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.
Assistant Group Leader - Peptide
Experience : 8-10 Years in Peptide Industry
Qualification : MSc / PhD Chemistry
Job Responsibilities :
• Should have hands-on experience of Solid phase peptide synthesis, purification and characterization.
• Should be able to establish Lab, activity and guide the team for synthesis in lab and large scale.
• Should be familiar with the different regulated market expectation for synthetic/recombinant peptides APIs.
• Should be familiar with modern separation and analytical chemistry techniques.
Desirable Responsibilities :
Product development responsibilities :
• To understand the accurate demand for the development of project for market to meet the timelines and quality.
• To do infringement analysis w.r.t. available literature and reports received from I PR team
• To prepare & review for modern developmental documents.
• Should have a good understanding for QbD approach for robust process development
Plant validation responsibilities :
• To review of documents related to Plant scale up such as BPRs, Validation Batch Protocols, Validation Reports and CPP and safety precautions.
• Coordination with Technology Transfer Team, Plant Production Team, and Plant QA for day to day operations.
DQA (API Documentation) AGL/GL
Experience : 8-12 YEARS
Qualification : M.Sc/M.Pharma essential Ph.D desirable
• The Ideal candidate should be dynamic with chemistry background and expert in regulatory and compliance.
• Should have good understanding of documentation in line with ICH requirement and QMS.
• Should have good understanding for QbD approach in documentation of robust process development.
• Should have good verbal and written expert of reviewing of scientific documents.
• Should be capable to understand regulatory query and response in consultation of Cross function.
• Review and approval of various sections of TTD
Section-1 Quality & Compliance responsibilities
• Ensure that all managed operations and activities are executed as per the applicable SOPs.
• Maintain control to ensure that all team members are trained on the relevant SOPs and support continuous learning/ capability building.
• Responsible for ensuring that the facilities are maintained to be fit-for-purpose.
• Encourage a culture of quality compliance and open communication that supports all employees to raise quality concerns or suggest improvements. Ensure compliance to all cGMP, GXP and any other regulatory requirements.
Section - 2 Technical responsibilities
• Review, Approval & tracking of SOPs along with related formats.
• Issuance & retrieval of all documents/formats as per requirement.
• Review & approval of Quality Plan [ Raw Material, In-Process, Intermediate. Finished Product], Change in Specification, Stability Protocol of all Projects.
• Review and approval of Nitrosamine Risk assessment, Impact assessment, Addendum before sharing with sites.
• Review and approval of Feasibility Report & Risk assessment of process.
• Review and Approval of BPR & Protocol w.r.t. Development/Scale up batches.
• Review of all investigations related to deviation/OOS/OOT validation and scale up.
• To track the implementation, Review & closure of Quality management system activities i.e. deviation, Change control, OOS.
• Review of BOM & performance evaluation report of KSMs for all projects.
• Arrangements of Vendor Qualification documents from CQC/CQA to CRD Team.
• Review and arrange the data w.r.t. Technology Package.
• Coordinate with all stakes holder i.e. ARD, RA, Packaging Department, Purchase, CQA/CQC for smooth running of projects.
• Ensure the timely dispatch of Impurities to all locations of Mankind Pharma. & as per requirements of marketing Team.
• Making sure that internal audits [Lab Note Book & GLP] are performed.
• Responsible for applying Form-25, Form-28 & Form-29 for all projects.
DGM/GM (Biotechnology) - Technology Transfer, Scale-up, MSAT
Essential requirements : MTech./PhD (Biochemical Engineering, Biotechnology, Biochemistry) with significant experience leading a team of scientists in Biotechnology industry for scale-up and technology transfer of mAbs/ Biosimilars/ Biologies on diverse platforms.
Job Function : The incumbent will lead a team of associates and scientists to scale up and transfer the production process for biosimilars/mAbs. Will be an interface between late-stage R&D and Manufacturing Plant.
• Responsible for scale up of lab early stage processes to Pilot and Manufacturing plant
• Collaborate for technology transfer of lab scale processes to Pilot plantand Manufacturing Plant
• Require to develop design space and keep strict control over factors affecting the Critical Quality Attributes, Critical Process Parameters and Key Process Attributes
• Looking for persons with sound knowledge of Upstream as well as the Downstream Processes
• Additional responsibilities may include but not limited to hiring, training, work planning and evaluation
• Responsible for aligning the work schedules to the overall project timelines and will be required to prepare and communicate work progress periodically.
RS/SRS/GL/SGL - Analytical Research
Essential requirements : MTech./MSc (Biotechnology, Biochemistry) with sufficient Industry experience in Biotechnology in a R&D setup in Analytical Research of mAbs/ Biosimilars/ Biologies.
Job Function : The incumbents will develop, validate and qualify methods based on HPLC/UPLC/LC- MS/Bioassay/CE/CD/FTIR for characterisation of biosimilars and mAbs.
• Responsible for development of methods to characterise the biosimilars and mAbs
• Responsible to vaildate and qualify the developed methods and prepare STPs/SOPs and related documentations.
• Person will have sound knowledge of recombinant proteins, biophysical, biological and biochemical methods and similarity analysis of biosimilars.
Research Scientist / Senior Research Scientist - Molecular Biology, Bacterial Fermentation, Protein Purification
Essential requirements : MTech./ MSc (Biotechnology, Biochemistry) with sufficient Industry experience in Biotechnology in a R&D setup in molecular biology, fermentation, protein isolation and purification.
Job Function : The incumbents will develop clones/cell lines, perform shake flask studies and fermentation for growth of microbial cells, isolate and purify recombinant proteins of biosimilars, peptides and mAbs.
• Responsible for development of clones/cell lines, perform shake flask studies and fermentation for growth of microbial cells, isolate and purify recombinant proteins of the biosimilars/ peptides and mAbs
• Responsible for developing the processes for upstream and downstream development of recombinant products
• You will have working knowledge of recombinant proteins, various expression systems and protein purification strategies
Location : Manesar, Gurugram, Haryana
If your profile matches with the above requirement, please mail your CV to firstname.lastname@example.org
Kindly mention the Job Title in the subject line.
Last Date : 20th September, 2023
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