Senior Bioprocess Engineer

Description

The site's Manufacturing Science and Technology (MSAT) team supports the Upper Merion biopharmaceutical site so that its goals are met. MSAT keeps manufacturing processes capable, compliant and productive while protecting product quality.

The team also drives continuous improvement across supply chains that Upper Merion supports and works with global MSAT on technology transfers and process improvement programs across the product lifecycle.

As a Senior Bioprocess Engineer, you will support manufacturing of biopharmaceutical products in the 2k or 5k value stream at Upper Merion. You will handle daily operations, change management, deviations and continuous improvement, acting as a technical leader for the site and value streams and delivering critical improvements or work packages for clinical and commercial products on your own.

You may manage upstream or downstream elements of drug substance technology transfers into Upper Merion from donors (R&D, third-party clients or contract manufacturers), or out of Upper Merion to other biopharmaceutical sites. You will also lead new biopharmaceutical applications and technologies, design and run technical studies and protocols to confirm scale-up and transfer success, and analyze data to write summary reports with recommendations.

The role gives you the chance to lead key activities and grow your career.

Responsibilities

• Lead clinical and commercial biopharmaceutical manufacturing in the 2k or 5k value stream at Upper Merion, providing subject matter expertise and technical oversight.
• Monitor processes in real time and on site in a 24/7 facility, supporting off-hours and weekend work as needed.
• Design and run technical studies and protocols for technology transfer, manufacturing execution and process improvement. Analyze the data and write summary reports with recommendations.
• Lead the introduction and scale-up of drug substance manufacturing processes transferred to Upper Merion from R&D or third-party clients for specific products.
• Manage relationships between cross-functional stakeholders, the Upper Merion site and global teams, acting as a matrix leader inside and outside the site.
• Track process trends and make sure key process parameters and attributes stay within control limits. Investigate and resolve process issues within timeframes that fit production and quality goals for each product.
• Train production staff on new equipment and process technologies as required.
• Help assess new products and technologies for feasibility and fit with the Upper Merion site, such as site impact assessments or reviews of requests for proposal.

Requirements

• Bachelor's degree (B.A. or B.S.) in a science field such as biotechnology, chemical engineering, biology, biochemistry or chemistry.
• At least 4 years of post-graduate industrial experience in technology or biopharmaceutical process development, or in biopharmaceutical manufacturing.
• Preferred: upstream experience with large-scale cell culture, cell banking, seed scale-up and small-scale models (including KLA).
• Preferred: downstream experience with bioseparations, purification technologies, or pharmaceutical manufacturing of biologics and large molecules, plus understanding of related analytical technologies.
• Preferred: strong interpersonal and matrix leadership skills, able to work well with peers, direct reports and senior staff in scientific, quality, engineering and operations roles.
• Preferred: strong verbal and written communication, able to lead the generation of options for resolving problems, set priorities, decide on courses of action and carry decisions through.
• Preferred: strong analytical and critical thinking skills.
• Preferred: a committed team player who works within and supports a team-based culture.
• Key skills listed: CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer.

Conditions

Based at the Upper Merion site, in a 24/7 manufacturing facility with off-hours and weekend support as needed.

Applicants requiring accommodation to apply can contact the US recruitment team by email at the company's site.

Employment agencies must have prior written authorization from the company's procurement or HR department before referring candidates; unauthorized referrals are not covered by fees.

US licensed healthcare professionals may have interview-related expenses reported under US Transparency requirements; details are on the CMS Open Payments website.

Benefits

• US employees can review the company's benefits summary on the company US Benefits Summary page.