Senior Scientist, Engineering

Job Description

Process Development Scientist

At our company we aspire to be the premier research-intensive biopharmaceutical company. Were 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 Ambr250) 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).

Education & Experience:

• Bachelors degree in Chemical Engineering Bioengineering Biological Engineering or a related field with six (6) years of relevant industry experience. OR

• Masters 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.

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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