Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

Supervisor II Assembly

Product Manager

Automation Department Manager (Automation MPDE Department Manager)

Reference Standard Coordinator

Sr R&D/Product DVL Engineer

Solutions Engineer- Public Sector

Engineering Manager

Job Overview: <ul><li>The Research Associate – II – Nitrosamines is responsible for conducting analytical research, method development, and risk assessment activities focused on nitrosamine impurities in pharmaceutical products.&nbsp;</li><li>The role supports regulatory compliance, safety assessment, and mitigation strategies in line with global regulatory requirements (such as those from the FDA, EMA, WHO, and ICH M7). This position requires a strong understanding of organic chemistry, analytical instrumentation, and impurity profiling.</li></ul> Responsibilities: <ul><li>Development, validation, and transfer of LC/MS methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub-ppb levels</li><li>Design and execution of experiments to identify root causes of Nitrosamine formation and develop mitigation strategies</li><li>Perform chemical extractions of container closure systems and drug product solutions</li><li>Utilize advanced mass spectrometry techniques (LC-MS and GC-MS) for identification and quantification of Nitrosamines</li><li>Prepare technical reports and support documentation for regulatory filings</li><li>Collaborate with subject matter experts, supervisors, and cross-functional teams</li><li>Interpret analytical data, evaluate results, and incorporate findings into project goals</li><li>Maintain compliance with relevant Quality System Regulations and GxP standards</li></ul> Requirements: <ul><li>Experience: 6–10 years in analytical chemistry focused on Nitrosamines</li><li>Education: Master’s degree or equivalent experience; PhD preferred with relevant experience</li><li>Skills Required:</li><li>Proficiency in LCMS/GCMS instrumentation and troubleshooting</li><li>Strong knowledge of Nitrosamine chemistry and analytical techniques</li><li>Experience in method development, validation, and regulatory reporting</li><li>Ability to analyze complex data and draw meaningful conclusions</li><li>Good documentation and technical report writing skills</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

Job Description: <ul><li>The role of a Manager – R&amp;D (Research &amp; Development) F&amp;D (Food &amp; Drink) Emulsions typically involves overseeing the research, development, and innovation of emulsions used in the food and beverage industry.&nbsp;</li><li>The manager leads the R&amp;D team to develop new emulsion-based products or improve existing ones to meet customer requirements, industry standards, and market demands.</li></ul> Responsibilities: Planning of Project technical feasibility experiment: <ul><li>End to end planning for Resource availability on time Planning of developmental trials, PDR studies/QBD additional studies for ANDA products</li><li>Planning of developmental trials, PDR studies/QBD additional studies for ANDA products.</li><li>Monitoring of development trials.</li><li>Compilation of the development data.</li><li>Ensuring development as per QBD approach</li><li>Review the technical documents e.g. DMBD, PDR and other protocols &amp; reports.</li><li>Coordination with CFTs (ADL, IRA, Procurement, Quality) for on time project execution.</li><li>Technology transfer of Drug product [ANDA, 505 (b)(2), Complex injectables]</li><li>Exhibit batch execution [ANDA, 505 (b)(2), Complex injectables]</li><li>Support for Process validation and commercial batches [ANDA, 505 (b)(2), Complex injectables]</li><li>Technology transfer documents review Products developed by CRO as per regulatory requirement.</li><li>Support &amp; coordination with CMOs for successful technology transfer</li><li>Fulfilling the regulatory requirements by designing the trials</li><li>Training &amp; knowledge enhancement of the team</li><li>Design &amp; Authorization of SOPs</li><li>Execution &amp; approval process of New Equipments/Instruments for projects in upcoming portfolio &amp; continuous improvement of Development Lab.</li><li>Adoption of GQP (Procedures integration with systems)</li></ul> Requirements: <ul><li>3–4 years of team handling experience</li><li>3–4 years of hands-on work in emulsions (oil-based and water-based)</li><li>Full product lifecycle exposure: development → scale-up → filing</li><li>Minimum 5–10 regulatory filings (e.g., ANDA, NDA)</li><li>Strong people management and leadership capabilities</li><li>Preferred experience in ophthalmic formulations</li><li>Background in injectable manufacturing environment is an added plus</li></ul>

Responsibilities: <ul><li>To Plan and establish production work schedule to meet delivery times and best utilize company production capacity by releasing work orders.</li><li>Scheduling for materials and production in Coordination with staff throughout the company to ensure timely delivery to customers by obtaining agreement for product ship dates.</li><li>To take full responsibility of the shift in terms of management of staff, management of production and quality targets and to ensure the smooth running of the production processes, produced within the shift in line with the company’s quality systems, processes and procedures.</li><li>To demonstrate excellent people management skills to develop and motivate direct reporting staff and to ensure that Health and Safety rules and regulations are adhered during the shift in line with the companies Health and Safety policy.</li><li>Confer with other supervisors and managers to coordinate operations and activities within or between departments.</li><li>Monitor, measure, and report on production related process performance/KPI’s, general issues and ensure the team is self-managed (SMT) on problem solving and troubling shooting skills to identify root causes and take fast effective action to resolve the problems in hand.</li><li>Assist in maintaining stock rooms and inventory accuracy and participate in physical inventory counts.</li><li>Demonstrate customer centric approach and adherence to customer expectations to promote a positive company image.</li><li>Responsible for on-the-job training of directs. Play active role in the TEOA plan/Kaizen initiative to achieve plans for future growth within the company.</li><li>Set departmental process and link to ISO procedure.</li><li>Stake holder Management</li></ul> Requirements:&nbsp; Professional Experience <ul><li>5 to 7 Years of experience in the same field and industry.</li><li>Bachelor’s degree in mechanical or Electronics Engineering</li><li>Advanced skills with Microsoft Office, especially Excel</li></ul>&nbsp;Leadership Experience: <ul><li>Deep understanding and professional experience of people management.</li><li>Excellent communication and convincing skills</li><li>Self-driven and detail-oriented</li><li>Desire to solve problems with analytical thinking</li><li>Good at people management and execution skills</li><li>Strong organizational skills and a team player</li></ul>&nbsp;Project Experience: <ul><li>Expert in material and production planning.</li><li>Knowledge of SAP</li><li>Quality and Environmental Management System knowledge</li><li>Excellent people management skills to develop and motivate direct reporting staff and to ensure that Health and Safety rules and regulations are adhered to during the shift in line with the companys Health and Safety policy</li><li>Assist in maintaining stock rooms and inventory accuracy and participate in physical inventory counts.</li><li>Play an active role in the TEOA plan/Kaizen initiative to achieve plans for future growth within the company.</li></ul>&nbsp;Qualifications: <ul><li>Bachelor of Science or above degree and an engineering background.</li><li>Preferably Mechanical, Electrical/Electronics, and Industrial Engineer</li></ul>&nbsp;Other Requirements: <ul><li>3-5+ years’ experience as a practitioner as an Engineer.</li><li>Knowledge in Mechanical, Electrical, and Pneumatic drawings.</li><li>Solid understanding of health and safety regulations and practices.</li><li>Strong decision-making and problem-solving skills.</li><li>Excellent communication and interpersonal skills.</li><li>Computer literate with capability in email, MS Office, and related communication tools.</li><li>Knowledge in various machines from Stamping, Molding, Plating, and Assembly.</li></ul>

Role Description: <ul><li>The Product Manager develops and helps execute product-level strategies.</li><li>Strategies will be based on market analysis, company objectives and product profitability, and will include recommendations on market share targets and customer bid tactics.</li><li>This position will also develop forecasts for existing and new products and work cross-functionally with Finance, Sales, Supply Chain, Portfolio Management and Regulatory.</li><li>The role requires having oversight of the commercialized products and near-term launches, providing inputs to long-range business cases and plans, and preparing support documents &amp; analytics for execution of sales activities.</li></ul> Responsibilities: Product Strategy <ul><li>Analyze market landscape using IQVIA and other data sources.</li><li>Recommend market share targets based on current share, # of competitors, cost position, supply capabilities and other factors.</li><li>Maintain product dashboard that provides relevant information to management and cross-functional team.</li></ul> Forecasting &amp; S&amp;OP <ul><li>Update and provide by-sku / by-customer forecasts to Finance and Supply Chain for use in official financial forecasts, incentive comp and supply plan forecasts.</li><li>Calculate and report forecast accuracy and customer award compliance measures.</li><li>Develop new forecasting tools and optimize existing models.</li><li>Support the Sales and Operations Planning (S&amp;OP) process reviews.</li></ul> New Products&nbsp; <ul><li>Co-lead the launch preparation process with the Launch Management team.</li><li>Work closely with Portfolio Management on business cases in order to prioritize launch sequencing and justify development/licensing/acquisition of new products.</li></ul> Other Commercial Operations Support <ul><li>Provide supporting documentation to Sales team such as sell sheets, analysis and other items needed to execute sales tactics.</li><li>Co-ordinate with cross functional team and ensure product information updated on our client portal.</li><li>Work with sales team and consultant to create and maintain VA website login.</li><li>Other items as assigned/identified.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in business, Finance, Analytics preferred.</li><li>MBA or masters degree in Analytics/Statistics preferred.</li><li>Minimum 3 years of generic pharmaceutical industry experience in inline/pipeline forecasting or Data Analytics.</li><li>Intellectual curiosity to go beyond the numbers/bring strategic ideas and insights.</li><li>Strong technical skills to build analytical tools, leverage secondary data and rollout plans.</li></ul> Knowledge <ul><li>Expert with MS office Suite, primarily MS Excel?Experience with SAP, Salesforce and IQVIA a plus.</li></ul> Skills &amp; Abilities <ul><li>Self-direct activities based on general direction given.</li><li>Handle multiple projects in a fast-paced team environment.</li><li>Identify priorities based on profitability and company objectives.</li><li>Create detailed business analysis, outlining problems, opportunities, and solutions.</li><li>Excellent analytical, mathematical, and creative problem-solving skills</li><li>Collaborate cross-functionally with Sales, Finance and Procurement colleagues to develop, analyze and implement strategic plans that maximize profitability.</li><li>Develop and maintain decision support systems that collect and synthesize sales data into knowledge that drives management decisions including resource allocations, opportunity identification, performance against expectations, and sales incentives.</li><li>Expand knowledge and experience by regular engagement with key stakeholders to understand business processes, policies, strategies and evolving business trends.</li><li>Interact with the team, management, and across departments to communicate changes to both current and proposed forecast changes.</li><li>Provide feedback and follow up communications across organization on any issues or market challenges.</li><li>Closely monitor the changing competitor landscape, turning insights into actionable and appropriate product strategies.</li><li>Review and recommend key products to stimulate profitable sales.</li><li>Ability to perform product profitability analyses and run multiple, complex scenarios and present to management for review/approval.</li><li>Brainstorm both short-term and long-term sales and profitability milestones and goals.</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li></ul>

Role Description: <ul><li>The MPDE Automation Manager will lead a team of automation engineers tasked with developing assembly processes for high-speed cable assemblies and coordinating with the Thailand manufacturing engineering team on the transition to mass production.</li></ul> Responsibilities: Lead a team of engineers who will: <ul><li>Develop cable assembly automation lines in accordance with LEANPD product development.</li><li>Drive for excellence in existing automation technologies and methods.</li><li>Strive to implement new automation technologies to provide improved process and tolerance control.</li><li>Support Product Development in the optimization designs (DFM) and piece parts for automation manufacturability.</li><li>Realizes proof of concept tooling, product samples and prototypes.</li><li>Act as the binding element between product development and automation engineering, ensuring the effectiveness and efficiency of this critical interface.</li><li>Maintain communication with project management team to understand current and future strategic business needs.</li><li>Prioritize and time manage a portfolio of projects/work efforts based on criticality and business need.</li></ul> Requirements: <ul><li>Bachelor or above degree with mechanical/electric related majors.</li><li>At least 5 years related experience managerial level in multinational manufacturing site.</li><li>Familiar with Lean, Six Sigma. etc. industrial methods/tools.</li><li>With 2 years or above work experience in cable assembly automation is preferred.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements	 <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Role Description: <ul><li>As Sr R&amp;D/PRODUCT DVL ENGINEER in Digital Data &amp; Networks (DDN) Business Unit, you will work in a global sustaining engineering team responsible for the continued support and evolution of production parts and products throughout their lifecycle.</li><li>This includes driving product lifecycle management, product extensions, rapid NPIs, VAVE initiatives, sustainability improvements, material and process changes, and manufacturing location transfers.</li><li>The role also involves providing technical support to plants, suppliers, and customers to ensure continuity, quality, and cost optimization.&nbsp;</li></ul> Responsibilities: <ul><li>Responsible for sustaining activities for the Antenna, RF, COAX cable and connector product lines.</li><li>Execute critical engineering projects, including manufacturing transfers, sustaining, product extensions, cost reduction (VAVE), sustainability and rapid New Product Introduction.</li><li>Represent engineering in customer meetings, project meetings and site visits, providing technical support and insights as needed.</li><li>Support the complete product life cycle (Design updates, Creation of product specifications, 3D/2D modeling, Prototyping, Product testing, Product qualification, Project Execution &amp; Sustaining till product end of life).</li><li>Work closely with PM and other cross functions in getting the right and clear requirements to make engineering evaluation/proposal to update the design.&nbsp;</li><li>Follow sustaining Project Process to support project team from PDE perspective to complete Project on time, quality and budget.</li><li>Technical support for customers, sales, PM and plant team. Define &amp; coordinate with test lab for necessary qualification testing, engineering analysis, trouble shooting and verification.&nbsp;</li><li>Apply engineering is the best practice to reduce costs and sustain exiting products to meet customers’ cost targets.</li><li>2D &amp; 3D drawing creation (Creo and SolidWorks Preferred) and release as per our client and procedures through ECR/ECN/PCN processes.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical, or a related Engineering discipline; advanced degree preferred.</li><li>8+ years working experience as new product development or sustaining engineering related positions including 3+ years of working experience on product development of Antenna, RF, COAX cable and connector.</li><li>Strong foundation in mechanical engineering principles with proven application in product development.</li><li>This position is highly technical and requires an individual who can work independently.</li><li>Understanding product compliance certification and qualification testing.&nbsp;</li><li>Experience in design for manufacturing and assembly (DFMA), design for cost (DFC), design for manufacturing (DFM)</li><li>Demonstrated problem-solving and root cause analysis.</li><li>Proven expertise in sustaining engineering and product lifecycle support, including design enhancements, prototyping, testing, and cost/productivity improvements (VAVE).</li><li>Understanding of product lifecycle management (PLM) and new product development (NPD) processes.</li><li>Hands-on experience with modern design and analysis tools including 3D CAD, modeling, Geometric Dimensioning &amp; Tolerancing (GD&amp;T), and simulation tools.</li><li>Knowledge of manufacturing processes such as machining, molding, stamping, and plating.</li><li>Basic understanding of quality tools and methodologies such as FMEA, Six Sigma, DOE, 8D, etc.</li></ul>

Responsibilities: <ul><li>As a Solutions Engineer you will orchestrate involvement of all technical activities and resources, holding accountabilities for all opportunities within assigned account(s) and provide architectural perspective across the product portfolio, including software and services.</li><li>Serve as a technical sales consultant and trusted advisor to customers.</li><li>Orchestrate resources to ensure technical success throughout the sales lifecycle.</li><li>Collaborate closely with Account Managers and internal teams to deliver driven, customer-focused solutions.</li><li>Provide experienced mentorship on solution build, implementation, and differentiation.</li><li>Build positive relationships with engineering teams, business units, partners, and customers across multiple technology domains.</li></ul> Requirements <ul><li>Bachelor of Engineering degree or equivalent. with 12 years of presales experience in a technical position</li><li>Shown experience in solution selling with products and technologies.</li><li>Highly motivated, adaptable, and eager to learn new technologies.</li><li>Broad understanding of end-to-end architecture with expertise in areas such as enterprise networks, data center, or security.</li><li>Strong communication, whiteboarding, and presentation skills for effective customer engagement.</li><li>Skilled in value-based selling, handling objections, and possessing solid technical knowledge in networking, SDN, network security, and data center technologies.</li></ul>

Job Summary: <ul><li>R&amp;D Team builds world-class SaaS solutions for industrial customers for their asset and network device management.&nbsp;</li><li>As a part of the high-performing engineering team, the engineering manager will build and maintain a software development team tasked to deliver high-quality software that delights our customers.&nbsp;</li><li>He/She will report to Senior Engineering Manager.</li></ul> Responsibilities: <ul><li>As a software engineering manager of a Cloud-based Platform, be both a highly technical, hands-on coder and an effective resource manager.</li><li>Communicate across functions and other stakeholders and drive engineering initiatives</li><li>Introduce and maintain AGILE SDLC best practices in the team.</li><li>Participate in Code Review, Technical design discussion&nbsp;</li><li>Be a subject matter expert in the Public Cloud and On-Prem based Data Platform</li><li>Define and influence product strategy</li></ul> Requirements:﻿ <ul><li>10+ years of software engineering work experience, including hands-on technical management.</li><li>In-depth knowledge on NMS and other network software</li><li>7+ years’ experience coding in one of the following languages: Go and Python.</li><li>Experience with Docker and Kubernetes for deployment and orchestration.</li><li>Hands-on knowledge on Public Cloud Services and infrastructure.</li><li>7+ years’ of demonstrated experience recruiting and managing technical teams, including performance management</li></ul>

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202 product manager pharma medical devices Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

Supervisor II Assembly

Product Manager

Automation Department Manager (Automation MPDE Department Manager)

Reference Standard Coordinator

Sr R&D/Product DVL Engineer

Solutions Engineer- Public Sector

Engineering Manager

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202 product manager pharma medical devices Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

Supervisor II Assembly

Product Manager

Automation Department Manager (Automation MPDE Department Manager)

Reference Standard Coordinator

Sr R&D/Product DVL Engineer

Solutions Engineer- Public Sector

Engineering Manager

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WhiteCrow is on a mission to connect companies with the best talent across the globe.