Senior Scientist 2

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.

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Job Summary

The Senior Scientist II – BioSeparations & Mass Spectrometry is the Subject Matter Expert (SME) for their field, demonstrates in depth working knowledge of scientific principles and leads the implementation of new methods/processes to solve problems. A Senior Scientist II – BioSeparations & Mass Spectrometry will demonstrate expertise in Reversed Phase, Ion Exchange and Size Exclusion Chromatography, Imaging Capillary Electrophoresis, Mass Spectrometry, and UV Spectroscopy testing methods. Other key methodologies applied include Identification (e.g., Sequencing, Accurate Mass, Unknown Peak ID) and Characterization of biologicals and large molecules (e.g., Peptide Map, Amino Acid Analysis, glycosylation Profile, Analytical Ultracentrifugation). A Senior Scientist II in this role routinely executes method development/method validation projects, troubleshoots equipment, documents proficiently in electronic laboratory notebooks, prepares and reviews summaries of observations, test procedures and project reports, and is capable of verbal and written presentations to internal and external audiences.

On-Site Expectations

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

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.

Qualifications

• 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.
• CDMO experience is preferred.

Knowledge, Skills, and Abilities

• Highly organized and detail oriented.
• Able to multitask in a fast-paced environment.
• Able to work independently, along with the ability to work well within a team.
• 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.
• CDMO experience is preferred.

Travel Expectations

• Up to 5% travel expected.

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 stand. The employee is occasionally required to walk; sit 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 frequently exposed to moving mechanical parts and the risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals 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, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.