The Principal Scientist I demonstrates in depth working knowledge of scientific principles (e.g. LC, GC, Dissolution, MS, etc.) and leads the implementation of new methods/processes to solve problems in a fast-paced environment. This role prepares and reviews summaries of observations and is capable of verbal and written presentations documented proficiently in laboratory notebooks to internal and external audiences. The incumbent will write and review SOPs, training modules, summary reports and technical reports to be sent to clients or used in regulatory filings and is responsible for ensuring complex technical information is well understood by team associates, management, and clients. The position help secure new business supporting BD in technical discussions...
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 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 KF and UV. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The Sr. Administrative Assistant drives results in a fast-paced environment and is responsible for administrative duties for multiple locations. The position provides site and departmental administration support including correspondence, travel & expense report reconciliation, overseeing & coordinating client agendas and all other site vistiors, and handles confidential details in a professional manner. The Sr. Administrative Assistant relies on experience and judgment to plan and accomplish goals, and maintains effective working relationship with leadership and employees. Assignments may be in various functional areas. The position works on assignments that are moderately complex in nature in which considerable judgment and initiative are required in...
The Project Manager is an essential partner with the Operations and site leadership team and is accountable for driving results in a dynamic environment by driving projects to completion. The Project Manager has a strong scientific and technical understanding of Alcami services with the ability to effectively interact and communicate directly with highly educated, innovative industry thought leaders. The Project Manager leads cross-functional project teams to deliver against contracted commitments and timelines. The Project Manager must have in depth knowledge of a product lifecycle through the regulatory phases from pre-clinical to commercialization to identify and propose the necessary activities to achieve successful regulatory approval. This role includes...
The Scientist I (Biologics) 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 (Biologics) position, HPLC, electrophoresis, UV, osmolality, ELISA, 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 Senior Quality Assurance Specialist, GMP Manufacturing 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...
The Quality Assurance Specialist - Packaging 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 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 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 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 Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing...
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, TOC, UV, osmolality, density, titration and pH are commonly employed in the described testing in addition to other key methodologies such as KF, CCIT and HPLC. Test methods employed may be compendial (i.e. USP, EP, JP) or proprietary (client supplied or developed by The Company) and may also assist with method verification / method validation projects as needed.
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, TOC, UV, osmolality, density, titration and pH are commonly employed in the described testing in addition to other key methodologies such as KF, CCIT and HPLC. Test methods employed may be compendial (i.e. USP, EP, JP) or proprietary (client supplied or developed by The Company) and may also assist with method verification / method validation projects as needed.
The Senior Materials Management Coordinator is accountable for driving results in a fast-paced environment by facilitating the log in of laboratory samples and the projects the lab will use for documentation of the analysis. This position provides administrative and organizational support related to materials management activities. The ideal candidate will maintain documentation and files to assure they are accurate and up-to-date and available to appropriate personnel.
The Associate Director, Laboratory Quality Operations is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Associate Director, Laboratory Quality Operations provides leadership to the site Quality team who perform 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 Associate Director, Laboratory...
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 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 Manager, Facilities and Maintenance is accountable for driving results in a fast-paced environment by managing and overseeing the programs and personnel related to maintenance of the facility, process equipment, critical utilities, general facility utilities. This includes routine support of day-to-day operations as well as special projects. Special projects include customer centric projects, plant shutdowns, and facility upgrades, renovations, or expansions. The Manager, Facilities and Maintenance administers these programs and projects by assisting in the development of project plans, schedules, and provides oversight of the work during execution. All activities are conducted under the regulatory agency requirements of the pharmaceutical industry 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 Director, Audit Compliance is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems and operating procedures. The Director of Compliance is responsible for providing leadership to the compliance group that is typically staffed by professional, salaried employees performing quality compliance functions across multiple company locations. The Director, Compliance interacts with site leadership, clients, and regulatory agencies as needed regarding quality issues, audits, and inspections.
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. These 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 Quality Specialist serves as quality host for client and regulatory agency audits and inspections. The position develops SOPs...
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. These 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 Quality Specialist serves as quality host for client and regulatory agency audits and inspections. The position develops SOPs or other quality documents...
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.
The Manufacturing Technician II 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 II OSD 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 II OSD employs acceptable techniques while working in manufacturing environments, including PPE gowning.
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.
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 Director of Supply Chain at Alcami is a pivotal leadership role accountable for driving results in a fast-paced, regulated manufacturing environment. This position oversees all aspects of supply chain execution – including warehousing, logistics, inventory control, production planning support, and procurement coordination – while leading performance tracking and continuous improvement initiatives across the organization.
The Director will have enterprise-wide responsibility for supply chain operations across all Alcami sites, ensuring standardized processes, consistent service levels, and scalable solutions that support both site-level execution and corporate growth objectives. This role requires close collaboration with key stakeholders in Project...
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 Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and writing reports and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing...
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 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 Specialist is accountable for driving continuous improvement of the Manufacturing operations, focused on People, Process and the Tools & Technology that drive continuous improvement. The environment is fast-paced and demands consistent results. Efforts are focused on all aspects of Aseptic Operations Dispensing, Compounding, Aseptic Filling via isolator technology and Visual Inspection. The Specialists will be the Manufacturing subject matter expert (SME) for focused areas of responsibility. They will also cross-train in various areas to expand operational proficiency to optimize overall process knowledge and support of operations. They will...
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 Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and writing reports and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing...
The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing...
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 Senior SAP PTM/EWM Functional Specialist is accountable for driving operational excellence through the optimization of SAP S/4HANA processes, specifically in the Plan-to-Manufacture (PTM) and Extended Warehouse Management (EWM) areas. This position plays a critical role in supporting and enhancing our SAP landscape following our recent go-live on RISE with SAP. The ideal candidate will serve as the functional subject matter expert, partnering with business and IT stakeholders to stabilize, support, and evolve our manufacturing and warehouse systems.
The Senior SAP FICO Functional Specialist is responsible for leading the design, implementation, and ongoing enhancement of SAP S/4HANA Finance and Controlling (FICO) processes. This role will serve as the finance subject matter expert and strategic partner to Accounting, FP&A, and Operational Finance teams to deliver business-aligned solutions. The consultant will support ongoing stabilization and continuous improvement following our successful go-live with RISE with SAP. Given our S/4HANA environment, experience with Fiori applications and a strong understanding of SAP Analytics and reporting tools is critical.
The Quality Assurance Specialist - Sterile Manufacturing cGMP 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 Senior Document Control Coordinator is accountable for driving results in a fast-paced environment by providing support related to documentation system requirements. The ideal candidate will maintain documentation and files to assure they are accurate, up-to-date, and available to appropriate personnel as necessary. The position maintains systems providing change control for master documents and generates requested documents and reports when requested.
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 Director, Pharma Storage is accountable for driving results in a fast-paced environment. The Director, Pharma Storage is a client-facing position responsible for regional oversight on behalf of the Pharma Storage department providing leadership and mentorship to all operations personnel within the region.
The Director, Pharma Storage ensures that Pharma Storage activities are executed in compliance with industry regulations, data integrity, and the quality management system. This leadership role manages short and long-term goals of the operation and implements and manages projects to ensure deadlines are met.
This role acts as a point of...
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 Calibration Field Technician II is proficient in multiple disciplines at customer sites and is able to work independently. The Calibration Field Technician II will set up equipment, perform calibration on various instruments including, but not limited to, temperature, relative humidity, CO2, voltage, pressure, time, rotation, mass, etc. following documented procedures using precision standards. Calibration and preventive maintenance will be performed in-house or off-site based on business needs.
The Sr. Environmental Health and Safety Specialist develops, implements, and sustains EH&S programs at the cGMP Operations, and at manufacturing, laboratory, and warehousing facilities. The Senior EH&S Specialist ensures the safety of all employees, visitors, and contractors, protection of the environment, and maintenance of compliance with all Federal, State, and local regulations. Reporting to the Senior Management in Operations, the Sr. EH&S Specialist works closely with the Corporate EH&S Director as well as other EH&S team members to ensure program alignment across the larger Alcami organization.
The Sr. Reporting and Analytics Analyst is responsible for leading the strategy, development, and delivery of enterprise reporting, analytics, and AI capabilities across platforms such as SAP SAC, Power BI, and Microsoft Fabric. This role is accountable for helping develop, deploy, and maintain SAP applications. This role is expected to help deliver accurate, scalable, and insight-driven solutions to support business decision-making. This position owns the end-to-end lifecycle of BI and AI applications — from data integration and modeling to visualization and automation and ensures alignment with organizational goals, data governance standards, and evolving technology trends. In addition, this role is responsible for enabling AI adoption by operationalizing...
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 Specialist is accountable for driving continuous improvement of the Manufacturing operations, focused on People, Process and the Tools & Technology that drive continuous improvement. The environment is fast-paced and demands consistent results. Efforts are focused on all aspects of Aseptic Operations Dispensing, Compounding, Aseptic Filling via isolator technology and Visual Inspection. The Specialists will be the Manufacturing subject matter expert (SME) for focused areas of responsibility. They will also cross-train in various areas to expand operational proficiency to optimize overall process knowledge and support of operations. They will support operations through root...
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.