AAIPharma Services Corp jobs in Raleigh, NC

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary 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 culture. On-Site Expectations 100% on-site position. 2nd Shift: Monday - Friday, 2:30pm - 11:30pm. Responsibilities Performs quality review and approval of documents, data, protocols, and/or reports. Performs GMP document creation and issuance (batch records, logbooks, forms, etc.). Performs visual inspection of parenteral product (requires qualification). Performs internal quality audits and/or inspections. Supports client audits and inspections, and regulatory inspections. Maintains quality databases. Assists with implementation and supports quality systems, including but not limited to, operations support, batch review and approval, training, vendor management, and overall regulatory inspectional readiness. Assists with quality improvement initiatives as needed. Consults with clients on production and documentation. Assists with development of SOPs or other quality documents. Maintains accurate files and records. Serves as an effective member of the Quality Assurance team and may serve as a mentor to others in area of expertise. Complies with company polices and SOPs. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications Bachelor's degree in Chemistry, Biology, or related field with 10+ years of GMP related experience, or Master's degree in related field. Minimum five years of related work experience. Knowledge, Skills, and Abilities Aseptic parenteral manufacturing. Grade C gowning. GMP and Annex 1 experience. 20/20 corrected vision for Visual Inspector qualification. Travel Expectations Rarely may be requested to travel to support other Alcami sites. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and the risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Manufacturing Specialist is accountable for driving continuous improvement of the Manufacturing operations, focused on People, Process and the Tools & Technology that drive continuous improvement. The environment is fast-paced and demands consistent results. Efforts are focused on all aspects of Aseptic Operations Dispensing, Compounding, Aseptic Filling via isolator technology and Visual Inspection. The Specialists will be the Manufacturing subject matter expert (SME) for focused areas of responsibility. They will also cross-train in various areas to expand operational proficiency to optimize overall process knowledge and support of operations. They will support operations through root cause investigations of Manufacturing related deviations, CAPA implementation and associated actions to support the Right First Time manufacture and batch release of critical clinical/commercial products. This SME is accountable for performing duties in accordance with Standard Operating Procedures (SOP) and works closely with the Manufacturing Leadership team, Technical Services, Quality Assurance, Engineering, and Supply Chain to ensure robust manufacturing of cGMP Sterile Injectable products. In addition to supporting manufacturing personnel, this hands-on SME should have a functional capability to perform the essential functions and activities alongside the Technicians, as necessary. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Supports Manufacturing during critical operations and transformation changes to the process. Shifts may include weekends and holidays to support operations as necessary. Responsibilities The primary role is to support manufacturing readiness and drive proactive process improvement through the creation and maintenance of cGMP production documentation, SOPs, and Risk Assessments. Follow established Standard Operating Procedures (SOPs) and cGMPs to execute protocols and procedures, ensuring compliance with regulatory requirements and company standards. Troubleshoot and investigate manufacturing discrepancies related to focus areas to identify root cause, utilizing investigative tools such as After-Action Reviews (AARs), 6M methodologies, fish-bone, etc. The specialist will lead Corrective/Preventative Actions through on-time implementation. Evaluate potential product impact of process excursions with support from Technical Services and Quality Assurance personnel. Author Change Controls to support process compliance, general improvement, and drive timely completion. Support the sample management program through notification of sample pick-up and readiness. Perform timely batch issuance requests and identify manufacturing/support related material needs. Conduct training to support various employee qualifications, and to ensure consistent and accurate manufacturing practices are implemented across manufacturing shifts for focus area. Perform necessary activities to support timely batch release. Utilize Subject Matter Expertise to support client/regulatory audit requests, including site tours, assist Project Management and provide pre/post-production batch related support to clients. Carries out duties in compliance with all state/federal regulations (FDA, EPA, OSHA and DEA). Provide technical on-the-floor support for dispensing, compounding, isolator filling, and/or visual inspection operations within controlled environments to assist Manufacturing supervision/management in varying capacities per focus area. Author annual reports, as necessary, for tracking and trending of manufacturing operations to report general process capabilities and identify areas of improvement. Other duties as assigned. Area of Focus (Formulation/Filling): Work proactively to identify areas to expand fill line capabilities and support associated qualification activities Support the execution of vial/syringe manufacturing activities to ensure timely completion and high product quality is maintained Track and trend manufacturing activities to generate data to support continuous process improvement. Understand relevant regulatory guidance (Annex 1, USP, CFR Part 210/211, ICH, etc.) and implement processes and procedures that align Implement and enforce good aseptic practices and technique to isolator manufacturing operations and good cleanroom technique to support an acceptable cleanroom environment Optimize compound and filling training processes through identification of potential procedural inefficiencies and continuous improvement through SOP and batch documentation ownership. Coordinate, schedule, and source materials to execute hands-on training activities for compounding and filling. Qualifications Related bachelor's degree preferred with 2+ years related experience in the manufacture of sterile injectable products in a regulated environment. Or applicants with high school or equivalent certification with 8+ years related experience in the manufacture of sterile injectable products in a regulated environment. Must have at least 1 year of experience in technical writing (deviations, SOPs, batch records, etc.). Must have demonstrated leadership and training experience. Knowledge, Skills, and Abilities Ideal candidates possess practical and analytical problem-solving skills and strategically manage discrepancies in alignment with SOPs and client interest. Strong knowledge of current Good Documentation Practices (GDP) required. Familiarity with USP guidance Annex 1 is highly desirable. Experience with any of the following equipment is highly desirable: Filter integrity testers, steam sterilizers (autoclaves) General compounding equipment (pH meters, mixers, stir plates, rigid/soft vessels) Single-use solution pathway parts including aseptic connectors and filtration assemblies Drug Product fillers including isolators Strong attention to detail and the ability to identify and proceduralize processes intended to implement functional layers of control to support the manufacturing of high-quality products through routine operations. Excellent communication and interpersonal skills, with the ability to effectively train and certify employees in a functional area of expertise. Ability to effectively present information and respond to questions from management and clients to inform or support new or existing operations. Ability to work independently and collaboratively in a fast-paced environment. Flexibility to adapt to changing priorities and support operations at variable capacities. Ideal candidates must readily adapt to variable operations required batch to batch. Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems is required. Receives general instructions on routine work and escalates potential questions/concerns to management in a timely manner. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, occasionally lift and/or move up to 75 pounds and occasionally lift and/or move over 75 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Occasionally, employees may be exposed to airborne particles, fumes or chemicals, therefore the ability to wear necessary PPE including PAPR is required. Employees occasionally may be required to moving mechanical parts and vibration. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Based on products, the use of PAPR or supplied air respirator may be required. Regulations may require employees to participate in routine medical surveillance.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Manager of Planning and Scheduling is a cross-functional leadership role responsible for driving all aspects of manufacturing planning, scheduling, capacity planning, inventory readiness, and seamless material availability to enable on time manufacturing execution. This position combines the strategic planning and leadership to enable execution of the production schedule on time and through release (end-to-end) of each batch, in compliance with GMPs. The Manager leads the efforts for scheduling and planning of manufacturing, staff development, provides technical guidance, and fosters a culture of accountability and continuous improvement. This role requires cross functional leadership and strong expertise in SAP (MM/IM/WM), supplier negotiations, and material flow management, with a proven ability to manage multi-priorities while coaching and developing a high-performing team. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Leadership & People Development Lead, coach, train, and develop planning and scheduling staff to build a high-performance team. Manage day-to-day operations, ensuring staff are fully trained, engaged, and aligned with business needs and objectives. Foster a culture of continuous improvement, accountability, and internal customer value. Represent the department in meetings and regulatory inspections, promoting audit readiness. Planning and Scheduling Execution Lead planning and scheduling strategies and collaborate with purchasing and logistics to ensure material and resources are available to execute the production schedule without delay. Manage supplier qualification, performance, and compliance with Quality and Regulatory expectations. Place and manage purchase orders aligned with production forecasts and schedules. Monitor inventory and material flow across sites to ensure on-time availability, risk mitigation, and supply continuity. Oversee batch prep and staging (Kitting of materials for a batch), transfers, and disposal of materials in alignment with SOPs. Prepare and present planning and scheduling metrics, inventory reports and capacity analysis for business and client needs. Prepare and measure capacity within the manufacturing operations. Considering each fill line, compounding suites and equipment to maximize compliance, output, and resources. Systems & Process Management Serve as a subject matter expert in SAP (MM/IM/WM), ensuring accuracy in establishing minimum inventory needs, inventory availability, and batch readiness management and postproduction transactions. Drive master data accuracy, standardization, and system improvements across sites. Collaborate with Manufacturing, Purchasing, Quality, Laboratories, Engineering, Project Management and Finance to execute Plan-to-Manufacture (P2M) and Procure-to-Order (P2O) processes. Identify and resolve bottlenecks, implementing corrective and preventive actions to enhance operational efficiency. Client & Cross-Functional Engagement Support client visits, audits, and inquiries, ensuring fulfillment of requests and building credibility and trust. Communicate effectively with internal and external stakeholders regarding material availability, supply risks, and alternative solutions. Build and maintain strong supplier and internal customer relationships to drive business success. Qualifications Bachelor's degree in Business, Supply Chain, Operations Management, Engineering, or related fields (required). APICS/CPIM certification a plus. 6+ years of supply chain, procurement, or materials management experience in a pharmaceutical, biotech, or CDMO environment. Minimum 2+ years of management/supervisory experience. Prior GMP or regulated business experience required; CDMO experience preferred. Knowledge, Skills, and Abilities Strong leadership skills with proven ability to build, develop, and retain high-performing teams. Expertise in SAP modules or other Enterprise systems: MM, IM, WM; deep understanding of P2P, P2M, and P2O processes. Strong supplier negotiation and relationship management skills across domestic and international markets. Ability to balance cost savings, supply reliability, and compliance. Demonstrated ability to lead cross-functional projects and continuous improvement initiatives. Excellent communication, presentation, and relationship-building skills across all organizational levels. Proficiency in MS Office Suite (Word, Excel, Outlook). Strong problem-solving, time management, and decision-making skills. Travel Expectations Up to 20% domestic travel. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Senior Supply Chain Project Specialist is a key cross-functional facilitator, responsible for driving end-to-end supply chain excellence with a focus on facilitating on-time project execution from order to batch release at the RTP site. This role combines strategic planning, scheduling, sourcing, and wholistic coordination of internal suppliers like Procurement, Logistics, Labs and Client facing teams, Manufacturing, Quality, Technical Services, and Engineering/Maintenance/Validations, to ensure on time execution of batch production through to disposition of the batch. Acting as facilitator and tracker of all deliverables needed to execute a batch through release of the batch in an efficient manner. This position ensures each project stays on track and coordinates and expedites activities as needed to meet the client and business needs. The role requires exceptional organizational and people management skills, expertise in SAP (MM/IM/WM) or EPR systems, GMP environments, supply chain and project management On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 7:00am - 3:30pm. Responsibilities Planning, Organizing, Cross functional Leadership & Project Management Lead and foster a culture of collaboration, accountability and continuous improvement to meet timelines and commitments. Serve as a cross-functional facilitator, influencing stakeholders across the organization. Promote a culture of on-time execution and delivery, compliance, transparency, and problem-solving. Monitor project metrics (On-Time Execution & Delivery & Schedule Adherence), ensuring transparency and timely reporting. Continuous Improvement & Compliance Drive initiatives to improve schedule adherence, reduce costs, and eliminate bottlenecks. Support operational excellence and champion continuous improvement efforts by analyzing trends, identifying risks, and implementing corrective actions. Collaborates with internal customers and provides a high level of customer service, including recommending solutions, resources, and alternative supply options. Ensures and promotes compliance with Company and Procurement policies and procedures. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Batch Readiness & Lifecycle Coordination Serve as the primary point of contact for all batch readiness activities-ensuring materials, documentation, and equipment are available and aligned prior to production start. Develop and maintain batch readiness trackers to proactively identify gaps or risks that could delay execution or release. Coordinate with cross-functional teams (Procurement, QC, Manufacturing, Technical Services, QA, and Logistics) to ensure all pre-batch and post-batch deliverables are completed within committed timelines. Partner with Scheduling and Manufacturing teams to ensure accurate alignment of production schedules with material availability, testing capacity, and resource readiness. Execution Tracking & Issue Resolution Track the progress of each batch from project initiation through final disposition, providing real-time visibility to stakeholders on status, key milestones, and bottlenecks. Lead daily or weekly tier meetings focused on batch status, upcoming milestones, and issue escalation. Identify and drive resolution of issues impacting timelines, escalating to leadership when necessary to remove barriers. Maintain project dashboards, timelines, and key performance indicators (e.g., On-Time Start, On-Time Release, Cycle Time, and Schedule Adherence). Qualifications Bachelor's degree in Supply Chain, Project Management, Operations Management, Engineering, Technical Services, or a scientific discipline preferred. 5+ years of experience in project management or supply chain, procurement, or inventory management within pharmaceutical, biotech, or CDMO environments. 2+ years leading cross-functional project teams. Proven expertise in GMP-regulated environments. Experience in CDMO manufacturing environment preferred.4 Knowledge, Skills, and Abilities Strong project management and people leadership and collaboration skills; ability to influence without direct authority. Advanced SAP (or equivalent) knowledge and proficiency with Planning, inventory control, and Materials Management processes. Strong collaboration and internal supplier management skills across the network. Excellent communication and presentation skills, with the ability to interact with senior leaders, internal stake holders, clients, and cross-functional teams. Proficiency in MS Office Suite, Smartsheet, Salesforce, and electronic document management systems. Strong business acumen with the ability to track timelines and commitments for all projects project and financials to budget and forecast for revenue. Strong sense of urgency and attention to detail. Drives performance. Holds self and others accountable. Excellent organization, communication and follow-up skills. Ability to self-direct and take constructive action in ambiguous situations. Extremely high standards of excellence. Analytical with a methodical approach to problem solving. Ability to handle multiple and sometimes competing priorities. Travel Expectations Up to 20% travel required. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary 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 Technician is able to apply independent judgment and perform in a small company environment, where rapid changes occur constantly. On-Site Expectations 100% on-site position in Morrisville, NC. 2nd Shift: Monday - Friday, 3:00pm - 11:30pm. Responsibilities Maintenance of WFI distribution, CCA, Boilers, USP and other utilities as assigned. Performs scheduled performance maintenance on equipment and records all necessary data as required and in accordance with Company SOP's and cGMP's. Installs and retrofits facilities equipment in accordance with Company SOP's and cGMP's. Ensures Maintenance Management informed of all developments on a routine basis. Performs necessary repairs to equipment and physical plant as required in a safe, clean, and efficient manner to response to maintenance work requests. Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors. Involved in developing solutions for equipment issues. Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner. Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external). Maintains an organized and clean workspace at all times. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Is on call periodically to monitor and respond to facility and manufacturing equipment repairs and issues. Other duties as assigned. Qualifications High School Diploma or equivalent with 6+ years of experience working in a regulated environment (FDA, NRC or similar performing repairs on production and/or utility equipment. Associate's Degree preferred. Prior pharma cGMP experience required. Knowledge, Skills, and Abilities Excellent knowledge of cGMP in a pharmaceutical or regulated environment required. Excellent verbal communications and presentation skills required. Advanced electrical troubleshooting required. Strong knowledge of general OSHA safety requirements preferred. Strong understanding of Standard Operating Procedures required. Ability to read P&ID's and electrical schematics required. Working knowledge of Microsoft Office (Word, Excel, PowerPoint) required. Working knowledge of Control Systems, PLCs & HMIs preferred. Working knowledge of Computerized Maintenance Management Systems to schedule and document work performed preferred. Working knowledge of JCI Metasys Building Management System preferred. Working knowledge of machinists' equipment such as mills and lathes preferred. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 80 pounds and occasionally lift and/or move over 100 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary 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. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities For Liquid and Sterile Formulation: Creates formulation development plans and executes well-designed experiments to define the qualitative and quantitative formulation composition. Conducts design of experiments (DoE) studies to identify and investigate key and critical quality attributes to confirm formulation robustness as per ICH Q8. Writes and executes protocols to prepare formulations for testing and characterization, methods development and technology transfer. Records and reports study results in compliance with good scientific policy and procedures. Evaluates new scientific technologies/equipment to enhance capability, capacity, and efficiency. Reports and presents scientific/technical results internally and to external clients. Utilizes complex tools/equipment, lab automation tools, and specialized facilities. Maintains and operates equipment according to safety standards and operating procedures. Reviews own work and conduct peer review. Participates in scientific conferences and contributes to scientific journals. Provides coaching and mentoring to junior colleagues and newcomers. Ensures timely completion and compliance with SOPs and all other relevant company training requirements. Other duties as assigned. Qualifications Bachelor's degree in Pharmaceutical Sciences, Chemistry, or equivalent with 6-8 years of experience or Master's degree with 2+ years of experience. Strong customer service focus and excellent customer contact skills. Knowledge, Skills, and Abilities Thorough fundamental knowledge and understanding of solubility and stability theory and practice. A solid understanding of drug solubilization and stabilization techniques in liquid dosage forms. Hands on expertise in aseptic techniques for liquid formulation, compounding, and manufacturing. Experience in aseptic filtration, terminal sterilization and lyophilization process techniques. Knowledge of raw material selection strategy and criteria for parenteral and liquid dosage forms. Basic understanding of physical characterization tools such as DSC, particle size and different viscometers. Hands-on experience in analytical techniques such as UV-Vis and HPLC. Basic understanding of quality attributes and regulatory requirements for parenteral and liquid dosage forms. Basic understanding of quality attributes for biologics formulations. Knowledge of methods for characterization and testing of liquid and parenteral dosage forms. Ability to plan and manage multiple tasks for timely achievement of results. Ability to efficiently organize work with little or no supervision. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Senior Supply Chain Specialist / Buyer is responsible for ensuring timely and compliant procurement, effective inventory control, and seamless material availability to support manufacturing operations across Alcami's sites. This cross-functional leadership role supports the end-to-end supply chain-from strategic sourcing and supplier management to material flow and system execution-bridging Supply Chain, Procurement, Manufacturing, and Quality. The role requires strong expertise in SAP (MM/IM/WM), GMP environments, and direct materials purchasing, with a proven ability to manage multi-site operations and lead continuous improvement initiatives. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities Lead sourcing strategies and negotiate supplier agreements for direct materials across multiple Alcami sites. Place and manage purchase orders to align with production forecasts and schedules, ensuring on-time material availability. Manage supplier relationships, including qualification, performance monitoring, issue resolution, and compliance with Quality and Regulatory expectations. Ensure adherence to contract terms, service levels, and documentation requirements, including supplier specifications and compendia updates. Monitor inventory levels and material flow across sites to support production needs, mitigate risk, and maintain supply continuity. Coordinate material movements, including receiving, staging, transfers, and disposal of expired materials in alignment with SOPs. Prepare and present inventory reports based on business and customer needs. Leverage SAP (MM/IM/WM) to manage procurement and inventory transactions, including vendor and material master data, PO lifecycle, and batch management. Act as a subject matter expert for materials management in SAP, driving data integrity and process consistency across sites. Analyze material usage and supply data to identify bottlenecks and implement improvement initiatives. Collaborate with Planning, Manufacturing, Quality, and Finance to execute Plan-to-Manufacture (P2M) and Procure-to-Order (P2O) processes. Support internal and client communications regarding material availability and supply issues, offering alternative solutions as needed. Ensure compliance with GMP, GDP, and internal procurement and quality standards. Provide mentorship to junior team members and cross-functional support as needed (e.g., shipping, receiving, material handling). Promote audit readiness and represent the supply chain function in regulatory inspections. Support continuous improvement by analyzing consumption trends, identifying bottlenecks, and implementing corrective actions. Other duties as assigned. Qualifications Bachelor's degree in Supply Chain, Operations Management, Engineering, or related field (required); APICS/CPIM certification a plus. 7+ years of materials or inventory management experience within a pharmaceutical, biotech, or CDMO environment. Previous work experience in a CDMO manufacturing environment preferred. Prior pharmaceutical/industry GMP experience required. Knowledge, Skills, and Abilities Demonstrated proficiency in SAP Inventory Management (IM), Warehouse Management (WM), Plan-to-Manufacture (P2M), and Procure-to-Order (P2O) processes. Deep proficiency in SAP MM (P2P) with working knowledge of vendor master, source lists, and PO processing. Strong negotiation skills and ability to manage supplier relationships across domestic and international markets. Demonstrated ability to drive cost savings while ensuring supply reliability and compliance. Experience supporting material staging, production order kitting, and goods issue to process orders. Proven track record managing inventory across multiple manufacturing and distribution sites. Proficiency with MS Office Suite especially Word, Excel, and Outlook. Ability to perform assigned tasks carefully and on schedule according to standard operating procedures and supervisor's instructions. Ability to work with people at all levels of the organization. Excellent verbal communication skills required. Travel Expectations Up to 20% travel required excluding training which will require travel. Physical Demands and Work Environment The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. The noise level in the work environment is usually quiet with periods of higher noise elevations when present in warehouse or manufacturing areas. The employee may be required to gain access to manufacturing personnel via general manufacturing areas only for work discussions or follow-up or be required to tour clients through the various facilities. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. #IND1

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Sr. Validations Specialist is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation of equipment and GxP computerized systems. Specific responsibilities include reviewing SOP's, composing/revising SOP's and validation master plans; supporting facility, utility, manufacturing equipment, conducting reviews of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; ensuring compliance with 21 CFR Part 11, Data Integrity, and functional requirements; developing documentations as required for projects; serve as the subject matter expert during audits and inspections and consulting on validation and cGMP questions and issues. The ideal candidate will work on extremely complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 4:00pm. Responsibilities Performs the qualification and validation of production equipment, utilities, and computer systems. Assists in equipment selection and specification. Works on complex problems of broad scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Maintains all documentation pertaining to qualification and validation. Develops procedures, protocols, and validation project plans. Serves as Validations resource for contractors and vendors. Executes procedures and protocols. Maintain the compliance of validated systems through on-going validation activities (e.g., change control, periodic system reviews, etc.). Composes/revises SOP's and master validation plans. Collaborate with cross-functional teams to assist in the planning, development, installation, operation, validation, and qualification of newly installed or updated equipment and/or computerized systems. Strong knowledge and experience with facility, utility, instrument, and equipment qualifications. Ensures completion & compliance with cGMP and all other relevant company training requirements. Acts as a certified trainer. Provide qualification guidance to IT for infrastructure and computerized system platforms. Other duties as assigned. Qualifications Bachelor's Degree in Engineering, Chemistry, Biology, or related field required. 5+ years of related experience required. Knowledge, Skills, and Abilities Excellent knowledge of quality assurance reviews of validations documentation. cGMP training and basic understanding. Excellent knowledge of pharmaceutical GMP environment. Basic knowledge of Kaye AVS. Good understanding of and ability to utilize Pro Cal. Strong communication skills (oral and written). Strong mechanical skills. Strong working knowledge of Microsoft Office applications. Ability to work on multiple projects simultaneously, with strong attention to detail. Ability to train and mentor others. Travel Expectations Less than 10% travel expected. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand; sit and stoop, kneel, crouch, or crawl. The employee is occasionally required to walk. The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock. The employee is occasionally exposed to fumes or airborne particles; toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Senior Compliance 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. 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 with the development of SOPs or other quality documents as needed. The position will perform the role of Lead Inspector for external audits and act as consultant with clients for all level of regulatory issues. The Sr. Compliance Specialist will provide guidance and mentoring for other compliance employees. On-Site Expectations Hybrid role with 3 days expected on-site. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Performs quality review and approval of documents, data, protocols, and/or reports. Performs internal and external quality audits and/or inspections. Serves as a Lead Inspector for external audits. Hosts client audits and inspections. Hosts regulatory inspections. Maintains quality databases. Assists with the implementation and supports quality systems, including but not limited to vendor management, training, internal audit program, and overall regulatory inspectional readiness initiatives. Assists with quality improvement initiatives as needed. Consults with clients on all levels of regulatory issues. Assists with development of SOPs or other quality documents as needed. Maintains accurate files and records. Serves as an effective member of the Compliance team and may serve as a mentor to others in area of expertise. Complies with company polices and SOPs. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications Bachelor's degree in Chemistry, Biology, or related field with 10+ years of GMP related experience, or Master's degree in related field with 5+ years of related experience, or equivalent educational and work experience. Knowledge, Skills, and Abilities Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise. Good written and oral communication skills. Good math skills. Good computer skills and knowledge of Microsoft Office products. Ability to be trained and to mentor. Ability to interact well with clients and regulatory agents. Ability to interact well with employees at all levels. Ability to negotiate. Ability to lead audits. Ability to act as a consultant. Travel Expectations Up to 5% travel expected. Physical Demands and Work Environment The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and listen. The employee is frequently required to stand, walk, and sit. The employee may be occasionally required to climb or balance.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Senior Network Administrator is accountable for driving results in a fast-paced environment by ensuring the stability and integrity of in-house voice, data, video, and wireless network services. This is achieved by managing local area networks (LANs) and wide area networks (WANs) across the organization. The Senior Network Administrator will be responsible for service and support of LANs, WANs, routers, switches, firewalls, wireless solutions, etc. within the infrastructure of a multi-site organization. The ideal candidate will work with other staff to assist with coordination of LAN/WAN related issues and activities, monitor performance and troubleshoot the overall network. The role will also participate as a local technical resource in system projects involving data center/network activities and be responsible to assist in the support of the end user community. The ideal candidate has a strong understanding of core networking concepts, network monitoring, troubleshooting and demonstrable experience with meeting deadlines while handling multiple projects concurrently. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Creates and maintains documentation as it relates to network configuration, network mapping, processes, and service records. Performs network maintenance, configuration, and capacity planning. Establishes service level agreements with end users. Designs, Installs, Configures, and Manages company LANs, WANs and wireless networks hardware and equipment, including routers, switches, wireless, UPSs, and other hardware. Conducts research on network products, services, protocols, and standards to remain abreast of developments within the networking industry. Oversees new and existing equipment, hardware, and software upgrades. Ensure that LAN/WAN configurations are compatible and consistent with the global standards of the company. Manage Firewalls. Investigates and troubleshoots network problems and performs LAN/WAN communication repair during and after hours. Monitors and tests network performance. Serves as a point of contact and resource for management, staff, and vendors in assigned areas related to network and IS service. Provides server/systems support when appropriate in addition to providing helpdesk and network/desktop support. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Able to work with minimum supervision to complete tasks and identify areas for improvement. Other duties as assigned. Qualifications BS degree in Computer Science or related field. 5+ years of experience in network administration at a senior level. CCNA required. Knowledge, Skills, and Abilities Strong background in configuring and maintaining Cisco Layer 2/3 Switches and Routers. Strong knowledge and experience in managing Cisco Meraki wireless access points, switches and firewalls. Strong background in routing protocols (BGP, EIGRP, RIP, OSPF). Strong understanding of TCP/IP networking. Strong background in configuring and maintaining Cisco Firewall Threat Defense firewalls with Firepower Management Console. Demonstrated background in Layer 1 build outs. Proven experience and thorough understanding of wireless standards and protocols. Experience with management of network monitoring tools such as SolarWinds / OpManager. Excellent computer skills, including Microsoft Office software. Working experience with managing VOIP systems / UcaaS. Established experience in network security fundamentals and concepts. Working experience with troubleshooting tools (tcpdump, wireshark, etc.). Working experience managing third party vendors such as ISPs. Experience with Change Management Processes. Excellent verbal and written communication skills. Strong documentation skills. Strong presenting skills. High attention to detail. Ability to effectively prioritize and execute in a high-pressure environment. Exceptional customer service orientation. Good analytical, logical thinking, and problem-solving skills. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. The noise level in the work environment is usually quiet with periods of higher noise elevations when present in warehouse or manufacturing areas. The employee may be required to gain access to manufacturing personnel via general manufacturing areas only for work discussions or follow-up or be required to tour clients through the various facilities. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. #IND1

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Manager, 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, process 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 Manager, Facilities and Maintenance administers these programs and projects by assisting in the development of project plans, 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, such as FDA, DEA, and EU as examples. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Provides leadership and direction to the Maintenance (GMP and Facilities). Plans and manages projects including facility/utility capital projects and other capital efforts. Ensures GMP compliance (e.g. deviation initiation and review, CAPA assignments, compliance reports, change control generation and review). Provides maintenance program oversight (preventative maintenance programs, repairs, spare parts program, pest control program, etc.). Reviews and provides oversight to the facilities maintenance work order creation, which includes troubleshooting and guidance. Responsible for utilities such as but not limited to HVAC, compressed air, WFI, Clean Steam, nitrogen, chilled water, etc. Manages bi-annual shutdowns. Owns site security, including maintaining the camera and badge reader systems at the site, maintaining the key control list and working with the Global Security Manager on implementation of security programs and site security plan. Maintains and broadcasts key metrics to management. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management. Directly supervises team of 5-8 direct reports. Participates in the hiring process of other employees. Makes hiring decisions of other employees. Schedules and reviews the work of other employees. Accountable for the curriculum assigned and timely completion of training of employees to meet regulatory requirements. Coaches, mentors and develops other employees. Prepares and delivers performance evaluations of other employees. Make recommendations of disciplinary actions of other employees. Other duties as assigned. Qualifications Bachelor's degree (Engineering disciplines) required. 6 plus years of regulated (FDA, DEA, NRC, DOE, etc.) applicable experience required; 8 to 10 years preferred. Minimum of 3 years supervisory experience required. Prior pharmaceutical experience required; CMO or CDMO experience preferred. Experience in aseptic operations a plus. Knowledge, Skills, and Abilities Expert knowledge of pharmaceutical facility operations and maintenance, and aseptic processing equipment. Knowledge of FDA regulated industry requirements, work order/calibration software, managing personnel, and EHS required. Excellent written and oral communication, coaching and mentoring skills required. Excellent ability to read and interpret engineering design, ability to read and understand equipment specifications and ability of track and trend data analysis required. Good negotiating skills required. Ability to manage a Maintenance team that works multiple shifts. Travel Expectations Up to 10% domestic travel. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently talk or hear. The employee is required some of the time to stand, walk, and sit. The employee is required to occasionally use hands to finger, handle, or feel; climb or balance; stoop, knell, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may occasionally work in wet or humid conditions, near moving mechanical parts, in high precarious places, near fumes, airborne particles or toxic chemicals.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss data and methods. Works on problems of moderate and sometimes advance scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Responsibilities Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines Independently develop and evaluate methodologies, design and implement experiments. Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability. Maintains compliant records with little or no supervision Able to write technical documents with assistance Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions Sets up various instrumentation for testing according to written test methods and with little to no supervision. As needed, troubleshoots laboratory instrumentation Leads a sample project with assistance May participate in client level meetings, with approval May lead and develop other team members. May advise clients on site procedures. Responsible for ensuring compliance with cGMP and other regulatory guidelines. Analyze information for technical correctness and accuracy Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor Perform routine laboratory procedures in a timely and efficient manner Gain familiarization with analytical techniques Participate cGMP activities Provides input on SOPs and client questions Maintain laboratory equipment and supplies as directed May support peer-led laboratory investigations process with assistance Maintain a clean and safe work-space Maintain laboratory notebook and/or computer files (i. e. LIMS) according to standard, accepted practices Participate in group and project meetings as required Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems Attend seminars as required Participate in and comply with all current safety, health and environmental programs Shows initiative and interest in learning new techniques and tests Participates in technical discussions and brainstorming sessions Communicates issues or challenges to senior staff and/or management May review test data acquired by others and witness others' notebooks Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed Provides input on SOPs and client questions With guidance, prepares well written and organized development reports Performs other related duties as assigned. Qualifications/Skills Working knowledge of experimental design, including chemistry supporting method development Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC. Working exposure to cross functional techniques including organic chemistry. Understands the chemical properties relating to method development, qualification /validation and troubleshooting. Able to comply to SOPs and basic regulatory compliance Working knowledge of scientific concepts, principles and procedures Actively and positively engages with team and supports process improvements Ability to read and execute compendial methodologies Strong understanding of current FDA and cGMP regulations General knowledge of chemistry and scientific calculations Hands on experience in analytical techniques such as HPLC, GC, etc Basic computer skills Ability to operate laboratory equipment and computers Ability to take direction from experienced scientists and contributes in a team environment Good problem-solving skills Good attention to details Can repeat and follow detailed scientific procedures with supervision Able to clearly present results verbally in group meetings and in written progress reports Routinely and effectively presenting findings to clients Good interpersonal skills and is willing to ask questions about procedures and concepts Aptitude and willingness to gain more skills and knowledge in support of GMP regulations Good written and verbal communication skills Familiarity with computer software such as Empower ChemDraw, Microsoft Word, PowerPoint, and Excel. Aptitude and willingness to gain more skills & knowledge. Good attention to detail and good problem-solving skills. Education, Experience & Licensing Requirements S. /B. A. Chemistry with 6+ years of experience in related industry or MS with 2+ years related experience Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Travel: Not applicable Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required. Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. S. /B. A. Chemistry with 6+ years of experience in related industry or MS with 2+ years related experience Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines Independently develop and evaluate methodologies, design and implement experiments. Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability. Maintains compliant records with little or no supervision Able to write technical documents with assistance Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions Sets up various instrumentation for testing according to written test methods and with little to no supervision. As needed, troubleshoots laboratory instrumentation Leads a sample project with assistance May participate in client level meetings, with approval May lead and develop other team members. May advise clients on site procedures. Responsible for ensuring compliance with cGMP and other regulatory guidelines. Analyze information for technical correctness and accuracy Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor Perform routine laboratory procedures in a timely and efficient manner Gain familiarization with analytical techniques Participate cGMP activities Provides input on SOPs and client questions Maintain laboratory equipment and supplies as directed May support peer-led laboratory investigations process with assistance Maintain a clean and safe work-space Maintain laboratory notebook and/or computer files (i. e. LIMS) according to standard, accepted practices Participate in group and project meetings as required Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems Attend seminars as required Participate in and comply with all current safety, health and environmental programs Shows initiative and interest in learning new techniques and tests Participates in technical discussions and brainstorming sessions Communicates issues or challenges to senior staff and/or management May review test data acquired by others and witness others' notebooks Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed Provides input on SOPs and client questions With guidance, prepares well written and organized development reports Performs other related duties as assigned.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Director, Information Security & End User Computing (EUC) is a senior IT leader responsible for safeguarding Alcami's information assets, overseeing enterprise security programs, and managing all end-user computing services and support functions. This role leads teams across security operations, infrastructure protection, and EUC support, ensuring reliable, secure, and high-quality technology experiences for all employees. The Director is expected to coach, develop, and grow technical talent while driving operational excellence, resilience, and continuous improvement across their areas of responsibility. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities Information Security Leadership Serve as Alcami's Information Systems Security Officer (ISSO) and lead enterprise security governance, assessments, and compliance programs. Manage security risk assessments across applications, cloud environments, and infrastructure. Maintain continuous security monitoring, vulnerability management, and incident response readiness. Oversee documentation and controls aligned with NIST RMF, ISO standards, and applicable regulatory frameworks. Partner closely with the CIO, CISO (if applicable), and other business leaders to strengthen Alcami's security posture. Contribute to COOP/DR strategy and ensure security considerations are embedded across all technology operations. End User Computing (EUC) Leadership Lead the EUC function, including Service Desk, desktop support, endpoint management, mobile devices, and collaboration tools. Oversee deployment, configuration, and lifecycle management of laptops, desktops, mobile devices, peripherals, printers, and standard office applications. Ensure timely, high-quality support for all users, with strong SLAs, KPI tracking, and a culture of ownership. Manage endpoint security controls, patching, and compliance across all devices. Drive standardization of images, device configurations, and application delivery. Strengthen ITIL-aligned service processes, change management discipline, and incident/problem management routines. Oversee Microsoft 365 administration in partnership with relevant infrastructure teams. People Leadership & Operations Recruit, develop, mentor, and retain high-performing teams across Security and EUC. Establish a culture of accountability, continuous learning, partnership, and proactive communication. Build operational roadmaps, establish strategic objectives, and manage departmental performance against goals. Develop and manage annual budgets for Security and EUC. Represent IT in cross-functional meetings and partner with customers across the organization to drive value. Continuous Improvement & Technical Leadership Drive innovation, process optimization, and automation across both Security and EUC operations. Provide technical guidance for troubleshooting complex security, infrastructure, and EUC issues. Maintain strong knowledge of emerging technologies, vulnerabilities, and best practices. Support audits, client assessments, and regulatory inspections. Qualifications Bachelor's degree in a related field; equivalent experience considered. 12+ years of experience in IT, including significant experience in Information Security and EUC operations. 6+ years of leadership experience managing technical teams. CISSP or equivalent security certification preferred. Deep expertise in security architecture, risk assessment, vulnerability management, and cloud security. Experience managing enterprise EUC environments, endpoint security, and Microsoft 365. Strong communication, customer engagement, and cross-functional collaboration skills. Proven ability to build high-performing teams and drive operational excellence. The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance. Knowledge, Skills, and Abilities Must have experience with the following: Cloud expertise, and the ability to teach Mobile experience SCADA, infrastructure protection, and/or engineering experience Must be eligible to obtain a sensitive clearance - Position of Public Trust - and may be required to obtain a higher security clearance. Ability to manage responsibility for security assessments of a variety of applications or domains, to include cloud computing, and to manage several project/initiatives of large size, complexity, and risk. Demonstrated proficiency in implementing security controls, conducting risk assessments, and documenting compliance measures based on NIST RMF and ISO standards to meet organizational and regulatory requirements. Demonstrated proficiency in successfully evaluating and supporting documentation, validation, and accreditation processes necessary to assure that new and existing information technology (IT) systems meet the organization's information assurance (IA) and security requirements. Demonstrated proficiency in ensuring appropriate treatment of risk, compliance, and assurance from internal and external perspectives. Demonstrated ability to support development of actionable security blueprints, principles, models, designs, standards, and guidelines to ensure enterprise IT architecture and support is consistent, usable, secure and adds value to the business. Experience with network and vulnerability scanning tools and technologies to interrogate systems for configuration and status. In-depth understanding of security architecture principles and best practices to design, implement, and maintain secure IT infrastructures in alignment with corporate policies and compliance standards. Experience in computer forensic techniques. Excellent technical knowledge of mainstream security technologies and understands operation of them, such as network security appliances, Intrusion Detection Policies, identity and access management (IAM) systems, anti-malware solutions, antivirus solutions, automated policy compliance tools, desktop security tools, CASB, Email Protection, DNS filtering, IPS/IDS, XDR, and Vulnerability Management. Expert knowledge of Microsoft product-based systems. Strong knowledge of Service Now administration. Strong knowledge of application deployment, OS deployment, OS patching, and inventory management. Demonstrated experience in advanced troubleshooting of computer hardware and software. Excellent communication and interpersonal skills. Strong technical skills for area managing. Strong business acumen. Strong understanding of company SOPs, and regulatory guidance documents. Strong knowledge of safety procedures and quality compliance for assigned area. Strong knowledge of cGMP requirements. Strong experience with client audits. Excellent analytical and problem-solving skill, with the ability to think strategically. Strong attention to detail as well as time and resource management. Good presentation skills. Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction. Promote a safe environment for work. Comply with the general policy of the company. High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction. Ability to develop and manage a high-performance team focused on quality, accountability, and meeting and exceeding expectations. Communicate well orally both for internal customers and team members as well as external customers. Ability to write reports and business correspondence. Ability to listen and respond well to external customers, partners, and colleagues at all levels. Highly goal and result oriented. Prioritizes tasks according to business objectives and can pursue several objectives simultaneously. Can work independently with a high degree of self-motivation. Knows how to obtain support from different collaborations. Tackles problems with enthusiasm and curiosity. Treats colleagues at all levels with respect. Very effective listening skills with the ability to hear attentively and process information correctly. Travel Expectations Up to 25% travel expected including training. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary 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 Practices. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects. Writes Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc. Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed. Author manufacturing investigations and complete CAPA assignments. Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols. Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products. Interact with clients during routinely scheduled project meetings. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications Bachelor's degree in Engineering, Pharmacy, Chemistry, or related field required. Minimum 2 years of experience of technical support and technical transfer in a sterile pharmaceutical manufacturing environment. Knowledge, Skills, and Abilities Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required. Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes. Proficiency with Microsoft office (Word, Excel, Outlook) required. Ability to interact with internal stakeholders and external customers. Working knowledge of EU regulations is preferred. Physical Demands and Work Environment The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places, risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard Additionally, the employee may be required to operate an industrial vehicle.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Senior Materials and Logistics Technician 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 Sr. Materials & Logistics Technician uses the electronic inventory system to track, document, and control all inventory. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Follows applicable SOPs and cGMPs to perform assigned duties and tasks. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Tracks, documents, and controls appropriate inventory using the electronic inventory system. Selects items from a generated pick list for production. Stages materials for dispensing and production; if required, returns unused or canceled materials to inventory. Distributes raw materials, packaging components, clinical supplies, and commercial manufactured products. Contacts freight carriers, coordinates shipping details and schedules pickups. Receives, stores, and inspects raw materials, packaging components, and active pharmaceutical ingredients. Reconciles raw materials, packaging components, and labeling usage at the time of depletion or disposition. Identifies hazardous materials and controlled substances. Processes and maintains inventory for retained samples for raw materials and finished product. Ships finished product and clinical and commercial batches. Monitors and confirms counts to maintain appropriate stock levels to meet project requirements. Monitors and maintains quarantine items for inventory and distribution. Adds or removes material from the electronic inventory system. Performs daily and weekly cleaning of the warehouse. Maintains inventory of consumable items. Other duties as assigned. Qualifications High school diploma or GED required. Associate's degree preferred. 3-5 years of general warehouse experience required. 1-2 years GMP or work experience in a regulated environment preferred. Experience with imports/exports and related documentation preferred. Experience with cold chain shipping methods preferred. Prior pharmaceutical or CDMO and hazardous goods experience preferred. Forklift certification required. Clean driving record required. Knowledge, Skills, and Abilities Knowledge of general warehouse practices and procedures required. Awareness of cGMP and cGMP warehouse practices and procedures preferred. Knowledge of electronic document systems required. Experience using AX preferred. Excellent communication, documentation, detail orientation and organizational skills required. Good basic computing skills required. Ability to operate a forklift. Travel Expectations Up to 5% domestic travel. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently stand, sit; walk; talk or hear; and reach with hands and arms. The employee is required some of the time to stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 25 pounds, some of the time up to 100 pounds, and occasionally more than 100 pounds. The employee must have distance vision, close vision, the ability to adjust focus to bring objects into sharp focus, and peripheral vision. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The SAP ABAP Developer will be responsible for designing, developing, testing, and supporting custom solutions and enhancements across SAP environments. This role combines strong expertise in traditional ABAP development (ECC and S/4HANA) with modern, cloud-native capabilities on SAP BTP. The developer will work closely with functional consultants, business analysts, and cross-functional stakeholders to translate requirements into robust, compliant, and scalable solutions. This is a hands-on technical role with broad impact-contributing to innovation, automation, and continuous improvement in a regulated pharmaceutical manufacturing environment. On-Site Expectations 100% on-site 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities ABAP Development: Design, develop, and maintain custom ABAP objects: Design, develop, and implement custom ABAP programs, enhancements, and interfaces (RICEFW: Reports, Interfaces, Conversions, Enhancements, Forms, Workflows) Classical/Interactive and ALV Reports BAPIs, BADIs, User Exits, Enhancements (Implicit/Explicit) Smart Forms, Adobe Forms, SAPscript OO ABAP (Object-Oriented ABAP) and Function Modules Develop and support interfaces using IDocs, RFCs, Web Services. Implement S/4HANA-specific features such as: Core Data Services (CDS) Views ABAP Managed Database Procedures (AMDP) OData services for SAP Fiori apps. Perform code optimization, debugging, and performance tuning. Collaborate with functional consultants to gather business requirements and translate them into technical designs. SAP BTP (Business Technology Platform) Development Design and implement cloud-based applications and extensions using SAP BTP services (e.g., SAP Extension Suite, Integration Suite). Develop Fiori applications and deploy them on BTP. Create and manage OData APIs, REST services, and event-driven integrations. Work with CAP (Cloud Application Programming) model for BTP applications. Implement security and authentication mechanisms (OAuth, SAML, XSUAA) within BTP applications. Build and maintain CI/CD pipelines and manage deployments to BTP environments. Integration & Collaboration: Integrate SAP on-premise systems (ECC/S4) with BTP using Cloud Connector or APIs. Work closely with cross-functional teams (Basis, Security, Functional, Integration) to ensure end-to-end solution integrity. Support system upgrades, patches, and migrations. Quality & Standards: Follow SAP development best practices, coding standards, and performance optimization guidelines. Document technical specifications, solution designs, and deployment procedures. Participate in peer code reviews. Author Change controls Other duties as assigned. Qualifications Bachelor's degree in Computer Science, Information Technology, Engineering, or related field (or equivalent professional experience). SAP ABAP or SAP BTP developer certification a plus. 5+ years of SAP ABAP development experience (ECC or S/4HANA). 2+ years of SAP BTP development experience, including building applications or extensions. Industry experience in pharmaceuticals, life sciences, or manufacturing. Knowledge, Skills, and Abilities Experience with at least one full SAP implementation or major upgrade. Experience with Agile/Scrum methodologies. Strong ABAP programming expertise: Reports, BAPIs, BADIs, Enhancements, Forms. Experience in modules like MM, SD, PLM, PP, PS, TM, FICO. Hands-on experience with S/4HANA ABAP: CDS Views, AMDP, OData service creation. Proficiency with SAP BTP services: Extension Suite, Integration Suite, CAP, SAPUI5/Fiori. Familiarity with SAP Cloud Connector and API Management. Knowledge of Git-based source control, CI/CD tools, and DevOps practices. Understanding of REST APIs, JSON, and modern web development concepts. Strong communication, stakeholder engagement, and project management skills. Strategic thinking and commercial acumen in supplier management. Strong analytical skills with the ability to interpret complex data and drive operational decisions. Excellent communication and organizational skills; strong attention to detail and compliance. Deep understanding of GMP/GDP, FDA, and international regulatory expectations. Strong sense of urgency and attention to detail. Extremely high standards of excellence. Ability to handle multiple and sometimes competing priorities. Travel Expectations Up to 20% travel expected excluding training which will require travel. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary 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. On-Site Expectations 100% on-site position. 2nd Shift: Monday - Friday, 3:00pm - 11:30pm. Responsibilities Performs calibrations, PMs and repair on a variety of instrumentation with supervision. Utilizes several database systems. Maintains all logs and required documentation. Reads and follows Standard Operating Procedures (SOP's). Provide excellent customer service Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications High School diploma or equivalent with 2+ years of relevant experience or an associate's degree with at least 1 year of relevant experience. Knowledge, Skills, and Abilities Basic understanding of circuits, components, equipment and instrumentation for manufacturing and laboratories. Excellent mechanical skills. Excellent verbal and written communication skills. Excellent organizational skills. Reliable, self-motivated, and a team player. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Project Manager 1 is responsible for providing project management support and coordination to cross-functional project teams and clients ensuring that project deliverables are accomplished as outlined in the project's development plan. In addition, this position will help coordinate project progress and completion with business operations to ensure timely and accurate revenue recognition. Responsibilities Key Job Responsibilities: Manage client(s) portfolio across Cambrex sites & cross functional teams. Develop Full Scale Project Plans & Project Resource Requirements Reconcile Project Level Strategy with Overall Organizational Capacity & Strategy Effective communication of client needs and escalations. Identify and analyze issues and mitigate risks to project deliverables. Escalation of critical project risks to management Meeting Scheduling & Attendance Meeting Notes & Action Item Tracking Track Project Task Progress and Completion dates Financial Monitoring & Milestone Invoicing Events Participate in resolution of business-related conflicts. Participate in business-related decisions and actions for managed projects. Promote a safe environment for themselves and their cross-matrix team. Supervise and plan duties with external firms (auditors, etc. ) Comply with the general policy of the company. Participate in key initiatives around operational excellence and site improvement programs. Host onsite customer visits Escalate client feedback. Facilitate change(s) of scope. Work closely with your direct manager when making decisions for programs supported. Essential Job Requirements: Ability to effectively present status updates and business correspondence Ability to listen and respond well to external customers, partners, and colleagues at all levels. Provide a high level of customer service (Internal and External) Ability to negotiate and manage conflict. Able to manage client requests professionally and in a timely manner. Understanding of project related scope and finances and status for project deliverables Basic application of project management techniques and tools. Prioritizes tasks according to business objectives and can pursue several objectives simultaneously. Knows how to obtain support from different stakeholders. Qualifications/Skills Knowledge Basic understanding of CDMO industry, Cambrex capabilities and pharmaceutical life cycle. Computer Understanding in Microsoft 365 Office Suite (word, excel, power point, teams, etc. ) Skills / Abilities: Highly goal and result oriented. Strong interpersonal skills Strong, Effective Communication (verbal & written) Time Management and Scheduling Highly organized Basic Business Acumen Ability to work in a fast-paced cross-functional team. Tackles problems with enthusiasm and curiosity Treats colleagues at all levels with respect. Basic leadership skills. Intermediate Problem-Solving Skills Education, Experience & Licensing Requirements A Bachelor's degree or higher, preferably in the life sciences with minimally 2+ years of related industry experience, experience managing projects preferred. Travel: As needed (5 - 10%) Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. Environment and Protective Equipment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc. LIMITATIONS AND DISCLAIMER The above is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. A Bachelor's degree or higher, preferably in the life sciences with minimally 2+ years of related industry experience, experience managing projects preferred. Key Job Responsibilities: Manage client(s) portfolio across Cambrex sites & cross functional teams. Develop Full Scale Project Plans & Project Resource Requirements Reconcile Project Level Strategy with Overall Organizational Capacity & Strategy Effective communication of client needs and escalations. Identify and analyze issues and mitigate risks to project deliverables. Escalation of critical project risks to management Meeting Scheduling & Attendance Meeting Notes & Action Item Tracking Track Project Task Progress and Completion dates Financial Monitoring & Milestone Invoicing Events Participate in resolution of business-related conflicts. Participate in business-related decisions and actions for managed projects. Promote a safe environment for themselves and their cross-matrix team. Supervise and plan duties with external firms (auditors, etc. ) Comply with the general policy of the company. Participate in key initiatives around operational excellence and site improvement programs. Host onsite customer visits Escalate client feedback. Facilitate change(s) of scope. Work closely with your direct manager when making decisions for programs supported. Essential Job Requirements: Ability to effectively present status updates and business correspondence Ability to listen and respond well to external customers, partners, and colleagues at all levels. Provide a high level of customer service (Internal and External) Ability to negotiate and manage conflict. Able to manage client requests professionally and in a timely manner. Understanding of project related scope and finances and status for project deliverables Basic application of project management techniques and tools. Prioritizes tasks according to business objectives and can pursue several objectives simultaneously. Knows how to obtain support from different stakeholders.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview Thank you for considering a future opportunity with Cambrex! If you are interested in joining our team but don't see a current role that fits your background, please submit your resume here. If we have future opportunities that match your skillset, we will contact you. While we are not currently hiring for a role linked to this specific posting, we would love to connect with talented individuals who are interested in potential future positions. By joining this talent pipeline, you will be the first to be notified when suitable opportunities arise within our Analytical R&D function. Cambrex's Analytical R&D positions will be on-site at our Durham, NC site. Responsibilities Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work with supervision and to evaluate and interpret generated data. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Qualifications/Skills Duties and Responsibilities • Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines • Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability. • Maintains compliant records with little or no supervision • Able to write technical documents with assistance • Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks • Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions • Sets up various instrumentation for testing according to written test methods and with little to no supervision. • As needed, troubleshoots laboratory instrumentation • Leads a sample project with assistance • May participate in client level meetings, with approval • Responsible for ensuring compliance with cGMP and other regulatory guidelines. • Analyze information for technical correctness and accuracy • Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor • Perform routine laboratory procedures in a timely and efficient manner • Gain familiarization with analytical techniques • Participate cGMP activities • Maintain laboratory equipment and supplies as directed • May support peer-led laboratory investigations process with assistance • Maintain a clean and safe work-space • Maintain laboratory notebook and/or computer files (i. e. LIMS) according to standard, accepted practices • Participate in group and project meetings as required • Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems • Attend seminars as required • Participate in and comply with all current safety, health and environmental programs • Shows initiative and interest in learning new techniques and tests • Participates in technical discussions and brainstorming sessions • Communicates issues or challenges to senior staff and/or management • May review test data acquired by others and witness others' notebooks • Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs • Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed • With guidance, prepares well written and organized development reports • Performs other related duties as assigned. Education, Experience & Licensing Requirements Skills and Competencies • Working knowledge of experimental design, including chemistry supporting method development • Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC. • Working exposure to cross functional techniques including organic chemistry. • Able to comply to SOPs and basic regulatory compliance • Working knowledge of scientific concepts, principles and procedures • Actively and positively engages with team and supports process improvements • Ability to read and execute compendial methodologies • Strong understanding of current FDA and cGMP regulations • General knowledge of chemistry and scientific calculations • Hands on experience in analytical techniques such as HPLC, GC, etc • Good computer skills • Ability to operate laboratory equipment and computers • Ability to take direction from experienced scientists and contributes in a team environment • Good problem-solving skills • Good attention to details • Can repeat and follow detailed scientific procedures with supervision • Able to clearly present results verbally in group meetings and in written progress reports • Good interpersonal skills and is willing to ask questions about procedures and concepts • Aptitude and willingness to gain more skills and knowledge in support of GMP regulations • Good written and verbal communication skills • Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel. • Aptitude and willingness to gain more skills & knowledge. • Good attention to detail and good problem-solving skills. Education, Experience, and Other Qualifications • B. S. /B. A. Chemistry with 4+ years of experience in related industry or MS with 0+ years related experience Supervision Received: Works under limited supervision. Physical Demands, Work Environment, and Travel Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required. Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. Travel: Little to no expected travel time. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-SK1Skills and Competencies • Working knowledge of experimental design, including chemistry supporting method development • Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC. • Working exposure to cross functional techniques including organic chemistry. • Able to comply to SOPs and basic regulatory compliance • Working knowledge of scientific concepts, principles and procedures • Actively and positively engages with team and supports process improvements • Ability to read and execute compendial methodologies • Strong understanding of current FDA and cGMP regulations • General knowledge of chemistry and scientific calculations • Hands on experience in analytical techniques such as HPLC, GC, etc • Good computer skills • Ability to operate laboratory equipment and computers • Ability to take direction from experienced scientists and contributes in a team environment • Good problem-solving skills • Good attention to details • Can repeat and follow detailed scientific procedures with supervision • Able to clearly present results verbally in group meetings and in written progress reports • Good interpersonal skills and is willing to ask questions about procedures and concepts • Aptitude and willingness to gain more skills and knowledge in support of GMP regulations • Good written and verbal communication skills • Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel. • Aptitude and willingness to gain more skills & knowledge. • Good attention to detail and good problem-solving skills. Education, Experience, and Other Qualifications • B. S. /B. A. Chemistry with 4+ years of experience in related industry or MS with 0+ years related experience Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work with supervision and to evaluate and interpret generated data. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.