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Planet Pharma · 19 hours ago

Senior Scientist

Boston, MA

Contract

Onsite

Mid, Senior Level

$47/hr - $48/hr

2+ years exp

Planet Pharma is seeking a detail-oriented and proactive Senior Associate Scientist, Specifications to support the specification management of siRNA drug substances and drug products. This role involves contributing to GMP-compliant operations, regulatory submissions, and specification oversight in a fully onsite environment.

BiotechnologyHealth CarePharmaceutical

H1B Sponsor Likely

Responsibilities

Initiate and manage specification change controls in a GMP environment

Review data and author/review technical documentation, SOPs, and protocols

Contribute to analytical and stability sections of regulatory submissions and assist with agency requests

Perform specification assessments for existing and new products

Maintain platform program specification documents

Provide technical support across projects as needed

Qualification

CGMP experienceHPLCTechnical documentation reviewStatistical analysisVeeva familiarityChemistry knowledgeAnalytical skillsInterpersonal skillsDetail-orientedSelf-motivatedWritten communicationVerbal communication

Required

BS or MS in Chemistry, Biochemistry, Analytical Chemistry, or related field

Minimum 2 years of professional experience in a cGMP analytical laboratory environment

Strong understanding of chemistry, QA/QC, and regulatory requirements

Experience working with and reviewing technical data and documentation

Preferred

Experience with stability studies conducted per ICH guidelines

Hands-on experience with HPLC and physico-chemical test methods (oligonucleotides preferred; oligosaccharides or proteins acceptable)

Familiarity with Veeva or similar data processing systems

Experience in statistical analysis

Company

Planet Pharma

Planet Pharma is a pharmaceuticals company.

Founded in 2009

Northbrook, Illinois, USA

1001-5000 employees

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

Cynthia Lewis

Senior Executive Recruiter, Life Sciences - PPG Advisory Partners

Emma Morris

President, PPG Advisory Partners

Company data provided by crunchbase