Scientist

Planet Pharma; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

Planet Pharma in the United States is seeking a Scientist in the Attribute Sciences group within Process Development. This 100% document-based role focuses on method transfer, method validation strategies, statistical analysis, and regulatory documentation for QC implementations across pivotal and late-stage programs.

Responsibilities include authoring protocols and reports per ICH guidelines, providing technical writing and data review, and cross-functional project support across clinical and

Qualifications

• Master's degree with 2+ years of operations or scientific experience OR Bachelor's degree with 4+ years of operations or scientific experience.
• Bachelor's in Biochemistry, Analytical Chemistry, Physical or Life Sciences.
• Direct experience with method transfer and method validation in pharma/biotech.
• Excellent written and oral communication for coordination of scientific results.

Responsibilities

• Oversee method transfer and method validation strategies for QC implementations in pivotal and late-stage programs.
• Perform statistical analysis and support data interpretation for regulatory documentation.
• Author protocols and reports in accordance with ICH guidelines and industry standards.
• Provide cross-functional technical writing and data review support across clinical and commercial programs.

Skills

Method transfer

Method validation

Statistical analysis

Technical writing

Data review

Communication skills

Education

Master's degree

Bachelor's degree

Biochemistry/Analytical Chemistry/Physical or Life Sciences

Job description

**This position is 100% computer based and this scientist will be working on the document side. No hands on lab responsibilities**

Biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering innovative human therapeutics. Attribute Sciences group within Process Development is seeking a Scientist.

The Scientist role in Commercial Process Development will be part of the global method implementation team responsible for method transfer and method validation strategies, statistical analysis, and documentation for implementing methods in Quality Control for pivotal and late stage programs. The role will provide technical support for critical large projects. Strong familiarity with the following method platforms is highly preferred: Chromatography, Bioassay, Device, PCR, Microbiology, Immunoassay, CE/Gel, Viral, and General. Protocol and report authoring according to regulatory and industry guidelines (i.e., ICH) and data analysis will be a core activity in this role. Strong technical writing and data review skills required. This individual may support clinical and commercial programs and locations throughout the company under the guidance of project leads.

Basic Qualifications: Pharma or Biotech

Basic Qualifications

• Masters degree and 2 years of Operations or Scientific experience OR Bachelors degree and 4 years of Operations or Scientific experience

Preferred Qualifications

• Bachelor's in Biochemistry, Analytical Chemistry, Physical or Life Sciences
• Strong understanding of methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General (compendia)
• Direct experience with method transfer and method validation processes from a Pharmaceutical or Biotechnology Company.
• Knowledge of analytical methods/technologies used in biologic and synthetic development and manufacturing
• Excellent written and oral communication skills for the timely coordination of scientific results in a fast-paced, multi-disciplinary, team-based environment
• Excellent data review and statistical analysis capability
• Demonstrated ability to manage projects cross functionally
• Demonstrated ability to propose and drive new scientific initiatives

*CO/NYC candidates might not be considered