Manager, Process Validation

As the manager of the process validation team in the chemical development department of Agilent Technologies Nucleic Acid Solutions Division, the candidate will be responsible for managing all process validation aspects of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing.

Essential duties and responsibilities include but are not limited to:

• Responsible for all aspects of personnel management of a team of process validation engineers.

• Responsible for leading all aspects of process validation through characterization, process performance qualification and continued process verification.

• Understands and complies with process validation requirements under current FDA, EMA and ICH guidance's.

• Conducts process validation by leading and executing validation studies at the bench and protocol driven studies at scale in a GMP environment.

• Provide work product updates to clients and project teams in the form of presentations, slides, memos and reports.

• Responsible for project scope assessment for resource and time commitment in formal quote submission generation on project validation projects.

• Contribute expert knowledge and ideas for approaches including assessment of process capability and acceptance criteria setting and support resolutions to quality observations (deviations and investigations).

• Design, executing and reporting of Design of Experiments (DOE) and associated statistical software calculations to support design space understanding, process validation and process consistency as it relates to oligonucleotide process control and operations.

• Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing.

• Contribute knowledge and ideas to the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities.

• Contribute to preparing chemical process descriptions and writing technical reports to support internal technology transfer into manufacturing and support in preparation of client Chemistry, Manufacturing and Controls (CMC) submissions.

• Responsible for representing process validation to customer and regulatory bodies in requests for information, inspections and audits of validated products.

• Maintain process compliance integrity by adhering to standard operating procedures (SOP's) and current good manufacturing practices (cGMP).

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field with 7+ years relevant experience and/or training or equivalent combination of education and experience.

• Leading process qualification studies at the bench and in a plant setting.

• Experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities.

• Process design, transfer and validation for API manufacturing experience.

• Adhering to current ICH, USP, FDA, EMA guidance's and standards for process validation pertaining to the manufacture of API's.

• Demonstrated experience with personnel management of a team of engineers is highly desirable.

• Knowledgeable in API process validation of oligonucleotide and/or similar unit operations for API's highly desirable.

• Ability to work with interdisciplinary project teams to understand project requirements, follow project timelines and responsibly deliver commitments made to the project team.

• Ability to satisfactorily complete all GMP and safety training in conformance with Agilent requirements. Ensure the compliance with all site and departmental safety policies.

• Knowledge of and skill in using computer software and hardware applications, including Microsoft products and the Internet.

• DOE software is highly desirable.

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