Sr. Scientist I - Biotech

Alcami Corporation • Durham, NC

111d

About The Position

A Senior Scientist I is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of (bio-)pharmaceutical product development or (bio-)pharmaceutical manufacturing. The Senior Scientist I may also be required to work on method development/method validation projects. For this position, HPLC, CE, icIEF and/or UV based methodologies are commonly employed in the described testing. Other key methodologies applied include cKF/KF, pH, and osmolality. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).

Requirements

• Bachelor’s degree in Biochemistry, Chemistry or related field with 8+ years of experience, or Master’s degree with 4+ years of experience, or Ph.D. with 2+ years of experience required.
• 2+ years of experience in Pharmaceuticals drug product development under cGMP is required.
• Excellent verbal and written communication and documentation skills required.
• Excellent detail orientation and organizational skills required.
• Excellent problem-solving and basic trouble-shooting ability required.
• Excellent knowledge of laboratory equipment and safety required.
• Expert knowledge of Laboratory Documentation is required.
• Ability to develop and implement new methods/processes required.
• Ability to plan and manage multiple tasks for timely achievement of results.
• Working knowledge of cGMP in a pharmaceutical or regulated environment required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

Nice To Haves

• Experience in molecular biology is a plus.
• Experience in bioassay methodologies is a plus.
• Experience with Mass Spectrometry for Identification and Characterization of biologicals and large molecules is a plus.
• CDMO experience is preferred.

Responsibilities

• Demonstrates strong expertise in biochemistry, mass spectrometry, chemistry, and protein chemistry.
• Develops and validates methods to determine purity, potency, identity, residuals, and characterization of pharmaceutical and biopharmaceutical products.
• Performs one or more of the following techniques: HPLC (SEC, AEX, CEX), LC-MS, UV, CE, icIEF, cKF/KF.
• Evaluates and interprets generated data.
• Performs GMP review of solutions and biochemical analysis involving spectroscopic, chromatographic and electrophoretic methods.
• Analyzes information for technical correctness and accuracy.
• Understands the theoretical basis of methods/experiments.
• Solves problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Writes test procedures, protocols, and 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.
• Effectively uses various laboratory software packages (Empower3, 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.

Benefits

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

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees