Scientist (Method Validation and Transfer)

Aequor; United States; Remoto; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Aequor is seeking a scientist for a 12-month contract (W2) that can be 100% remote in the United States. The role focuses on document-intensive work in analytical method validation and transfer with no hands-on lab duties.

The ideal candidate has a Master’s degree with related experience or a Bachelor’s with several years in pharma/biotech, and will contribute to protocol authoring, data review, and regulatory-compliant documentation for QC method implementations.

Competenze

• Master’s degree and 2 years of Operations or Scientific experience OR Bachelor’s degree and 4 years of Operations or Scientific experience.
• Experience with analytical method platforms such as Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General methods.

Mansioni

• Data verification of analytical method validation and transfer documents.
• Data analysis including statistical analysis.
• Drafting analytical method validation and transfer plans, protocols, data appendices, and reports.

Conoscenze

Analytical method validation

Method transfer

Data analysis

Statistical analysis

Formazione

Master’s degree in Biochemistry/Analytical Chemistry

Bachelor’s degree in Life Sciences

Descrizione del lavoro

Duration: 12 Months with possible extension

Terms: Contract W2 only

Description:

This position can be 100% remote

EW will be supporting U.S. core business hours, EW will be working a standard 8 hour day. No preference on time zone, but the ask is the EW may be required to support workload outside of their time zone on occasion.

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

• 3+ years of pharma/biotech experience
• Analytical method validation and transfer strategy and documentation experience

Ideal candidate with a bachelor's degree in Biochemistry, Analytical Chemistry, Physical or Life Sciences. Strong understanding of analytical methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General (compendia).

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

• Master’s degree and 2 years of Operations or Scientific experience OR Bachelor’s 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

Top 3 Must Have Skill Sets:

• Analytical method validation and transfer experience
• Familiarity with analytical method technologies
• Self-starter with good communication skills

Day to Day Responsibilities:

• Data verification of analytical method validation and transfer documents
• Data analysis including statistical analysis
• Drafting of analytical method validation and transfer plans, protocols, data appendices, and reports