Sr. Principal Scientist - Mass Spectrometry and Bioseparation

 

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 Sr. Principal Scientist – Bioseparation & 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 Sr. Principal Scientist – Bioseparation & Mass Spectrometry will demonstrate expertise in Mass Spectrometry, Reversed Phase, Ion Exchange and Size Exclusion Chromatography, Imaging Capillary Electrophoresis, 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, N/C terminal modifications, PTM (deamidation, oxidation) disulfide bond location, Amino Acid Analysis, glycosylation Profile, Analytical Ultracentrifugation). A Sr. Principal Scientist in this role will develop qualitative, quantitative and semi quantitative methods for API, impurity and excipients by HPLC, LC-MS or LC-MS/MS. The scientist 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. The incumbent will work on extremely complex problems in which analysis of situations or data requires an evaluation of tangible and intangible variables, as well as strong familiarity with scientific literature.

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 Chemistry or related field with 21+ years GMP related experience; OR Master’s degree in related field with 17+ years related experience; OR PhD in related field with 16+ years related experience.

Knowledge, Skills, and Abilities

• Expert knowledge of the pharmaceutical/biopharmaceutical industry, including regulatory guidelines under cGMP, is required.
• Expert knowledge in handling, analyzing and characterizing peptides, monoclonal antibodies, recombinant proteins, and nucleic acids is required.  Knowledge of cell therapy and gene therapy and small molecules is a plus.
• Expert working knowledge of Reversed-Phase, Ion Exchange, and Size Exclusion UPLC/HPLC is required.
• Expert working knowledge of Imaging Capillary Electrophoresis is required.  Knowledge of Gel Electrophoresis is a plus.
• Expert working knowledge of Mass Spectrometry and UV Spectroscopy is required.
• Expert working knowledge of Identification (e.g., Sequencing, Accurate Mass, U