Downstream Operations Scientist

Downstream Operations Scientist

Context of the Job: NIIMBL (the National Institute for Innovation in Manufacturing Biopharmaceuticals) is the largest industry-led public-private partnership dedicated to biopharmaceutical manufacturing innovation with participation from well-over 200 companies, government agencies, and other partners collectively innovating manufacturing approaches. As part of these activities, NIIMBL is home to a technical operations team that works collaboratively with scientists from across the biopharmaceutical manufacturing industry including manufacturers, suppliers, and government agencies. The Downstream Operations Scientist is responsible for leading downstream purification unit operations in NIIMBL’s continuous mAb purification process that is part of a Process Intensification program. The work will involve 21CFR58 compliant downstream operations and data analysis, including utilizing automation systems. The scientist will also collaborate with bioreactor specialists and an analytical team, and have access to state-of-the-art knowledge from across the industry and government in guiding the work.

NIIMBL’s extensive portfolio of research, development, demonstration, and innovation activities is funded by federal, private, state, and other sources with the parent sponsoring government agency being the National Institute of Standards and Technology (NIST). NIIMBL is also a member of the Manufacturing USA network of institutes, a multi-billion dollar investment by the federal government to advance United States competitiveness in advanced manufacturing innovation. Institutionally at the University of Delaware, NIIMBL reports to the Vice President for Research, Scholarship & Innovation.

Among other activities, NIIMBL executes technical projects that advance the readiness levels of relevant technologies, assays, and methods. The scopes of scientific projects generally include many organizations as partners and collaborators such as scientists from several large and small companies, a scientist from a federal agency, and a scientist from a university. Many of these projects will be hosted at the University of Delaware in a state-of-the-art laboratory facility purpose-built for such studies. These projects will involve a diverse set of technologies and approaches and address drug substance, drug product, and analytical needs by the industry appropriate to several types of biopharmaceuticals: therapeutic antibodies and proteins, gene therapy vectors, vaccines, antibody-drug conjugates, bispecific antibodies, and cell therapies, among others.

Major Responsibilities: The role requires demonstrating NIIMBL’s Core Values and ensuring all decisions, actions, and teamwork practices align with the organization’s Business Principles. It involves serving as a lead technical scientist on multiple projects involving downstream purification unit operations for the manufacture of industrially relevant products and related activities. The scientist will evaluate and introduce new technologies and analytical tools to existing processes, adhere to 21CFR58 GxP guidelines, set up, operate, troubleshoot, maintain, and clean downstream bioprocessing equipment. The position includes using manufacturing experience to identify process parameters and define their setpoints, performing design of experiments to confirm the impact of process parameters on impurity levels, product recovery, and potency, and characterizing performance of existing purification and formulation unit operations, including column chromatography (e.g., ProA, SEC, CEX, AEX), filtration, tangential-flow filtration, and bulk filling. The role also involves developing new filtration unit operations such as tangential-flow filtration, virus filtration, and depth filtration, as well as developing new chromatography unit operations from screening and characterization to optimization and initial scale-up. It includes optimizing buffer compositions to improve stability and solubility of target molecules, collaborating with an analytical team to adapt and troubleshoot research analytical methods such as HPLC, SDS-PAGE, enzyme activity and endotoxin assays to quantify yield, activity, and purity at various stages of the manufacturing process, and documenting all work and analyses in an electronic lab notebook with tracking and trend analysis of method performance. Additional duties include analyzing process performance trends, performing statistical data analysis, presenting data to teams, partnering with the Informatics Infrastructure team on deploying structured data capture systems, drafting and revising SOPs and batch records, maintaining detailed documentation of lab activities and data, compiling data to present at team meetings, authoring, reviewing and editing technical reports and manuscripts intended for publication, staying current with relevant technologies and scientific literature, and performing other job-related duties as assigned.

Qualifications

• A Masters with 5+ years or a PhD with 2+ years in chemical engineering or a relevant life science discipline. Industrially relevant downstream purification experience is required, with preference for experience in a 21CFR58-compliant GxP environment. Hands-on experience with a range of downstream unit operations and control systems, with experience in DeltaV preferred. Ability to operate chromatography skids and other bioprocess equipment for purification of industrially relevant materials. Knowledge of biotech manufacturing processes and equipment including depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations. A contribution mindset driven by initiative, excellent interpersonal and management skills with a collaborative team orientation, demonstrated leadership through communication, respect, influence, persuasion, and trust, strong problem-solving and critical thinking abilities, excellent writing, communication, and presentation skills, and proficiency in MS Excel, PowerPoint, Word, and Microsoft Project. Strong organization and planning skills, attention to detail, and the ability to function in a rapidly changing environment.

Location

Newark, DE

Notes: NIIMBL is a large-scale effort dedicated to supporting the manufacturing of biopharmaceuticals, established by a cooperative agreement with the National Institute of Standards and Technology (NIST) as a public/private consortium of diverse member organizations, including industry, academia, non-profit organizations, state governments, and federal agencies. NIIMBL is a member of the Manufacturing USA network of institutes funded by the federal government to advance United States competitiveness in advanced manufacturing innovation. Institutionally at the University of Delaware, NIIMBL reports to the Vice President for Research, Scholarship & Innovation.