Scientist III - Bioassay

Job Summary

The Scientist III, Bioassay is accountable for driving results in a fast-paced environment by performing routine and non-routine testing in support of pharmaceutical product development and manufacturing. The Scientist III, Bioassay may also be required to work on method development and method validation projects. The Scientist III, Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA, real-time PCR, flow cytometry, enzymatic activity assays, binding kinetic assays and other biochemical testing methods. Strong problem-solving and troubleshooting skills along with proficiency in analyzing data, laboratory documentation, data presentation and collaboration will help ensure success in this position.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:30am - 5:00pm.

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.
• Assists 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

• Associate’s degree and 16+ years of related experience.

• OR Bachelor’s degree and 6+ years of related experience.
• OR Master’s degree with 2+ years of related experience.
• OR PhD with 0+ years of experience required.
• 2+ years of experience in Pharmaceutical, CDMO, or cGMP preferred.

Knowledge, Skills, and Abilities

• Working knowledge of peptides, monoclonal antibodies, recombinant proteins is required, and knowledge of cell therapy and gene therapy is preferred.
• Knowledge of Cell-based Bioassays required.
• Working knowledge of Real-time PCR preferred.
• Strong knowledge of ELISA/immunoassays required.
• Working knowledge of Enzymatic Activity Assays preferred.
• Working knowledge of Laboratory Documentation is required.
• Working 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.
• Good problem solving and trouble shooting ability required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
• Working knowledge of SoftMax and Empower preferred.

Travel Expectations

• Up to 5% travel required.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. 

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.