Senior Bioprocess Engineer

GSK; Upper Merion Township (Montgomery County); On-site; USD 110,000 - 140,000; Full time

Job summary

GSK Upper Merion is seeking a Bioprocess Engineer in Manufacturing Science and Technology (MSAT) to support 2k/5k value streams, enabling scalable biopharmaceutical manufacturing and successful tech transfer at the Upper Merion site.

You will lead technical studies, monitor processes for a 24/7 facility, manage deviations, and drive continuous improvements while collaborating with R&D, QA, and manufacturing teams.

Qualifications

• 2+ years of post-grad biopharma process development/manufacturing
• Bachelor's degree in science field (biotech/chem eng/biology/biochem/chem)

Responsibilities

• Provide technical oversight for 24-7 manufacturing operations.
• Design and execute studies for technology transfer and process improvements.
• Analyze data and prepare summary reports with recommendations.
• Train production staff on new equipment and processes.

Skills

CMC Strategy

Data-Driven Decision Making

Data Integrity

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Process Optimization

Project Leadership

Risk Awareness

Scientific Writing

Technology Transfer

Education

Bachelor's degree in science (biotechnology / chemical engineering / biology / biochemistry / chemistry)

Job description

The Manufacturing Science and Technology (MSAT) organization is a site-based team, providing technical support to ensure Upper Merion Biopharm site goals and objectives are achieved. The primary objective role of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team is also responsible for delivering continuous improvements to the existing supply chains supported by UM Biopharm and working with global MSAT to execute technology transfers and implement process-related improvement programs across the product lifecycle. The MSAT Bioprocess Engineer will support Upper Merion manufacturing to enable successful manufacturing for biopharmaceutical products in the 2k or 5k value streams at Upper Merion. This individual is accountable for supporting day-to-day operations, change management, deviations, and continuous improvements. This individual may also be asked to support certain elements (such as upstream or downstream) of the transfer of drug substance biopharmaceutical production technologies from donors (R&D, third party clients or contract manufacturing organizations) to the Upper Merion site; or from the Upper Merion site to other biopharmaceutical manufacturing sites. This individual is also expected to support the delivery of new biopharmaceutical applications and technologies, design and execute technical studies and protocols to confirm scale-up and successful technology transfer, analyze data and compile summary reports to make recommendations, and deliver improvements to the existing supply chains supported by Upper Merion and the wider organization. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Support the successful delivery of clinical and commercial biopharmaceutical manufacturing at Upper Merion in the 2k or 5k value stream by providing technical subject matter expertise and technical oversight. Provide real-time and in-person process monitoring and technical oversight for a 24-7 manufacturing facility which will require off hours and weekend support as needed. Design and execute technical studies and protocols to support technology transfer, manufacturing execution, and process improvements. Analyze data and compile summary reports to make recommendations based on technical study execution. Support the introduction and scale-up of primary manufacturing processes (drug substance) transferred from R&D or third party clients for specific products to the Upper Merion site. Manage the relationships between cross functional stakeholders and the Upper Merion site and global teams. Responsible for process trend monitoring, analyses and assurance that key process parameters and attributes remain within control limits. Responsible for investigating and resolving process issues in a manner and timeframe consistent with production and quality goals for specific products. Provide technical training to production staff for new equipment and process technologies as required. Contribute to the evaluation and feasibility/facility fit of prospective new products and technologies into the Upper Merion site (e.g. site impact assessments, or review of requests for proposal).

Basic Qualifications

• B.A. / B.S. degree in a science field such as biotechnology or chemical engineering, biology, biochemistry or chemistry
• 2+ years of post-graduate industrial experience in technology/biopharmaceutical process development or biopharmaceutical manufacturing

Preferred Qualifications

• Upstream Experience with large scale cell culture, cell banking, seed scale-up, small scale models (including KLA)
• Downstream Experience with bioseparations, purification technologies, or pharmaceutical manufacturing of biologics and large molecules
• Understanding of analytical technologies related to the above
• Strong interpersonal and matrix leadership skills
• Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines
• Strong verbal and written communication skills
• Able to provide leadership to generate options to resolve problems, prioritize, and decide appropriate courses of action
• Effective at implementing decisions
• Strong analytical and critical thinking skills
• Committed team player prepared to work within and embrace a team-based culture

Skills

• CMC Strategy
• Data-Driven Decision Making
• Data IntegrityDebate Moderation
• Digital Fluency
• GxP Regulations
• Lean Management
• Problem Solving
• Process Optimization
• Project Leadership
• Risk Awareness
• Scientific Writing
• Technology Transfer

Why GSK?

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We are 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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.