance with procedures, 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 dedication to doing the job right the first time.

Duties & Responsibilities:

General:

  • 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.
  • Good Documentation practices.
  • 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 but not limited to the technology transfer process for New Products Introduction, Products Improvements, and new raw material qualification.
  • 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, corrective/preventative actions, and new product release data collection and analysis.
  • 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 solving supply issues, global change control (GCC), root cause analysis, and remediation for technical-related issues. Corrective Action and Preventative Action (CAPA) implementation and follow up to ensure CAPA efficiency 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, and support in conducting scale-up activities including pilot-scale and validation as required.
  • Support in documentation, writing technical documents but not limited to Product Impact Assessment, Technical Justifications, manufacturing work instructions, and INV reports.
  • Decisions made at this level are limited in scope and authority.
  • May assist in process, packaging, cleaning or equipment validation as and when required

Qualifications

Experience: Generally, requires (5-8) years related experience. Previous experience in a Pharm-Neutraceutical healthcare/food technology and manufacturing environment desired.

Knowledge, Skills and Abilities:

  • 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.
  • Knowledge of scientific principles for liquid/semi-solid formulation development (i.e., solution, suspension, semi-solid), solid dosage development, and other formulation development (i.e., Sterile Food Product, Lozenges, Multivitamin Sachets, Tablets, Powders), engineered products and devices as applicable.
  • Understanding of the process equipment and in-process control instruments. (Mfg technology like Aspectic food filling, Liquid Manufacturing, Nutraceutical tablets, liquid manufacturing).
  • Knowledge on 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.
  • Ability to apply selected lean tools to a situation. Tools include- 5S, Visual Management, Mistake proofing, kanbans/ rhythm wheels, and other Lean principles.
  • Know how of statistical methods such as Six Sigma, statistical tools for data analysis. (i.e., CpK, Probability of failure), and risk management tools (FMEA, etc.).
  • Know how 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.
  • Proficient with regulatory requirements in the development, validation, and manufacture of consumer cosmetic and OTC monograph drug products (regulatory agencies such as, DCGI, IP, FDA, FSSAI, CODEX, JEFCA, USFDA, MHRA etc.).
  • Strong analytical, excellent technical writing skills are required. Experience with MS Word, Excel and Project software packages is required. Excellent interpersonal, influencing, communication, listening, and problem-solving/decision-making skills are preferred.

Are you ready to impact the world?

Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
Primary Location
India-Maharashtra-Greater Mumbai-
Organization
Johnson & Johnson Private Limited (8080)
Job Function
R&D
Requisition ID
2206048186W

Expected salary:

Location: Mumbai, Maharashtra

Job date: Thu, 09 Jun 2022 22:45:41 GMT

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