Greetings from Glenmark Pharmaceuticals..!!!
We are hiring following positions
Research Associate – Analytical Method Validations (Respiratory)Location: Nashik / Aurangabad
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
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
Sr. Research Officer / Research Scientist – MDI FormulationsDesired 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.
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)
Research Officer – Analytical DevelopmentRoles 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