3+ years of pharma/biotech experience Biotech/ pharma experience required 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 Top 3 skills: Analytical method validation and transfer experience Familiarity with analytical method technologies Self-starter with good communication skills
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 Salary and Other Compensation38 The annual [salary/hourly rate] for this position is between $38.00 - $40.00 per hour . Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: [medical insurance], [dental insurance], [vision insurance], [401(k) retirement plan], [life insurance], [long-term disability insurance], [short-term disability insurance], [paid parking/public transportation], [Paid time off], [Days/hours of paid sick and safe time], [Days/hours of paid vacation time], [Weeks of paid parental leave], [Paid holidays annually], [any additional benefits applicable].
Benefits
Paid Time Off (PTO)
Sick Leave
401(k) Plans
Other Retirement and Savings
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