Sr. Scientist I - Bioassay

Responsibilities

• Performs laboratory analysis of pharmaceutical and biopharmaceutical products utilizing analytical instrumentation.
• Analyzes and documents data in accordance with Alcami SOPs.
• Documents results in electronic laboratory notebook.
• Performs one or more of the following techniques: cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing methods.
• Supports troubleshooting and problem solving activities for cell-based and biochemical tests.
• Evaluates and interprets generated data.
• Contributes to operational initiatives to support continued growth of the organization.
• Develops and validates biological tests to determine purity, identity, and potency of pharmaceutical and biopharmaceutical products.
• Writes standard operating procedures (SOPs), test procedures, specifications, and summary reports.
• Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Affords assistance in removal of hazardous waste, routine equipment cleaning, and restocking of consumable products and reagents.
• Interacts with team members, management, and clients to discuss data and project progress.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Effectively uses various laboratory software packages (SoftMax, ProCal, Master Control, ELN, etc.).
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Safely handles potent compounds.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• Bachelor’s degree and 8+ years of related experience OR Master’s degree with 4+ years of related experience OR PhD with 2+ years of experience required.
• 2+ years of experience in Pharmaceutical, CDMO, or cGMP preferred.
• Working knowledge of peptides, monoclonal antibodies, recombinant proteins is required, and knowledge of cell therapy and gene therapy is preferred.
• Expert knowledge of Cell-based Bioassays required.
• Expert knowledge of Real-time PCR preferred.
• Expert knowledge of ELISA/immunoassays required.
• Strong knowledge of Enzymatic Activity Assays preferred.
• Strong knowledge of Laboratory Documentation is required.
• Strong knowledge of cGMP in a pharmaceutical or regulated environment is preferred.
• Strong verbal communications and presentation skills required.
• Strong time management and organization skills required.
• Strong knowledge of Laboratory equipment and safety required.
• Strong problem solving and trouble shooting ability required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
• Working knowledge of SoftMax and Empower preferred.