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Supervisor - Biopharm - Upstream Processing

Employer
GSK
Location
King of Prussia, Pennsylvania
Salary
Competitive
Closing date
Oct 9, 2022

View more

Discipline
Other, Other
Organization Type
All Industry, Pharma
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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 scientists

Location: King of Prussia, PA

Details ( Your Responsibilities ):
  • 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.


Why you?

Basic Qualifications:

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


Preferred Qualifications:

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.


Why GSK?

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:

  • 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.


*This is a job description to aide in the job posting, but does not include all job evaluation details.

*LI-GSK

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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