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8.0 - 13.0 years
9 - 12 Lacs
Pune, Solapur
Work from Office
Literature search and patent review of products. Responsible for formulation development of DPI & pMDIs formulations for US, EU, ROW, CSI and IRF markets. Responsible for planning and execution of development- Scale-up for pulmonary formulations. Required Candidate profile Must have experience into FD Inhalation 8-13years Exp Required Responsible for lab maintenance and upkeep of the laboratory and equipment’s.
Posted 4 weeks ago
3.0 - 8.0 years
5 - 15 Lacs
Hyderabad
Work from Office
Job Description Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements. You will be responsible for designing and implementing stability studies for injectable formulations to ensure product quality and shelf life. You will be accountable for troubleshooting formulation and process-related issues during development and manufacturing stages. You will collaborate with cross-functional teams to ensure alignment of formulation development with regulatory requirements and commercial objectives. You will be responsible for staying current with emerging technologies and regulatory guidelines in injectable drug development and incorporating them into your work. You will mentor junior scientists and contribute to the continuous improvement of the formulation development process. Qualifications Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams.
Posted 1 month ago
6 - 9 years
6 - 9 Lacs
Ahmedabad
Work from Office
Hiring for ARD Inhalation department for SEZ Matoda, Ahmedabad location Designation : Executive/Sr.Executive/ Assistant Manager Qualification : M.sc, M.Pharm Experience : 6 to 9 years Please find below job description : Method Development, Stability, Method Validation & routine analytical activities for MDI DPI. Operation and troubleshooting of MDI/ DPI instrument like NGI, ADSA, PSD, DUSA etc. for day-to-day analysis. Hands on experience of HPLC, GC, GCMS, LCMS, Karl Fischer Titrator etc. Preparation and review of Standard test procedure, approval of specifications,analytical methods, SOPs and change control. Literature search and DMF review. Co-ordinate with inter & intra department contact for related issues. Knowledge on Stability evaluation, Tech Transfer and query work. Interested candidate can share cv on with caption " CV for ARD Inhalation" on chandanid@amneal.com
Posted 2 months ago
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