Lead Biotech Associate-Shift

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.

Overview:

• A fantastic and exciting opportunity has arisen for a
  contract Lead Manufacturing Biotech Associate
  
• The Lead Manufacturing Biotech Associate will work across
  the site self-directed work teams and hub teams to identify and resolve issues
  in order to allow the site to deliver on our commit culture that support
  Quality, EHS, Learning and Continuous improvement. Reporting to the Downstream
  Shift Lead, this role is a critical role on the manufacturing team, with
  responsibility focused on a team-based commitment to batch progression and
  technical SME knowledge.
  
• This individual, being the most senior member of the
  shift suite operations team, will take ownership of the direct activities
  occurring within a suite. The lead BioTech Associate will act as point person
  for the progression of the batch, liaising with the Manufacturing shift lead
  and shift engineer on team delivery throughout the shift. The role will involve
  project management and problem solving of issues as they occur and also SME
  involvement in new projects on behalf of Manufacturing, training and development
  of new employees and ensuring the operations area is at the standard required.
  The Lead BTA will act as primary delegate for the manufacturing shift lead with
  responsibility for ensuring the finite schedule is delivered in a safe and
  compliant manner.
  
  

Requirements

What you will do:

Bring your energy, knowledge, and innovation to:

• The production of biologic drug substance on their
  designated shift and act as a coach and a technical point of contact for others
  on the shift team, acting as a key liaison for the manufacturing shift lead for
  ongoing operations in a process area.
  
• Trouble shooting and problem solving in conjunction with
  the ability to lead the self-directed work teams in their processing area.
  
• The progression of an automated recipe using paperless
  technology in order to generate the drug substance through filtration and
  purification of the product.
  
• Setting up the single use equipment between runs,
  carrying out the production process according to world class GMP and EHS
  principles and driving to optimize and improve the processing activities
  through use of standard work and lean processing techniques.
  
• Focusing on delivery to the patient through living the  culture including a commitment to safety,
  focusing on right first time in everything we do and concentrating on the
  engagement and development of self and peers.
  
• Act as a coach or mentor to one’s peers on specific unit
  operations as required to support the value stream
  
• Lead and sponsor approved projects and continuous
  improvement initiatives that are in alignment with the site strategies.
  
• Act as primary delegate for the manufacturing shift lead
  during emergency events.
  

What skills you will need:

• Minimum of a Bachelor’s Level 8 degree in a technical,
  engineering or science based discipline or equivalent
  
• At least 5 years’ experience in the biopharmaceutical
  industry.
  
• Leadership Skills – demonstrated ability to lead and
  achieve outstanding results.
  
• Proven record of accomplishments in a regulated industry,
  thorough knowledge of current Good Manufacturing Practices (cGMP) and general
  technical and biologic operations understanding required.
  
• Ability to think logically and be proactive under
  pressure.
  
• Ability to work as part of a team and on own initiative
  in a constructive manner.
  
• This role is a site-based position. This role will
  involve working shifts, on a 24/7 basis.
  
• Shift role: 3-2-2 at first, later 4-on/4-off