Stelis Biopharma Private Limited (Stelis) is a vertically integrated biopharmaceutical company with R&D, process scale up and end –to- end manufacturing capabilities from drug substance to finished drug products in all injectable formats. Stelis has a state of the art research facility in Bengaluru along with a soon-to-be commissioned 200,000 square feet integrated bio-manufacturing facility catering to biologic APIs and injectables conforming to international standards. The principal shareholders of Stelis are Strides Pharma, Tenshi Life Sciences Private Limited ( Integrated Life Sciences Company) and GMS Holdings ( Group of diversified business and assets with a strong biopharma franchise in the MENA region).
DS Manufacturing - Associate and Sr. Associate
Qualification and Experience
Upstream Manufacturing – M.pharm/ B.pharm/ B.sc/ M.Sc/ Any Engineering with 3-6 Years of relevant Experience
Key Skills : Responsible for Monitoring and operation of Fermenters, Centrifuge. Homogenizer, TFF, Autoclave, filter integrity, etc. Responsible to perform the IQ, OQ, PQ related to Upstream processing Equipment In Drug substance facility. Responsible for Preparation of cell bank. Seed development for the manufacturing batch process. Responsible for Preparation of Protocols, SOPs, BMRs, BPRs and other related documents.
Qualification and Experience
Downstream Manufacturing - M.pharm/ B.pharm/ B.sc/ M.Sc/ Any Engineering with 3-6 Years of relevant Experience
Key Skills : Responsible for Monitoring and operation of High/Low pressure Chromatography system. TFF, Lyophilizer, Autoclave. Filter integrity, etc. Responsible to perform the IQ, OQ, PQ related to Downstream processing Equipment in Drug Substance facility.
Quality Control
Qualification and Experience
M.pharm/ B.pharm/ B.sc/M.Sc/ Any Engineering with 3-6 Years of relevant Experience
Key Skills : Testing of intermediates, finished products using standard operating procedure and Instrumental techniques (HPLC. GC, CE). Preparing Quality reports. Including analytical reports (for In-process and finished products). Certificates of Analysis (CoA) and stability reports. Responsibility for peptide mapping. Glycan analysis. Charge related variants by CEX. and HIC, SEC analysis.
QC Microbiology
Qualification and Experience
M.Pharm/B.Pharm/ B.sc/ M.Sc/ Any Engineering With 3 to 6 Years of Experience
Key Skills : Responsible for Environmental monitoring of Sterile and Non Sterile facility. Responsible for Handling Excursions. Investigation and completion of reports. Responsible for Preparation of trends analysis for Environment monitoring. Responsible for Checking and Review of microbiology data and report of microbiological analysis.
QA - Validation
Qualification and Experience
M.Pharm/B.Pharm/ B.sc/ M.Sc/ Any Engineering With 3 to 6 Years of Experience
Key Skills : Develop. Implement, control, and upgrade validation approach and systems to ensure that GMP Quality Systems are complied with from Project to commercial manufacturing activities of Drug Substance and Drug product at the manufacturing facility. Coordinate and perform all vendor qualification and compliance audits as applicable to Validations.
IPQA
Qualification and Experience
M.Pharm/B.Pharm/ B.sc/ M.Sc/ Any Engineering With 3 to 6 Years of Experience
Key Skills : To ensure the cGMP compliance in the Fill finish Manufacturing and Fill finish manufacturing Warehouse areas. All in process quality assurance activities which are executing in the shop floor. Providing Line clearance to the shop floor activities (FFM, Warehouse, Labelling and Packing, and distribution Warehouse) as per the respective records/procedures.
Engineering & Maintenance - Associate and Sr. Associate
Qualification and Experience
Engineering/ Diploma in Electrical. 3-6 Years of relevant Experience
Key Skills : Experience in handling Operation & Maintenance of Electrical in Pharma- Injectable Formulation/DS- Fermentation (Microbial / Mammalian) manufacturing setup. Should have experience in handling Preventive. Breakdown 8 Maintenance of electrical equipment's related to Formulation- Filling lines. Isolators, Autoclaves. Packing lines. Pass boxes. LAF 8 Compounding vessels.
Qualification and Experience
Engineering / Diploma in Mechanical. 3-6 Years of relevant Experience
Key Skills : Experience in handling Operation & Maintenance of Pharma Injectable Formulation/DS- Fermentation (Microbial / Mammalian) In manufacturing setup. Should have experience In handling Preventive, Breakdown & Maintenance of Mechanical equipment's related to Formulation- Filling lines. Isolators, Autoclaves. Packing lines. Pass boxes. LAF & Compounding vessels.
Qualification and Experience
Engineering/ Diploma in Electronics/ Instrumentation. 3-6 Years of relevant Experience
Key Skills : Experience in handling Operation &Maintenance related to Automation & Instrumentation In Pharma Injectable Formulation/DS- Fermentation (Microbial / Mammalian) in manufacturing setup. Knowledge of SCADA. PLC, HMI, Ladder logic. Software back up.
IT - Sr. Associate and Team Leader
Qualification and Experience
Any Engineering grduatc with 7-9 Years of relevant Experience
Key Skills : Maintain 21 CFR part 11 Compliance in all system and process. Support CSV activities related to IT. Implement the data integrity and security measures as per the IT Guidelines. Ensuring regular data backup as per the SQP.
Date: Sunday 23rd June 2019
Time : 9:00 AM to 12:30 PM
Interview Venue
Stelis Biopharma, Plot No. 293, Bommasandra, Jigani Link Road, Jigani Industrial Area, Anokal Taluk, Bengaluru - 560105
Required Documents : Resume, Latest Salary break-up letter & 3 Pay Slips; 1 Passport Size Photo, ID Proof, Highest Educational Certificates and Mark sheets.
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