Senior Scientist, Engineering

** Job Description*
* ** Process Development Scientist*
* At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and use the power of leading-edge science to save and improve lives around the world.

** Responsibilities*
* + Part of a project team focusing on process characterization, technology transfer, and validation of biopharmaceutical molecules with line-of-sight for licensure and commercialization.

+ Responsible for planning or executing scale studies to support commercial process validation, process characterization, and investigation evaluations, including studies performed either in-house or externally.

+ Design, plan, and execute laboratory experiments to generate high-quality data. Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports.

+ Collaborate with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within our company network and at contract manufacturing organizations (CMOs).

+ Provide technical leadership in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA)). Lead technical investigations and process changes that drive improvements to yield and/or robustness.

+ Author required regulatory and technical documentation associated with process Tech Transfer and validation. Ensure that process/product are developed and documented according to standard company practices. Support regulatory queries and inspections as required.

+ Lead assignment execution against accelerated, critical-path timelines in a right-first-time manner.

** Qualifications*
* _Required_

+ Experience in large molecule process development, including scaling (up and down) and tech transfer of drug substance processes.

+ Experience in upstream lab scale experimental execution, Design of Experiments (DOE), statistical data analysis, and presentation of results/conclusions.

+ Experience in authoring technical documentation to support regulatory submissions leading to product licensure.

+ Outstanding communication and people skills. Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.

+ Working comprehension of analytical methods to characterize large molecules, US/EU regulatory requirements, and working knowledge of cGMPs principles and regulations.

_Preferred_

+ Hands-on expertise with mammalian cell culture bench scale and high-throughput bioreactor systems (e.g., 2L, 3L, Ambr
250) and ability to oversee teams through these requirements as lab lead.

+ Expertise with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.

+ Expertise with mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling, Quality by Design (QbD), and Lean Six Sigma principles.

+ Expertise supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).

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* Education & Experience:

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* + Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experience. OR

+ Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of relevant industry experience. OR

+ Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with a no minimum relevant knowledge.

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* Required Skills:

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* Adaptability, Biodesign, Biological Engineering, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Cross-Functional Collaboration, Design of Experiments (DOE), Detail-Oriented, Good Manufacturing Practices (GMP), Mammalian Cell,…