Sr Associate Process Development

Thousand Oaks, CA 91320 US

Posted: 12/12/2025 2025-12-12 2026-01-11 Employment Type: Contract Job Category: Scientific Job Number: 624423 Is job remote?: No Country: United States

Job Description

Target PR Range: 29-39/hr

• Depending on experience

The ideal candidate for the Process Development Senior Associate role is a detail-oriented laboratory professional with hands-on experience supporting analytical workflows in a pharmaceutical, biopharmaceutical, or comparable laboratory environment. This individual has working knowledge of Empower and/or Chromeleon software used to control HPLC and related analytical instruments, demonstrates strong Good Documentation Practices (GDP), and communicates clearly with cross-functional teams. A bachelors degree in chemistry, biochemistry, or a related scientific discipline is required, while years of experience are flexible as comprehensive training will be provided. Candidates must be comfortable working on-site in a GMP setting, supporting data verification activities, and contributing reliably throughout a one-year project engagement.

Data Verifier - BioVia Notebook, Empower, and Chromeleon Data (Regulatory Filing Support)

Overview

We are seeking a detail-oriented and highly disciplined Senior Associate to perform data verification for a Rapid Analytics Lab located at Thousand Oaks California. This role will focus on verifying Notebook entries, Empower chromatographic data, and Chromeleon instrument data to confirm alignment with reporting requirements and Good Documentation Practices (GDP). The ideal candidate possesses strong analytical expertise, exceptional diligence, and a deep understanding of expectations for data review.

Key Responsibilities

• Perform comprehensive verification of analytical data packages, including Notebook records, Empower chromatographic results, and Chromeleon sequences and reports.
• Confirm data accuracy, traceability, and compliance with internal SOPs and regulatory expectations (e.g., FDA, EMA, ICH).
• Ensure that data used in regulatory filings are complete, consistent, and appropriately linked to source systems.
• Identify discrepancies or omissions in data packages and work collaboratively with laboratory analysts and technical leads to resolve issues.
• Verify metadata, audit trails, instrument parameters, and processing methods to ensure appropriate data governance and ALCOA+ principles.
• Participate in process improvement initiatives related to data verification workflows and digital system integration.
• Maintain organized, inspection-ready documentation to support internal audits and health authority inspections.

Basic Qualifications

• Bachelors degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biotechnology, Analytical Sciences) or equivalent combination of education and relevant experience.
• Experience working with laboratory information systems, including Empower and/or Chromeleon, and electronic Laboratory Notebook systems (ELN/LIMS).
• Strong understanding of chromatographic techniques (Capillary Electrophoresis/HPLC/UPLC), data processing, and instrument workflows.
• Demonstrated familiarity with data integrity principles

Preferred Qualifications

• 2+ years of experience in data verification and analytical laboratory operations.
• Minimum: Bachelors degree
• Direct experience in preparing or supporting data for regulatory filings.
• Knowledge of analytical method validation, transfer, release, and stability testing.
• Ability to clearly communicate data issues, trends, and resolutions to cross-functional teams.
• High aptitude for working with digital systems, data governance tools, and structured documentation.

Key Competencies

• Exceptional attention to detail and accuracy
• Strong organizational and prioritization skills
• Ability to work independently while collaborating effectively with analysts, SMEs, and regulatory teams
• Professional communication and documentation skills
• Commitment to data integrity and continuous improvement

BASIC QUALIFICATIONS:

Masters degree

OR

Bachelors degree and 2 years of Process Development experience

OR

Associates degree and 4 years of Process Development experience

OR

High school diploma / GED and 6 years of Process Development experience

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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