Senior Associate – Drug Product

Manufacturing

About Stelis

Stelis Biopharma is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), with a complete and integrated end-to-end offering. We work side-by-side with our clients as true partners, with customer-centric collaboration and communication. We provide world-class process development and manufacturing infrastructure for both drug substance (mammalian and microbial-based therapeutic proteins and viral vectors) and drug product (lyophilized vials, liquid vials, pre-filled syringes, cartridges and devices). Our highly experienced quality and regulatory personnel help us meet global quality standards, ensure compliance and guide our clients through the regulatory approval process. Our three state of the art facilities are staffed by over 700 highly talented professionals. As the most agile CDMO in the industry, Stelis Biopharma is a trusted CDMO partner of choice. To learn more, visit www.stelis.com

Primary responsibilities

  • Perform manufacturing activities such as operation and cleaning of autoclaves / sterilizers, compounding vessels, filtration vessels, pass-boxes, filter integrity machines, LAFs, bag sealing machines, weighing balances, filling line equipment / accessories, cRABS / oRABS and Lyophilizer 
  • Preparation of equipment / equipment accessories / glassware by performing cleaning-in-place (CIP), cleaning out-of-place (COP), conducting operator inspections / checks and sterilization-in-place (SIP)
  • Support the validation of equipment, process / product (media fill) and process areas
  • Identify and implement manufacturing procedures as per the GMP requirements
  • Prepare and review IQ, OQ and PQ protocols of autoclaves / sterilizers, compounding vessels, filtration vessels, pass-boxes, filter integrity machines, LAFs, bag sealing machine, weighing balances, filling line equipment / accessories, cRABS / oRABS and Lyophilizer
  • Prepare and execute media fill studies for cartridge, pre-filled syringe and vial suites
  • Prepare and deliver training on QMS and safety SOPs in the department
  • Prepare / review SOPs / protocols related to equipment and drug product facility
  • Work according to company policies, procedures and regulatory requirements
  • Timely initiation, investigation, impact assessment and closure of QMS elements
  • Adhere to the EHS guidelines and ensure good housekeeping standards 

Key requirements

  • Bachelor’s in pharmacy with minimum 5 years of relevant experience or master’s in pharmacy with minimum 3 years of relevant experience
  • Strong background and knowledge of manufacturing and compliance
  • Ability to work collaboratively with cross-functional teams 
  • Effective communication skills are required, both written and verbal

Reference code: ASADP01

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