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Current Openings - R & D

Purchase

Job Title :Purchase - AM/Sr.Executive/Executive – Pharma/Biopharma

No. Of Positions : 5

Job Requirements :

  • Looking for candidates with Pharma Work experience.
  • Having 2-5 years experience in procurement. (Lab Chemicals and consumables, Engineering, Maintenance, civil, General Consumables, stationery, Safety Items)
  • Should be from Pharma background
  • Knowledge of Tally and preparation of PO in SAP and its distribution
  • Knowledge of MS office

Job Description:

  • Internal Co-ordination with Stores, Finance & user dept. for daily activities like receipt of material, payments to vendor.
  • Daily review of indents, Keep track and update status to end user on weekly/monthly basis or as and when required, seek clarifications of requirement from the end user.
  • Preparation of comparative statement & Purchase Orders.
  • Bill forwarding to finance for payment.
  • Co-ordination for collection of Material from Transport godown along with store person.
  • Routine follow up for purchase order-delivery of materials.
  • Keeping track of payment.
  • Reporting to HOD for daily activities.


Cell Culture (R&D Biologics)

Job Title : Purchase - Cell Culture (R&D Biologics) - Associate Scientist / Scientist

Experience : 4 - 5 Years of working experience in Pharma Industry

Education : Bachelor's (Preferred)

No. Of Positions : 3

Job Type : Full-time

Job Description :

  • Hands-on experience in cell line maintenance (CHO-S, CHO DG44 and/or Sp2/0), cell banking, revivals
  • Hands-on experience in Cell line development - transfections (chemical/electroporation), clone selection, media optimization, development of high expressing stable clones expressing Mab, fusion proteins and glycoproteins.
  • Be able to interface with the analytical group for clone selection and establishment of quality parameters
  • Experience in Clean Room processes and documentation.
  • An individual will also be expected to document work in the laboratory notebook.
  • Leadership - Ability to lead a team of 2-3 members and hands-on experience in DoE will be a definite plus.


Upstream Process Development - Mammalian

Job Title:Upstream Process Development (Biopharma) - Sr. Manager/Manager/DM

Job Description :Sr. Manager/Manager/DM Upstream Process Development

No. Of Positions : 1

Description :

  • 8-10 years experience in RnD, in CHO cell line based MAbs/fusion proteins/Glycoproteins upstream process development that includes
  • Scales between 15ml (Ambr), 2-10L glass bioreactors (Sartorius, NBS etc) and 50L SUB (Sartorius, Pall, GE)
  • Cell revival, banking, seed preparation, media/additives preparation
  • Bioreactors setup, sampling, sample analysis
  • Should have managed team of 6-10 RnD staff, including training/documentation
  • Well versed with clean room techniques, RnD Bioreactor setup and GLP documentation processes
  • Technology transfer experience to Manufacturing will be a definite advantage
  • Hands-on experience with DoE software will be a definite advantage
  • Candidates to highlight achievements in above areas.


Upstream Process Development - Mammalian

Job Title : Upstream Process Development - Mammalian (Biopharma) - Sr. Research Associates/Asst-Managers

Experience : 4 - 6 Years of working experience

Education : Bachelor's (Preferred)

No. Of Positions : 3

Job Type : Full-time

Job Description :

  • 4-6 years experience in RnD, in CHO cell line based MAbs/fusion proteins/Glycoproteins upstream process development that includes
  • Scales between 15ml (Ambr), 2-10L glass bioreactors (Sartorius, NBS etc) and 50L SUB (Sartorius, Pall, GE)
  • Cell revival, banking, seed preparation, media/additives/buffer preparation
  • Bioreactors setup, sampling
  • Should have managed team of 2-4 RnD staff
  • Well versed with clean room techniques, RnD Bioreactor setup and GLP documentation processes
  • Hands-on experience with DoE software will be a definite advantage
  • Candidates to highlight achievements in above areas.
  • Research,Technology Transfer,Process Development,scale up,pilot scale,CHO cells,MAbs,Upstream,Mammalian Cell Culture,GLP,glycoprotiens,Fusion protiens


Analytical Development

Job Title : Analytical Development (Biopharma) - Sr.research Associate / Scientist

Experience : 2 - 5 Years of working experience

Education : Bachelor's (Preferred)

No. Of Positions : 3

Job Type : Full-time

Job Description :

  • Method Development for in-process characterization/estimation of yields of MAbs / fusion proteins / Glycoproteins
  • Hands-on experience with PAT tools, Analysis, and de-bottlenecking of processes developed results obtained
  • Should have worked closely with process groups (Upstream, Downstream or Formulation Development) on debottlenecking processes being developed for fermentation, purification or formulation of recombinant proteins
  • Hands-on experience in running and analyzing raw data from any of the following - HPLCs (with fluorescence/PDA/UV/QDa detectors), BLI, DSC, CZE, Multimode readers, Fluorescence/IR Spec, multi-chemistry analyzers
  • Maintaining GLP records, identifying and incorporating the latest Process Analytical technologies into development programs for existing and new molecules

Expected to be a team player with potential leadership qualities. Previous experience in the Biopharma Industry is MUST.

Urgent Opening in R&D for Analytical Development!!

Analytical

Position Title : Executive / Sr Executive  

Education Qualification :  M. Pharma / B. Pharma / MSc

Experience : 1 - 6 Years experience

Job Description :

Analytical method development of formulations. Injection, ophthalmic and derma product experience Onco and non-onco


Analytical Documentation

Position Title : Executive / Sr Executive  

Education Qualification :  M. Pharma / B. Pharma / MSc

Experience : 2 - 6 Years experience

Job Description :

Responsible for preparation of Raw material / Finished product Spec & STP, General Procedures, SOPs, E&L risk assessment and change notifications. Coordination with GMP


Project Management

Position Title : Trainee / Executive / Sr Executive  

Education Qualification :  M. Pharma / B. Pharma

Experience : 1 - 6 Years experience

Job Description :

Preparation of Project timelines, co -ordination with CFT team, Project costing, interaction with CRO and CMO


Formulation Development Oral solid dosage form (FDD - Onco and non-onco)

Position Title : Executive / Sr Executive  

Education Qualification :  M. Pharma

Experience : 2 - 6 Years of working experience

Job Description :

Formulation development of Onco and Non-Oncological drug products: IPR/Regulatory landscape assessment, formulation development trials, Scale up trials, Stability studies, co -ordination with CFT team for smooth regulatory filings


Formulation Development Department Oral solid dosage form((FDD )

Position Title : Dy Manager / Manager  

Education Qualification :  M. Pharma

Experience : 8 - 12 Years experience

Job Description :

Development of Non-infringing formulations for Para IV strategies, 505(b)2 Products etc. Review and monitoring of documents according to USFDA, EU and ICH guidelines including MFC, Specifications (In process, finished and shelf life) and stability protocol, Product development report as per QbD.


Formulation Development Department Onco -Injectable(FDD )

Position Title : Tr. Executive / Executive / Sr Executive  

Education Qualification :  M. Pharma

Experience : 1 - 4 Years experience

Job Description :

Onco Injectable Formulation development experience.


Pharmacovigilance and Clinical Affairs Department

Position Title : Executive / Sr.Executive / Assistant Manger  

Education Qualification :  M. Pharmacy / Pharm D

Experience : 3 - 5 Years experience

Job Description :

  • Profound knowledge of regulatory guidelines.
  • Able to travel frequently for monitoring the clinical studies executed in different CRO’s.
  • Knowledge on Management of Clinical Trial sites.
  • Knowledge on BE-NOC and Import- License applications for the conduction of clinical studies.
  • Experience in Medical writing activities viz clinical study protocols, clinical study reports (Module 5 eCTD), Non-clinical and Clinical overviews (module 2.4 & 2.5).

Position Title : Executive to Assistant Manager  

Education Qualification : M. Pharmacy (pharmacology)/ Doctor of Pharmacy /M.B.Bs/B.D.S

Experience : 1 - 5 Years experience

Job Description :

The Drug Safety Associate will provide technical and process-related support to drug safety management (post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).


SCM (Supply Chain Management)

Position Title : Dy Manager  

Education Qualification : M.com / B.com + MBA

Experience : 5 - 8 Years experience

Job Description :

Source identification /Evaluation/ procurement for RM/PM/SPM /consumables for commercial procurement


Position Title : Sr Executive  

Education Qualification : M.com / B.com

Experience : 3 - 5 Years experience

Job Description :

RM/PM/SPM/ consumables - procurement - PO preparation, follow up with vendor and delivery


Position Title : Executive  

Education Qualification : M.com / B.com + MBA

Experience : 2 - 3 Years experience

Job Description :

RM/PM/SPM/ consumables - procurement - PO preparation, follow up with vendor and delivery


RAD (Regulatory)

Position Title : Sr Manage  

Education Qualification : M.Pharma / B.Pharma

Experience : 10 - 12 Years experience

Job Description :

Must have adequate knowledge to file the products in different Geographic's (US & Europe)


E&L (Extractable and leachable)

Position Title : Executive / Sr Executive 

Education Qualification :  M.Pharma (Pref analytical chemistry) / MSc (Chemistry or analytical chemistry)

Experience : 2 - 5 Years experience

Job Description :

To support sample processing, Basic understanding of chromatographic instruments, Preparation of reagents, Importance of calibration, Good laboratory practices & safety.


IPR

Position Title : Executive / Sr Executive / AM  

Education Qualification :  M.Pharma

Experience : Fresher

Job Description :

IPR functions; Patent searching, report preparation, patent drafting etc.


Packaging Development

Position Title : Executive / Sr Executive  

Education Qualification :  M. Pharm / B. Pharm / Diploma / PG in Packaging Technology

Experience : 2 - 6 Years experience

Job Description :

Development of primary and secondary packaging materials. Documents preparation, characterization & Testing of reference product.


Position Title : Asst.Manager / Dy.Manager  

Education Qualification : M. Pharm / B. Pharm / Diploma / PG in Packaging Technology

Experience : 8 - 10 Years experience

Job Description :

Responsible for Development of primary and secondary packaging materials. Documents preparation, characterization of product.


Position Title : Designer  

Education Qualification : Diploma in Graphic design, Experience in CorelDraw and Adobe

Experience : 3 - 5 Years experience

Job Description :

Artwork designer for Label, Carton, Leaflet and other packaging designs



Formulation R&D (Transdermal dosage form)

Position Title : Officer / Executive  

Education Qualification :  M. Pharma

Experience : 2 - 5 Years experience

Job Description :

  • Literature survey along with patents relevant for product.
  • Studying journals and research articles, keep up with the latest technologies/ methods for product development.
  • Prepare product development plan (PDP), stability protocols and product development reports (PDR).
  • Performing Pre-Formulation studies.
  • To follows cGMP, GLP, GDP and other pharmaceutical guidelines to comply the regulatory aspects.
  • Planning and execution of different formulations/ approaches for the product development as part of QbD.
  • Planning and execution of compatibility studies for the product.
  • Co-ordination with cross functional team for smooth development and execution of plans.
  • Preparation/compilation of stability data of the product developed to get the inference.
  • Preparation of tentative specifications along with the proper justification for products.
  • Access the process and include the mitigation steps/ control strategies based on inference from the stability data, (if required) to get the desired CQAs in the set specifications.
  • Updating of Log book, Product book, Calibration records.
  • Creation of raw material code, product development code SFG code at respective stages of the product development.
  • Performing IQ, OQ PQ for the instruments/equipments.

Preparation of Standard operating procedures and guidelines.



Analytical R&D

Position Title : Officer / Executive  

Education Qualification :  M. Pharma / B. Pharma / M.Sc (Chemistry)

Experience : 2 - 5 Years experience

Job Description :

  • Job Description: Literature survey along with patents relevant for product.
  • Analysis of development batches samples.
  • Stability studies for Pharmaceutical drug products.
  • Analytical method developments for Assay, RS, Dissolution, Diffusion etc.
  • Performance of Analytical Method validations.
  • Reverse engineering of RLD Products.
  • Responsible for calibration of analytical instruments.
  • Support to preparation of STP, SOP’s & general procedures.
  • Timely documentation of executed activities as per applicable GLP practices.
  • Ensure the cleanliness of working area.
  • Ensure to take care of all safety standards while working.
  • Responsible for compliance of all SOPs and guidelines applicable.
  • Literature Survey (Using USP, EP, BP, JP and Public domain like Sci-finder, STN, Science direct, Elsevier. etc).
  • Support for Analytical Method Transfers to plant.


Quality Assurance

Position Title : Manager / Sr.Manager  

Education Qualification :  M. Pharma

Experience : 12 - 15 Years experience

Job Description :

(Hands on experience on VQM, CMO quality management, regulatory support)

Handling of QMS during pilot/exhibit/commercial stage in various identified CMOs within and outside India for solid orals, injectable, ophthalmic and semisolid dosage forms (non-oncology). Facility audits of identified CMOs as per schedule, audit report and CAPA. Quality agreement and their management. Review and approval of exhibit batch documents (technology transfer documents) at pilot/exhibit stage. Submission of CMC documents to RA team.. Support Project management and formulation development during technical project management. Support ROW regulatory team for filling requirement.


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