Sr. Scientist I - Biologics

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

 

Are you interested in joining our team?

Job Summary

The Senior Scientist I, 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 Sr. Scientist I, Bioassay may also be required to work on method development and method validation projects. The Senior Scientist I, 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 techiniques 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.

On-Site Expectations

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

• 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.

Knowledge, Skills, and Abilities

• 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.

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