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The 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 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 activities,...
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The Senior Manufacturing Technician 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 Sr. Manufacturing Technician 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 Sr. Manufacturing Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Sr. Manufacturing Technician works collaboratively to support other manufacturing areas as required.
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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.
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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.
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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)...
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As a Technical Writer, you are a key member of the Technical Services team, responsible for developing FDA- and GMP-compliant documentation supporting primary and secondary pharmaceutical packaging operations. Your primary responsibility is Technical Writing- authoring product-specific Master Batch Records (MBRs) executed during production, as well as equipment and component specific validation tests. You will also assist with the execution of qualification activities as needed, supporting new product introductions and validated packaging operations.
The Technical Writer position requires a strong understanding of packaging equipment and processes, along with the ability to clearly communicate technical concepts to diverse internal and...
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As a Production Line Leader, you’ll oversee daily packaging line operations, ensuring that products are manufactured efficiently, safely, and to the highest quality standards. The Production Line Leader will coordinate workflows, support training for production associates, and maintain accurate packaging documentation—all while fostering a collaborative, high-performance environment. The Line Leader serves as a bridge between production teams and management, ensuring clear communication, smooth operations, and full compliance with Good Manufacturing Practices (GMP).
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As a Manufacturing Operator, you are a hands-on, production-oriented team member responsible for operating, maintaining, and troubleshooting packaging equipment to ensure consistent production output. You will play a critical role in minimizing downtime, executing changeovers, and supporting continuous improvement efforts on the production floor. This position requires both mechanical aptitude and operational focus, as you will run equipment while also performing preventative maintenance, resolving issues in real time, and ensuring all activities meet cGMP and safety standards.
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As a Manufacturing Operator, you are a hands-on, production-oriented team member responsible for operating, maintaining, and troubleshooting packaging equipment to ensure consistent production output. You will play a critical role in minimizing downtime, executing changeovers, and supporting continuous improvement efforts on the production floor. This position requires both mechanical aptitude and operational focus, as you will run equipment while also performing preventative maintenance, resolving issues in real time, and ensuring all activities meet cGMP and safety standards.
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The Plant QA Specialist is a hands-on quality role that serves as the primary quality representative on the production floor, ensuring packaging operations comply with SOPs, GMP requirements, and quality standards. The position is responsible for conducting inspections, reviewing batch records, supporting material release activities, managing deviation documentation, and assisting with investigations, CAPAs, risk assessments, and change controls. This role partners closely with production teams to provide real-time quality guidance, improve deviation reporting, and support continuous improvement initiatives. Ideal candidates have a bachelor's degree in a relevant scientific field, experience in quality or manufacturing environments, strong documentation and...
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The Plant QA Specialist is a hands-on quality role that serves as the primary quality representative on the production floor, ensuring packaging operations comply with SOPs, GMP requirements, and quality standards. The position is responsible for conducting inspections, reviewing batch records, supporting material release activities, managing deviation documentation, and assisting with investigations, CAPAs, risk assessments, and change controls. This role partners closely with production teams to provide real-time quality guidance, improve deviation reporting, and support continuous improvement initiatives. Ideal candidates have a bachelor's degree in a relevant scientific field, experience in quality or manufacturing environments, strong documentation and...
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The Maintenance Mechanic is responsible for maintaining facility systems, including electrical, mechanical, plumbing, and HVAC equipment, through repairs, inspections, and preventive maintenance activities. The Maintenance Mechanic also manages external maintenance vendors by sourcing contractors, coordinating work, and ensuring compliance with safety and company standards. Additionally, the role supports equipment installations by setting up electrical and utility connections, collaborating with operations and engineering teams, and ensuring all work meets applicable codes and regulations. Accurate documentation, reporting, and maintenance of facility records and schematics are essential responsibilities. Candidates should have a high school diploma or GED, strong...
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The Maintenance Mechanic is responsible for maintaining facility systems, including electrical, mechanical, plumbing, and HVAC equipment, through repairs, inspections, and preventive maintenance activities. The Maintenance Mechanic also manages external maintenance vendors by sourcing contractors, coordinating work, and ensuring compliance with safety and company standards. Additionally, the role supports equipment installations by setting up electrical and utility connections, collaborating with operations and engineering teams, and ensuring all work meets applicable codes and regulations. Accurate documentation, reporting, and maintenance of facility records and schematics are essential responsibilities.
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As a Production Trainer - GMP/Packaging you are responsible for managing organizational compliance surrounding annual training with a focus on ensuring production employees are trained, competent, and operating in full compliance with cGMP/cGDP standards. The Production Trainer - GMP/Packaging will design and deliver structured training programs with a focus on tactical production skills, support onboarding and skill development, and serve as a key link between Quality, Operations, and Continuous Improvement.
This is a highly hands-on role, combining classroom instruction, administrative oversight, floor-based training, and real-time coaching. The Production Trainer will actively observe operations,...
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The Sr. Validation Engineer - Packaging is responsible for leading validation and qualification activities that support compliant pharmaceutical packaging operations, including packaging equipment, utilities, facilities, and computerized systems. The Sr. Validation Engineer - Packaging develops and executes validation protocols, maintains validation documentation, manages change controls, and ensures systems remain inspection-ready and compliant with cGMP, data integrity, and 21 CFR Part 11 requirements. The position partners closely with engineering, quality, operations, IT, contractors, and equipment vendors to support the installation, qualification, and ongoing performance of packaging-related equipment and systems. Additionally, the role serves as a validation...
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The Maintenance Supervisor is responsible for ensuring the reliability, compliance, and operational readiness of production lines and facility equipment to support safe, efficient, and uninterrupted packaging operations. This role oversees line setups, changeovers, and production interruptions, coordinating with technical teams to minimize downtime while maintaining cGMP and quality standards. The Maintenance Supervisor leads and develops Maintenance Mechanics, ensuring maintenance activities are performed safely, scheduled appropriately, and completed on time to support production objectives. Additionally, the role manages capital equipment, facility improvement, and tooling projects, ensuring all initiatives meet regulatory, operational, budgetary, and timeline...
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The Engineering Manager is responsible for leading engineering, maintenance, and facilities, functions to support compliant pharmaceutical packaging operations. This role oversees the reliability, performance, and continuous improvement of production equipment, facility systems, and engineering programs while ensuring adherence to safety, quality, and regulatory requirements. As a member of the site leadership team, the Engineering Manager drives strategic initiatives, manages engineering projects, develops technical talent, and partners cross-functionally to optimize operational performance, minimize downtime, and support business growth. The position also provides oversight of validation strategy, technical documentation programs, facility maintenance, and...
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As an Incoming Quality Specialist, you are a key member of the Quality Assurance (QA) team, responsible for ensuring all incoming materials—including packaging components, bulk products, and materials—meet required quality and GMP standards before release for use in manufacturing and packaging operations.
This is a quality support role with both administrative and inspection-focused responsibilities, emphasizing documentation control, incoming product verification, and customer communication. You will work cross-functionally with Planning, Warehouse, Production, Customer Service, and external customers to ensure materials and documentation are reviewed, approved, released, and archived correctly.
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The Manufacturing Engineer - Packaging is responsible for the development, optimization, and support of manufacturing processes, tooling, and production equipment within a regulated pharmaceutical packaging environment. This role partners closely with Operations, Technical Services, Quality Assurance, suppliers, and customers to improve manufacturing performance, implement new technologies, and support new product introductions. The Manufacturing Engineer - Packaging drives continuous improvement initiatives, enhances operational efficiency, supports quality systems, and ensures manufacturing processes remain compliant with applicable regulatory and customer requirements. The role also serves as a key contributor to process validation activities, root cause...
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The Sr. Project Engineer leads capital, construction, utility, process improvement, and validation projects from concept through completion, ensuring they are delivered on time, within budget, and in compliance with quality, safety, cGMP, and company standards. This hands-on role partners with cross-functional teams to define project requirements, develop implementation plans, manage contractors and vendors, oversee budgets and schedules, and drive project execution. The position is responsible for construction management activities including scope development, bid and RFP processes, design reviews, value engineering, and cost control. Additionally, the Sr. Project Engineer supports equipment and facility validation efforts by coordinating IQ/OQ/PQ activities,...
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The Packaging Engineer is responsible for designing and managing pharmaceutical packaging systems from concept through implementation, ensuring all components and processes work efficiently together. The Packaging Engineer translates client requirements into practical specifications, oversees changes to packaging systems, and supports serialization and compliance in a GMP environment. Acting as a technical expert, the engineer troubleshoots packaging issues, collaborates with operations to optimize performance, and trains team members on new packaging processes.
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The Process Engineer - Packaging is responsible for optimizing manufacturing performance by coordinating production trials, validating process changes, and ensuring improvements are effective, sustainable, and aligned across the entire production process. Acting as a technical expert, this individual evaluates how equipment, systems, and technologies interact, identifying opportunities and resolving obstacles to keep production lines running smoothly, efficiently, and in harmony. The Process Engineer - Packaging develops and maintains technical documentation, standardizes best practices, and supports Continuous Improvement initiatives through the application of Lean and Six Sigma methodologies. Additionally, the role analyzes production metrics such as OEE,...
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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...
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The Associate Scientist, QC Chemistry 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, QC Chemistry may also assist with method development/method validation projects. For this position, UV-Vis, Dissolution, HPLC, GC, Titration, and/or KF based methodologies are commonly employed in the described testing.
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The Senior Manager, Engineering is responsible for the equipment and system performance of a cGMP manufacturing facility. The Sr. Engineering Manager leads, manages, and coaches engineering staff to ensure equipment and systems are designed, installed, and consistently perform as intended when needed. The Sr. Manager develops an engaged, high performing team that demonstrates Alcami core values with a culture of safety and quality.
The Sr. Manager of Engineering assists with developing strategies, processes, systems, procedures, and metrics to achieve a high level of equipment availability, reliability, and performance. The Sr. Manager monitors equipment work orders, change controls, qualification status, and readiness. Manages...
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The Warehouse Manager is responsible for leading all warehouse operations supporting GMP-regulated pharmaceutical development, manufacturing, testing, and shipping activities. This role ensures compliant receipt, storage, inventory management, and movement of materials while maintaining the highest standards of quality, safety, inventory accuracy, and regulatory compliance. The Warehouse Manager partners closely with Supply Chain, Manufacturing, Quality, and Project Management teams to support a fast-paced, client-focused CDMO environment and drive operational excellence.
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The 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 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.
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The 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. This position will involve manufacturing and scientific computer system installation, test execution, and support.
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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, flow cytometry, 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.
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The Senior Manager of Metrology is accountable for driving results in a fast-paced environment by supervising the daily activities of the Metrology group that performs calibrations, diagnostics, repair, maintenance and equipment qualification of laboratory analytical instrumentation such as HPLC and gas chromatography. The ideal candidate will develop production and resource plans that meet production goals in terms of safety, quality, output, cost and financial savings for the Company. The Senior Manager of Metrology will complete and review calibration documentation and the work of the Metrology team.
The Sr. Manager, Metrology is accountable for driving results in a fast-paced environment by supporting general pharmaceutical metrology...
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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...
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The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety 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 lab or manufacturing facility. Activities include reviewing documents and data, supporting 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 develops SOPs or other quality documents as needed.
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The Technical Trainer is accountable for driving results in a fast-paced environment. The Technical Trainer is an experienced learning and development professional with technical training and cGMP expertise in the pharmaceutical, biotech or life science industries. The Technical Trainer prepares and teaches programs to help workers learn new skills and refresh skills. They assess training needs, teach hands on classes, and create new material to ensure the employees are ready to perform tasks associated with their position. The Technical Trainer has the ability to develop, implement, manage, and measure the effectiveness of technical training and development programs.
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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...
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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...
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The 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. The Scientist II 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 KF and UV. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
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The Sr. Scientific Specialist - Specification Generation is accountable for driving results in a fast-paced environment by effectively performing activities of varying complexity and ensures quality and compliance with applicable regulatory requirements. These activities include generation of specifications to support manufacturing and packaging activities, review of test procedures, maintaining current compendia and regulatory requirements, consulting on quality and compliance issues, and maintaining specification and test procedure supporting documentation. The position will provide guidance and mentoring for other employees and assist with the development of SOPs and company improvement initiatives. The Sr. Scientific Specialist - Specification Generation is...
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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.
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The Sr. Administrative Assistant drives results in a fast-paced environment and is responsible for administrative duties for multiple locations. 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. The position works on assignments that are moderately complex in nature in which considerable judgment and initiative are required in...
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The Warehouse Courier Driver will support internal transportation needs, coordinating deliveries among multiple locations and mapping out the most efficient route. In addition, transport activities may occur between Alcami sites. This position is challenged with a daily routine that changes based on customer demand and generally takes place in a fast-paced work environment. When not driving, the Warehouse Support Driver will assist with a wide range of tasks including but not limited to support of materials control, receiving manufacturing items, assisting in kitting batchas as well as assisting with outgoing shipments as needed, assisting with external deliveries and orders, restocking supplies, etc.
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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.
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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.
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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...
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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.
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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).
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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.
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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...
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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).
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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...
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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.