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 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 Senior Supply Chain Project Specialist is a key cross-functional facilitator, responsible for driving end-to-end supply chain excellence with a focus on facilitating on-time project execution from order to batch release at the RTP site.
This role combines strategic planning, scheduling, sourcing, and wholistic coordination of internal suppliers like Procurement, Logistics, Labs and Client facing teams, Manufacturing, Quality, Technical Services, and Engineering/Maintenance/Validations, to ensure on time execution of batch production through to disposition of the batch.
Acting as facilitator and tracker of all deliverables needed to execute a batch through release of the...
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 Project Manager will coordinate a multidisciplinary project team to assure the accurate and timely completion of all contract writing and managing, ERP, invoicing, designing and implementing project plans, acting as the primary liaison with the project team and client communicating project information to appropriate staff members. The Senior Project Manager may serve as program manager and assist clients with their drug development programs, specifically in the lab services unit of the business. The Sr. Project Manager may also be called upon to participate in the corporate management process and shall actively engage in and support business development efforts.
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 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 Manager of Planning and Scheduling is a cross-functional leadership role responsible for driving all aspects of manufacturing planning, scheduling, capacity planning, inventory readiness, and seamless material availability to enable on time manufacturing execution. This position combines the strategic planning and leadership to enable execution of the production schedule on time and through release (end-to-end) of each batch, in compliance with GMPs.
The Manager leads the efforts for scheduling and planning of manufacturing, staff development, provides technical guidance, and fosters a culture of accountability and continuous improvement. This role requires cross functional leadership and strong expertise in SAP (MM/IM/WM), supplier negotiations, and...
The role of Facilities Coordinator is to provide support to the Facilities and Purchasing Departments as defined in the responsibilities listed below. The position will report to the Director of Facilities and will also provide support to other Administrative Associates, departments and Alcami personnel as needed. The position may provide relief for front desk duties to cover receptionist absences, or depending on the need, may provide all receptionist duties for the site.
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...
The Scientist II - QC 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 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.
A Senior Scientist I is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of (bio-)pharmaceutical product development or (bio-)pharmaceutical manufacturing. The Senior Scientist I may also be required to work on method development/method validation projects. For this position, HPLC, CE, icIEF and/or UV based methodologies are commonly employed in the described testing. Other key methodologies applied include cKF/KF, pH, and osmolality. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The Sr. Supervisor, Metrology is accountable for driving results in a fast-paced environment by supporting general pharmaceutical metrology activities. Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and metrology master plans; supporting facility, utility, manufacturing equipment, and laboratory instrument metrology efforts; conducting reviews of metrology documentation such as metrology plans, system/functional requirements, protocols and summary reports. The position requires strong leadership behaviors and the ability to train and mentor staff.
The Senior Materials and Logistics Technician 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 Sr. Materials & Logistics Technician uses the electronic inventory system to track, document, and control all inventory.
The Desktop Engineer will help ensure proper computer operation so that end users can accomplish business tasks. This includes receiving, prioritizing, documenting, and actively resolving end user help requests. Additionally, problem resolution may involve the use of diagnostic and help request tracking tools, as well as require that the individual give in-person, hands-on help at the desktop level. This position will involve manufacturing and scientific computer system installation, test execution, and support.
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).
As a Sample Receipt Processing Technician, you will facilitate the logging 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: receives, processes, and logs in samples and standards, initiates chain of custody tracking and creates projects for laboratory testing, conduct inventory ordering, receipt, and management.
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, Manufacturing 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 Director, Quality 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 Director of Manufacturing Quality Operations interacts with clients and...
The Scientist III-HPLC/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.
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 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 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 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 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 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 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 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 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 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 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 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.