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...

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 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 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 Scientist II (Microbiology) is accountable for driving results in a fast-paced environment by performing complex microbial analysis and performing microbiological testing to support Alcami’s sterile manufacturing facility as well as external clients. Alcami is especially interested in candidates with experience in sterility testing using an isolator, experience in microbial genetic identification, using a MicroSeq and experience with kinetic endotoxin testing using MCS and 96-well plate readers. Additional areas of desired knowledge and experience include growth promotion testing and microbial method development and validation. The Scientist II...

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 Sr. Scientist II 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. A Sr. Scientist II will routinely lead 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: CKF/KF, MS, ICP-MS, Particle Size, CCIT, UV.

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 Senior Manufacturing Technician 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 Senior Manufacturing Technician OSD is a key role responsible for overseeing and executing advanced production tasks in the manufacturing of oral solid dosage pharmaceuticals, such as microsphere manufacturing. This position entails a high level of technical expertise in OSD processes (Drug Substance manufacturing will be considered), leadership in troubleshooting, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP). The Senior Manufacturing Technician performs the...

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 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 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 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 Sr. Administrative Assistant drives results in a fast-paced environment and is responsible for administrative duties for multiple locations in the Durham/Morrisville, NC area. The position provides site and departmental administration support including correspondence, travel & expense report reconciliation, overseeing & coordinating client agendas and all other site vistiors, and handles confidential details in a professional manner. The Sr. Administrative Assistant relies on experience and judgment to plan and accomplish goals, and maintains effective working relationship with leadership and employees. Assignments may be in various functional areas. This Sr. Administrative Assistant is the front desk receptionist at the Durham, NC location. The...

The Calibration Technician I will help set up equipment, change batteries, assist with data entry and perform calibration on various instruments including, but not limited to, temperature, relative humidity, CO2, voltage, pressure, time, rotation, etc. following documented procedures using precision standards.  Calibration and preventative maintenance will be performed in-house or off-site based on business need.

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 Technical Evaluations Specialist drives results in a fast-paced environment by assessing requests for proposals (RFPs) received from our Sales and Business Development team or customers. The Sr. Technical Evaluations Specialist demonstrates subject-matter-expertise and superior technical and scientific knowledge for assigned business units (Lab Services and/or Drug Product) to develop proposals, including associated costs. This position collaborates with Sales and Business Development, Project Management, and Operations to provide technical guidance to customers, which includes direct customer interface. The Senior Technical Evaluations Specialist demonstrates a high level of independence and expertise, including coaching and mentoring less experienced...

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.

The Lab Informatics Specialist will be responsible for evaluating and improving the Waters NuGenesis system, which is used by the Laboratory Services business unit. The Lab Informatics Specialist will collect and analyze data to then identify and implement effective solutions. This role will develop, configure, and customize the system, while working collaboratively with various departments to understand requirements and maintain data integrity.

The HVAC-R/Facilities Technician is responsible for performing routine and emergency maintenance on Alcami’s pharma storage warehouses, laboratory and building refrigeration, air conditioning and heating systems. Availability is required to respond to equipment failures. A high level of precision and accuracy is necessary for this position. This will be achieved through the creation of procedures and checklists combined with consistent compliance with each. The person in this role will perform routine preventive maintenance and repairs for equipment belonging to Alcami and their customers. This position is also responsible for creating, modifying, and executing procedures and reports....

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 Manufacturing Technician (Compound/Fill/Finish) is accountable for results in a fast-paced environment and assists with the manufacturing of sterile injectable products in vial and syringe configurations for clinical/commercial distribution. The Senior Manufacturing Technician is a key role responsible for overseeing and 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, leadership in troubleshooting, and responsibility for maintaining quality and...

The Sr. Scientist II 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. A Sr. Scientist II will routinely lead 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: CKF/KF, MS, ICP-MS, Particle Size, CCIT, UV.

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 Vice President, Business Development is accountable for results in a dynamic and fast-paced environment to drive revenue for the assigned business segments. Business segments include Drug Product development and manufacturing from pre-clinical to late phase clinical and commercial manufacturing including sterile fill-finish, oral solid dose manufacturing, and formulation development, for complex products and generic drug development. The Vice President, Business Development needs a scientific background including laboratory and/or pharmaceutical manufacturing experience, with a proven track record of sales experience in the biopharma and/or CDMO industries. The ideal candidate is a highly inquisitive and motivated self-starter with a tenacious drive and...

Alcami is seeking a proactive and results-oriented Business Development Manager to join our team in the Northwest region. 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...