Senior Research Professional
5 days ago
Job Title:
Senior Research ProfessionalAt Planet Pharma, we are seeking an experienced Senior Research Professional to join our team.
Job Summary:
The successful candidate will lead and provide scientific oversight of analytical/microbiological strategy and studies for the evaluation of safety attributes of protein and cell therapy drug products, drug substances, and process intermediates.
Responsibilities:
- Lead method development, qualification, validation or verification, troubleshooting, and sample analysis by QbD approach and harmonized to USP monographs.
- Develop and execute assays for endotoxin, sterility, mycoplasma, and adventitious agents using GC-MS, qPCR, in-vitro cellular assays, and fluorescent endpoint and chromogenic assays.
- Autor protocols and associated reports per Good Documentation Practices (GDP).
- Compile data packages, reports, and author/review sections for regulatory filings.
- Provide technical leadership and scheduling for a small team of associates and junior scientists.
Requirements:
- Ph.D. with 8+ years of industry experience or master's degree with 10+ years of industry in Biology, Microbiology, Virology, and/or Molecular Biology fields.
- GMP or Quality experience with proficiency with regulatory compliance and FDA guidelines for Title 21 Code of Federal Regulations part 211 current Good Manufacturing Practices (cGMP) and Good Clinical (Research) Practices (GCP), ICH standards for analytical test methods as required, United States Pharmacopeia (USP).
- Prior experience developing and supporting protein drug substance and drug product development.
Estimated Salary:
$120,000 - $150,000 per year, depending on qualifications and experience.
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