Planet Pharma
Sr Associate Process Development
Planet Pharma, Thousand Oaks, California, United States, 91362
Sr Associate Process Development
at
Planet Pharma
Location: Thousand Oaks, CA
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
Bachelor’s 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: Bachelor’s 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.
Qualifications
Masters degree, OR Bachelors degree and 2 years of Process Development experience, OR Associate’s degree and 4 years of Process Development experience, OR High school diploma / GED and 6 years of Process Development experience.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr
at
Planet Pharma
Location: Thousand Oaks, CA
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
Bachelor’s 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: Bachelor’s 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.
Qualifications
Masters degree, OR Bachelors degree and 2 years of Process Development experience, OR Associate’s degree and 4 years of Process Development experience, OR High school diploma / GED and 6 years of Process Development experience.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr