The Sr. 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. The Sr. Manufacturing Specialist will support operations through root cause investigations of...
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 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.
Responsibilities for a Validation Engineer I involve validation equipment operation, protocol development, protocol execution and associated activities. This position will support a wide range of validation activities, including laboratory and manufacturing equipment of all types, laboratory and manufacturing technical support services, facilities/utilities, computerized systems, and data integrity assessment/remediation. The Validation Engineer I works with supervision to gain experience with more experienced staff.
The Metrologist is a team player working in a fast-paced environment by performing calibration and preventive maintenance (PM) tasks of instruments including pressure, temperature, relative humidity, volumetric and mass in pharmaceutical manufacturing and laboratory environments. The ideal candidate will have a basic understanding of calibration and instrumentation and the use of computerized equipment and software to perform testing functions.
The Automation Engineer is accountable for driving results in a fast-paced environment by being responsible for multiple capital and process improvement related projects. The Automation Engineer’s primary responsibilities will center around:
- Evaluating and implementing new ways to automate systems that drives efficiency and compliance.
- Testing automation equipment and processes (driving FAT, SAT, and commissioning activities within the Engineering Department and aiding the Validation Department with qualification efforts).
- Programming new automated components (i.e. door interlock systems, etc.).
- Evaluating existing auto-generated reports for...
The Manufacturing Technician I - Oral Solid Dosage (OSD) is accountable for results in a fast-paced environment and assists with the manufacturing of oral solid dose products for commercial distribution. The Manufacturing Technician I performs the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employs acceptable techniques while working in manufacturing environments, including PPE gowning.
The 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. 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 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...
As a Materials Control Coordinator, 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 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 Sr. Maintenance Technician is accountable for driving results in a fast-paced environment by directly supporting a wide range of service disciplines covering HVAC systems, black and clean utilities, electrical troubleshooting, mechanical equipment repair and general maintenance in an FDA registered pharmaceutical processing environment. The Sr. Maintenance Technician operates in a highly technical fast paced environment requiring past experience related specifically to keeping production business running. The Sr. Maintenance Technician applies critical thinking and considers all business impact aspects before taking job related actions that could cause unwanted consequences such as loss of revenue, unsafe events, and other risks. The Sr. Maintenance...
The Senior Scientist I, Bioassay is accountable for driving results in a fast-paced environment by performing routine and non-routine testing in support of pharmaceutical product development and manufacturing. The Sr. Scientist I, Bioassay may also be required to work on method development and method validation projects. The Senior Scientist I, Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing methods. Also, knowledge in techniques such as HPLC, icIEF, or CE-SDS is desirable. Strong problem-solving and troubleshooting skills along with proficiency in analyzing data, laboratory documentation, data presentation and collaboration will help...
The Quality Systems Sr. Manager is accountable for driving results in a fast paced environment, continuously challenging performance in regards to quality standards, systems and operating procedures.
Responsibilities include the technical oversight of investigations and Quality Systems. This position will be performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the manufacturing facility.
Activities include reviewing documents and data, investigation review/approval, CAPAs, Change Control, supporting audits and inspections, consulting on quality and compliance issues, and performing trend analysis where...
The Pharma Storage Operations Technician I is responsible for the safe and proper handling of client products in accordance with company procedures and client specific requirements. This shipper/receiver position is challenged with a daily routine that changes based on client demand and generally takes place in a fast-paced work environment at varying environmental conditions.
The 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 SAP Project System (PS) Analyst – Senior / Lead is responsible for leading the optimization and support of Alcami’s SAP S/4HANA environment with a primary focus on Project System functionality and deep integration with Order-to-Cash (OTC) and Finance processes. Acting as the functional authority for SAP PS, this role enables efficient project planning, cost tracking, and settlement across client and internal initiatives. The analyst partners with cross-functional stakeholders and AMS resources to drive system stability, enhance process design, and deliver scalable improvements. With strong configuration expertise and a proactive leadership mindset, this role ensures SAP PS operates as a reliable backbone for project execution and financial visibility.
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 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 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 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 Manufacturing Project Planner 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...
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 Manufacturing (cGMP) Production Scheduler is responsible for driving results in a fast-paced environment by primarily ensuring material availability to support the production schedule. The Manufacturing Production Specialist role reports into Operations and is focused on managing Manufacturing inventory levels, supporting material/product level revisions, interacting/coordinating with Supply Chain employees regarding suppliers, and supporting other Operational activities as required.
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 Director, Laboratory Operations - Biologics is accountable for driving results in a fast-paced environment by providing strategic, technical, and operational leadership for the Biologics department within Laboratory Operations. The Director, Laboratory Operations - Biologics is responsible for the success of site operations and achieving company goals. This position requires a balance of scientific expertise, business acumen, and customer focus to ensure high-quality services, efficient execution, and sustained growth. The...
The Scientist III - Mass Spec is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. The Scientist III is also required to work on method development/method validation projects. For this position, HPLC, LC/MS and GC/MS based methodologies are commonly employed in the described testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The 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 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).
The Manufacturing Supervisor is accountable for results in a fast-paced environment and is responsible for maintaining product quality by supporting GMP operations of life-saving sterile injectable drug products intended for clinical trials and commercial distribution. The Manufacturing Supervisor operates in alignment with established Standard Operating Procedures (SOPs) and approved Batch Records, which are developed in accordance with regulatory expectations and current Good Manufacturing Practices (cGMPs). The Manufacturing Supervisor oversees a team of Manufacturing Technicians and ensures utilization of acceptable cleanroom techniques while working in manufacturing/inspection environments and is expected to demonstrate proficiency in all department...
The Scientist III-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 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 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 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 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 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 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 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...