For Professionals

Pick your region

Search Profiles by Job Title

ENGLISH IN

ENGLISH UK

Deutsh

Español

Français (canada)

Français (france)

italiano

polski

português (brasil)

Login

Edit My Profile

Sign Out

My Account

Skills

Location

School

Company

Name

Search By

Contact Us

Terms of Use

Blog

Accessibility

Privacy Policy

Fraud Awareness

Cookie Policy

About Us

Sitemap

Do Not Sell or Share My Personal Information

All Regions

Bold.pro

Facebook

Instagram

Youtube

Pinterest

What is a Bold Profile?

Job Title

How to Search by

For Employers

Experience

Profile

Photo

Contact

Overview

Education

Certifications

Timeline

Tell them why you're reaching out:

I am contacting you because * :

I am contacting you to:

Edit basic information displayed on your Profile

Contact Info

Don't wait! With a free professional profile on Bold.pro you can:

Check your email for submission confirmation and future notifications.

The person you’re trying to reach has disabled the Contact Request option

Contact request cannot be submitted

Success!

Your request is on the way!

Cast a wider net to find even more talent for your team. Start by exploring these profiles.

Cast a wider net to find even more talent for your team. Explore more profiles to find your next great hire.

Cast a wider net and connect with like-minded professionals. Start by exploring these profiles.

Cast a wider net and connect with like-minded professionals. Explore more profiles to grow your network.

You might have mistyped the address or the page has moved.

If you got there from another site, we'd appreciate if you

The Bold Profile you're looking for is no longer available.

We've integrated with our largest Resume Building website, MyPerfectResume, to help you build a professional Bold Profile. Once finished, your Profile will appear on Bold.pro.

You will be redirected from Bold.pro to MyPerfectResume

Associate Principal Engineer

Use our expert recommendations below to get started.

Tell us about your accomplishments

Add anything else you want to know.

Additional information

What are your affiliations?

Select time slots on the calendar below

When are you available to work?

Fill out this section or it will be deleted

This section can't be empty

What skills would you like to highlight?

Showcase your certifications.

What certifications do you have?

Tell us about your {sectionName}

What interests do you have?

What languages do you know?

Focus on your years of experience or amount of courses you have completed.

Showcase your career overview

Highlight your full skillset on your Bold Profile

Show your skills

What software skills do you have?

Briefly tell us about your background

Share your contact information with {name}

See my work availability

Availability

Available

University Overview

Job overview

Hi, I’m

Not Available

If you plan to reach out about a job, feel free to let me know so I don't miss your message.

Bold Profiles Footer Logo

Bold Profiles

By filling out this form, you consent to being contacted and agree to our

Desired Job Title

Work Preference

WORK PREFERENCE

Job Search Status

Location Preference

Important To Me

Work Location

Work Type

Analytical scientist with extensive expertise in diverse scientific methods, including specimen analysis and tobacco and nicotine testing. Proficient in operating specialized instrumentation such as LC-MS/MS, GC-MS, and GC-FID/TCD. Strong foundation in Specimen Validity Testing (SVT) and proven track record of managing workflows, interpreting complex data, and ensuring compliance with stringent regulatory standards set by SAMHSA, CAP, CLIA, GLP, and ISO/IEC 17025. Exceptional analytical skills and meticulous attention to detail in both routine and complex analysis. Committed to delivering precise and reliable results.

Laboratory analyst with GC/MS experience and a background in analytical testing across multiple lab environments. Brings strong attention to detail, familiarity with chemical analysis techniques, and a commitment to accuracy, safety, and quality standards.

An inquisitive product manager with 12+ years of cumulative experience in business development and scientific expertise on the characterization of mAbs, fusion proteins, insulins, peptides, and small molecules using mass spectrometry. Regulatory data generation, authoring, submission, and handling queries from the regulatory bodies like the US FDA, MHRA, DCGI, and EMA.


  To grow with a leading organization that utilizes my abilities to the fullest extent possible, helping me realize and develop my potential and be a part of a team that scales great heights.

8 years in Drug metabolism and Pharmacokinetics:

  Drug Metabolism & Pharmacokinetics (DMPK) department.
  Expertise in Quantitative Bioanalysis.
  Familiar in metabolite identification by using Unit mass & HRMS.
  Validation as per USFDA guidelines
  Familiar in In-vitro DMPK assays.
  Hands on In-vivo study.

9+ years in Analytical Field:

  Analytical Experience (Formulation Analytical Department)
  Expert in Analytical Method development and Validation (USFDA/ICH Guidelines).
  API characterization, generating COA for the API.
  Determination of % Assay.
  Performing Related substances activity.
  Conducting forced degradation studies as per ICH guidelines.
  Familiar in Impurity profiling using HPLC & LC-MS/MS (Hyphenated techniques).

9+ years in Extractable & Leachable (E&L):

  Designing the protocol for Extractable and Leachable study as per PQRI, Biomedical device (ISO) and USP-NF guidelines for diverse packaging materials and finished products like parenteral, inhaler, topical products, ink migration study etc.
  Conducting the extraction studies by using Accelerated Sample Extraction (ASE), sonication, incubation and soxhlet techniques etc.
  Preparation of report and reviewing.
  Ink migration study of packaging materials as per PQRI.
  Correlation of Extractable and Leachable data. Contact equipment parts extractable study.
  Method development and Validation as per ICH Q2 (R2) guideline. Analysis of E&L samples by HPLC-UV/RI/ELSD/CAD, LC-UV/MS, GC-FID/MS & ICP-MS.
  Characterization of potential leachable using hyphenated technique.
  Correlation of extractable data with leachable study results and taking decision.
  Conducting Medical device E&L for the products such as Stents, Sutures, Lens etc. according to ISO guidances.
  Providing extensive training on E&L to the subordinates.
  Building the core E&L team
  Promptly responding all the customer and regulatory queries.


Sakshi Gandhi

Summary

Overview

Work History

Analyst – GCMS/MS, GC Orbitrap & GC-FID

Analyst – GCMS/MS

Intern

Education

MSc - Food Technology

BSc - Biotechnology

Skills

Certification

Timeline

Analyst – GCMS/MS, GC Orbitrap & GC-FID

Analyst – GCMS/MS

Intern

BSc - Biotechnology

MSc - Food Technology

Similar Profiles

Ehris Faulkner, MFSEhris Faulkner, MFS

Caroline ChandlerCaroline Chandler

Phanikumar NasikaPhanikumar Nasika

Govindarajan SrinivasanGovindarajan Srinivasan