Responsibilities for a Validation Engineer II involve validation equipment preparation, protocol execution, and final report generation. This position will perform a wide range of validation activities focused on environmental chambers, including: cryo-freezers, cold rooms, refrigerators, incubators, depyrogenation ovens, stability chambers and warehouses, as well as sterilizers and CSV. Interface with customers and equipment end users. The Validation Engineer II works with minimal supervision and will independently work at customer sites with small and medium projects.
The Manufacturing Supervisor is accountable for results in a fast-paced environment and is responsible for maintaining product quality by supporting GMP operations of life-saving sterile injectable drug products intended for clinical trials and commercial distribution. The Manufacturing Supervisor operates in alignment with established Standard Operating Procedures (SOPs) and approved Batch Records, which are developed in accordance with regulatory expectations and current Good Manufacturing Practices (cGMPs). The Manufacturing Supervisor oversees a team of Manufacturing Technicians and ensures utilization of acceptable cleanroom techniques while working in manufacturing/inspection environments and is expected to demonstrate proficiency in all department...
The Laboratory Support Technician is accountable for driving results in a fast-paced environment by assisting the laboratory staff with a wide range of tasks including laboratory housekeeping, glassware washing, equipment setup, and stocking supplies.
The Calibration Field Technician I performs routine calibration and preventive maintenance of Alcami and customer equipment. Calibration may include temperature, relative humidity, CO2, voltage, pressure, time, rotation, etc. following documented procedures using precision standards. Calibrations and Preventative Maintenance will be performed in-house and at customer sites. Create, modify, and execute calibration procedures and calibration certificates. Perform testing to support the quality management system and report, troubleshoot and make recommendations about quality issues relating to calibration. Assist in filing, data entry, and general record keeping.
The Stability Coordinator I is accountable for driving results in a fast-paced environment by generating protocols and facilitating the log in of samples and projects for lab documentation and reporting of data for client stability programs. This position provides administrative and organizational support related to stability storage activities, including protocol generation, sample receipt, inventory, login for testing, transfer/shipment, and storage. The ideal candidate will maintain electronic documentation and files to assure they are accurate and up-to-date and available to appropriate personnel.
The Senior Manager, Quality Operations of Pharma Storage is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Senior Manager, Quality Operations provides leadership to the site Quality team who performs quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives, directs the implementation of quality plans, and works with lab management to ensure department goals and objectives are met. The Senior Manager interacts with clients and...
The Visual Inspection Technician II is accountable for results in a fast-paced environment and responsible to perform tasks for the quality inspection of sterile injectable products for commercial distribution and clinical trials. The Visual Inspection Technician II handles and inspects manufactured products by following standard operation procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). In addition, the Visual Inspection Technician II employs acceptable techniques while working in manufacturing environments, including PPE gowning, and provides training and coaching to less experienced Visual Inspection Technicians as required. The Visual Inspection Technician interacts with customers as needed.
The Sr. Scientist I, Microbiology is accountable for driving results in a fast-paced environment by performing more complex microbial analysis and assisting in method development and validation. This position takes on the role of troubleshooter and trainer and will provide direct assistance to manufacturing and cleanroom qualification efforts. The Sr. Scientist I, Microbiology participates more actively in lab investigations and corrective and preventative actions. The role initiates procedural revisions and performs editing and review functions. The Sr. Scientist I, Microbiology may serve as a primary technical contact with clients.
The Supply Chain Specialist is responsible for driving results in a fast-paced environment by primarily ensuring material availability to support the production schedule. The Supply Chain Specialist’s responsibilities include managing inventory levels, supporting material/product level revisions, interacting/coordinating with suppliers on a variety of topics, and supporting other business functions as required.
The Sr. Metrologist is accountable for driving results in a fast-paced environment by performing calibration and diagnostics repair of process instrumentation including pressure, temperature, flow, relative humidity and mass in pharmaceutical manufacturing and laboratory environments. A fundamental knowledge of clean utilities systems including WFI and Clean Steam is required. Additional experience with analytical instrumentation including HPLC, gas chromatography, and laboratory equipment desired. Maintaining calibration of metrology standards and completing and reviewing calibration documents. The ideal candidate will use computerized equipment and software to perform testing functions and produce graphs.
The Manufacturing Technician I - Oral Solid Dosage (OSD) is accountable for results in a fast-paced environment and assists with the manufacturing of oral solid dose products for commercial distribution. The Manufacturing Technician I performs the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employs acceptable techniques while working in manufacturing environments, including PPE gowning.
The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed.
The Sr. Reporting and Analytics Analyst is primarily responsible for strategy, development, and delivery of enterprise reporting solutions with a strong emphasis on Microsoft Power BI. This role focuses on building advanced dashboards, KPIs, data models, and analytics solutions that drive decision-making. Supporting competencies in Python, C#, .NET, and SDLC best practices ensure effective integration, automation, and platform governance.
The Quality Control Data Review Specialist is an effective member of the Laboratory Operations team. Position is accountable for driving results in a fast-paced environment by effectively performing various activities at range of complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and process inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance-oriented training as necessary. The QC Data Review Specialist assists with the development of SOPs or other quality documents as needed. Business needs and deadlines will require the...
The Packaging Technician I is accountable for driving results in a fast-paced environment by inspecting, labeling and packaging of solid dose and parenteral pharmaceutical products for commercial distribution and clinical trials. The Packaging Technician I will operate inspection and packaging-related processing equipment by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices.
The Manufacturing Supervisor is accountable for results in a fast-paced environment and is responsible for maintaining product quality by supporting GMP operations of life-saving sterile injectable drug products intended for clinical trials and commercial distribution. The Manufacturing Supervisor operates in alignment with established Standard Operating Procedures (SOPs) and approved Batch Records, which are developed in accordance with regulatory expectations and current Good Manufacturing Practices (cGMPs). The Manufacturing Supervisor oversees a team of Manufacturing Technicians and ensures utilization of acceptable cleanroom techniques while working in manufacturing/inspection environments and is expected to demonstrate proficiency in all department...
The Sr. Maintenance Technician is accountable for driving results in a fast-paced environment by directly supporting a wide range of service disciplines covering HVAC systems, black and clean utilities, electrical troubleshooting, mechanical equipment repair and general maintenance in an FDA registered pharmaceutical processing environment. The Sr. Maintenance Technician operates in a highly technical fast paced environment requiring past experience related specifically to keeping production business running. The Sr. Maintenance Technician applies critical thinking and considers all business impact aspects before taking job related actions that could cause unwanted consequences such as loss of revenue, unsafe events, and other risks. The Sr. Maintenance...
The SAP ABAP Developer will be responsible for designing, developing, testing, and supporting custom solutions and enhancements across SAP environments. This role combines strong expertise in traditional ABAP development (ECC and S/4HANA) with modern, cloud-native capabilities on SAP BTP. The developer will work closely with functional consultants, business analysts, and cross-functional stakeholders to translate requirements into robust, compliant, and scalable solutions. This is a hands-on technical role with broad impact—contributing to innovation, automation, and continuous improvement in a regulated pharmaceutical manufacturing environment.
The Process Engineer (Sterile) II for our parenteral site in Charleston, SC is accountable for driving results in a fast-paced environment by providing technical support for the manufacturing facility, including, troubleshooting equipment, validated processes, process deviations and investigations, transfers of new processes and technologies into the site and preparation of documentation to support validation and process transfer activities.
The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. The ideal candidate will assist internal teammates and partner with individuals from other departments for the development of SOPs and associated documents, and process improvements. The Sr. Quality Assurance Specialist will provide guidance and mentoring to Operations personnel in achieving a high level of GMP compliance and instilling quality...
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...
The Calibration Technician I will help set up equipment, change batteries, assist with data entry and perform calibration on various instruments including, but not limited to, temperature, relative humidity, CO2, voltage, pressure, time, rotation, etc. following documented procedures using precision standards. Calibration and preventative maintenance will be performed in-house or off-site based on business need.
The Shipper/Receiver - Pharma/GMP is responsible for the safe and proper handling of client products in accordance with company procedures and client specific requirements. This is a cross-functional and cross-campus position that is challenged with a daily routine that changes based on client demand and generally takes place in a fast-paced work environment at varying environmental conditions. The hours are Monday - Friday, 10:30am - 6:30pm.
The Materials & Logistics Technician II is accountable for results in a fast-paced environment by following applicable SOPs and cGMPs to perform tasks for the receipt, storage, inventory, and distribution of raw materials, intermediate or finished drugs or drug products and components. The Materials & Logistics Technician II also identifies hazardous materials. The Materials & Logistics Technician II uses the electronic inventory system to track, document and control all inventory.
The Site Process Engineer (Sterile) for our parenteral site in Charleston, SC is accountable for driving results in a fast-paced environment by providing technical support for the manufacturing facility, including, troubleshooting equipment, validated processes, process deviations and investigations, transfers of new processes and technologies into the site and preparation of documentation to support validation and process transfer activities. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.
The Manufacturing Technician III (Compound/Fill/Finish) is accountable for results in a fast-paced environment and assists with the manufacturing of sterile injectable products in vial and syringe configurations for clinical/commercial distribution. The Manufacturing Technician III is a key role responsible for overseeing and executing advanced production tasks involving compound, fill and finish processes for sterile injectable pharmaceutical products executed via aseptic isolator technology. This position entails a high level of technical expertise in aseptic processes requiring single-use components, leadership in troubleshooting, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP). The Manufacturing Technician...
The Scientist II - Chemistry (ICP) is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist II (Chemistry) position, ICP, GC-MS, LC-MS, HPLC, TOC, UV, osmolality, density, and pH are commonly employed in the described testing in addition to other key methodologies such as KF and titration. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company) and may also assist with method development / method validation projects.
The Scientist III - UV/HPLC (Development Labs) 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, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed.
The FP&A Manager provides critical financial analysis and reporting support to the FP&A team and business unit leaders. This individual contributor role focuses on delivering accurate financial insights, maintaining financial models, and supporting strategic initiatives across the organization. The Financial Planning and Analysis Manager will collaborate with cross-functional teams to prepare analyses, develop KPI dashboards, and assist with budgeting and forecasting process. This is a high-impact position with a high growth Private Equity backed company ideal for someone who is detail-oriented and thrives on solving complex business challenges and influencing outcomes through data-driven insights.
A Senior Scientist I - Analytical Testing performs analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. HPLC, dissolution and/or GC based methodologies are commonly employed in the described testing. Other key methodologies applied include titrations, UV, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The Sr. Validations Specialist is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation of equipment and GxP computerized systems. Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and validation master plans; supporting facility, utility, manufacturing equipment, conducting reviews of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; ensuring compliance with 21 CFR Part 11, Data Integrity, and functional requirements; developing documentations as required for projects; serve as the subject matter expert during audits and inspections and consulting on validation and cGMP questions and issues. The ideal candidate...
The Visual Inspection Technician I is accountable for results in a fast-paced environment and responsible to perform tasks for the quality inspection of sterile injectable products for commercial distribution and clinical trials. The Visual Inspection Technician handles and inspects manufactured products by following standard operation procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). In addition, the Visual Inspection Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning.
The Manufacturing Technician I is accountable for results in a fast-paced environment and assists with the manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician I assists with the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employ acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician I works collaboratively to support other manufacturing areas as required.
The Scientist II (Chemistry) is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist II (Chemistry) position, HPLC, TOC, UV, osmolality, density, and pH are commonly employed in the described testing in addition to other key methodologies such as KF and titration. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company) and may also assist with method development / method validation projects.
The Manufacturing Technician III (Compound/Fill/Finish) is accountable for results in a fast-paced environment and assists with the manufacturing of sterile injectable products in vial and syringe configurations for clinical/commercial distribution. The Manufacturing Technician III is a key role responsible for overseeing and executing advanced production tasks involving compound, fill and finish processes for sterile injectable pharmaceutical products executed via aseptic isolator technology. This position entails a high level of technical expertise in aseptic processes requiring single-use components, leadership in troubleshooting, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP). The Manufacturing Technician...
The Scientist I (Chemistry) is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist I (Chemistry) position, HPLC, TOC, UV, osmolality, density, and pH are commonly employed in the described testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The Associate Scientist will support early-phase development of oral solid dosage (OSD) formulations, including tablets, capsules, and granules. This individual will be responsible for formulation and process development, manufacture of development and stability batches, and execution of analytical testing to support preclinical and clinical programs. The role requires strong technical aptitude, attention to detail, and enthusiasm for hands-on laboratory work in a dynamic, fast-paced environment.
The Manufacturing Technician I is accountable for results in a fast-paced environment and assists with the manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician I assists with the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employ acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician I works collaboratively to support other manufacturing areas as required.
The Metrologist is a team player working in a fast-paced environment by performing calibration and preventive maintenance (PM) tasks of instruments including pressure, temperature, relative humidity, volumetric and mass in pharmaceutical manufacturing and laboratory environments. The ideal candidate will have a basic understanding of calibration and instrumentation and the use of computerized equipment and software to perform testing functions.
The Quality Systems Sr. Manager is accountable for driving results in a fast paced environment, continuously challenging performance in regards to quality standards, systems and operating procedures.
Responsibilities include the technical oversight of investigations and Quality Systems. This position will be performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the manufacturing facility.
Activities include reviewing documents and data, investigation review/approval, CAPAs, Change Control, supporting audits and inspections, consulting on quality and compliance issues, and performing trend analysis where...
The Senior SAP SD / Order-to-Cash Lead is responsible for driving operational excellence through hands-on support and optimization of Alcami’s SAP S/4HANA environment, with primary ownership of Sales & Distribution (SD) and the end-to-end Order-to-Cash (OTC) process. This role plays a critical part in stabilizing and enhancing SAP following recent go-lives and ongoing transformation initiatives.
Project Systems (PS) is used across Labs, Manufacturing, and Services, making strong understanding of SD–PS–Finance integration essential. The ideal candidate is a hands-on SAP SD practitioner who partners closely with Commercial, Finance, Project Management, Operations, and IT to ensure accurate order execution, project-based billing, revenue recognition, and...
The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. The ideal candidate will assist internal teammates and partner with individuals from other departments for the development of SOPs and associated documents, and process improvements. The Sr. Quality Assurance Specialist will provide guidance and mentoring to Operations personnel in achieving a high level of GMP compliance and instilling quality...
The Director, Laboratory Operations - Biologics is accountable for driving results in a fast-paced environment by providing strategic, technical, and operational leadership for the Biologics department within Laboratory Operations. The Director, Laboratory Operations - Biologics is responsible for the success of site operations and achieving company goals. This position requires a balance of scientific expertise, business acumen, and customer focus to ensure high-quality services, efficient execution, and sustained growth. The...
The Scientist III - Mass Spec 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 is also required to work on method development/method validation projects. For this position, HPLC, LC/MS and GC/MS based methodologies are commonly employed in the described testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The Manufacturing Supervisor is accountable for results in a fast-paced environment and is responsible for maintaining product quality by supporting GMP operations of life-saving sterile injectable drug products intended for clinical trials and commercial distribution. The Manufacturing Supervisor operates in alignment with established Standard Operating Procedures (SOPs) and approved Batch Records, which are developed in accordance with regulatory expectations and current Good Manufacturing Practices (cGMPs). The Manufacturing Supervisor oversees a team of Manufacturing Technicians and ensures utilization of acceptable cleanroom techniques while working in manufacturing/inspection environments and is expected to demonstrate proficiency in all department...
The Scientist III-Ion Chromatography 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, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The Manager, Laboratory Operations - Biologics is accountable for driving results in a fast-paced environment by providing strategic, technical, and operational leadership for the biologics department of Bioseparations & Mass Spectrometry within Laboratory Operations. This position requires a balance of scientific expertise, business acumen, and customer focus to ensure high-quality services, efficient execution, and sustained growth. The ideal candidate will be a collaborative leader with a proven track record in biologics development and testing, who thrives in a client-driven CDMO environment.
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, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The Senior Compliance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. The ideal candidate will assist with the development of SOPs or other quality documents as needed. The position will perform the role of Lead Inspector for external audits and act as consultant with clients for all level of regulatory issues. The Sr. Compliance Specialist will provide guidance and mentoring for other compliance employees.