Scientist III - Analytical , Compendial , Raw Material Testing - Weekend 1st Shift
Morrisville, North Carolina, United States · On-site
Senior
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 r…
Morrisville, North Carolina, United States · On-site
Senior
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 r…
Skills: Engineering management, cGMP compliance, Capital project management, Equipment reliability, Team leadership
Morrisville, North Carolina, United States · On-site
Mid level
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 r…
Skills: cGMP, Manufacturing leadership, Root cause analysis, CAPA, Technical writing
Business Development Manager, Pharma Storage - Mid Atlantic
United States · Remote Solely
Mid level
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 r…
Skills: Business development, Sales, Pharma storage, Customer relationship management, Salesforce
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 r…
Skills: Audit compliance, Regulatory requirements, cGMP, CAPA, Change control
Morrisville, North Carolina, United States · On-site
Senior+
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 r…
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 r…
Skills: Driving, Route planning, Good documentation practices, Temperature monitoring, Customer service
Morrisville, North Carolina, United States · On-site
Mid level
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 r…
Morrisville, North Carolina, United States · On-site
Senior+
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 r…
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 r…
Skills: Technical evaluations, Proposal writing, Sterile drug product, CDMO, Costing
North Charleston, South Carolina, United States · On-site
Entry level
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 r…
Morrisville, North Carolina, United States · On-site
Entry level
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 r…
Skills: Environmental monitoring, cGMP compliance, SOP adherence, Sampling, Data analysis
Manufacturing Technician II - Sterile Injection - 12-Hr Night Shift 2-2-3
Morrisville, North Carolina, United States · On-site
Mid level
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 r…
Wilmington, North Carolina, United States · On-site
Entry level
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 r…
Morrisville, North Carolina, United States · On-site
Entry level
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 r…
Skills: Environmental monitoring, cGMP, SOP compliance, Sampling, Data analysis
Quality Control Data Review Specialist - Weekend 1st Shift
Morrisville, North Carolina, United States · On-site
Mid level
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 r…
Skills: Quality control, Data review, Chromatography, GMP compliance, Regulatory compliance
Manufacturing Technician I - Sterile Injection - 12-Hr Night Shift 2-2-3
Morrisville, North Carolina, United States · On-site
Entry level
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 r…
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 r…
Skills: HPLC, CE, icIEF, UV Spectroscopy, Method Development
Manufacturing Technician II - Sterile Injection - 12-Hr Day Shift 2-2-3
Morrisville, North Carolina, United States · On-site
Mid level
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 r…
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 r…
Skills: Talent Sourcing, Recruitment, Interviewing, Candidate Engagement, Relationship Building
Scientist III - Analytical , Compendial , Raw Material Testing - Weekend 1st Shift
The Scientist III performs routine and non-routine analytical testing, including HPLC and wet chemistry, to support pharmaceutical product development and manufacturing. They are also responsible for evaluating data, writing technical reports, and ensuring compliance with cGMP and safety regulations.
Requirements
Candidates must have an Associate's degree with 16+ years of experience, a Bachelor's degree with 6+ years, a Master's with 2+ years, or a PhD. Strong knowledge of USP, EP, and JP compendial requirements and hands-on experience in a cGMP pharmaceutical environment are required.
Full job description
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.
Are you interested in joining our team?
Job Summary
The Scientist III is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. The Scientist III may also be required to work on method development/method validation projects. For this position, HPLC, dissolution and/or GC based methodologies are commonly employed in the described testing. Other key methodologies applied include titrations, UV-Vis, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
On-Site Expectations
100% on-site position.
1st Shift: Friday - Sunday, 7:00am - 7:00pm.
Responsibilities
Develops and perfomes routine analytical analysis via HPLC, TOC, UV, and/or particle size based on various compendia.
Performs GMP review of solutions and wet chemical analyses and chromatography.
Performs one or more of the following techniques: residual solvents, assays (potencies, related substances), dissolution, elemental impurities, moisture content, identification, and various other wet chemistry-based measurements.
Evaluates and interprets generated data.
Analyzes information for technical correctness and accuracy.
Understands the theoretical basis of methods/experiments.
Solves problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Writes test procedures, protocols, and reports.
Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
Assists in removal of hazardous waste, routine equipment cleaning, and restocking of consumable products and reagents.
Maintains a safe, clean, and organized work environment free of safety hazards.
Safely handles potent compounds.
This position will be required to supervise, handle, or process hazardous waste under Resource and Conservation guidelines promulgated under 40 CFR 262.177(a)(7), Personnel Training. This includes completion of initial and annual RCRA training and documented as required in Alcami records. This training also includes familiarity with emergency response procedures, emergency equipment, and emergency systems.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.
Qualifications
Associate’s degree and 16+ years of related experience.
Bachelor’s degree and 6+ years of related experience.OR
Master’s degree with 2+ years of related experience required or PhD with 0+ year of experience.
Experience in Pharmaceutical, CDMO, or cGMP required.
Knowledge, Skills, and Abilities
Demonstrated hands-on experience performing compendial and raw material testing within a pharmaceutical, biotechnology, or CDMO environment required.
Strong knowledge of USP, EP, and JP compendial requirements and their application to pharmaceutical raw material and finished product testing.
Excellent verbal and written communication and documentation skills required.
Excellent detail orientation and organizational skills required.
Excellent problem-solving and basic trouble-shooting ability required.
Excellent knowledge of Laboratory equipment and safety required.
Expert knowledge of Laboratory Documentation is required.
Working knowledge of cGMP in a pharmaceutical or regulated environment preferred.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
Travel Expectations
Up to 5% travel to clients is required.
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.
Related keywords
ScientistAnalyticalCompendialRaw Material TestingHPLCDissolutionGCTitrationsUV-VisAAIRGMPPharmaceuticalCDMOUSPEP
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. Alcami provides fully integrated lab services, drug product manufacturing, and cGMP pharma storage and support services including environmental monitoring, calibration, and validation. Alcami’s private equity ownership includes GHO Capital, The Vistria Group, and Ampersand Capital Partners.
Offices: 2320 Scientific Park Dr, Wilmington, NC 28405, US · 4620 Creekstone Drive, Durham, NC 27703, US · 4221 Faber Place Dr, Charleston, SC 29405, US · 4260 Forest Park Ave, St. Louis, MO 63108, US · 627 Davis Dr, Suite 100, Morrisville, NC 27560, US
Sterile Fill-Finish Development & ManufacturingOral Solid Dose Development & ManufacturingLaboratory ServicesEnvironmental MonitoringPackaging & LabelingAnalytical TestingDevelopment TestingCleanroom ServicesChemistryMicrobiology
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. Alcami provides fully integrated lab services, drug product manufacturing, and cGMP pharma storage and support services including environmental monitoring, calibration, and validation. Alcami’s private equity ownership includes GHO Capital, The Vistria Group, and Ampersand Capital Partners.
Offices: 2320 Scientific Park Dr, Wilmington, NC 28405, US · 4620 Creekstone Drive, Durham, NC 27703, US · 4221 Faber Place Dr, Charleston, SC 29405, US · 4260 Forest Park Ave, St. Louis, MO 63108, US · 627 Davis Dr, Suite 100, Morrisville, NC 27560, US
Sterile Fill-Finish Development & ManufacturingOral Solid Dose Development & ManufacturingLaboratory ServicesEnvironmental MonitoringPackaging & LabelingAnalytical TestingDevelopment TestingCleanroom ServicesChemistryMicrobiology