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.
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