Staff Scientist, Biologics Product Development - San Francisco (Mission Bay), CA | Biospace
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Staff Scientist, Biologics Product Development

Nektar Therapeutics

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Location:
San Francisco (Mission Bay), CA
Posted Date:
8/1/2017
Position Type:
Full time
Job Code:
Salary:
Based on Experience
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Biotechnology, Chemical Engineering, CMC, Formulation, Pharmaceutical, Process Development, Protein,

Job Description

Position Summary:  
Participates and usually leads in developing formulations for stable and releasable PEG-protein therapeutics.  Designs and conducts pre-formulation and formulation development studies for parenteral liquid and lyophilized biologic drug products to ensure stability and manufacturing feasibility for pre-clinical and clinical trials.   Prepares CMC drug product sections for Regulatory filings and provide technical oversight of clinical scale to commercial scale production.  May participate in the development of patent applications.  This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.  

Responsibilities:  
Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible factors.  Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.  Acts independently to determine methods and procedures on new assignments. Serves as both an internal and external consultant.

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.  Present and discuss the data and project progress at those meetings.  Maintains and ensures safe laboratory environment and work practices.  Remains current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences.  Writes formulation development plans and formulation development reports.  Writes 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.  



Requirements

A PhD in a scientific or engineering discipline is required.  Equivalent experience may be accepted. A minimum of 10 years work experience in a biotechnology/pharmaceutical industry, preferably in a process development, 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 development for biologics. Hands-on experience with most of the commonly used analytical and formulation production equipment. 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 be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought. Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment. Excellent written and verbal communications and team work skills are essential. Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work.  Must possess good oral and written communication skills. Ability to present technical information to both technical and non-technical audiences is required. Must be able to demonstrate sound judgment. Excellent problem solving and troubleshooting skills.  Ability to analyze and interpret data to make business critical decisions. Strong organizational skills are required. Ability to work on several projects or initiatives concurrently, with superior time management skills and ability to prioritize appropriately. 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.  Experience with regulatory filings is a plus.  Previous management skills are a plus. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills.