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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. 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.

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<p style="margin-bottom:0in;margin-top:0in">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.</p><p style="margin-bottom:0in;margin-top:0in"> </p><p style="margin-bottom:0in;margin-top:0in">Are you interested in joining our team?</p>

Job Summary:
<p style="margin:0px">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.</p>

On-Site Expectations:
<ul><li>100% on-site position.</li><li>1st Shift: Monday - Friday, 8:00am - 5:00pm.</li></ul>

Responsibilities:
<ul><li>Demonstrates strong expertise in biochemistry, mass spectrometry, chemistry, and protein chemistry. Experience in molecular biology is a plus.</li><li>Develops and validates methods to determine purity, potency, identity, residuals, and characterization of pharmaceutical and biopharmaceutical products. Experience in bioassay methodologies is a plus.</li><li>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.</li><li>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.</li><li>Documents results in electronic laboratory notebook.</li><li>Evaluates and interprets analytical data.</li><li>Writes standard operating procedures (SOPs), test procedures, specifications, protocols, project reports (e.g., development/validation), and client communications.</li><li>Positively interacts with team members, management, and clients to discuss data and project progress.</li><li>Leads deviations, investigations, and root cause analysis.</li><li>Participates in regulatory agency and/or client audits.</li><li>Maintains a safe, clean, and organized work environment free of safety hazards. Safely handles potent compounds.</li><li>Ensures timely completion and compliance with cGMP and all other relevant company training requirements.</li><li>Participates in scientific conferences and contributes to scientific journals.</li><li>Leads and mentors associate scientist(s).</li><li>Other duties as assigned.</li></ul>

Qualifications:
<ul><li>Bachelor’s degree in Biochemistry, Chemistry, or related field with minimum 10 years of experience,</li><li>Master’s degree in Biochemistry, Chemistry, or related field with a minimum of 6 years’ experience; OR</li><li>Doctoral degree in a related field with a minimum of 4 years’ experience.</li><li>5+ years of experience in Pharmaceutical/Biopharmaceutical analytical drug product development under cGMP is required.</li><li>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.</li><li>CDMO experience is preferred.</li></ul>

Knowledge, Skills, and Abilities:
<ul><li>Highly organized and detail oriented.</li><li>Able to multitask in a fast-paced environment.</li><li>Able to work independently, along with the ability to work well within a team.</li><li>5+ years of experience in Pharmaceutical/Biopharmaceutical analytical drug product development under cGMP is required.</li><li>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.</li><li>CDMO experience is preferred.</li></ul>

Travel Expectations:
<ul><li>Up to 5% travel expected.</li></ul>

Physical Demands and Work Environment:
<p style="margin:0px">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.</p><p style="margin:0px">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.</p>

Alcami Corporation

Sr. Scientist II - Biotech , Mass Spec

Analysis Skills

Analytical Development

Antibodies

Application Programming Interface (API)

Biochemistry

Biological Assay

Biotech and Pharmaceutical

Chemistry

Chromatography

Conferences

Current Good Manufacturing Practice (cGMP)

Depth Perception

Detail Oriented

Dosage Forms

Drug Development

Drug Products

Gene Therapy

Identify Issues

Instrumentation

Laboratory Notebook

Manufacturing

Mass Spectrometry

Medical Products

Mentoring

Microsoft Exchange Server

Molecular Biology

Multitasking

Nucleic Acid

Organizational Skills

Pharmaceutical Analysis

Physical Demands

Problem Solving Skills

Procedure Development

Product Development

Quality Assurance Methodology

Quality Control

Regulations

Root Cause Analysis

Scientific Principles

Small Molecule Drugs

Software Patches

Standard Operating Procedures (SOP)

Testing

Time Management

UV Spectroscopy

Willing to Travel

[AW]-iCims

ADAPTED_NOW

In addition, bioMérieux offers a competitive Total Rewards package that may include: · A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options · Company-Provided Life and Accidental Death Insurance · Short and Long-Term Disability Insurance · Retirement Plan including a generous non-discretionary employer contribution and employer match. Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel — Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance.

YEAR

<h2><strong>Position Summary</strong></h2><p>Contributes, with technical and scientific expertise to the design and development of high quality products on time, within budget, and with a high degree of customer satisfaction. Acts as a team leader for 2nd shift (Sunday – Thursday 3 – 11 PM).</p><h2><strong>Primary Duties</strong></h2><ol><li><p>Leads 2nd shift team for completion of assigned activities with limited supervision.</p></li><li><p>Process biological specimen samples using aseptic techniques and following lab safety protocols.</p></li><li><p>Performs data collection, interprets, and draws conclusions in an organized manner to continue the development process.</p></li><li><p>Contributes to the development of tools for analyzing large performance data sets generated from experiments.</p></li><li><p>Produces and presents technical information, both written and verbal, for internal and external audiences.</p></li><li><p>Contributes to continuous improvement initiatives.</p></li><li><p>Fosters relationships and promotes a team environment to achieve project goals. </p></li><li><p>Perform all work in compliance with company quality procedures and standards.</p></li><li><p>Perform other duties as assigned.</p></li></ol><div> </div><h2><strong>Qualifications</strong></h2><h3><strong>Required Education, Training and Experience</strong></h3><ul><li><p>Bachelor's degree required: Microbiology preferred, Biology</p></li><li><p>5 years of professional related experience in Product Development of medical diagnostics or devices required, microbiology preferred</p></li></ul><h3><strong>Preferred Education, Training and Experience</strong></h3><ul style="list-style-type:square"><li>Indirect or direct experience leading a team preferred</li><li>Fields of Knowledge: Microbiology preferred, Biology, Biochemistry and/or Medical Diagnostics</li><li>Experience with antibiotic susceptibility test method initiation (automated and reference methods) preferred</li><li>Proficient in skills necessary for good laboratory safety, aseptic technique, and basic microbiology technique. 5S methodology experience preferred</li><li>Experience in product development in a regulated environment highly preferred</li><li>Experience managing large data sets; experience with JMP or other statistical software preferred</li></ul><div> </div><h2><strong>Knowledge, Skills, and Abilities</strong></h2><ul><li><p>Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes</p></li><li><p>Comfortable giving clear, direct, and actionable feedback</p></li><li><p>Demonstrates assertiveness and confidence in the face of a challenge</p></li><li><p>Written communications – including the ability to communicate technical data in written form</p></li><li><p>Informing others by sharing clear, timely information to ensure alignment</p></li><li><p>Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time</p></li><li><p>Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel — Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance</p></li><li><p>Teamwork and collaboration across diverse teams and fast-paced projects</p></li><li><p>Achievement orientation, analytical thinking, flexibility, information seeking</p></li></ul><div> </div><h2><strong>Working Conditions</strong></h2><ul><li><p>Ability to remain in stationary position, either sitting or standing, for prolonged periods: Yes</p></li><li><p>Ability to ascend/descend stairs, ladders, ramps, and the like: Yes</p></li><li><p>Ability to wear PPE correctly for extended periods: Yes</p></li><li><p>Ability to move or lift objects weighing up to 55 pounds in all directions: Yes</p></li><li><p>Travel required: 5% (5% domestic)</p></li><li><p>Position is lab-based and follows work practices for working with laboratory biohazards and chemical hazards</p></li></ul><p> </p><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">The estimated salary range for this role is between $92,000-$135,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">In addition, bioMérieux offers a competitive Total Rewards package that may include: </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        Company-Provided Life and Accidental Death Insurance </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        Short and Long-Term Disability Insurance </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        Retirement Plan including a generous non-discretionary employer contribution and employer match. </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        Adoption Assistance </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        Wellness Programs </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        Employee Assistance Program </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        Commuter Benefits </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        Various voluntary benefit offerings </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        Discount programs </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">·        Parental leaves </div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px"></div><div style="background-repeat:no-repeat;outline:none;color:rgb( 51 , 51 , 51 );font-family:'open sans' , 'helvetica';font-size:14px;font-style:normal;font-weight:400;letter-spacing:normal;text-indent:0px;text-transform:none;word-spacing:0px">#LI-US</div>

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Microbiology Jobs in Caldwell, NC

Sr. Scientist II - Biotech , Mass Spec Alcami Corporation

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