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Manager, Analytical
2 weeks ago
Kenvue is currently recruiting for:
Manager - R&D Analytical Self Care NPD
Who we are
At Kenvue , we realize the extraordinary power of everyday care.Built on over a century of heritage and rooted in science, we're the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson's and BAND-AID® Brand Adhesive Bandages that you already know and love.Science is our passion; care is our talent.Our global team is made up of ~ 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers.With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day.We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you Join us in shaping our future-and yours.For more information, click here .
Location: Mumbai
What you will do
Kenvue is recruiting a Manager for R&D Analytical to be based in Mumbai, India.This individual will lead the analytical activities on Self Care OTC (over the counter) such as defining the analytical strategy, execution planning, timing, resource requirements and interdependencies to complete the project deliverables.This individual will be a people leader and provide technical guidance and oversight to all analytical activities for the registration and approval of new products and post launch changes for OTC products.
RESPONSIBILITIES:
* Management of people, projects, processes applied to Analytical R&D for the Innovation Pipeline in support of the portfolio
* Deliver project milestones, excellence in execution of analytical studies (raw material and drug product) and documentation in compliance with requirements from internal policies and applicable regulations
* Planning and executing the analytical strategy for new product development:
1.Pre-formulation and compatibility studies
2.Test Method Development
3.Test Method Validation and Transfer to Quality Control Labs (internal and external) and CRO's
4.Stability Studies (developmental and pivotal) to support new product development
5.Impurity and degradation pathway assessments
6.Technical justifications
7.Laboratory and non-conformance investigations
8.Provide management guidance to technical team for method development/validation/transfer, laboratories investigations and troubleshooting, stability assessment, and critical feedback to project teams for new product launches
* Preparation of Analytical CMC sections for filings and support in answering questions and deficiency letters from Health Authorities especially in the EU region
* Communicate the project progress to management, business partners, and team members.Attend and/or facilitate project and technical meetings
* Assessment of internal processes identifying opportunities and implementing improvements such as: organization of activities, redistribution of tasks, reduction of lead time and rework
* Active participation in internal and external audits, from the preparation for the audit to responses to observation and closing out of action plans/commitments
* Lead and manage team of scientific professionals: performance, development and coaching
What we are looking for
Education:
* Minimum MSc, B Pharm, M.Pharm, Ph.D.or equivalent science stream with minimum of 10 to 12 years of work experience
Experience:
* A strong analytical background in HPLC, UPLC, GC and other analytical techniques is required.Experience with advanced chemistry will be advantageous
* Experience with method validation and method transfer is required
* Experience with stability studies according to regional regulations is required
* Strong knowledge about the regulations and/or guidelines related to method development & validation for drug products, drug substance is mandatory for this position.Technical and compliance requirements for EU region are preferred
* Strong technical writing skills and project management skills are necessary
* People management/team handling experience is required
Kenvue is proud to be an Equal Opportunity Employer.All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
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