Senior Scientist
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- 2507040245W
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Was wir tun
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Rollenberichte an:
Global API Synthesis ManagerStandort:
Asia Pacific, India, Maharashtra, Greater MumbaiArbeitsort:
HybridWas Sie tun werden
Senior Scientist R&D Materials
This position reports into Manager and is based at Mumbai, India.
What will you do
Senior Scientist RMC (R&D) is responsible for supporting Change Management processes within the Asia Pacific Region (APAC) and supporting global base business operations as needed, specifically as it relates to supplier driven changes and troubleshooting for internal and external manufacturing sites. This position works closely with global business partners to deliver some global initiatives.
The Senior Scientist RMC (R&D) will collaborate with a group of technical professionals to manage and provide technical guidance on raw material projects for existing marketed products including, Over the Counter (OTC) monograph drug products, New Drug Applications (NDA) and Class II Medical Device products in the Consumer portfolio. The portfolio includes brands such as TYLENOL®, MOTRIN®, BENADRYL ®, NICORETTE ®, ZYRTEC®, IMODIUM ®, CALPOL®, and SUDAFED ®
Key Responsibilities:
As a Senior Scientist at APAC Materials, this role is characterized by a diverse and impactful set of responsibilities:
- Drive the execution of raw material qualification projects for cost improvement projects, raw material discontinuations, and supplier driven changes. This is achieved through close collaboration with the Global Materials team, R&D and key stakeholders like Source, Quality, Tech Ops.
- Ensure smooth execution of Business Continuity project, support for Raw Material & API related investigations, Supplier issues, Documentations and other API related assessment following internal SOPs.
- Shall possess synthetic chemistry experience and conduct thorough assessments of the impact of raw material changes on formulations across the spectrum of Self-Care & other categories.
- Perform in-depth review of DMF and RM characterization (HPLC, DSC, mass spectrometry, FTIR, and others).
- Meticulously document change control and related activities in various systems, adhering to defined processes with a commitment to compliance.
- Craft compelling technical justifications, reports, and summaries based on robust scientific experimentation and rationale, ensuring harmonization with project leads.
- Focus on driving science-based problem solving and identify improvement opportunities
- Cultivate strong collaboration with cross-functional teams, including R&D formulators and Tech Ops Scientists, to facilitate seamless communication and ensure the timely sharing of qualification data before implementing raw material changes in both internal and external manufacturing sites.
- Lead independently to make a detailed execution plan & coordinate with key stakeholders to ensure our products can comply with the latest regulation requirements timely, following changes in the current regulatory requirements.
- To contribute to the areas which lack a standardized process in daily work.
- To proactively connect with global key stakeholders, to improve the APAC process through learning from other’s strengths and offsetting their own weaknesses.
- Participate in multi-functional teams to understand problems, support investigations, implement resolution, and develop optimized processes
What we are looking for
Required Qualifications
- Minimum of Master’s Degree in Chemistry /Pharmacy/Life Science with 7-10 years of experience OR a PhD with 5 years of experience
Desired Qualifications
- Experience in the Pharmaceutical Industry is required.
- Experience in the scale-up, manufacturing and plant troubleshooting of API or Solid & or Liquid Dose OTC/ NDA/ Pharmaceutical products is required
- Experience in Synthesis or manufacturing of API’s or pharmaceutical products is strongly preferred
- Strong technical expertise in raw materials, synthesis and a comprehensive understanding of their impact on Over the Counter (OTC) and New Drug Application (NDA) formulations is highly preferred.
- Deep understanding of standard methodologies and procedures that apply to the support of marketed products locally and globally is preferred
- A deep understanding of GxPs is required
What’s In It For You
- Competitive Benefit Package
- Learning & Development Opportunities
- Employee Resource Groups
- This list could vary based on location/region.
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.
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