Research Associate- Analytical

**Research Associate - Analytical**:
Domnic Lewis mandated to hire Research Associate - Analytical

**Analytical Team-**
**Knowledge and Skill Set Requirements**
- Hold a master//'s degree in pharmaceutical sciences (M. Pharm) or (M.sc) Chemistry.
- Must be competent and should have technical knowledge on analytical skills like HPLC, UV

spectroscopy, DSC, Dissolution testing and experience developing analytical methods on drug
substance RS and impurities. Experience in analysis of soft gels would be an advantage.
- Proactive in identifying issues during analysis and proposing solutions
- High level understanding of theory, instrumentation and troubleshooting.
- Must work well in a team and across cross functional teams.
- Must have strong knowledge in documentation skills.
- Effective and good communication skills.
- Must be able to work under minimum supervision.

**Roles and Responsibilities**
- Execute all Lab activities in a safe and reliable manner in line with Pharmaceutical GLP/GMP

and/or internal guidelines
- Analytical testing of the dosage forms for Assay, dissolution, related substances and other

tests as per the requirements with a specific focus on soft gelatin capsules
- Able to work independently complying with all in house SOP//'s and good documentation

practices
- To travel to other company locations or customer places or contract manufacturing units for

carrying out method transfer activity as and when required
- To meet the set priorities, scope, timeline and deliverables
- To document method development reports, prepare presentation and publication of

technical data in international journals.

**(NPD team)**

**Analytical Department (NPD team)**

qualifications and relevant experience will also be considered

**Responsibilities**:

- Execute analytical testing of solid oral dosage forms including tablets, capsules, softgels, ODTs,

and extended-release tablets, covering assay, dissolution, related substances, and stability
studies.
- Independently develop and validate analytical methods for drug substances, impurities, and

excipients as per ICH for assay, RS, dissolution, CU, and other in process and finished dosage form
tests.
- Specialize in analytical support for advanced formulations such as ER, DR, ODTs, and softgels,

including reverse engineering and competitor profiling.
- Handson experience and expertise in handling trouble shooting of wide range of analytical

instrumentation including HPLC, UPLC, GC, GC-MS, LC-MS/MS, ICP-MS, UV, IR, FTIR, XRD, DSC,
TGA, KF, dissolution apparatus (App 1-4), rheometers, texture analyzers, microscopy, and
potentiometers.
- Troubleshoot complex analytical issues, perform root cause analysis (RCA), and stability

problems, OOS/OOT results, and impurity spikes.
- Ensure robust documentation practices, prepare validation protocols, justification reports
- Guide junior scientists, coordinate effectively with cross-functional teams
- Ensure GLP/GMP compliance, lab readiness, and consistent delivery within timelines and scope

across multiple concurrent projects.
Support analytical method transfer activities at customer sites, contract manufacturing
organizations (CROs), or other internal locations as needed.

**Requirements**:

- Master//'s degree in pharmaceutical sciences (M. Pharm) or M.Sc. Chemistry preferred, strong
- Hands-on analytical experience in pharmaceutical development.
- Strong technical expertise in analytical instruments and method development and validation.
- Proficient in documentation, analytical thinking, and troubleshooting.
- Excellent communication and team collaboration skills.
- Demonstrated ability to manage multiple projects independently and meet tight deadlines.