Hikma Pharmaceuticals

Analyst

• Stays updated with regulatory and quality standards, evolutions in GXP compliance and best practices where needed everywhere in the world
• Performs required Method validation, verification, transfer and stability samples analytical work and fills out relevant documentation, including generating reports and filling CoAs.
• Performs request, label and management of assigned products process validation batches and stability samples for the new geographical and presentations filings.
• Supports the management of critical documents and CAPA in addition to the preparation of quality management and audit reviews
• Acts as primary contact for the related sites to support the introduction of assigned products for the identified purpose
• Ability to remain update in all analytical techniques required.

Analyst, Pharmaceutical Development

Scientist

• Supports Commercial Production at the Cherry Hill pharmaceutical manufacturing facility through the Administration of User Account Creation and Maintenance, Software Archival to support (Backup, Restoration, Disaster Recovery), and System Administration and Troubleshooting for Production based systems
• Assists in investigations of manufacturing challenges, data integrity issues to support Commercial production equipment usage and product release
• Responsible for Stand alone User Administration of Computer Controlled Systems in the Cherry Hill Production environment to ensure compliance to 21 CFR Part 11 and cGMP practices
• Responsible for Software Archival as determined by Site management and cGMP practices
• Archival of Software Backup of Production based system for Disaster Recovery, and Periodic Data backup, etc
• Works with Information Technology to automate backup systems for secure, timely data capture and continued business continuity
• Maintain database for Software Records and User maintenance
• Handles routine tasks timely, accurately

Scientist, Production Systems

Engineer

• Consult as Process and Formulation Champion on cGMP/ FDA/ Hikma quality requirements and execute process registration (ANDA, NDA, PAS, etc.)/ scale-up/ validation and commercial production for 3rd Party/ CMO & in-house products during project selection, process development, filing, transfer, evaluation, launch and life-cycle phase
• Lead as Hikma’s Technical Services representative for in-house process flow & equipment requirements for different products (solids, non-solids, nasals, inhalation, etc.) and spearhead 3rd Party/ CMO site visits, process and equipment requirements, and other technical considerations during project selection, and execution
• Drive gap and risk assessments including statistical data analysis for process scale-up, and process design/ improvement initiatives (e.g. PAT, DOE) during development/ registration/ transfer and lead mitigation and implementation activities
• Lead strategy development for filing and validation (e.g. lot sizes, number of lots, sampling plan etc.) and drive requirements (e.g. protocols, batch records, etc.) for registration scale-up, evaluation, transfer, and process validation batch production
• Create and/ or review documentation (e.g. Master Manufacturing Formula/ batch records, protocols/ reports, technical justifications for matrix approach etc.), and master data for production of batches for registration/ filing/ scale-up, evaluation, and process validation
• Travel to 3rd party locations as lead representative of Process Transfer - Technical Services during registration/ evaluation/ scale-up/ process transfer/ validation/ commercial lot manufacturing to provide subject matter expertise and technical support on process and quality requirements of Hikma to mitigate risks during commercial production
• Lead process development, registration, and FDA filing tasks with R&D and project teams from 3rdparty/ CMO and Hikma to establish robust control strategy for future commercial process
• Collaborate with stakeholders (e.g. Product Development, Production etc.) during development, pilot lot production, registration, etc. to optimize or develop product formulation, and process flow, and resolve complex issues relating to CPPs, CQAs, AQL, analytical methods/ testing, quality deviations and other process risks
• Collaborate with Analytical Development, Quality labs etc. to set-up testing requirements for in-process controls, release and stability; influence in establishing product specifications based on process and data trends
• Co-lead with Product Development to generate development/ registration QbD reports and ensure robust documentation of development history/data prior to process validation/ PPQ
• Collaborate with Drug Regulatory Affairs (DRA) at 3rd Party/ CMO and Hikma to author/ or review documentation required for product filing (ANDAs, NDAs, PAS, CRLs, and other FDA correspondences) to support timely approvals
• Leverage lessons from registration scale batches and coordinate with Production/ Engineering team to drive procurement or modification of key manufacturing equipment to support commercial production
• Lead the planning and execution of process transfers and scale-up/ evaluation, process validation/ PPQ and commercial production/ CPV of new and existing products (3rd Party/ CMO, Transfer (In/ Out) Buy-ins, Inter-site etc.) following Hikma requirements; drive resolutions to complex process problems and influence teams to adopt solutions to meet commercialization/ product launch timelines/ deliverables
• Lead as a process champion/ point of contact for process validation (process design, PPQ, & CPV) / commercial production at Hikma
• Lead proactive planning and strategies for the scale-up/ transfer/ validation lot manufacturing including commercial lot size determination, no. of lots for validation, documentation etc. to support product launch goals
• Lead functional and cross-functional investigations in collaboration with Quality function of 3rd Party and Hikma to determine root causes, assess product impact, determine path forward, and develop/ implement CAPAs
• Influence organizational partners to support these initiatives
• Lead process improvement/ optimization, CAPA, and other process changes during commercial manufacturing/ CPV stage
• Influence organizational partners to support execution of these initiatives
• Coordinate with Quality/ Change Management, Drug Regulatory Affairs (DRA) etc. to lead the implementation of critical process changes (e.g. API/ raw materials, process parameters, batch size optimization etc.)
• Lead the development of response strategies and corrective actions to resolve process quality/ product stability deviations on commercially marketed products in coordination with Quality, DRA, etc.
• Support Life-Cycle Operations to plan and perform continuous process verification (CPV) or re-validation
• Mentor and develop other members of the Technical Services department and promote knowledge transfer within Technical Services
• Act as a subject matter expert on core technologies and/or process engineering/ validation topics
• Identify and proactively create opportunities to mentor Process Engineer(s) on equipment/ process technologies, validation strategies, quality investigations/ CAPA, conflict management etc.
• Lead knowledge sharing of best practices, quality and safety incidents, new process technologies, etc. within Technical Services organization
• Drive documentation to standardize best practices, and author Work Instructions, SOPs, etc. to support process documentation requirements under Hikma’s quality management system
• Support Technical Services management to resolve complex challenges related to process/ equipment, validation, quality investigations etc.

Senior Process Engineer – Technical Services

Full-stack Engineer

• Transferring products from R&D or partners to Operations, including leading packaging development, registration, site transfers, start-up of commercial production, and transfer to lifecycle support.
• Minimize and remove obstacles during development, product transfer, validation, and commercialization through utilization of risk-mitigation strategies, best practice sharing, and influence with R&D, Operations, and external colleagues.
• Support department management as group representative in technical and business meetings.
• Act as a technical subject matter expert and mentor for the Technical Services group and the site.
• Demonstrate influence, leadership, and influential teamwork skills with development partners/customers during the packaging development and registration of site transfers and new product NDAs and ANDAs, ensuring that all project timelines are met.
• Provide packaging engineering expertise, i.e. critical review, assessment, influence and strategy, for responsible projects assigned within Organic Launch, Business Development, Contract Manufacturing Organization (CMO), Alternate API, and targeted dormant products.
• Create all associated master data for assigned projects.
• Create all associated structure technical data for assigned projects.
• Create all specifications required for the container/closure systems for assigned projects.
• Create all associated aggregation/serialization requirements for assigned projects.
• Attend all required team meetings to support assigned projects and ensure to achieve key milestone datas.
• Perform all necessary line trials, including all necessary documentation such as protocols/reports/PO’s, to support proper evaluation of form, fit, function of proposed container closure systems.
• Support all regulatory audits as required.
• Generate all required regulatory submission documents for assigned projects and provide support in generating responses to regulatory authorities.
• Support other Technical Service Packaging Engineers with peer review; as well as, provide appropriate mentoring.
• Influence and Collaborate with Purchasing to source new packaging components, if needed.
• Interact with outside vendors to design new packaging components.
• Influence and Liaise with Change Management to support packaging component changes.
• Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.
• Influence and Liaise with Flow Packaging group to ensure consultation of launch projects for efficient transfer of applicable projects for life cycle transfer.
• Drive continuous improvement activities for launched products through initial commercial production phase, until transfer of launched products to lifecycle support with Operations.

Principal Engineer, Packaging – Technical Services

Operator

• Preparazione di soluzioni bulk secondo procedure e standard qualitativi.
• Attività di predisposizione lotti, pesate, dissoluzioni, filtrazioni.
• Utilizzo apparecchiature tecniche: bilance, dissolutori, pHmetri, sistemi di filtrazione.
• Registrazione accurata delle attività nei documenti di lotto.
• Gestione autonoma di sistemi di depirogenazione, sterilizzazione e autoclavi.
• Rispetto delle SOP, soprattutto nelle aree a contaminazione controllata.
• Conformità a sicurezza, qualità e normative ambientali.

Operator, Compounder

Support Engineer

• Closely monitoring and analyzing manufacturing process flows
• Preparing, filing, and maintaining departmental SOPs, reports, protocols, batch records, and related documentation
• Identifying potential hazards and safety issues
• Conducting engineering analysis and applying preventive measures
• Following up on validation matters and handling procurement, warehouse management, logistics, CAPEX and OPEX activities, spare parts management, equipment qualification and calibration, and training follow-ups

Technical Support Engineer

Account Manager

• Identifies marketplace trends, communicates those trends to the sales team, and capitalizes on opportunities
• Prepares and utilizes sales tools to maximize effective customer presentations
• Utilizes product knowledge and sales skills to identify and meet customer needs
• Collaborates with Sales, Marketing, Customer Service, and Finance to provide a market-leading service level to our customers
• GPO Pull through
• Develops key accounts
• Achieves quarterly and annual territory sales goals
• Increases sales in assigned territory and develops new business opportunities
• Launches new products and programs
• Manages territory effectively and maintains a regular call schedule to key accounts
• Manages day-to-day operations of the sales and marketing function with customers and colleagues
• Collaborates with internal departments (Customer Service, Finance, etc.) and external groups (wholesalers) to follow-up on any issues, questions or concerns expressed by our customers
• Applies effective organization, planning and time management skills
• Manages expense budget responsibly
• Completes reports as requested by management containing information about sales calls and marketplace conditions
• Plans effectively
• Customer interaction
• Meets sales targets and goals
• Works and communicates with employees
• Business and product knowledge
• Manages and controls T&E expenses
• Policies and Procedures
• Ensures alignment with Standard Operating Procedures and adheres to Hikma’s core values
• Adheres to corporate policies and procedures
• Metrics
• Achieve or exceed quarterly and annual sales goals
• Maintain appropriate number of weekly sales calls
• Complete reports in a timely manner
• Provide competitive information on a regular basis
• Monthly reporting requirements
• Competitive Intelligence

Territory Account Manager

Executive

• Maintain regular and reliable onsite attendance to support project execution and business objectives.
• Lead the development and execution of complex capital programs and projects, including scope definition, cost estimation, scheduling, and engineering solutions for initiatives across Product Safety & Security, Quality, Supply Chain, Manufacturing, and Warehouse Operations, with investments up to $200 million.
• Ensure project activities are executed in compliance with company policies and applicable safety, environmental, health, regulatory, and cGMP requirements.
• Provide leadership to cross-functional project teams by aligning objectives, managing risks, resolving issues, removing barriers, coordinating resources, and ensuring successful project delivery within approved timelines and budgets.
• Establish and manage strategic supplier relationships, including vendor selection, contract oversight, performance management, and service delivery governance to maximize value and ensure compliance with corporate and legal standards.
• Manage project resources, including employees, consultants, contractors, and external partners, to optimize project outcomes and achieve the lowest total cost of ownership.
• Oversee project implementation, operational readiness, and closeout activities, including documentation, financial reconciliation, training, maintenance handoff, and project archiving.
• Serve as an active member of the Capital Investment Committee, providing strategic input on capital investments, site master planning, asset optimization, business priorities, market trends, regulatory considerations, and long-term growth opportunities.
• Drive the development, implementation, and sustainability of business processes, SOPs, and work instructions to support operational excellence and ongoing performance improvements.
• Represent assigned programs and projects to leadership, governance committees, customers, external partners, and industry stakeholders, providing clear communication on project status, risks, and outcomes.

Senior Program Executive

Technician

• Monitoring and maintaining all production equipment on the production floor
• Responsible for mechanical maintenance requirements for high-speed filling, packaging, equipment component prep and compounding
• Perform troubleshooting of high-performance production equipment and evaluate critical spare parts
• Maintain equipment logs and documentation according with SOP, cGMP and all updated guidelines
• Completes necessary corrective and preventive work orders, as well as assigned trainings, OEM and outside contractors
• Performs all set-ups and change overs and/or repairs of equipment as necessary per production needs and schedules
• Work closely collaboratively with Operations and engineering organization/personnel to meet all production objectives and site goals/KPIs

Mechanical Technician – 2nd Shift

Customer Success Manager

• Serve as a primary point of contact for customer inquiries
• Support external sales activities by identifying opportunities
• Build and maintain strong relationships with healthcare organizations
• Collaborate with internal teams to ensure customer needs are addressed
• Proactively identify potential issues and resolve them before escalation
• Analyze customer trends and requests to identify opportunities for improvement

Customer Engagement Associate

General

• Follows all relevant departmental policies, processes, standard operating procedures and instructions so that work is carried out in a controlled and consistent manner.
• Follows the day-to-day operations related to own job to ensure continuity of work.
• Certifies that the condition of the products received are being checked, to ensure the well-being of the products and their integrity.
• Contributes to the identification of opportunities for continuous improvement of processes and practices taking into account ‘international best practice’, improvement of business processes, cost reduction and productivity improvement.
• Complies with all relevant safety, quality and environmental management policies, procedures and controls to ensure a healthy and safe work environment.

Shipping Officer

Data Scientist

• Develop and deploy machine learning models to enhance financial forecasting, anomaly detection, and predictive analytics
• Work with large datasets from SAP ECC, ERP systems, and external sources, integrating them into Azure Databricks for analytics
• Collaborate with finance, accounting, and business teams to understand challenges and develop data-driven solutions
• Design and optimize data pipelines to enable ML model training, validation, and deployment
• Utilize LLM, NLP, time-series analysis, and deep learning to extract insights from structured and unstructured data

Senior Data Scientist

Research Analyst

• Literature survey and performing pre-formulation & formulation trials for any of the new products to fulfill the company’s research objectives.
• Documentation and reporting all formulation trials observation and results according to the predetermined procedures.
• Operate the laboratory instruments and equipment according to their SOPs and complying to the GMP standards and procedures after having the necessary training.
• Prepare samples for stability & Bio-equivalence studies.
• Performing pilot, scaling up & validation batches and preparing the required documents.
• Complying with the occupational safety and waste procedures in Hikma.
• To perform any other task related to the job description or nature.

Associate Scientist, Formulation Development – Research & Development Pharmacist

Learning and Development

• Assist the collection and entering of employee data
• Maintaining and supporting the development and implementation of new/improved HR policies, systems, and procedures

HR Officer – Training Program

• Perform qualitative, quantitative chemical and physical testing and as specified by compendia or specification for API's, starting materials, packaging components and finished products.
• Perform peer review of analytical testing documentation and resolve discrepancies.
• Complete and/or conduct required training according to the laboratory curriculum.
• Maintain laboratory data in an orderly manner in laboratory notebooks, worksheets, and documents.
• Re-validate microbiological methods.
• Author technical reports for analytical methods improvement.
• Perform investigational, troubleshooting and advanced analytical techniques to troubleshoot approved commercial analysis.