Scientist I / II Biologics Production Outsourcing Specialist Full-time

Research Scientist

The Biotherapeutics Production group at AbbVie is seeking a research scientist to coordinate and manage biologics generation outsourcing at CROs. The group routinely outsources protein production for hundreds of biologics molecules per year at scales of 100 mg to 50 grams to generate therapeutic biologics in support of AbbVie's worldwide drug discovery efforts.

Key Responsibilities:

• Execute and coordinate outsourcing of therapeutic biologic production at CROs at scales of 100 mg – 50 grams for all required purification requests (hundreds/year) in alignment with functional goals and group scientific objectives.
• Collaborate with CRO vendors, and manage all aspects of protein production, including ordering, sequence design, expression method, scale selection, primary capture, secondary purification strategy, as well as all QC and analytical work.
• Ensure successful and timely execution of outsourcing projects through sound planning and strategy design, as well as risk management.
• Manage pre-registration and post-registration of generated molecules in appropriate IT systems.
• Develop strategy for two-way data sharing and receipt with each vendor to allow seamless tracking of requests and import of data to LIMS system, as well as to increase efficiency and accuracy of data delivery.
• Perform biophysical characterization and analytical QC (including SEC, intact and reduced mass spectrometry, endotoxin and HCP testing) for all proteins that require QC beyond what vendor offers.
• Work with vendors to align their QC methodologies (SEC columns, buffers, MS reduction protocol, and HCP assay) with standard methods used in BDS-BP group, and advance collaboration with vendors to deliver equivalent QC data packages as those generated internally eliminating the need for internal QC of outsourced projects.
• Interact with requestors and collaborators to keep them informed of the progress and status of their outsourced projects.
• Communicate results and unexpected observations in timely manner to management and appropriate audience.
• Resolve unexpected scientific problems that arise by utilizing novel approaches and collaborative partnership with internal and external colleagues and vendors.
• Work independently on the design, execution, and interpretation of experimental results.
• Analyze, document, and report data concisely and rigorously.

Qualifications:

• Bachelors or Masters in biology, chemistry, biochemistry or related field with typically 5+ (BS) or 2+ (MS) years of experience.
• Prior experience with all aspects of biologics production, including expression plasmid design, stable and transient protein expression in CHO cells, primary protein capture methods using Protein A, CH1, kappa select, and secondary purification strategies using AEX, CEX, and HIC resins.
• Prior experience working with CROs, specifically doing protein production.
• Prior experience performing analytical QC of biologics including, SEC, intact and reduced mass spectrometry, endotoxin and HCP testing, peptide mapping, released glycan analysis, and CE-SDS.
• Experience in process development and process optimization, including expression optimization, and purification process development.
• Proficiency in overcoming problems (i.e. low expression, aggregation, aberrant glycosylation, poor chain pairing, difficult separations) with challenging therapeutic protein production.

Pay Range: $75000 – 142500 USD