Scientist, Biologics Formulation and Drug Product Development
Participates in developing formulations for stable and releasable PEG-protein therapeutics. Designs and develop preformulation, and conduct formulation screening and optimization studies for parenteral liquid and lyophilized biologic drug products to ensure stability and manufacturing feasibility for pre-clinical and clinical trials. This position contributes to and supports the company’s research and product development efforts to create high value therapeutics to address unmet medical needs.
Responsible for design and development of new biologics drug formulations. Also responsible for formulation optimization with a view to establish the quality and stability of drug products. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining optimal results.
Designs, executes, and interprets formulation studies based on defined deliverables, planning activities to meet project timelines by working closely with project managers and senior technical team members of the biologics function. Understands the basic elements of rational formulation design and factors that affect the stability of proteins. Implements formulation development based on sound physicochemical information derived from preformulation studies. Capable of experimental design and data interpretation techniques such as Design of Experiments (DoE) and statistical data evaluation techniques. Present and discuss the data and project progress at those meetings. Capable of design short term and long term stability studies and conduct the characterization to support clinical needs. Perform lab scale lyophilization process for process development and optimization. Maintains and ensures safe laboratory environment and work practices. Writes formulation development plans and formulation development reports.
Performs day-to-day planning, execution and analysis of laboratory experiments independently with minimal supervisions. Defines complex problems, develops approaches and develops experiments with sound judgment. Writes and/or approves complex reports and protocols. Maintains knowledge of regulatory compliance requirements and best practices for pharmaceutical development.
A PhD in a scientific or engineering discipline is preferred. Equivalent experience may be accepted. A minimum of 2 years work experience in a biotechnology/pharmaceutical industry, preferably in formulation development, is required. Post-doctoral work may serve as experience. Exceptional non-PhDs, with demonstrated capabilities and relevant experience (e.g MS with >6 years, B.S. with >10 years) will also be considered.
Experience in formulation development for biologics. Hands-on experience with most of the commonly used analytical and formulation equipment. Experience in design of experiments (DoE) and associated software. Must have a solid understanding of biologics formulation development, protein chemistry and biophysics, as well experience with standard analytical characterization techniques (SEC, IEC, ICE, RP-HPLC, particle characterization). Excellent written and verbal communications and team work skills are essential. Must be equally comfortable working independently and collaboratively as part of a team. The successful candidate will have excellent problem solving and troubleshooting skills, as well as the ability to work on several projects or initiatives concurrently and prioritize appropriately, and with superior time management skills. Good computer skills are required. Working knowledge of MS word, Excel, Power point is required. Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are a plus.