Scientist I/Associate Scientist II, Bioprocess Engineering

Company Name:
Job Description
This position can be filled at either the Associate Scientist II level or the Scientist I level.
This position fulfills a critical role within BioProcess Engineering for upstream technology transfer and manufacturing support. The position will focus on tech transfer and support of both cell culture and microbial fermentation processes producing recombinant proteins, monoclonal antibodies, or antibody variants. The BioProcess Engineering department (within Research and Development) is responsible for production of materials for tox studies, process scale up, and transfer of clinical and commercial processes to manufacturing. Members of the technology transfer group work closely with the process development and manufacturing groups to support transfers across all stages of process development (from toxicology lots through manufacturing lots to support BLA filings) to internal manufacturing sites or contract manufacturing organizations. Group members also provide technical oversight for on the floor operations and for resolution of non-conformances.
Major duties: Transfer upstream processes from Cell Culture and Fermentation Development (UK and US) sites into clinical and commercial manufacturing sites, either CMO or internal. Perform process manufacturing assessment including fit-to-plant assessment and process risk analysis. Ensure timely execution of tech transfer activities in order to meet project timelines. Review and approve manufacturing batch records. Manage technical relationship between sending and receiving upstream organizations. Monitor and support manufacturing processes real-time in the manufacturing facility. Review, trend, analyze, and interpret manufacturing data from ongoing production campaigns to ensure consistent product quality and process performance. Identify and solve complex manufacturing or bioprocess technical problems with limited data in timely manner. Effectively communicate and collaborate in a matrix team setting to implement technical solutions. Perform lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances. Proactively influence process decisions to help avoid non-conformances. Provide input on process development strategies. Write technical reports utilizing sound scientific reasoning and interpretation of the available data. Generated documents will include process flow diagrams, process descriptions, manufacturing campaign summary reports, technical support studies, and regulatory filings such as INDs and BLAs. Routinely present experimental findings to cross-functional project teams and management. Develop consensus within the department as well as in cross-functional teams. Support application of QbD approaches in manufacturing. Participate in the development and implementation of tools to improve process predictability. Help build business systems to improve the tech transfer process. Seek out, develop, and implement emerging technologies and provide input on continuous process improvement.
Supervision: This position will not have any direct supervisory responsibilities.
Position Requirements
This position can be filled at either the Associate Scientist II level or the Scientist I level.
Requires sound decision making with limited data and guidance. Requires thorough understanding of cell culture and/or fermentation processes from vial thaw through production. Experience in fermentation or cell culture harvest methods is highly desired, but not required. After an initial training period, the successful candidate is expected to have a high level of autonomy in order to provide in person support at various manufacturing sites. This includes providing updates to line management and the team leads. Interdepartmental project transfers require influencing and interpersonal skills.
Education: B.S. or M.S. in chemical engineering, biotechnology, or biology. Experience: For the Associate Scientist II level we require a B.S. with 8-10 years of experience or M.S. with 5-8 years of experience in biotechnology or a related field. For the Scientist I level, we require a B.S with 10-13 years of experience or M.S. with 8-10 or a Ph.D. with 5 - 8 years of experience in biotechnology or a related field.
Additional Notes
Must be able to work independently. Experience with operating bench, pilot, or production scale reactors/fermenters is required. Working knowledge of the scale-up/scale-down principles of cell culture or fermentation processes is essential. Experience with data and statistical analysis are required. Proven experience in preparing detailed and thorough technical protocols and reports is required. Excellent written and oral communication skills are required. Experience with being an effective and influential contributor and leader to projects governed by matrix teams is required. Experience with either cell culture bioreactors or microbial fermenters is required. Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory is highly desired. PAT (Process Analytical Technology) and/or regulatory requirements for manufacturing clinical therapeutics is desired. Position requires periodic weekend work (cell culture) and/or periodic late night shifts (fermentation)and will require some travel to CMO or other sites. The ideal candidate would have both microbial and cell culture experience, but candidates with only one or the other will be considered.
Title: Scientist I/Associate Scientist II, Bioprocess Engineering
Location: MD, Gaithersburg - Corporate Headquarters
Req ID: 7646
Position Category: Development - Bioprocess Engineering

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