Mankind Pharma, the 7th largest Pharmaceutical Company of India, was incepted in 1995 with a meagre capital of 50 lakhs and 20 employees. Today, we are amongst the top 5 fastest growing Pharmaceutical companies of India with an employee base of more than 10000 and heading towards a turnover of INR 3000 crores.
Post : Research Associate / Research Scientist / Group Leader / Assistant Group Leader
Research Associate / Research Scientist
Locations : Manesar, Gurugram, Haryana
Department : Analytical Validation Laboratory - API
Qualification : MSc / M Pharmacy
Experience : 3 to 6 Years
Skills Required
• Having good hand on analysis exposure on LCMS, GCMS, ICPMS, PXRD, HPLC, 1C, and GC instruments.
• Having the experience to perform analysis on sophisticated instruments (like ICPMS, LCMS, GCMS, HPLC and 1C etc.)
• Sound knowledge of calibration to perform and review of calibrations of Laboratory instruments as per schedule.
• Hand-on exposure to perform the method validation and method transfer as per current regulatory guidelines/requirements.
• Having the experience to prepare and review of Analytical Method Validation / Method Verification / Method Transfer Protocols and Reports.
• Having good understanding of compliance environment and experience of Good Laboratory Practices and Good Documentation Practices.
Research Associate / Sr Research Associate / Assistant Group Leader
Locations : Manesar, Gurugram, Haryana
Department : Biotechnology - Research & Development
Qualification : MSc / MTech / PhD
Experience : 2 to 10 years in Biotechnology Industry R&D (Candidates from Manufacturing operations will not be suitable)
Skills Required
• Incumbents will be required to work for cell line development, clone development, isolation, screening and cell banking for therapeutic monoclonal antibodies in animal cell culture platform.
• The selected clones will be taken up for lab-scale process development up to 10 L bioreactor (glass) and 50 L bioreactor (SU), media and feed optimisation and Technology Transfer to Pilot Plant/CRO for scale-up.
• Additional job requirements will include diligent record keeping, data analysis and presentation, work planning and execution as per the project schedules.
Specialization : mAb, Cell line development, Clone Development, Bioreactor Process development & Optimization, Upstream
Research Scientist / Sr Research Scientist
Locations : Manesar, Gurugram, Haryana
Department : Formulation Development - Documentation
Qualification : B.Pharmacy + Msc / M.Pharmacy
Experience : 4 to 5 years
Skills Required
• Preparation and compilation of Production development report in accordance with Quality by design approach
• To maintain record of issuance and archival of laboratory note books, log books, equipment log records
• Preparation and review of in house guideline, SOP, Policy, Standard practice related to R&D
• Preparation and compilation of technology transfer documents including but not limited to following :
* API quantity breakup
* Bill of material
* Product manual
* Product summary report
* Sampling plan
* Stability protocol
* Quality risk assessment
* Thermal cycling study
* In-use stability study
* Photo stability study
Key Skills Required : Communication with various CFT for new product introduction at plant level
Microsoft Office (Word, Excel, PowerPoint)
Group Leader / Assistant Group Leader
Locations : Manesar, Gurugram, Haryana
Department : Formulation Development - R&D (Injectable / Parental)
Qualification : M.Pharmacy with industrial experience
Experience : 8 to 12 Years in pharmaceutical industry or CRO Environment
Skills Required
• Supervise the lab experiments/compatibility/QbD studies activities, to provide the technical inputs to finalize the formulation and manufacturing process. To evaluate the Q1/Q2/Q3 assessment.
• To do literature review regarding the developmental products, key information of the RLD, SBOA information search, review of patent landscape about the projects.
• To review the lab notebooks online, maintain the lab do the document lab scale activities in Lab, note book and maintain relevant documentation online.
• To compile and review lab scale batches stability data for insight for the development activity.
• To coordinate with cross functional team including analytical, packaging, regulatory, intellectual property departments and productions departments.
• To involve in the filter validation and external lab studies like D-value study, to send the samples, review the protocols and reports.
• API & Excipients vendor's finalization, Container and closures finalization.
• To involve SAP, QMS, technology transfer related activities.
• To involve trial, scale-up and submission batch executions in production site.
• To prepare product specifications as per ICH/USP monographs/regulatory guidance documents. Preparation of justifications for specifications.
• To prepare product trial batch documents, risk assessment reports, sampling plan and technology transfer documents, stability protocols and product development report for submission.
• Compilation of the stability and development studies data, presentation and scientific discussion of the data with seniors and management, planning of new trials based on the outcome of compiled data.
• Response to the regulatory regarding the query raised for the formulation and process with sound scientific justification.
• To intimation of shortage raw materials, lab wares, spare parts of lab equipment's etc.
• Excellent written and verbal communication and presentation skills
Research Associate / Research Scientist / Sr Research Scientist
Locations : Manesar, Gurugram, Haryana
Department : Intellectual Property Rights Portfolio Management US
Qualification : B.Pharmacy + MBA (Pharm) / M.Pharm
Experience : 2 to 10 Years
Skills Required
• From Initial screening to finalization of product portfolio grid for US business
• Constantly review & monitor US market and suggest new potential Generics product to strengthen portfolio of in-house development
• Evaluation of dosage form for US market and finalization of portfolio grid which includes Day-181 launch, Complex and other potential Generics
• Tracking NCE molecules approved for US market. Identify, analyse and suggest potential product for NCE-1, FTF and PIV strategy products
• Business case preparation and analysis. Estimate Pricing. Market share, tentative budgets, COGS calculation, market entry dates & revenue forecast etc.
• Leveraging the in-house pipeline of US portfolio to Europe & other potential market for value maximization
• Responsible for monthly MIS for Management
• Create and lead summary presentations for management team
• Identify potential API for in-house development strategically important for vertically integration
• Any projects assigned within scope of portfolio management
Please share your resumes on careers.rnd@mankindpharma.com and do mention the position in the subject line.
Only Relevant CVs will be considered for taking it forward)
Last Date : 10th March 2024
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