Are you interested in directly supporting and providing oversight on Drug Product manufacture while leading a team of trained scientists? If so, this Supervisor role within Biopharm Upstream Processing could be an exciting opportunity to consider. Job Purpose
As a Supervisor within Biopharm Upstream Processing you will be responsible for the manufacture of clinical supply of investigational biopharmaceutical molecules and provide direct oversight to a team of 5-10 scientistsLocation: King of Prussia, PADetails ( Your Responsibilities )
Why you? Basic Qualifications:
- Responsible for Right First Time in the manufacture of investigational material through attention, focus, planning, and adherence to procedural and regulatory expectations
- Safe, compliant, and hands-on supervision of processing of large scale cell culture and fermentation steps under cGMP regulatory conditions. Processing steps include: Small scale/scale-up from vial thaw, end of production, media preparation, operation of stainless steel and single use bioreactors, harvest operations, CIP, SIP, washer and autoclave operation
- Demonstrates ability to “think outside the box” and suggest new process/operational improvements to assist with improvements to the safety, compliance, Right First Time, and cost profiles of biopharmaceutical Upstream Processing operations
- Reviews and approves executed load documentation (washer and autoclave), Media Forms, and/or Batch Records prior to submission to Quality Assurance (QA) to insure adherence to cGMPs and proper documentation practices
- Leads deviation investigations and implementation of CAPAs stemming from Safety or Compliance observations
- Authors Standard Operating Procedures (SOPs), Investigation reports, Safety Assessments, and various other protocols
- Assists with the coordination and implementation of special projects such as validation or complex investigations
- Strives to identify process improvement opportunities with impact on safety, compliance, and efficiency/cost
- Drives facility upkeep (maintenance of clean, organized, & clutter free area that is audit ready at all times)
- Identifies and troubleshoots problems in the execution of processing activities; interprets results, proactively assesses options and impact and takes action to rectify or communicate to appropriate decision makers and/or area Manager
- Anticipates/recognizes potential problems with equipment and/or supplies, and takes action to solve or prevent problems
- Provides mentoring, training, and guidance to less experienced personnel
- Performs data management tasks and performs compliance checks for documentation in logs, media forms, batch records, and electronic systems in accordance with company policy and legal requirements
- Demonstrates ability to perform complex data management
- Prepares oral or written presentations of results with interpretation for projects. Prepares and communicates conclusions and recommendations for next steps, to “project” member
- May be required to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary
- Attends to regular safety and cGMP training: maintains accurate and complete safety and role-specific training records, consistent with company policy and legal requirements
- Ensures manufacturing personnel comply with Standard Operating Procedures (SOPs) and that training is completed on time
- Provide support to the Site Safety Team(s) and other EHS&S initiative as required.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field
- Minimum 4 years of direct GMP manufacturing experience and upstream processing in a biotechnology manufacturing facility
If you have the following characteristics, it would be a plus:
- Master's degree
- One (1) Year of Direct Supervision of 3-5 Individuals
- Thorough knowledge of Good Manufacturing Practices (GMP) regulations
- Understands the implications of procedures and deviations within his/her own discipline
- Thorough knowledge of routine laboratory/plant equipment and demonstrates technical expertise with working familiarity with a number of methods, techniques, laboratory procedures and processes
- Ability to suggest new process/operational improvements in relation to set objectives and carry through implementation
- Possesses knowledge of how to analyze and interpret experimental/process data.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
*This is a job description to aide in the job posting, but does not include all job evaluation details.
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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