Sr Associate Process Development

Thousand Oaks, CA 91320

Posted: 01/13/2026 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
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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.