Bioprocess Associate

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.

Role Description:

This role will be part of Manufacturing Self Directed workteam/ Hub in our new state of the art single use multi-product biotech facility.The organisational structure at the site will be based on self-directed workteams (SDWT) where decisions will be made at the level where the data exists.The BTA is responsible for all procedures and processes associated with themanufacture of Drug Substance at manufacturing facility, at the higheststandards of Safety, Quality and Compliance. The BTA will be responsible forundertaking manufacturing operations involved in the production of biologicdrug substance on their designated shift. Key responsibilities include theexecution of an automated recipe using paperless technology to progress thedrug substance through inoculation and cell culturing activities, leading tofiltration and purification of the product in a state-of-the-art single use technology-basedfacility. The incumbent will be involved in setting up the single use equipmentbetween runs, carrying out the production process according to world class GMPand EHS principles. The BTA will also be involved in driving to optimise andimprove the processing activities through use of standard work and leanprocessing techniques while supporting operations team to consistently deliveron specific Key Performance Indicators (KPIs). At all times this role isfocused on delivery to the patient through living the culture including acommitment to safety, focusing on right first time in everything we do and aconcentrating on the engagement and development of self and peers.

Role Functions:

· Primary responsibilities include but not limitedto:

· Support operations team to consistently deliveron specific Key Performance Indicators (KPIs), e.g. Environmental Health andSafety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE),compliance and team training.

· Complete COMMIT cards to highlight ways ofworking within our SDWT's and Hubs and across our site that support our COMMITculture.

· Provide immediate feedback to others at any timeto reinforce good safety and improvement behaviours and acts.

· Execute commercial manufacturing processesaccording to established work instructions and Standard Operating Procedures(SOPs).

· Ensures that all assigned task related tomanufacturing documentation support is in accordance with good manufacturingpractices.

· Routinely talk about any safety issues you areconcerned about.

· Work as part of a dedicated proess team whereflexibility and teamwork are a key requirement.

· Generate SOPs/ Work Instructions (WIs) to ensurecompliance with regulatory standards.

· Adhere to Right First-Time principles.

· Provide assistance and/or support maintenance,engineering, quality or other colleagues as requested.

· Escalate issues as appropriate tomanager/designee.

· Maintain a high level of personal expertise andworking knowledge of all aspects of the manufacturing process and processequipment through continuous training and development.

· Liaise with other groups and individuals toensure planning of tasks is effective and linked into the manufacturing processplan and site schedule.

· Challenge and identify improvements to thesafety and environmental programmes on site.

· Celebrate with use of proactive recognitiontools that inspire teams and individuals you collaborate with.

· Take part in shift handovers and tier 1meetings, raising concerns or issues promptly and providing options forresolutions.

· Act as an ERT during emergency situation iftrained.

Experience, Knowledge & Skills

· Demonstrate success in a team environment ineither a project or work related activities.

· Desire to learn and develop.

Technical:

· Understanding of Drug Substance ManufacturingOperations.

· Understanding of GMP requirements in aBiopharmaceutical Facility.

· Excellent communication skills and the abilityto work in a cross functional collaborative environment.

Qualifications & Education:

· Level 7 qualification in a science orengineering discipline, or level 6 with a minimum of 1 - 3 years' experience ina GMP Manufacturing environment.

· This role is a site-based role.

· This role will involve working Shifts, on a 24/7basis.