Job Description

Bring oligonucleotide medicine to the world by joining us to lead the high-output process validation group. You will oversee an exciting portfolio of clinical and commercial stage RNAi drugs. As a key leader in the chemical development department you will develop implementation strategies for process validation  while collaborating across scientific disciplines of process and analytical chemistry and chemical engineering.  

Join a dedicated team with this exciting new opportunity for an Associate Director, Process Validation at our Frederick, Colorado GMP facility. Work in our multifaceted, fast-paced, API-Biopharma manufacturing environment with the ability to contribute to the growing industry of oligonucleotide (DNA-RNA) based therapeutics.

Responsibilities:

Lead and manage a team of scientists and managers that develop chemical processes for manufacture of oligonucleotide APIs.

Lead and manage process validation programs in accordance with FDAs Stage 1, 2 and 3 and EU EudraLex.

Ensures programs are compliant and justifiable with Company policies and regulatory guidance’s.

Apply organic chemistry development experience with control strategies to issues of process optimization, scale-up and laboratory process transfer to mid and kilo-scale GMP manufacturing. 

Oversee development of robust, scalable processes for API production that is used in clinical and commercial settings.

Responsible for optimization and scale-up of processes and process validation activities, ensuring the successful transition of early stage to late stage/commercially viable processes.

Responsible for preparing chemical process descriptions and writing technical reports to support internal technology transfer into manufacturing and support in preparation of client CMC submissions.

Provide regular interface with clients that includes project proposal generation, technical goals, activities and status updates and summary documents of the project.

Direct the day-to-day activities of direct reports and project teams, maintaining progress on projects and ensuring that experiments are complete and scientifically sound.

Oversee regular internal project review meetings and ensures schedules meet the timeline requirements.

Contribute to responses to client RFP (request for proposal) including technical approach and resource allocation.

Responsible for representing process validation to customer and regulatory bodies in both written responses and audit settings.

Qualifications

Bachelor’s or Master’s Degree or equivalent

5+ years experience formally or informally leading people, projects and/or programs; 10+ years preferred

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Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least April 1, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $168,160.00 - $262,750.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

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 visit www.agilent.com/en/accessibility.

Travel Required: Occasional

Shift: Day

Duration: No End Date

Job Function: R&D