LSC have a great contract opportunity for a External Manufacturing Drug Substance - Technical Operation to join a global biopharmaceutical company in Cork.
If you have minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES
- Work with External Partners to achieve business goals and to establish a common culture that benefits our company, External Partners, and patients.
- Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
- Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
- Provide on-site coverage at External Partner in support of Commercial and / or Technology Transfer Person-In-Plant Activities.
- Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
- Must Have Drug Substance Technical Transfer Experience for this role.
- Antibody Drug Conjugate experience/ Conjugation experience is preferred for this role
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Kieran O'Sullivan at LSC on 021-4777329 if you have anymore questions about this External Manufacturing Drug Substance - Technical Operation opportunity!