Formulation Scientist

Description

Manager's Update:

100% Onsite Role

• Top Skills: SEC, HPLC, Chemical Stability (Gel electrophoresis)
• Must be a Matrix oriented professional
• PhD would be overqualified in this role
• Formulation testing exp. would be required
• structural characterization of biologics e.g. HPLC, UPLC, capillary electrophoresis, particle analysis, and other biophysical techniques (UV-vis, DLS, DSC, etc.) for protein characterization is a requirement.
• Antibody/Antibody conjugate exp. would be great to have
• BS with 4+ years and Masters with 2-4 years of relevant lab exp. would be required
• Must have protein formulation/protein characterization exp.
• Min. educational qualification: BS
• This position is falls under Biologics Drug Product Development dept./group
• protein purification exp. Would not be going to work
• Any chromatography exp. would be required
• Egar to learn kind of professional is required
• Prior industry exp. would be a top choice in this role but research exp. would also work
• Formulation chemist would be considered as a good fit in this role
• Master's with more than 4 years of experience would also be considered as overqualified
• 80% of the time the person needs to involve within a laboratory and 20% of the time they need to involve in the documentation side (ELN, LIMS)
• Must have exp. with large molecules

Location: Lake County, IL - ONSITE

Contract: 1 year with possible extension

Scientist II, Biologics Drug Product Development

• The Biologics Drug Product Development team develops antibody drug conjugates (ADC) and other biologics by state-of-the-art formulation and analytical technologies.
• We create valuable intellectual property through new formulation compositions, cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.
• We are looking for a highly motivated person to support Developability and Formulation Development.
• The candidate will support early-stage assessment of candidates coming out of the Discovery pipeline, as well as the design and development of stable and robust drug product formulation for biologics used in clinical trials.
• In this role, the candidate will be part of a global team and will work closely with scientists from multiple functional areas, including Discovery, Analytical, and Process R&D.

Key Responsibilities Include:

• Support the biologics characterization and stability assessment activities of the assigned biologics, including candidate screening and selection for clinical studies and commercialization of monoclonal antibodies, antibody drug conjugates, bispecifics, and fusion proteins.
• Execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), and screen excipients (buffers, stabilizers, surfactants, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
• Prepare concise and sound scientific presentations of experimental results to the management and assist in authoring detailed scientific technical reports.
• Stay current with the scientific literature and support new scientific initiatives. 

Qualifications

• BS or MS in a scientific field and typically 4 (BS) or 2 (MS) years of relevant experience.
• Extensive hands on expertise using analytical methods for chemical and structural characterization of biologics e.g. HPLC, UPLC, capillary electrophoresis, particle analysis, and other biophysical techniques (UV-vis, DLS, DSC, etc.) for protein characterization is a requirement.
• Scientific understanding of the structure & function of monoclonal antibodies, antibody constructs/conjugates, bispecifics, and fusion proteins and their modes of degradation/stabilization.
• Strong laboratory skills focused on formulation development for monoclonal antibodies and antibody constructs/conjugates (standard excipient selection, functional excipients, high throughput assays).
• Solid understanding of the various unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized NBEs.

Key Leadership Competencies:

• Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
• Excellent oral communication skills in a scientific setting, as well as sound technical writing and documentation competencies are required.
• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.