Description

Kenvue is currently recruiting for:

Principal Scientist-R& D Analytical

This position reports to Manager-R& D Analytical Operations and is based at Mumbai, India

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® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22, 000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact 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 .

Role reports to: Manager

Location: Mumbai

What you will do

The Principal Scientist, Analytical R& D will lead analytical activities for complex new drug products from pre-formulation studies through process validation studies, including pre-formulation studies, method development and validation, stability studies and process evaluation analysis. This individual will work with cross-functional teams to define requirements, deliverables and milestones to meet regulatory requirements, and assure business goals are met. This individual will potentially supervise or oversee a team of analysts supporting analytical project activities, including allocation of resources and prioritization across multiple activities or projects.

Key Responsibilities

• Identify, evaluate, and implement new analytical technology as required for project activities.

• Responsible for leading method development activities for various dosage forms across markets.

• Issue, review and approve technical documents including analytical method development summary, method validation protocols and reports, in compliance with standard operating procedures and regulatory requirements.

• Participate on cross-functional teams and recruit and mentor analytical Scientists.

• Deliver project milestones, excellence in execution of analytical studies (raw material and drug product as applicable) and documentation in compliance with requirements from internal policies and applicable regulations.

• 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.

• Active participation in internal and external audits, from the preparation for the audit to responses to observation and closing out of action plans/commitments.

• Strong decision-making skills and capable to drive actions in ambiguous or uncertain situations

Technical/Operational Experience:

• • Experience with HPLC and UPLC is required. Experience with Atomic Absorption, Ion chromatography, and/or Gas Chromatography, ICP-MS is preferred.

• • Strong experience of method development across various dosage forms preferred.

• • Experience working with LIMS systems and other documentation systems is preferred.

• • Previous experience in working with Formulations, Quality and New Product Development teams is preferred.

• • Strong knowledge of GMPs is required.

• • Experience interacting with the FDA, EPA, and/or DEA during audits and inspections is preferred. Broad knowledge and experience with regulatory requirements including ICH, FDA, and compendia (e.g. USP, JP, EP, etc.) is highly preferred.

• • Strong written and oral communication skills are required.

• • It is preferred that this candidate have strong technical writing skills with understanding of compliance both from quality and regulatory standpoint.

• • This individual will be able to work independently, while managing multiple priorities successfully.

• • The ability to influence others without direct line authority is highly preferred.

• • Display of critical managerial traits and project management skills would be evaluated for future potential and growth.

What we are looking for

Required Qualifications

• Minimum MSc, B Pharm, M. Pharm, Ph.D. or equivalent science stream with minimum 12-15 years of work experience

• Experience in working within Pharmaceutical or OTC environment is required.

Desired Qualifications

• Experience of working in GMP set-up and in a Global organization, preferred

• Experience of participating in Quality audits, preferred

• Experience managing others is preferred.

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