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
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
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
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
As a global healthcare company, we take on some of the world’s biggest healthcare challenges. By delivering a sustainable business, we provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We are committed to widening access to our products, so more people can benefit, no matter where they live in the world or what they can afford to pay. Each of our three businesses benefits from GSK’s commercial infrastructure, integrated supply networks and significant global presence.
As a global company, our reward packages are designed to meet the needs of our geographically diverse workforce. They are benchmarked against industry standards and relevant to your job, no matter where you live.
Our reward package includes:
- A competitive base salary
- An annual bonus that rewards you for your individual contribution to our strategy, as well as business targets
- Benefit programs designed to support you and your family, including access to healthcare and well-being programs, pension plan membership, savings programs, time off and childcare support
- Employee recognition programs which reward exceptional achievements
- Share ownership schemes which link your reward to GSK’s longer term performance
- A performance and development program that helps you identify what you need to do, and the behaviors you need to demonstrate, to achieve success.