Materials Scientist [Self Care / Technical Compliance]

Materials Scientist [Self Care / Technical Compliance]

Что мы делаем

At Kenvue, мы осознаем необычайную силу повседневной заботы. Основанный на более чем вековом наследии и уходящий корнями в науку, мы являемся домом культовых брендов, включая NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® и BAND-AID®, которые вы уже знаете и любите. Наука – наша страсть; забота – это наш талант.

Кто мы

Наша глобальная команда – это ~ 22 000 блестящих людей с культурой рабочего места, где каждый голос имеет значение, а каждый вклад ценится. Мы увлечены идеями, инновации и стремление поставлять нашим клиентам лучшие продукты. Обладая опытом и эмпатией, быть Kenvuer означает иметь возможность влиять на миллионы людей каждый день. Мы ставим людей на первое место, заботимся о настолько, завоевываем доверие наукой и смело решаем – и вас ждут блестящие возможности! Присоединяйтесь к нам, чтобы формировать наше будущее и ваше. Для получения дополнительной информации, нажмите here.

Role reports to:

GER PESQ E DESENV

Местонахождение:

Latin America, Brazil, Sao Paulo, Sao Jose dos Campos

Место работы:

Гибрид

Что ты будешь делать

The Materials Scientist Self Care  – Technical Compliance will be responsible to work on analytical deliverables on Self Care (OTC) projects, reviewing and writing technical documents in compliance with standard operating procedures and regulatory requirements ensuring also data integrity. Additionally will lead supplier changes implementation, compendial updates and providing plant support to solve materials issues from internal/external manufacturing plants under restricted timelines. This position will coordinate and execute technical aspects of projects, applying knowledge of analytical chemistry fundamentals to guide raw material analysis, characterization strategies and specification setting. Additionally, the scientist will write and review technical documents, ensuring compliance with standard operating procedures and regulatory requirements. 

Key Responsibilities 

•    Review/elaborate analytical technical documents to support product development and life cycle management projects, including test method validation protocols and reports, certificates of analysis, and other related documents applicable to raw materials, all in accordance with regulatory requirements from LATAM and US health authorities, as well as compliance policies. 
•    Assess and implement changes to APIs and Excipients, including monographs changes, ensuring regulatory compliance and quality standards are met.
•    Establish materials specifications, ensuring they align with industry standards and meet project requirements.
•    Support development of justifications for API specifications based on international guidelines and local regulatory requirements, ensuring thorough documentation for audits and reviews.
•    Exhibit a sense of urgency in addressing challenges, prioritizating and ensuring timely resolutions to achieve project objectives successfully.
•    Communicate clearly with internal teams within Kenvue Self-Care, including Regulatory, Product Development and Quality fostering collaboration and alignment.
•    Identify process improvement opportunities to streamline and simplify procedures, documentation and systems.
•    Prepare and review comprehensive technical documents, including protocols, reports and and technical assessments. Review analytical raw data to ensure data integrity in the R&D environment. Perform and review statistical evaluations of data from analytical validation studies.

What we are looking for 
Required Qualifications:
•    Education: minimum Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering or related field is required.
•    Minimum experience of 2 year in Pharmaceutical industry is required.
•    A strong analytical background in HPLC, UPLC, GC and other analytical techniques is required. 
•    Experience with method validation, method transfer is required.  
•    Knowledge about the regulations and/or guidelines related to method development for drug substances is mandatory for this position.
•    It is preferred that this candidate have strong technical writing skills.
•    Fluent level of English 
•    Good communication and collaboration skills.
•    Person that thrives in uncertain circumstances. Adapt to changes in the work environment; manage multiple tasks and competing demands. 

Desired Qualifications:
•    Experience in implementing technical projects or in site issues support to manufacturing/production area is a differential.
•    Familiarity with regulations and guidelines related to method development and validation for drug substances

What’s in it for you
•    Annual base salary. This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.
•    Competitive Total Rewards Package*
•    Paid Company Holidays, Paid Vacation, Volunteer Time & More!
•    Learning & Development Opportunities
•    Employee Resource Groups 
•    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.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

#LI-MB2
 

Если вы являетесь человеком с ограниченными возможностями, пожалуйста, ознакомьтесь с нашим страница помощи инвалидам для получения информации о том, как запросить приспособление.