Manufacturing Biotech Associate
Manufacturing Biotech Associate
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Job Description
About PSC Biotech
Who are we
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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Overview:
This role will be part of Manufacturing Self Directed work team/ Hub in our new state of the art single use multiproduct biotech facility . The organisational structure at the site will be based on selfdirected work teams (SDWT) where decisions will be made at the level where the data exists.
The BTA is responsible for all procedures and processes associated with the manufacture of Drug Substance at manufacturing facility at the highest standards of Safety Quality and Compliance.
This role is a site based role.
This role will involve working shift on a 24/7 basis.
Requirements
Responsibilities:
- Participate in internal audit programs and risk assessment compliance activity.
- implemented.
- Coach shift teams related to RFT documentation.
- Lead by example through coaching and mentoring on Production systems skill transfer.
- Coach CAPAs Change actions/ SOP updates training module development/revision related to cell area
- Utilise realtime data analytics for making decisions on the value stream improvement intiatives.
- Troubleshoot and resolved issues and delays
- Leads and participates in investigations arising from manufacturing documentation aspects when required.
- Promote EHS leadership behaviours and engages employees at all levels on EHS issues.
- Promote an environment where everyone speaks up for our culture of safety and looks out for one another.
- Confirms that all activities have been correctly completed by the end of shift such as Realtime batch record/ SAP Comet review and elogs review.
- Be a visible leader of safety initiatives and stay actively involved in safety forums.
- Act as a Cell Lead and be responsible for a unit operation.
- Any other duties as and when assigned by the Manager.
Skills & Education:
- Ability to interact with multiple stakeholders across numerous departments.
- Excellent communication skills.
- Ability to manage multiple priorities and know when to escalate issues for resolution.
- Excellent trouble shooting skills as well as an ability to coach and mentor selfdirected teams through complex problem solving.
- Level 7 qualification in a science or engineering discipline or Level 6 with a minimum of 13 years experience in a GMP regulated Manufacturing environment.
- Experience of Upstream/ Downstream Processing.
- Experience in a highly regulated pharmaceutical manufacturing environment would be desirable.
- Proven record of accomplishments in a regulated industry.
- Startup experience in a large scale commercial drug substance facility or similar.
Level 7 qualification in a science or engineering discipline, or Level 6 with a minimum of 1-3 years experience in a GMP regulated Manufacturing environment. Experience of Upstream/ Downstream Processing. Experience in a highly regulated pharmaceutical manufacturing environment would be desirable. Proven record of accomplishments in a regulated industry.
Education
Level 7 qualification in a science or engineering discipline, or Level 6 with a minimum of 1-3 years experience in a GMP regulated Manufacturing environment. Experience of Upstream/ Downstream Processing. Experience in a highly regulated pharmaceutical manufacturing environment would be desirable. Proven record of accomplishments in a regulated industry.
Employment Type
Full Time
