17 days old

Investigator

GSK
King of Prussia, PA 19406
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: May 18 2020

Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Investigator role could be an exciting opportunity to explore.

As an Investigator, you will be responsible for the manufacture of clinical supply of investigational biopharmaceutical molecules. Specifically: hands-on cGMP large scale cell culture or microbial fermentation for use in early phase clinical trials

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

  • Safe, compliant, and Right First Time, hands-on and 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
  • Serves as main upstream SME and resource in communications with other functional groups (e.g. cross functional teams, deviations, audits, and inspections)
  • Manages complex assignments, where independent action and a high degree of initiative are required in order to resolve problems and make recommendations
  • Leads a team of 5-15 Scientists. Manages daily activities within the area which include: scheduling, training, personnel efforts, resource allocation, development of direct reports
  • Develops associate and senior scientists into process/area Subject Matter Experts (SMEs)
  • Supporting technology transfer through active participation in ensuring that new processes fit and execute consistently
  • May be required to serve as the area Manager, in the absence of the area Manager
  • Responsible for Right First Time in the manufacture of investigational material through attention, focus, planning, and adherence to procedural and regulatory expectations
  • 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 USP 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

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 with at least 4 years of direct GMP manufacturing experience and upstream processing in a biotechnology manufacturing facility or Pilot Plant
  • Thorough knowledge of Good Manufacturing Practices (GMP) regulations
  • Experience analyzing and interpreting experimental/process data
  • US work authorization is required for this role. Sponsorship is not available at this time

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Understands the implications of procedures and deviations within his/her own discipline
  • Ability to suggest new process/operational improvements in relation to set objectives and carry through implementation
  • Thorough knowledge of routine laboratory/plant equipment and demonstrates technical expertise with working familiarity with a number of methods, techniques, laboratory procedures and processes

Why GSK?

Our values and expectationsare 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.

*LI-GSK

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.

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 GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.

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Posted: 2020-05-20 Expires: 2020-06-19

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Investigator

GSK
King of Prussia, PA 19406

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