Biotech Associate

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 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.

• This role will be part of Manufacturing Self Directed
  work team/ Hub in our new state of the art single use multi-product biotech
  facility. The organizational structure at the site will be based on
  self-directed 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 Our Company’s manufacturing
  facility, at the highest standards of Safety, Quality and Compliance.
  
• The BTA will be responsible for undertaking manufacturing
  operations involved in the production of biologic drug substances on their
  designated shift. Key responsibilities include the execution of an automated
  recipe using paperless technology in order to progress the drug substance
  through inoculation and cell culturing activities, leading to filtration and
  purification of the product in a state-of-the-art single use technology based
  facility. The incumbent will be involved in setting up the single use equipment
  between runs, carrying out the production process according to world class GMP
  and EHS principles. The BTA will also be involved in driving to optimize and
  improve the processing activities through use of standard work and lean
  processing techniques while supporting operations team to consistently deliver
  on specific Key Performance Indicators (KPIs). At all times this role is
  focused on delivery to the patient through living the culture including a
  commitment to safety, focusing on right first time in everything we do and a
  concentration on the engagement and development of self and peers.
  
• Complete COMMIT cards to highlight ways of working within
  our SDWT’s and Hubs and across our site that support our COMMIT culture.
  
• Provide immediate feedback to others at any time to
  reinforce good safety and improvement of behaviors and acts.
  
• Execute commercial manufacturing processes according to
  established work instructions and Standard Operating Procedures (SOPs).
  
• Ensure that all assigned task related to manufacturing
  documentation support is in accordance with good manufacturing practices.
  
• Routinely talk about any safety issues you are concerned
  about.
  
• Work as part of a dedicated process team where
  flexibility and teamwork are a key requirement.
  
• Generate SOPs/ Work Instructions (WIs) to ensure
  compliance with regulatory standards.
  
• Adhere to Right First-Time principles.
  
• Provide assistance and/or support for maintenance,
  engineering, quality or other colleagues as requested.
  
• Escalate issues as appropriate to manager/designee.
  
• Maintain a high level of personal expertise and working
  knowledge of all aspects of the manufacturing process and process equipment
  through continuous training and development.
  
• Liaise with other groups and individuals to ensure
  planning of tasks is effective and linked into the manufacturing process plan
  and site schedule.
  
• Challenge and identify improvements to the safety and
  environmental programmes on site.
  
• Celebrate with use of proactive recognition tools that
  inspire teams and individuals you collaborate with.
  
• Take part in shift handovers and tier 1 meetings, raising
  concerns or issues promptly and providing options for resolutions.
  
• Act as an ERT during emergency situation if trained.
  

Requirements

Additional Notes:

• 11 months contract
  
• onsite, no overtime, no travel