The Project Manager II 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 II 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 II leads cross-functional project teams to deliver against contracted commitments and timelines. The Project Manager II 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...
The Project Manager II 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 II 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 II leads cross-functional project teams to deliver against contracted commitments and timelines. The Project Manager II 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...
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 Scientist III, 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 Scientist III, Bioassay may also be required to work on method development and method validation projects. The Scientist III, 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 ensure success in...
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...
Category
Manufacturing
Position Type
Full-Time
Working Hours
Night Shift: 12-Hour Rotating (2-2-3), 7:00pm - 7:00am
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 Scientist II - QC Chemistry is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist II QC Chemistry position, HPLC, dissolution, 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 Scientist I - QC Chemistry is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist I - QC Chemistry position, HPLC, dissolution, UV, osmolality, density, and pH are commonly employed in the described testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The Visual Inspection Technician 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 Associate Scientist - 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 Associate Scientist (Microbiology) may assist in providing problem solving support and Laboratory Investigation Report...
The Manufacturing Technician III (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 Technician III 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 compliance with Good Manufacturing Practices (GMP). The Manufacturing Technician...
Category
Manufacturing
Position Type
Full-Time
Working Hours
Night Shift: 12-Hour Rotating (2-2-3), 7:00pm - 7:00am
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-Vis, 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...
Category
Manufacturing
Position Type
Full-Time
Working Hours
Night Shift: 12-Hour Rotating (2-2-3), 7:00pm - 7:00am
The Manufacturing Specialist - Aseptic supports cGMP manufacturing and troubleshoots unexpected manufacturing events, preparing, conducting, and evaluating continued process verification activities; and providing on-going support of commercial and clinical manufacturing. The Manufacturing Specialist works closely with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position requires good leadership behaviors and ability to train others.
The Business Development Associate is accountable for results in a fast-paced environment by researching and identifying new leads as prospects to meet business development goals. This is an entry-level position with a career path and upward mobility into business development roles. The Business Development Associate is a “hunter” – a highly inquisitive and motivated self-starter with a tenacious drive and ability to research and generate new business prospects for the entire Alcami service offerings including Lab Services, Biologics drug product, oral solid dose, Biostorage and other Pharma Support services, through cold calling and email campaigns. The Business Development Associate assists and works collaboratively with cross functional team...
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 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 Principal Quality Specialist (Manufacturing) is accountable for driving results in a fast-paced environment by effectively performing activities of substantial variety and complexity 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 manufacturing facility.
These activities include reviewing documents and data, conducting 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 serves as quality host for client and regulatory agency...
A Proposal Writer (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. Technical Evaluations Specialists demonstrate technical and scientific expertise for assigned business units (focusing on Sterile Drug Product) to develop proposals, including associated costs. Technical Evaluations Specialists collaborate with Sales and Business Development, Project Management, Finance, Legal, and Operations to provide technical guidance to customers. This includes direct customer interface. Technical Evaluations Specialists demonstrate a high level of independence.
The Visual Inspection Technician II is accountable for results in a fast-paced environment and responsible to perform tasks for the quality inspection of sterile injectable products for commercial distribution and clinical trials. The Visual Inspection Technician II handles and inspects manufactured products by following standard operation procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). In addition, the Visual Inspection Technician II employs acceptable techniques while working in manufacturing environments, including PPE gowning, and provides training and coaching to less experienced Visual Inspection Technicians as required. The Visual Inspection Technician interacts with customers as needed.
The Scientist II is accountable for driving results in a fast-paced environment by performing analytical-biotech routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. The Scientist II 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 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 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 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.
Category
Manufacturing
Position Type
Full-Time
Working Hours
1st Shift: Monday - Wednesday, 6:30am - 7:00pm & every other Thursday, 6:30am - 7:00pm
The Quality Specialist II - Audit Team is accountable for driving results in a fast-paced environment by effectively performing activities directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, 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 II - Audit Team is heavily involved in client audits. During audits, this position will partner with audit hosts and serve as subject...
The Quality Specialist II - Audit Team is accountable for driving results in a fast-paced environment by effectively performing activities directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, 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 II - Audit Team is heavily involved in client audits. During audits, this position will partner with audit hosts and serve as subject...
The Manager, Audit Compliance is accountable for driving results in a fast-paced environment, continuously challenging performance in regard to quality standards, systems, and operating procedures. Responsibilities include oversight of client audit response and associated team. This position will be performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements. Activities include reviewing documents and data, CAPAs, Change Control, supporting audits and inspections, consulting on quality and compliance issues, 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...
The Associate Manufacturing Specialist is accountable for driving results in a fast-paced environment by being responsible to manufacture various products following a specific protocol while in full compliance with all cGMP procedures and guidelines.
The Associate Manufacturing Specialist is responsible for handling, reviewing, and ensuring the accuracy, completeness, and compliance of all manufacturing documentation associated with formulation and aseptic filling operations. This role ensures that Good Documentation Practices (GDP) are consistently upheld and that batch records are processed efficiently to support on-time product release.
The Sr. Maintenance Technician is accountable for driving results 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 as a key team member in a highly technical schedule-based environment requiring experience related specifically to keeping production at a ready state. 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 Technician is able to apply independent...
The Talent Acquisition Sourcer is accountable for driving results in a fast-paced environment by assisting the Talent Acquistion team in identifying candidates. The TA Sourcer is a recruitment specialist who proactively researches, identifies, and engages potential candidates before they even apply for a job. They specialize in finding "passive" talent using advanced search techniques and builds talent pipelines for current and future roles. The Talent Acquisition Sourcer works with the TA team in a supporting role while developing the skills to advance to a TA Partner.
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 Sr. Director, Engineering, Validation and Maintenance is responsible for the strategic leadership, development, and execution of engineering, validation, maintenance, reliability, and manufacturing automation programs that support current operations and future growth of the site. This role provides end-to-end lifecycle ownership of facility, utility, manufacturing, laboratory, and automation systems, ensuring regulatory compliance, operational excellence, asset reliability, and business continuity.
The Sr. Director leads all aspects of engineering, including capital project planning and execution, facility and utility design, equipment procurement, installation, commissioning, and lifecycle management. The role oversees 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, LC/MS, HPLC, and/or electrophoresis 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 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 Manager, Engineering is responsible for the equipment and system performance of a cGMP manufacturing facility. The Engineering Manager leads, manages, and coaches engineering staff to ensure equipment and systems are designed, installed, and consistently perform as intended when needed. The Manager develops an engaged, high performing team that demonstrates Alcami core values with a culture of safety and quality.
The Manager Engineering assists with developing strategies, processes, systems, procedures, and metrics to achieve a high level of equipment availability, reliability, and performance. The Manager monitors equipment work orders, change controls, qualification status, and readiness. Manages engineering processes associated...
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...
Category
Manufacturing
Position Type
Full-Time
Working Hours
Night Shift: 12-Hour Rotating (2-2-3), 7:00pm - 7:00am
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...
Category
Manufacturing
Position Type
Full-Time
Working Hours
Day Shift: 12-Hour Rotating (2-2-3), 7:00am - 7:00pm
The Supervisor, 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, processing 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 Supervisor, Facilities and Maintenance facilitates implementation of projects, schedules, and provides oversight of the work during execution. All activities are conducted under the regulatory agency requirements of the pharmaceutical industry and related products that are manufactured at Alcami,...
Category
Facilities Maintenance
Position Type
Full-Time
Working Hours
Day Shift: 12-Hour Rotating (2-2-3), 7:00am - 7:30pm
The Senior SAP FICO Functional Consultant is responsible for leading the design, implementation, and ongoing enhancement of SAP S/4HANA Finance and Controlling (FICO) processes. This role will serve as the finance subject matter expert and strategic partner to Accounting, FP&A, and Operational Finance teams to deliver business-aligned solutions. The consultant will support ongoing stabilization and continuous improvement following our successful go-live with RISE with SAP. Given our S/4HANA environment, experience with Fiori applications and a strong understanding of SAP Analytics and reporting tools is...
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 Vice President, Business Development is responsible for driving revenue growth across assigned business segments in a dynamic, fast-paced environment. This role focuses on securing new business opportunities for drug product development and manufacturing services spanning preclinical, clinical, and commercial phases, including oral solid dose manufacturing, formulation development, complex products, and generic drug development.
The ideal candidate combines a strong scientific background with laboratory and/or pharmaceutical manufacturing experience and a proven track record of success in Oral Solid Dose manufacturing sales within the CDMO industry. This individual is highly curious, self-motivated, and results-driven, with...
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 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 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 Senior 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 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 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 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 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...
Category
Manufacturing
Position Type
Full-Time
Working Hours
Day Shift: 12-Hour Rotating (2-2-3), 7:00am - 7:00pm