Senior Associate Scientist Biopharmaceutical Pilot Registration Lab

Role Description
As a Senior Associate Scientist in the Biopharmaceutical Pilot Registration Lab you will play a vital role in the development scale-up and technology transfer of CHO-expressed monoclonal antibodies for veterinary use. You will operate in a GMP-regulated environment collaborating with multidisciplinary teams to ensure a successful transition from development to pilot to commercial manufacturing. This role requires hands-on technical expertise in upstream and/or downstream processing as well as strong organizational and communication skills. The position is based in Lincoln Nebraska with frequent interactions with colleagues and external partners located around the globe.

Position Responsibilities

• Advanced experience in setting up programming operating and troubleshooting large-scale equipment for expression (mammalian cell culture) and/or purification of recombinant therapeutic proteins
• Represent the lab as a key technical leader in cross-functional project teams collaborating with process development and manufacturing teams driving process optimization and scale-up ensuring seamless high-quality technology transfer
• Demonstrate advanced expertise in authoring and reviewing process documentation SOPs protocols technology transfer documents and regulatory filings ensuring the highest standards of scientific rigor and quality
• Hands-on execution and support of upstream cell culture (shake flask to 2000-L production scale) and/or downstream purification (centrifugation chromatography filtration) to produce GMP batches of drug substance.
• Drive continuous improvement by optimizing existing workflows and procedures
• Ensure accurate and compliant documentation in accordance with current GMP standards
• Perform preventative maintenance on portable and stationary equipment
• Maintain clean and perform steam-in-place procedures for equipment

Education and Experience

• Bachelors degree (minimum) in biological sciences chemical engineering or related field. Advanced degree would be advantageous.
• Significant practical experience and theoretical knowledge of upstream cell culture and/or downstream processing (centrifugation filtration chromatography)
• Proven track record in GMP-regulated environments including process scale-up and tech transfer to commercial facilities.

Technical Skills Requirements

• Strong scientific and engineering background in the principles for process scale-up and robustness
• Experience with instrumentation control systems and advanced troubleshooting for pilot-scale GMP operations including practical experience with automated control and data capture systems such as SCADA Delta V and Unicorn
• Knowledge of equipment specification qualification operation and maintenance in a regulated environment
• Experience with large-scale bioreactor and/or purification equipment
• Working knowledge of GMP systems (change control SAP LIMS) is desirable
• Willingness to work flexible hours including after-hours monitoring as needed
• Ability to perform physically demanding tasks typical of a pilot-scale lab environment
• Excellent aseptic technique
• Experience with cGMPs inspection and compliance
• Demonstrated ability to work independently on multiple concurrent programs
• Familiarity with regulatory frameworks for veterinary biopharmaceuticals is desirable
• Strong organizational and people skills
• Excellent written and verbal communication skills
• Proven ability to work effectively as part of a collaborative team

Full time

Regular

Colleague

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