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 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 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 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 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...
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
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
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, AA, IR, KF. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
The Materials & Logistics Technician II 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 & Logistics Technician II also identifies hazardous materials. The Materials & Logistics Technician II uses the electronic inventory system to track, document and control all inventory.
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
Day Shift: 12-Hour Rotating (2-2-3), 7:00am - 7:00pm
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...
Category
Manufacturing
Position Type
Full-Time
Working Hours
Day Shift: 12-Hour Rotating (2-2-3), 7:00am - 7:00pm
The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. The ideal candidate will assist internal teammates and partner with individuals from other departments for the development of SOPs and associated documents, and process improvements. The Sr. Quality Assurance Specialist will provide guidance and mentoring to Operations personnel in achieving a high level of GMP compliance and instilling quality...
Category
Quality Assurance
Position Type
Full-Time
Working Hours
Night Shift: 12-Hour Rotating (2-2-3), 7:00pm - 7:00am
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 Senior Drug Product Operations Sample Coordinator is accountable for driving results in a fast-paced environment by facilitating the log in of samples and projects for lab documentation, coordinating the sampling and the transfer materials/components and drug products from manufacturing to the laboratory, and managing the project timelines for issuance of COAs. The Sr. DP Operations Sample Coordinator provides administrative and organizational support related to materials management activities in manufacturing. The ideal candidate will maintain documentation and files to assure they are accurate, up-to-date, and available to appropriate personnel.
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 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 III OSD employs acceptable techniques while working in manufacturing environments, including PPE gowning.
The Shipper/Receiver - Pharma/GMP is responsible for the safe and proper handling of client products in accordance with company procedures and client specific requirements. This shipper/receiver position is challenged with a daily routine that changes based on client demand and generally takes place in a fast-paced work environment at varying environmental conditions.
The Scientist 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 Director, Manufacturing Technical Services provides strategic and operational leadership in a fast-paced environment by steering comprehensive manufacturing support for Drug Product Development. This role serves as the principal subject matter expert in the Sterile manufacturing area, ensuring clients receive elite technical and engineering solutions for their manufacturing processes. The Director partners closely with Commercial and Business Leaders to drive budgeting, establish long-term project timelines, and deliver high-level technical recommendations. The Director continuously evaluates cutting-edge technology to maintain Alcami’s position at the forefront of the industry. The Director,...
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 Compliance Specialist 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, conducting audits, supporting inspections, and maintaining quality databases. The Compliance Specialist will perform the role of Lead Inspector for external audits and act as consultant with clients for all levels of regulatory issues.
The Senior Compliance Specialist 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, conducting audits and supporting inspections, and maintaining quality databases. The ideal candidate will assist with the development of SOPs or other quality documents as needed. The Senior Compliance Specialist will perform the role of Lead Inspector for external audits and act as consultant with clients for all levels of regulatory issues. The Sr. Compliance Specialist will provide guidance and mentoring for other compliance employees.
The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing...
The Senior Manager, Quality Operations is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Senior Manager, Quality Operations provides leadership to the site Quality team who performs quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives, directs the implementation of quality plans, and works with lab management to ensure department goals and objectives are met. The Senior Manager interacts with clients and regulatory agencies...
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, titrations UV, AA, IR methodologies are commonly employed in the described testing. Other key methodologies applied include HPLC, dissolution and/or GC based. 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. For this position, Titrations, CKF/KF, dissolution and/or CCIT based methodologies are commonly employed in the described compendial testing. Other key methodologies applied include: TLC, HPLC, GC, UV.
The Sr. HVAC/R Technician is responsible for performing routine and emergency maintenance during business hours, unless otherwise notified of an emergency on Alcami’s laboratory and building refrigeration, air conditioning, and heating systems. Availability is required to respond to equipment emergencies. The Sr. HVAC/R Technician 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...
The Shipper/Receiver - Pharma/GMP 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 Senior Scientist I, Bioassay is accountable for driving results in a fast-paced environment by performing routine and non-routine testing in support of pharmaceutical product development and manufacturing. The Sr. Scientist I, Bioassay may also be required to work on method development and method validation projects. The Senior Scientist I, Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing methods. Strong problem-solving and troubleshooting skills along with proficiency in analyzing data, laboratory documentation, data presentation and collaboration will help ensure success in this position.
The Senior Scientist I, Bioassay is accountable for driving results in a fast-paced environment by performing routine and non-routine testing in support of pharmaceutical product development and manufacturing. The Sr. Scientist I, Bioassay may also be required to work on method development and method validation projects. The Senior Scientist I, Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing methods. Also, knowledge in techniques such as HPLC, icIEF, or CE-SDS is desirable. Strong problem-solving and troubleshooting skills along with proficiency in analyzing data, laboratory documentation, data presentation and collaboration will help...
The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing engineering support for clinical and commercial parenteral Drug Product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: evalutation of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.
The Scientist - Formulations is accountable for driving results in a fast-paced environment and leading formulation development studies for the design and identification of safe, stable, robust and manufactural pharmaceutical dosage forms. The Scientist - Formulations independently designs, plans, performs, interprets and reports results of scientific experiments for the preparation and timely delivery of drug products (DP), processes and procedures needed for technology transfer and manufacture of the product. The position requires superior leadership behaviors as well as expertise in functional competencies including scientific principles, laboratory practices, cGMPs and regulatory requirements for pharmaceuticals and biologicals.
The Scientist - Formulations is accountable for driving results in a fast-paced environment and leading formulation development studies for the design and identification of safe, stable, robust and manufactural pharmaceutical dosage forms. The Scientist - Formulations independently designs, plans, performs, interprets and reports results of scientific experiments for the preparation and timely delivery of drug products (DP), processes and procedures needed for technology transfer and manufacture of the product. The position requires superior leadership behaviors as well as expertise in functional competencies including scientific principles, laboratory practices, cGMPs and regulatory requirements for pharmaceuticals and biologicals.
The Associate Director, Laboratory Quality Operations is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Associate Director, Laboratory Quality Operations provides leadership to the site Quality team who perform quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives; directs the implementation of quality plans and works with lab management to ensure department goals and objectives are met. The Associate Director, Laboratory...
The 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 Director, Quality (Packaging Operations for Manufacturing) is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Director, Quality (Packaging Operations for Manufacturing) provides leadership to the site Quality team who performs quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action...
The Director, Manufacturing Sterile Operations is accountable for driving results in a fast-paced environment by providing leadership to the site’s manufacturing function. Focus areas for the role include operational leadership, parenteral (Filling and Visual Inspection) manufacturing process, project management, continuous improvement, change management, manufacturing investigations/corrective actions, participation in business reviews, and support of regulatory and client audits.
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.