S

Senior Scientist - Analytical R&D

Chestnut Ridge United States

5 months ago


Years of Experience

3 - 15 years

Workplace Type

On-site

Seniority Type

Senior

Industry

Pharmaceuticals


Analyse your salary

Want to know how much a Senior Scientist - Analytical R&D make in Chestnut Ridge United States?

Get Salary insights for Senior Scientist - Analytical R&D in Chestnut Ridge United States. Know how your salary compares to the industry average. Our AI analyzer uses other candidates' stated pay expectations to identify market trends.


Skills

cglpcgmpuplchplctroubleshooting

Contact our TA to know more about the job

Shamia Pawaskar

Talent Advocate at WhiteCrow


Description

About our client

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.


Job description

Responsibilities:


  • Independently lead analytical method develop and validation activities for assigned ANDA products.
  • Develop and validate analytical methods for release and stability testing.
  • Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.
  • Identify specification requirements and set up specifications and specification justifications for raw materials and drug products.
  • Resolve complex problems in method or product development.
  • Develop and understand product stability to guide design of stability studies in support of product registration.
  • Generate technical documents to support regulatory submissions.
  • Provide timely analytical support on deficiency responses and product approval inspections.
  • Review laboratory notebooks, raw data and technical documentation in support of regulatory filings.
  • Interact with other depts: Formulations, Regulatory Affairs, Production, Strategic Sourcing, etc., to support timely new product development/submission of new ANDAs.


Requirements:


  • Peer review of lab notebooks.
  • Evaluate, troubleshoot/improve existing analytical methods when necessary.
  • Continuously update knowledge of latest technologies related to analytical science
  • Work in compliance with cGMP/cGLP regulations.
  • Strong knowledge of analytical chemistry and concepts in developing and validating methods to meet correct pharmaceutical standards.
  • Superior knowledge of major analytical techniques such as HPLC/UPLC, dissolution, FT-IR, physical characterization, etc.
  • Strong knowledge of FDA, ICH, and USP guidance and regulations.

Sign up to create profile

Fill in your details to create profile on WhiteCrow

Why get hired via WhiteCrow?

We take your privacy seriously

We take your privacy seriously

By default, your profile stays hidden from past & current employers. We only showcase your anonymous profile to employers and seek your permission before revealing your full profile.

Know more

Personal & Dedicated Talent Advocate

Personal & Dedicated Talent Advocate

Our Talent Advocates are here to help: from providing insider knowledge to guiding you through interviews to negotiations.

Know more

Exclusive Jobs from Top Companies

Exclusive Jobs from Top Companies

Gain access to mid to senior level executive job opportunities at more than 90 of the Fortune 500 companies globally on WhiteCrow.

Know more

Why get hired via WhiteCrow?

With our unique combination of AI matching technology and human expertise, WhiteCrow will help you get discovered for your unicorn role.

Know more

Contact our TA to know more about the job

Shamia Pawaskar

Talent Advocate at WhiteCrow


People also viewed

Analytical Scientist II

Chestnut Ridge, United States

2 days ago


QC Chemist I

Chestnut Ridge, United States

a month ago


Senior Sales Engineer

Bengaluru, India

2 months ago


Chemist III

Chestnut Ridge, United States

14 days ago


Sales Manager - Specialty Food Ingredients

Netherlands, Belgium, Germany, Luxembourg, Austria

8 months ago


Sales Officer (GT)

Delhi, India

22 days ago


Quality Assurance Specialist/Engineer

Gorinchem, Netherlands

4 months ago


Sales Officer

Chennai, India

a day ago


Product Lead

Makati, Philippines

3 months ago


Sales Officer

Rajkot, India

a day ago


View more jobs

Sign up to create profile

Fill in your details to create profile on WhiteCrow