Alcami Corporation · 23 hours ago
Sr. Scientist II - Biotech
Durham, NC
Full-time
Onsite
Mid, Senior Level
4+ years expAlcami Corporation is a company that delivers reliable solutions for transformative medicines from discovery to commercialization. The Senior Scientist II – BioSeparations & Mass Spectrometry will serve as a Subject Matter Expert, leading method development and validation projects while ensuring compliance with regulatory standards.
Pharmaceuticals
Responsibilities
Demonstrates strong expertise in biochemistry, mass spectrometry, chemistry, and protein chemistry. Experience in molecular biology is a plus
Develops and validates methods to determine purity, potency, identity, residuals, and characterization of pharmaceutical and biopharmaceutical products. Experience in bioassay methodologies is a plus
Supports analytical studies for peptides, proteins, nucleic acids, carbohydrates, cell & gene therapy products, as well as small molecule drugs in parenteral, solid dosage forms, transdermal patches, intermediates, and APIs
Maintains an expert knowledge and mastery of equipment, instrumentation, procedures, and scientific methodologies necessary to perform complex research or projects. Performs routine analytical procedures necessary for support of formulation development, manufacturing, and QC stability activities
Documents results in electronic laboratory notebook
Evaluates and interprets analytical data
Writes standard operating procedures (SOPs), test procedures, specifications, protocols, project reports (e.g., development/validation), and client communications
Positively interacts with team members, management, and clients to discuss data and project progress
Leads deviations, investigations, and root cause analysis
Participates in regulatory agency and/or client audits
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
Participates in scientific conferences and contributes to scientific journals
Leads and mentors associate scientist(s)
Other duties as assigned
Qualification
Required
Bachelor's degree in Biochemistry, Chemistry, or related field with minimum 10 years of experience
Master's degree in Biochemistry, Chemistry, or related field with a minimum of 6 years' experience; OR
Doctoral degree in a related field with a minimum of 4 years' experience
5+ years of experience in Pharmaceutical/Biopharmaceutical analytical drug product development under cGMP is required
Demonstrated experience in development, validation and troubleshooting chromatographic, electrophoretic, mass spectrometry and other spectroscopic methods for one or more of the following products: peptides, monoclonal antibodies/recombinant proteins, nucleic acids, cell therapy, and gene therapy
Preferred
CDMO experience is preferred
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase