Senior Bioprocess Engineer

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 Senior 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 is expected to be a technical leader within the site and value streams, independently supporting the delivery of critical improvements or work packages for the clinical and

commercial portfolio. The individual may be asked to manage 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 lead 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:

• Lead 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.
• Lead 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. This individual is expected to serve as a matrix leader within and outside the Upper Merion site.
• 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:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

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

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

• 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.

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Skills

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