Scientist III - Bioassay

Alcami Corporation•Wilmington, NC

2d•Onsite

About The Position

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, enzymatic activity assays, binding kinetic assays and other biochemical testing methods. Also, knowledge in techniques such as HPLC, icIEF, or CE-SDS is desirable. 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.

Requirements

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.
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.
Strong knowledge of ELISA/immunoassays required.
Working knowledge of Laboratory Documentation is required.
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.

Nice To Haves

Knowledge in techniques such as HPLC, icIEF, or CE-SDS is desirable.
Working knowledge of Real-time PCR preferred.
Working knowledge of Enzymatic Activity Assays preferred.
Working knowledge of cGMP in a pharmaceutical or regulated environment is preferred.
Working knowledge of SoftMax and Empower preferred.

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.