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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 Head of Sterile Operations is accountable for driving results in a fast-paced environment by directing operations for Alcami’s parenteral site. The Head of Sterile Operations develops site-wide production and resource plans, and manages key performance metrics to manage and meet production goals. As the Manufacturing Sterile Site Head, talent management and succession planning are critical deliverables. This role ensures proper staff training and development to achieve results or proactively manages expectations towards alternative solutions. The Site Head develops and implements key strategic policies and procedures to address complex problems requiring in-depth analysis and independent judgment within broadly defined practices and...
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 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 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 Packaging Technican 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 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 Senior 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. The Sr. Desktop Engineer position will involve manufacturing and scientific computer system installation, test execution, and support.
The Sr. Validations Specialist is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation of equipment and GxP computerized systems. Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and validation master plans; supporting facility, utility, manufacturing equipment, conducting reviews of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; ensuring compliance with 21 CFR Part 11, Data Integrity, and functional requirements; developing documentations as required for projects; serve as the subject matter expert during audits and inspections and consulting on validation and cGMP questions and issues. The ideal candidate...
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 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.
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...
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 a 96-well plate reader. Additional areas of desired knowledge and experience include growth promotion testing and microbial method development and validation. The Scientist II (Microbiology)...
The Scientist I (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 a 96-well plate reader. Additional areas of desired knowledge and experience include growth promotion testing and microbial method development and validation. The Scientist I (Microbiology)...
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 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 Scientist II / 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 II / 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 Pharma Technician is responsible for the safe and proper handling of client products in accordance with company procedures and client specific requirements. This is a cross-functional and cross-campus position that 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 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 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 at the RTP facility. 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...