Technical Operations
6 months ago
Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Job Title: Technical Operations - Manufacturing Drug Specialist
RequirementsJob Description:
Our engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
The External Manufacturing (ExM) Technical Operation organization is seeking a highly motivated individual for a Technical Transfer position. ExM Tech Ops is accountable for technology transfers and commercial production of Large Molecule Drug Substance at our External Partners (EPs). This person will have the opportunity to participate in all these areas. This may include supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity optimization.
Requirements
Responsibilities include:
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.
Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
Responsible for participation in creating, sharing, and adopting best practices and business process strategies.
Education Minimum Requirement:
Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Required Experience and Skills:
Must Have Drug Substance Technical Transfer Experience for this role (4/5 Years).
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
Travel will be a requirement of this position at approximately 25%
This role will be 100% onsite, based in Louth.
Strong communication and teamwork skills
Preferred Experience and Skills:
Proven expertise in biologic drug substance upstream and downstream operations, analytical testing, process development and tech transfer.
Demonstrated ability to independently manage projects/work to schedule/deadlines Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
Experience in deviation management and/or change control and/or equipment support, and/or project management.
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