Job Description

Our company, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of biologics, vaccines, pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

As part of our Manufacturing Division, within the Manufacturing System Design & Commercialization, the Biologics Process Development & Commercialization department provides the technical process leadership and laboratory capabilities in support of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). For pipeline programs, this team supports various commercialization activities, including technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions.
Technical scope:

• Participates in and/or leads cross-divisional technical teams focusing on late stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.
• Responsible for laboratory-scale and 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 (e.g., statistical process control (SPC) and/or multivariate analyses (MVA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness
• Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, analytical, and site readiness.
• Position will interact with and influence various functions across the late stage development and commercialization ( i.e., process development, analytical, quality, technical operations, external manufacturing, regulatory, value chain management). Position will also lead functional area on cross-functional and cross-divisional teams and may manage a small team of scientists/engineers.
• Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to standard company practices.

• BS, MS or PhD in Chemical Engineering/Biochemical Engineering/Chemistry/Biochemistry/Biological Engineering/Biological Science with 10 years (for BS), 8 years (for MS), or 4 years (PhD) relevant experience.

• Technical expertise in purification of biological molecules, including laboratory models for chromatography and filtration systems.
• Experience with technology transfer and scale-up of processes to pilot and manufacturing scales for biologics manufacture.
• Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.

• Experience with downstream purification of biological molecules required, with an in-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.
• Technical operations experience in the manufacture of biological molecules at the pilot- and/or commercial-scale is a plus.
• Prior experience in late stage process development, process characterization including viral clearance studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
• Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes.
• Working understanding of analytical methods to characterize biologics and /or US/EU regulatory requirements and / or working knowledge of cGMPs is a plus