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 Tech III is a key role responsible for 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, ability to troubleshoot, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP). The Manufacturing Tech. III performs the operation of...
The Manufacturing Technician II (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 Tech II is a key role responsible for 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, ability to troubleshoot, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP). The Manufacturing Tech. II performs the operation of...
The Sr. Manufacturing Specialist - Aseptic supports cGMP manufacturing and troubleshoots unexpected manufacturing events, preparing, conducting, and evaluating continued process verification activities; and providing on-going support of commercial and clinical manufacturing. The Sr. Manufacturing Specialist works closely with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position requires superior leadership behaviors and ability to train others.
The Lead Manufacturing Technician (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 Lead Manufacturing Technician is a key role responsible for leading and overseeing 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).
A Senior Scientist I 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. 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 EH&S, 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 Environmental Monitoring Technician I is accountable for driving results in fast-paced environment by performing monitoring of the pharmaceutical manufacturing environment and utilities in compliance with cGMP and internal SOPs. The Environmental Monitoring Technician must be detail-oriented and possess organizational skills with a large quantity of data.
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 Lead Metrologist is considered a Subject Matter Expert in the Metrology field. They will be accountable for driving results in a fast-paced environment by performing calibration and diagnostics repair of Analytical instrumentation including HPLC, GC, Spectrophotometers and other complex equipment in pharmaceutical laboratory environments. Some travel will be required to support other Alcami sites. They will provide oversight into tasks being performed by other team members and provide guidance to ensure the success of the team.
In addition, the Lead Metrologist will develop/update processes & procedures to improve the quality and efficiency of the department. Maintaining calibration of metrology standards and completing and...
The Senior Validation Engineer is accountable for driving results in a fast-paced environment by supporting pharmaceutical validation activities. The Senior Validation Engineer will support the implementation and execution of Alcami’s validation program for our drug product manufacturing facilities that comply with company policies and procedures. This includes commissioning and qualification of new equipment, instrumentation, utilities, facilities, cleaning validation, and computerized systems; validation lifecycle activities to include periodic review; requalification and maintenance of site validation plans. The role will support site change control activities to include validation impact assessment, updates to procedures and validation...
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 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).
A Senior Scientist I 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 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 Control Data Review Specialist (2nd Shift) 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...
The Supervisor, Warehouse provides leadership to the Materials Control team and is accountable for the receipt, storage, inventory, and distribution of raw materials, intermediate or finished drugs or drug products and components, including hazardous materials. The Supervisor reviews shipping documentation, coordinates logistics, and manages real-time inventory accounts within the electronic inventory system. The Supervisor determines work assignments and communicates expected deliverables and timelines, leads investigations, and provides troubleshooting support when applicable.
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...
A Packaging Process Engineer designs, implements, and optimizes packaging processes to improve efficiency, quality, safety, and/or reduce cost. The Process Engineer analyzes production workflows, identifies bottlenecks, and develops solutions using engineering principles and data analysis. Process engineers also ensure compliance with industry standards and regulatory requirements, while monitoring system performance and troubleshooting issues.
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 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 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 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.