Associate Principal Scientist, Downstream Process Engineering

Job Description

As part of Our Company’s Manufacturing Division, within the Vaccine Science and Technology (VS&T) organization, the Vaccine Drug Substance Commercialization (VDSC) Downstream Process department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and commercial manufacturing purification processes for vaccines.  VDSC supports a combination of commercialization activities for pipeline and commercial program support, 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 purification activities within VDSC.

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 standard our company practices.

• Manages a team of downstream scientists.

Education Minimum Requirement:

• Bachelor of Science (BS) degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with ten (10) years’ experience in purification; OR

• Master of Science (MS) degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with eight (8) years’ experience in purification; OR

• PhD in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with four (4) years’ experience in purification

Required Experience and Skills:

• Experience managing people and teams.

• Technical expertise in purification of biological and/or vaccine molecules, including laboratory models for chromatography and/or filtration systems.

• Experience with technology transfer and/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 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 unde