Staff Scientist, Biologics Product Development
Lead formulation and DP manufacturing process development for PEG-protein therapeutics. Design and conduct pre-formulation and formulation development studies for parenteral liquid and lyophilized biologic drug product dosage forms. Execute stability and manufacturing feasibility studies for pre-clinical and clinical candidates. Prepare CMC drug product sections for Regulatory filings and provide technical oversight of clinical scale to commercial scale production. This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
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 pre-formulation studies. Capable of experimental design and data interpretation techniques such as Design of Experiments (DoE) and statistical data evaluation techniques. Acts as the lead and in-house formulation development expert on multiple programs. Plans project scopes of work internally and at contract development organizations. Plays a key role in the tech transfer of formulations into contract manufacturing organizations. Remains current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences. Writes formulation development reports and reviews appropriate technical MBR, SOPs for use internally and at CMO and/or CROs. Support cGMP manufacturing at CMOs.
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. Interfaces with various departments and partners. Plans and coordinates activities with other team members. Writes and/or approves complex reports and protocols. Maintains knowledge of regulatory compliance requirements. May assist with implementing organizational systems, identifying capital equipment, and projecting resource requirements. May lead staff or a group, provides training as needed, and ensures adherence to company policies and quality requirements. Performs other duties as required.
Working knowledge of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment. Experience in design of experiments (DoE) and associated software. Must have a solid understanding of biologics formulation development, processing and standard analytical characterization techniques. Must possess good oral and written communication skills. Ability to present technical information to both technical and non-technical audiences is required. Experience with regulatory filings is a plus. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills.
A PhD in a scientific or engineering discipline or equivalent experience is required. A minimum of 10 years work experience in a biotechnology/pharmaceutical industry is required. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Expertise in formulation and/or DP manufacturing process development/scale up for biologics. Hands-on experience with most of the commonly used analytical and formulation production equipment. Previous management skills are a plus.
Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function.