Research
Associate - Analytical Method Validations (Respiratory)
Location: Nashik / Aurangabad
Roles and
Responsibilities
This role is based out of Glenmark's Aurangabad Manufacturing plant and
involves supporting R&D team with Analytical Validations and Development
process of Respiratory portfolio dosage forms (Inhalers, Aerosols of various
indications, Nebulizers, Tablets / capsules etc.) for Global Markets. The
goal of this role is to deliver services with an accuracy in results and within
agreed timelines set by Group leader.
- Perform Method Validation at Manufacturing
Plant and R&D site - Ensure
that all tasks assigned by the functional manager/Seniors are completed
within time and with appropriate quality. Conduct/Execute validation
activity as per protocol. Daily online calculation of validation related
activity
- Prepare
Validation Protocol and Report as per guideline and regulatory requirement
- Calibration
and qualification of Instruments - Ensure that all tasks completed as per
SOP and according to GLP procedure within time
- Follow
current GLP System in the lab maintain the quality and accuracy of the
work throughout the year
Desired
Candidate Profile
Education (degree / diploma) - M.Pharm - Pharmaceutics Chemistry / Ph. D /
M.Sc. Analytical Chemistry
Experience - Should have 2 to 6 years total work experience in Analytical
Method Development
Knowledge and Skills (Functional / Technical) - Should be well
acquainted with handling below equipment like HPLC/UPLC/Spray View etc.
Other
requirements (licenses, certifications,
specialized training) - Experience in handling ANDA
Interested candidates who meet the above criteria can send their CVs to
Dhurjuti Dhibar (Dhurjuti.Dhibar@glenmarkpharma.com
) and Bhushan Wadgaonkar (Bhushan.Wadgaonkar@glenmarkpharma.com)
Sr. Research
Officer / Research Scientist - MDI Formulations
Roles and
Responsibilities:
The role involves support to various activities that are involved in
formulation development process of MDI dosage form for US/EU/ROW and India
market. The goal of this role is to deliver commercialization of formulations
in MDI dosage for India/ROW or regulated markets and other Services with
accuracy in results within agreed timelines.
Below listed are a few deliverables in the role:
- Literature
and patent search - Should perform literature search from reference book,
Should have some basic understanding of patent and generic formulation
development.
- Subject
knowledge - Should think and come up with Novel/Innovative formulation
ideas or strategy
- Documentation
and data review - Should review relevant data like in vitro study ,
characterisation studies
- Regulatory
requirements - Should have knowledge towards development activities as per
regulatory/IP requirements etc.
- Competitor
product procurement and characterization, Evaluation/optimization of
excipients and primary packaging Materials
- Pre
formulation development - knowledge of Pre-formulation studies
- Process
Finalization - know basic mfg. process during development
- Stability
studies and report writing - aware stability conditions and keep track and
evaluate stability data
- Technology
transfer of the product at Plants and Exhibit Batches at Plant (as per the
Requirement of Regulatory)
Desired
Candidate Profile
Education (degree / diploma) - M. Pharm - Pharmaceutics /Ph. D
Experience - Should have minimum of 6 to 10 years of work experience in
Formulation and Development of MDI dosage formulations preferably for US/EU
Mkts.
Other requirements (licenses, certifications, specialized
training)-
- Updated
technical knowledge. Relevant to MDI dosage form
- Should
aware of FDA guidance to take out RLD details etc.
- Should
aware of basic understanding of technology to initiate developmental work
related to MDI dosage form
- Should
have experience in handling ANDA
- Should
be well conversant with commercialization of few formulations in MDI
dosage for India/ROW or regulated market
- Should
be thorough in documentation to provide MFC and BOM based on development
and facility available.
Interested candidates who meet the above criteria can send their CVs to
Dhurjuti Dhibar (Dhurjuti.Dhibar@glenmarkpharma.com)
and Bhushan Wadgaonkar (Bhushan.Wadgaonkar@glenmarkpharma.com)
Research
Officer - Analytical Development
Roles and
Responsibilities
The role involves support to various activities that are involved in
Analytical Development process for various dosage forms like Tablets, hard /
Soft Gelatin capsules, Nasal, Nebulizers & NMEs for different Markets.
Desired
Candidate Profile:
- Initial
Sample Analysis - Analysis for Assay, Related substance, Dissolution
profile, BRS & APSD.
- Stability
Study Analysis
- Method
development as per QbD approach with reference from latest research
articles.
- In-Vitro
study & Characterization study to be perform as per approved protocol
- Working
standard preparation & Standardization as per SOP, STP and according
to GLP.
- Analytical
Technology transfer and Validation support at different site.
- Calibration
and qualification of Instruments
Suitable candidate can send their profiles on Bhushan.Wadgaonkar@glenmarkpharma.com,
Dhurjuti.Dhibar@glenmarkpharma.com.
