Job Title: Scientist I Analytical

Location: 466 Devon Park Dr., Wayne, PA 19087 (Onsite)
Duration: 1 Year (Possible Extension)

Pay Rate: $35 $40.00/hour (W2 All-Inclusive)

No. of Positions: 3
Interview Mode: Onsite

JOB DESCRIPTION

Assist in the development and execution of methods related to the testing and characterization of biotherapeutics using analytical instrumentation and methodologies. Under minimal supervision, may be responsible for method feasibility, method development, method optimization, method transfers, method qualifications, method validations, and routine testing under both R&D and cGMP environments. Additionally, will be responsible for client interaction, interpretation, and reporting of data for assigned research projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform and troubleshoot laboratory experiments, tests, and procedures within regulatory compliance for the characterization and analysis of biotherapeutics through use of analytical testing and characterization instrumentation and methodologies.
• Perform routine testing techniques such as:
  • Chromatographic Analyses including Process Related Residuals
  • Quantitative Monosaccharide and Sialic Acid Analysis
  • ELISA / Immunoassay Analyses
  • Process Residual / Drug Product Excipient Analyses
  • N-Terminal Sequencing
  • Amino Acid Compositional Analysis / Extinction Coefficient Determination
  • Use of Empower and Chromelion Software
• Review, interpret, analyze, evaluate, integrate, and present experimental data with the assistance of senior technical staff as appropriate.
• Perform tabulation and statistical analyses of study data.
• Prepare high-quality final reports including integration of supporting subcontractor reports as required.
• Assist in technical review of procedures, data, and documentation.
• Participate in long-term projects (SOP redesigns, CTMs, or report formats).
• Interact with clients regarding project design, scheduling, and conduct.
• Collaborate across departments to coordinate projects, discuss issues, and prepare reports.
• Attend scientific meetings, conferences, and training courses to enhance skills.
• Generate analytical data and technical reports for both cGMP and R&D grade testing.
• Participate in laboratory instrumentation and equipment preventative maintenance and qualification programs.
• Maintain a safe working environment and adhere to company policies.
• Perform equipment troubleshooting and repair with minimal guidance.
• Maintain clear, accurate, and timely documentation of all laboratory work.
• Compose quality documentation, including deviation reports and change control documentation.
• Create, review, and edit SOPs, protocols, and testing documentation.
• Follow all SOPs, CTMs, and cGMP as they relate to assigned tasks.
• Train and support junior staff and participate in method transfer and training of analytical personnel.
• Maintain training records and ensure up-to-date procedural compliance.
• Work effectively independently and in team settings.
• Perform all other related duties as required.

QUALIFICATIONS

• Education: Bachelor s degree (B.A./B.S.) in Chemistry, Biotechnology, or related scientific discipline. M.S. or Ph.D. preferred.
• Experience: Minimum 3 years of relevant experience within a contract research, academic, or pharmaceutical industry setting, with emphasis on characterization and analysis of biotherapeutics.
• Knowledge of cGMPs or regulatory affairs in the pharmaceutical/biological industries preferred.
• Demonstrated ability to operate HPLC, Plate Reader, Capillary Electrophoresis (CE), Spectrophotometer, and other analytical laboratory equipment.
• Ability to handle multiple projects, prioritize work, and meet deadlines in a regulated environment.
• Strong analytical and problem-solving abilities with the ability to anticipate and recognize potential issues.
• Excellent interpersonal, verbal, and written communication skills; able to collaborate across teams.
• Computer proficiency in MS Word, Excel, Outlook, and analytical tools such as Empower, Chromelion, and LIMS.

PHYSICAL AND WORK ENVIRONMENT REQUIREMENTS

• Ability to perform lab-based work including pipetting, lifting up to 10 50 pounds, and handling chemicals.
• Regular exposure to chemical fumes, biohazards, and lab instrumentation under moderate noise conditions.
• Must wear appropriate protective clothing (gloves, lab coat, safety glasses).
• May require occasional overtime, weekend, or holiday coverage.

CANDIDATE SELF-ASSESSMENT QUALIFYING SKILL MATRIX

Please fill out the below matrix while applying. Use a scale of 1 (Beginner) to 10 (Expert) for the Self-Rating column.