Principal Scientist I - 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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The Principal Scientist I- 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 Principal Scientist I - 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 Principal Scientist I in this role will develop qualitative, quantitative and semi quantitative methods for API, impurity and excipients by HPLC, LC-MS or LC-MS/MS.

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.

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

• 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.

• BS or BA in Chemistry or related field required with minimum of 15 years' experience; OR
• Master's degree in Chemistry or related field with a minimum of 11 years' experience; OR
• Doctoral degree with a minimum of 10 years' experience.

• 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, Unknown Peak ID, etc.) and Characterization of biologicals and large molecules (e.g., Peptide Map, Amino Acid Analysis, glycosylation Profile, Analytical Ultracentrifugation, etc.) is required.
• Ability to apply scientific principles, theories and concepts to research problems, to develop solutions for analytical problems, and to design/execute non-routine experiments with minimal supervision, is required.
• Ability to correctly analyze data/results, interpret outcome of experiments, and to propose appropriate follow-up with minimal supervision, is required.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures and governmental regulations and write reports, business correspondence and procedure manuals, is required.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public, is required.
• Proficiency with Microsoft Office Software, is required.

• Up to 5% travel required.

While performing the duties of this position, the employee must regularly stand and bend, and is frequently required to sit and walk, crawl, or stoop. Employee must frequently use hands to finger, handle or feel objects, tools or controls. Must be able to talk and hear. Employee must frequently lift up to 25 pounds without assistance and move over 50 pounds with mechanical aid. Specific vision ability required by this job includes close vision, distance vision, depth perception; the ability to adjust focus, and observe color changes. The noise level is moderate to noisy. Occasionally, employee is exposed to airborne particles and fumes. Employee is exposed to various chemicals.

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.