The Environmental Health and Safety (EH&S) Intern assists the EH&S department with ensuring routine inspections are conducted in a variety of safety and environmental areas and updating databases evacuation plans and other areas. The intern will complete company onboarding activities and provide feedback to ensure our onboarding program is efficient and engaging. Interns will develop their skills and increase their knowledge of CDMO regulations and activities while working in a world-class pharmaceutical environment. The Alcami Intern Program is a minimum 10-week paid program. Alcami interns are provided hands-on work experience building upon knowledge and skills learned in the classroom. Interns work...

The HVAC-R Mechanic (MA) is responsible for performing routine and emergency maintenance during business hours, unless otherwise notified of an emergency on Alcami’s biorepository, laboratory and building refrigeration, air conditioning, and heating systems. Availability is required to respond to equipment emergencies. The HVAC-R Mechanic is the Subject Matter Expert (SME) responsible and accountable for preventing excursions for CTUs. This includes providing guidance to end users as well as assisting with design and maintenance. This will be achieved through the creation of procedures and checklists combined with consistent compliance with each by yourself and team members under your leadership. The individual in this role will lead and perform routine...

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 Manufacturing Technician I (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. I 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 Technician I performs the operation of...

The Manufacturing Technician I (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 I 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 Technician I performs the operation of...

The Sr. Scientist I, Analytical is accountable for driving results in a fast-paced environment by performing more complex analysis and assisting in method development and validation. This position takes on the role of troubleshooter and trainer and will provide direct assistance to manufacturing and product onboarding qualification/establishment efforts. The Sr. Scientist I, Analytical participates more actively in lab investigations and corrective and preventative actions. The role initiates procedural revisions and performs editing and review functions. The Sr. Scientist I, Analytical may serve as a primary technical contact with clients.

The Materials Control 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 Materials Control Technician uses the electronic inventory system to track, document and control all inventory. 

The Senior HR Business Partner (Sr. HRBP) position is responsible for aligning business objectives with employees and management in areas of assignment and with the Company. The Sr. HRBP will collaborate directly with Site Leadership to deliver Human Resources management services, programs, and solutions to the applicable site and companywide. The position formulates partnerships across the assigned areas to deliver value-added service to management and employees that reflects the business objectives of the organization. The Sr. HRBP maintains an effective level of business literacy about the business unit's financial position, its midrange plans, its culture, and its competition. The Sr. HRBP is a part of the assigned Site Leadership team and part of the corporate...

The Manufacturing Technician III - 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 III 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 III employs acceptable techniques while working in manufacturing environments, including PPE gowning.

Responsibilities for a Validation Engineer II involve validation equipment preparation, protocol execution, and final report generation. This position will perform a wide range of validation activities focused on environmental chambers, including: cryo-freezers, cold rooms, refrigerators, incubators, depyrogenation ovens, stability chambers and warehouses, as well as sterilizers and CSV. Interface with customers and equipment end users. The Validation Engineer II works with minimal supervision and will independently work at customer sites with small and medium projects.

Responsibilities for a Validation Engineer II involve validation equipment preparation, protocol execution, and final report generation. This position will perform a wide range of validation activities focused on environmental chambers, including: cryo-freezers, cold rooms, refrigerators, incubators, depyrogenation ovens, stability chambers and warehouses, as well as sterilizers and CSV. Interface with customers and equipment end users. The Validation Engineer II works with minimal supervision and will independently work at customer sites with small and medium projects.

The Sr. Supply Chain Specialist is accountable for driving results in a fast-paced environment by primarily ensuring material availability to support the production schedule. The Sr. Supply Chain Specialists responsibilities include managing inventory levels, supporting material/product level revisions, interacting/coordinating with suppliers on a variety of topics, and supporting other business functions as required.

The Human Resources Intern will partner with HR Business Partners and HR management on several projects. The main project will be the development of career matrices and career profiles. The HR Intern will also assist with day-to-day activities to support the team.    The Alcami Intern Program is a minimum 10-week paid program. Alcami interns are provided hands-on work experience building upon knowledge and skills learned in the classroom. Interns work side-by-side with industry leaders in a dynamic, fast-paced environment who are passionate about being part of a team developing life-saving drugs around the world. The program...

The Associate Scientist 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 Associate Scientist may also assist with method development/method validation projects. For this position, UV-Vis, FTIR, HPLC, Titration, particle size, cKF, and/or TOC based methodologies are commonly employed in the described testing.

The Quality Control Data Review Specialist is an effective member of the Laboratory Operations team. Position is accountable for driving results in a fast-paced environment by effectively performing various activities at range of complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and process inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance-oriented training as necessary. The QC Data Review Specialist assists with the development of SOPs or other quality documents as needed. Business needs and deadlines will require the...

The Quality Control Data Review Specialist is an effective member of the Laboratory Operations team. Position is accountable for driving results in a fast-paced environment by effectively performing various activities at range of complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and process inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance-oriented training as necessary. The QC Data Review Specialist assists with the development of SOPs or other quality documents as needed. Business needs and deadlines will require the...

The Director, Engineering, Validation, and Maintenance drives results in a fast-paced environment by developing and executing engineering, validation, and maintenance strategies supporting on-going and future facility, utility, manufacturing, and laboratory systems throughout the life cycle of an asset. Engineering includes but is not limited to project scope, cost estimates, schedules, design, procurement, installation/construction, and plant engineering. Validation includes factory acceptance tests, commissioning, installation qualification, operational qualification, performance qualification, and re-qualification program. Maintenance includes but is not limited to preventative maintenance, work order repairs, and facilities programs including security,...

The Calibration Intern will work closely with a peer mentor to learn basic calibration skills, following documented procedures using precision standards. They will help set up equipment, change batteries, assist with data entry, and perform calibration on various instruments. They will help maintain routine checks on laboratory standards and update control charts as needed. The Intern will complete company onboarding activities and provide feedback to ensure our onboarding program is efficient and engaging. Interns will develop their skills and increase their knowledge of CDMO regulations and activities while working in a world-class pharmaceutical environment. The Alcami Intern Program is a minimum 10-week paid program. Alcami interns are provided hands-on work experience...

The Senior Materials Management Coordinator is accountable for driving results in a fast-paced environment by primarily coordinating samples throughout the manufacturing process. The Coordinator will log-in all samples that directly support the production process to ensure material availability for the production schedule and/or batch testing. This includes raw materials, components, in-process, bulk and/or finished product samples. This position also requires always maintaining sample integrity and ensuring correct documentation accompanies the log-in and shipment of samples when required. The ideal candidate will maintain documentation and files to assure they are accurate and up-to-date and available to appropriate personnel.

The Aliquoting Intern is responsible for the safe and proper handling of client products in accordance with company procedures and client specific requirements. Intern will primarily support and perform aliquoting of customer active pharmaceutical ingredients in a clean room and/or glove box environment, while adhering to GDP/GMP compliance requirements. Additional job duties may include receiving, inventorying, and shipping of client products in accordance with documented requirements. This 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 Associate Scientist 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 Associate Scientist may also assist with method development/method validation projects. For this position, UV-Vis, FTIR, HPLC, GC, Titration, and/or AA based methodologies are commonly employed in the described testing.

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 Senior HR Business Partner (Sr. HRBP) position is responsible for aligning business objectives with employees and management in areas of assignment and with the Company. The Sr. HRBP will collaborate directly with Site Leadership to deliver Human Resources management services, programs, and solutions to the applicable site and companywide. The position formulates partnerships across the assigned areas to deliver value-added service to management and employees that reflects the business objectives of the organization. The Sr. HRBP maintains an effective level of business literacy about the business unit's financial position, its midrange plans, its culture, and its competition. The Sr. HRBP is a part of the assigned Site Leadership team and part of the corporate...

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 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 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, ICP-MS/OES, 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 II (Chemistry) is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist II (Chemistry) position, HPLC, TOC, UV, osmolality, density, and pH are commonly employed in the described testing in addition to other key methodologies such as KF and titration. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company) and may also assist with method development / method validation projects.

The Manufacturing Technician 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 Calibration Field Technician I performs routine calibration and preventive maintenance of Alcami and customer equipment. Calibration may include temperature, relative humidity, CO2, voltage, pressure, time, rotation, etc. following documented procedures using precision standards. Calibrations and Preventative Maintenance will be performed in-house and at customer sites. Create, modify, and execute calibration procedures and calibration certificates. Perform testing to support the quality management system and report, troubleshoot and make recommendations about quality issues relating to calibration.  Assist in filing, data entry, and general record keeping. 

The Supervisor supervises and coordinates Environmental and Utility Monitoring activities and provides technical leadership for the assigned operations area. Staff typically includes hourly non-exempt employees. Expected to coach, train, and develop skills of the subordinate staff. This role will interact with clients and is responsible for successfully meeting client and departmental objectives in a timely manner.

The Metrology Administrator provides essential support to ensure efficient and effective operation of the Metrology department. This position interfaces with customers, vendors, and other departments. Coordinates with vendors for third party calibration projects, processes customer and metrology equipment, and creates and maintains an organizational system for easy retrieval of ongoing metrology information.

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 Principal Scientist I– Bioseparation & Mass Spectrometry is the Subject Matter Expert (SME) for their field, demonstrates in depth working knowledge of scientific principles and leads the implementation of new methods/processes to solve problems.  A Principal Scientist I – Bioseparation & Mass Spectrometry will demonstrate expertise in Mass Spectrometry, Reversed Phase, Ion Exchange and Size Exclusion Chromatography, Imaging Capillary Electrophoresis, and UV Spectroscopy testing methods.  Other key methodologies applied include Identification (e.g., Sequencing, Accurate Mass, Unknown Peak ID) and Characterization of biologicals and large molecules (e.g., Peptide Map, N/C terminal modifications, PTM (deamidation, oxidation) disulfide bond location,...

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 Business Analyst is accountable for driving results in a fast-paced environment by managing client contract requirements, providing financial guidance to project managers, creating invoices, performing project closings/reconciliations, reviewing payment history and reviewing CRM and ERP entries for accuracy.

The Senior Manager, Validations for our parenteral site drives results in a fast-paced environment by leading the GxP system validation activities for the site. The Senior Manager ensures relevant equipment, facility, utility, and computer systems are in compliance with applicable regulations including GAMP5, FDA Title 21 Code of Federal Regulations (CFR) Part 11 and Annex 11. This essential leader develops Standard Operating Procedures (SOPs), and templates related to Equipment, Facilities, and Utilities (EFU) systems and testing. Duties include overseeing and executing the validation of new systems, evaluating and performing periodic reviews of existing validated systems and maintaining required change control procedures. Responsibilities also include all...

Alcami is seeking a proactive and results-oriented Business Development Manager to join our team. This position is accountable for driving results in a dynamic and fast-paced environment by increasing sales and revenue for assigned business segments, specifically Analytical Testing and Development Services. The ideal candidate will possess a scientific background including laboratory or pharmaceutical manufacturing experience with a proven track record of sales experience in the pharmaceutical, biotech, or CDMO industries. This individual is highly inquisitive and motivated, a self-starter with a tenacious drive and ability to generate new business prospects, with a demonstrated ability to maintain and grow strategic customer relationships within small-mid-sized...

The Business Development Manager, Pharma Storage is accountable for selling biostorage services in a dynamic and fast-paced environment to support the growth of the pharma storage and services business. The Business Development Manager uses their technical knowledge and experience to ensure excellent communication and to meet customer standards, satisfaction, and timelines. The position requires superior leadership behaviors as well as expertise in the knowledge, skills, and abilities for this role.

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, CE, icIEF, and 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 Senior Manufacturing Maintenance Technician is accountable for driving results in a fast-paced environment by directly supporting a wide range of service disciplines covering HVAC systems, mechanical and electrical troubleshooting, mechanical equipment repair and general maintenance in an FDA registered pharmaceutical processing environment. The Sr. Manufacturing Maintenance Technician operates in a highly technical fast paced environment requiring experience related specifically to keeping production business running. The Sr. Manufacturing 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...

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 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 Visual Inspection Technician I is accountable for results in a fast-paced environment and responsible to perform tasks for the quality inspection of sterile injectable products for commercial distribution and clinical trials. The Visual Inspection Technician handles and inspects manufactured products by following standard operation procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). In addition, the Visual Inspection Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning.

The Manufacturing Technician 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 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 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 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 Business Development Sr Manager - Pharma Services is accountable for the sales of the company’s pharma support services (IQ/OQ/PQ Validation and Calibration) within the defined territory. Duties include lead generation, creating sales opportunities, growing the sales pipeline and winning new business as well as expanding business with current customers.