Senior Specialist MS&T

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.

Job Description

The Senior Specialist MS&T (Downstream Process
Sciences) delivers a range of technical support to the Drug Substance Business:
supporting technical investigations within the Integrated Process Team,
supporting significant projects in the MS&T laboratory, while creating an
inclusive culture that

energizes a Safety First, Quality Always, with a
continuous improvement mindset.

Requirements

• Leading, designing, supporting and executing downstream
  technical projects (e.g. UFDF(Ultrafiltration/Diafiltration), Chromatography,
  filtration) at small scale to support large -scale
  
• manufacturing.
  
• Executing experimental design, data analysis and
  interpretation to resolve technical projects and
  
• complex investigations/deviations.
  
• Supporting, training and mentoring the Process Sciences
  team during small scale model run execution, including buffer preparation,
  lab -scale equipment set up, run execution, sampling and data analysis.
  
• Author and review standard operating procedures (SOPs),
  protocols and reports as required.
  
• Identifying and supporting continuous improvement
  opportunities through Lean Six Sigma methodologies.
  
• Leading process improvement, technical problem -solving
  and troubleshooting with end -to -end product focus. Assist in investigations,
  ensuring effective Root Cause Analysis and CAPAs.
  
• Supporting alignment and knowledge exchange with
  departments, development organizations, other commercial nodes and external
  manufacturing partners.
  

Qualification and Experience:

General Competencies:

• Demonstrated leadership and change management skills with
  a continuous improvement focus
  
• Proven track record of delivering high performance
  through development and coaching of a team.
  
• Evidence of continuous professional development.
  
• Strong collaboration to promote knowledge sharing and
  implementation of best practices across the site.
  
• Desire to continuously learn, improve and develop.
  

Technical:

• Experience in downstream drug substance manufacturing,
  process development, process characterisation studies, downstream technology,
  and/or process modeling.
  
• Technical experience in the drug substance manufacture of
  biological molecules at the lab, pilot and/or commercial -scale.
  
• Experience in designing and executing experimental
  programs in the laboratory, including smallscale lab experience, e.g. AKTA
  Avant chromatography, UFDF, NFF (Normal Flow Filtration).
  
• Working knowledge of statistical methods for DOE design
  and data analysis (e.g., JMP or Design Expert software)
  
• Demonstrated leadership and proven track record of
  delivering projects of technical complexity
  
• Experience with technology transfer, regulatory filing,
  and commercial drug substance manufacturing of biologics is a plus.
  
• Technical writing skills.
  
• Knowledge of and experience in applying structure problem
  solving, Six Sigma and Lean methodologies.
  
• Desirable evidence of continuous professional
  development.
  
•  
  

Minimum Education/Experience:

• A Masters degree in Biological Sciences/Chemistry
  /Chemical Engineering/Biological Engineering with 2+ years experience or a
  Bachelor’s degree in Biological Sciences/ Chemistry /Chemical
  Engineering/Biological Engineering with 4+ years experience
  
• Experience leading technical related projects.
   
  

Required Skills:

• Data Analysis, Estimation and Planning, Chromatography,
  DOE, Process Design, Process Improvements, Project Planning, Regulatory
  Compliance, Root Cause Analysis (RCA), Six Sigma, Standard Operating Procedure
  (SOP), Technical Support, Technical Writing, Technology Transfer