Downstream Bioprocess 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 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

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 opportunity has arisen for a Downstream Bioprocess Associate.

The site will play a pivotal role in the manufacture of our biologicsbased medicines including in the area of immunooncology. Our Biotech Facility will be our first ever LargeScale MammalianBased Drug Substance Facility with the mission and ambition to manufacture breakthrough medicines from Ireland serving patients around the world. This facility is a significant supplier of drug substances for our ImmunoOncology treatments and will also be critical in the future supply of new biotechnology products to its global network.

We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another s thinking and approach problems collectively. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.

Requirements

Role Functions:

• Work with the manufacturing operations group project design team the CQV team the Automation/CSV reps to facilitate the development and validation of the Biotech facility manufacturing facility.
  
• Support Equipment Design/ HAZOP and Room programming reviews as per requirements.
  
• Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs)e.g. EHS metrics Production Plan OEE compliance and team training.
  
• Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
  
• Work as part of a dedicated process team where flexibility and teamwork are a key requirement
  
• Generate SOPS/Electronic Batch Records for startup.
  
• Adhere to Right FirstTime principals
  
• Provide assistance and/or support maintenance engineering quality or other colleagues as requested.
  
• Escalate issues as appropriate to Process Lead
  
• 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.
  

Experience Knowledge & Skills:

General:

• Demonstrated successes in a team environment such as project teams Lean Six Sigma team etc.
  
• Demonstrated problem solving capabilities.
  
• Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment
  

Technical:

• Experience in a highly regulated pharmaceutical manufacturing environment is desirable.
  
• Startup experience in a largescale commercial drug substance facility desirable but not essential.
  
• Good understanding of Upstream/Downstream Processing and experience an advantage.
  

People:

• Ability to interact with multiple stakeholders across numerous departments
  
• Excellent communication skills and the ability to work in a cross functional collaborative environment.
  
• Good interpersonal skills attentiveness and an approachable manner for interactions with inter departmental colleagues.
  
• High degree of problemsolving ability and adherence to scheduled timelines
  

Qualification:

• Minimum of a Level 7 qualification in a science or engineering discipline.
  
• A level 6 with a minimum of 3 years experience in a GMP Manufacturing requirement shall be deemed equivalent.
  

Shift Pattern:24/7 4Cycle shift (2 Days 2 Nights 4 days off)