Sr Associate Process Development jobs in United States
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Planet Pharma ยท 2 weeks ago

Sr Associate Process Development

positionThousand Oaks, CA
timeFull-time
remoteOnsite
seniorityMid, Senior Level
money$29/hr - $39/hr
date2+ years exp

Planet Pharma is a company focused on providing support in pharmaceutical and biopharmaceutical environments. They are seeking a detail-oriented Senior Associate to perform data verification for a Rapid Analytics Lab, ensuring data accuracy and compliance with regulatory expectations.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

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

Qualification

EmpowerChromeleonDocumentation PracticesChromatographic techniquesData verificationAnalytical expertiseProfessional communicationAttention to detailOrganizational skills

Required

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
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

Preferred

2+ years of experience in data verification and analytical laboratory operations
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

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.
dateFounded in 2009
location
Northbrook, Illinois, USA
people-size1001-5000 employees
web-link
http://planet-pharma.com

H1B Sponsorship

Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase