Job Description
As part of Our Company’s Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Bioseparation Sciences (BSS) department provides the technical downstream process leadership and laboratory capabilities in support of late-stage pipeline and commercial drug substance manufacturing processes for vaccines and biologics. BDSC supports second generation process development and various commercialization activities including process characterization, process science support for technology transfer to internal and external manufacturing sites, manufacturing investigation, process validation, and authoring of regulatory submissions.
We are seeking a Senior Scientist to join our team and contribute to late-stage clinical process development, technology transfer, and commercialization efforts. The ideal candidate will have a strong technical background in downstream processing, with a proven ability to drive process and mechanistic models and build digital twins within Industry 4.0 technologies.
Technical Scope and Responsibilities:
- Participate in teams focusing on late-stage clinical process development, characterization, and technology transfer, with a focus on licensure and commercialization.
- Provide technical leadership for the design of experiments, data analysis and interpretation, and the execution or management of laboratory activities.
- Drive process and facility models to support tech transfer and facility fit.
- Focus on downstream processing, with emphasis on process models, digital twins, and Industry 4.0.
- Actively engage with internal and external partners and represent the functional area on cross-functional teams and external collaborations.
- Author BLA regulatory filings and technical documentation.
- Support validation of new software and technologies validation for GMP application.
- Ensure digital solutions are deployed in conjunction with existing process monitoring.
- Represent the function in global digital programs and cross-functional digital initiatives.
Education Minimum Requirement:
- MSc (3+ years of experience), Ph.D. or equivalent degree in Chemical Engineering, Biochemistry or a relevant scientific or engineering discipline.
- Significant experience in downstream process development within the biopharmaceutical industry.
- Proven expertise in process modeling, digital twins, and Industry 4.0 technologies.
- Strong leadership and project management skills.
- Excellent communication and collaboration abilities.
Required Experience and Skills:
- Technical background in purification of large biological molecules, including laboratory techniques for chromatography and filtration systems.
- Hands-on experience in small-scale laboratory downstream process.
- Deep understanding of process modeling methodologies and proficiency in modeling software such as Cadet, Gproms, GoSilico, Aspen or others.
- Capable of designing model calibration experiments and validating the models using laboratory experimental data.
- Excellent oral and written communication skills. Demonstrated ability to effectively articulate understanding of process science to drive decision-making, impact assessments, design of studies, and other activities in a multi-disciplinary team environment.
Preferred Experience and Skills:
- Experience with downstream purification of large biological molecules required, with 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 must.
- Experience with mechanistic models and digital-twin concepts and application.
- Prior experience with automation systems and IOT (Internet of Things).
- 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 organizations for development and/or manufacturing.
- Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
- Business Knowledge: High performance in delivery of work. Looks for better, simpler ways, takes initiative and runs proactively with actions.
- Demonstrated self-management, prioritization, and organizational skills.
Employee Status: Regular
Relocation: Domestic/International
VISA Sponsorship: Yes
Travel Requirements: No Travel Required
Flexible Work Arrangements: Hybrid
Shift: 1st - Day
Valid Driving License: No
Hazardous Material(s): n/a
Job Posting End Date: 11/1/2024
Requisition ID: R316586
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