Associate Principal Scientist, Engineering

Job Description

As part of Our Company’s Manufacturing Division, within the Large Molecule Science and Technology (LMS&T) organization, the Bioprocess Drug Substance Commercialization (BDSC) department provides the technical process leadership and laboratory capabilities in support of drug substance manufacturing processes for late-stage pipeline and commercial products for biologics (therapeutic proteins) and vaccines.  BDSC supports various combinations of commercialization activities, including process development and characterization, laboratory experiment design and execution, technology transfer to internal and external manufacturing sites, process validation, manufacturing investigations and trend analysis, process enhancements, next generation process development, and authoring of regulatory submissions.

Under the general scientific and administrative department direction and working in conjunction with internal and external program partners, this individual will support late stage and commercial program activities within BDSC.

Scope includes:

• Participates in and/or leads cross-divisional technical teams focusing on late-stage clinical process development, characterization, and/or technology transfer and validation with line-of-sight for licensure and commercialization.

• Responsible for laboratory-scale and/or manufacturing scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally.  Provides technical leadership for the design of experiments, data analysis and interpretation, as well as mentoring of junior staff in the execution of internal or management of external laboratory activities.

• Provides technical leadership in the interpretations of trends observed in commercial process monitoring and for further technical investigations and process improvement changes.

• Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including upstream, analytical, and secondary manufacturing and GMP site readiness.

• Actively interacts with internal and external counterparts.  Represents functional area on cross-functional and cross-divisional teams.

• Authors required regulatory and technical documentation.  Ensures that processes are developed and documented according to our Company standard practices.

Education Minimum Requirement:

• Degree in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with number of years in related field: 10 years with BS, 8 years with MS, or 4 years with PhD.

Required Experience and Skills:

• Technical expertise in purification of biological (including complex multi-specific antibody variants) and/or vaccine molecules, including laboratory models for chromatography or filtration systems.

• Experience with technology transfer or scale-up of processes to pilot and manufacturing scales for biologics and/or vaccine manufacture.

• Excellent oral and written communication skills.  Ability to effectively articulate understanding of purification process science, to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.

Preferred Experience and Skills:

• Deep technical knowledge of harvest, preparative chromatography, tangential flow filtration, and/or normal flow filtration desired.  Demonstrated understanding of the fundamentals and/or modeling of unit operations.

• Technical operations experience in the manufacture of biological (including complex multi-specific antibody variants) and/or vaccine molecules at the pilot or commercial scale.

• Prior experience in late-stage process development, process characterization, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and working with external contract organization for development and or manufacturing.

• Working knowledge of statistical methods for DOE design and data analysis (JMP or Design Expert software).

• Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics and/or vaccine processes.

• Working understanding of analytical methods to characterize biologics and/or vaccines and cGMP US/EU regulatory requirements.

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