Process Validation Manager

Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

The world’s most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.

Agilent Technologies Nucleic Acids Solutions Division is looking to add a Process Validation Manager to support process development, pre-validation and process validation activities. This position will support the Boulder and Frederick facilities.

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 follows process validation requirements under current FDA, EMA and ICH guidance’s.

• Conducts process validation by leading and driving 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, implementing 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.

• Share 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).

Qualifications

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 minimum 7 years proven experience and/or training or equivalent combination of education and experience.

• Demonstrated experience in leading process qualification studies at the bench and in a plant setting.

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

• Demonstrated experience with process design, transfer and validation for API manufacturing.

• Demonstrated experience with 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.

#LI-DT1

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.

Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please see all of our notices for EEO below.

Pay Range

$130,240.00-$203,500.00

The salary range for this position may differ based on your actual work location.

Eligible for Company Car

Benefits in Brief

Travel Required

No

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

R&D