Manager – ADL GMP

CEO Executive Assistant

Reference Standard Coordinator

Solutions Engineer- Public Sector

Engineering Manager

Manufacturing Engineer

Senior Manufacturing Engineer

IT Application Specialist

Solar Design Engineer

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>

Responsibilities: <ul><li>Manage CEO’s calendar, travel plans, agendas, and correspondence, including confidential materials.</li><li>Serve as the primary liaison between the CEO, board members, senior management, and external stakeholders.</li><li>Organize and prioritize requests, provide recommendations, and make decisions aligned with the CEO’s style and organizational policies.</li><li>Oversee special projects, ensuring seamless execution and effective communication.</li><li>Draft correspondence, acknowledgment letters, and materials to support CEO operations.</li><li>Maintain CEO profile and represent the CEO in internal and external communications.</li><li>Assist with hospitality and logistical arrangements for board members and guests.</li><li>Track project progress, customer satisfaction, and risk mitigation strategies.</li></ul> Requirements: <ul><li>Bachelor’s degree or equivalent experience.</li><li>5–10 years supporting C-level executives.</li><li>Expert proficiency in Microsoft Office and desktop publishing software.</li><li>Strong organizational, time-management, written, and verbal communication skills.</li><li>Ability to manage competing priorities independently, maintain discretion, and work professionally with diverse stakeholders.</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>

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>

Responsibilities: <ul><li>Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.</li><li>Provide technical support for new product introduction (NPI), including process design, tooling, and equipment validation.</li><li>Conduct root cause analysis and lead corrective/preventive actions (CAPA) to&nbsp;</li><li>resolve production issues.</li><li>Collaborate with cross-functional teams (R&amp;D, Quality, Supply Chain, Maintenance) to ensure smooth project execution and production readiness.</li><li>Prepare and maintain process documentation, work instructions, and training materials.</li><li>Monitor key production metrics (yield, scrap, cycle time, downtime) and implement continuous improvement initiatives.</li><li>Participate in lean manufacturing, Six Sigma, and Kaizen activities to drive operational excellence.</li><li>Ensure compliance with safety standards, environmental regulations, and ISO/IATF quality system requirements.</li><li>Support cost reduction projects through process improvement, automation, and supplier collaboration.</li></ul> Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.</li><li>3–5 years of relevant experience in manufacturing engineering; automotive or electronics industry experience preferred.</li><li>Strong knowledge of manufacturing processes such as machining, assembly, injection molding, stamping, or PCB assembly (depending on industry).</li><li>Familiarity with APQP, PPAP, FMEA, Control Plan, and other quality tools.</li><li>Proficiency in CAD software (e.g., AutoCAD, SolidWorks, Creo) and MS Office.</li><li>Hands-on experience with Lean Manufacturing and problem-solving methodologies (5Why, 8D, DMAIC).</li><li>Good communication and coordination skills; able to work in cross-functional and multicultural teams.</li><li>English: able to read and write technical documents; spoken English is a plus.</li></ul>

Responsibilities: <ul><li>Lead and support process improvement projects to optimize manufacturing efficiency, reduce waste, and improve quality</li><li>Develop, validate, and implement manufacturing processes and tooling for new and existing products</li><li>Collaborate with product development, quality, and production teams on new product introduction and design for manufacturability</li><li>Identify root causes of production issues and implement corrective and preventive actions</li><li>Lead Lean Six Sigma and 5S initiatives across the production floor</li><li>Support capacity planning and equipment layout optimization</li><li>Develop and maintain process documentation, work instructions, and standard operating procedures</li><li>Ensure compliance with safety standards, quality systems, and regulatory requirements</li><li>Mentor junior engineers and provide technical guidance to the operations team</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Manufacturing Engineering, or a related field</li><li>Minimum 5 years of experience in a manufacturing or industrial engineering role, preferably in a high-mix, low-volume environment</li><li>Strong knowledge of Lean Manufacturing, Six Sigma, and process optimization techniques</li><li>Experience with manufacturing tools such as PFMEA, control plans, SPC, and root cause analysis</li><li>Proficient in CAD software and Microsoft Office applications</li><li>Excellent analytical, problem-solving, and communication skills</li><li>Ability to lead cross-functional teams and manage multiple projects</li><li>Experience in the electronics or connectivity components industry is an advantage</li></ul>

Responsibilities:﻿ <ul><li>Lead initiatives that enhance manufacturing efficiency, improve product quality, and support continuous improvement efforts at our manufacturing facility.</li><li>The successful candidate will work closely with cross-functional teams to implement innovative solutions, ensure process stability, and drive productivity across operations. Lead and support process improvement projects to optimize manufacturing efficiency, reduce waste, and improve quality .</li><li>Develop, validate, and implement manufacturing processes and tooling for new and existing products Collaborate with product development, quality, and production teams on new product introduction and design for manufacturability</li><li>Identify root causes of production issues and implement corrective and preventive actions Lead Lean Six Sigma and 5S initiatives across the production floor</li><li>Support capacity planning and equipment layout optimization</li><li>Develop and maintain process documentation, work instructions, and standard operating procedures</li><li>Ensure compliance with safety standards, quality systems, and regulatory requirements</li><li>Mentor junior engineers and provide technical guidance to the operations team</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Manufacturing Engineering, or a related field</li><li>Minimum 5 years of experience in a manufacturing or industrial engineering role, preferably in a high-mix, low-volume environment.</li><li>Strong knowledge of Lean Manufacturing, Six Sigma, and process optimization</li><li>techniques</li><li>Experience with manufacturing tools such as PFMEA, control plans, SPC, and root</li><li>cause analysis</li><li>Proficient in CAD software and Microsoft Office applications</li><li>Excellent analytical, problem-solving, and communication skills</li><li>Ability to lead cross-functional teams and manage multiple projects</li><li>Experience in the electronics or connectivity components industry is an advantage</li></ul>

Responsibilities: <ul><li>Take ownership of the application management for our internal core systems: Microsoft 365, Business Central, and Dynamics CRM.</li><li>Ensure operational stability and act as the first point of contact for internal queries related to these platforms.</li><li>Collaborate with various departments to develop new requirements and processes, ensuring their optimal implementation within our systems.</li><li>Provide technical support for Dynamics CRM, including interfaces and data flows.&nbsp;</li><li>Analyze and optimize existing processes, leveraging Power BI reports for data-driven insights.</li><li>Work closely with external partners and internal stakeholders to maintain and advance system operations.</li><li>Actively contribute to the digitization and automation of our internal workflows.&nbsp;</li></ul> Requirements: <ul><li>Several years of experience managing Microsoft 365, Business Central, and Dynamics CRM.</li><li>Proficiency with Power BI and an interest in data-driven decision-making.</li><li>Enjoy working with diverse departments and have a good understanding of business processes.</li><li>Strong analytical skills, independent and structured working style.</li><li>Good communication skills and a high level of quality awareness.</li><li>Native-level German; good English skills are an advantage.</li></ul>

Responsibilities: <ul><li>Work with cross functional teams to transform VOC into internal specifications and design features, documented properly as Product Requirements Document.</li><li>Design and develop new products for renewable applications using metallic and polymeric material to meet customer requirements</li><li>Assess technical risk and compliance of project</li><li>Prototype sample development for feasibility studies</li><li>Product Data management of engineering bill of materials</li><li>Executing on cost optimization/reduction (VA/VE) opportunities for the business</li><li>Engineering communication with global team and localize global product teams in China</li><li>Preparing design verification test plans, Design C Process FMEAs, FEAs</li><li>Engineering sample preparation for design and process verification tests</li><li>Executing test plan within the lab, ensuring successful product testing and verification results</li><li>Perform failure mode analyses and improvements to optimize product</li><li>Recording results of design reviews, design decision meetings, and writing technical summaries</li><li>Assisting with product compliance and approvals for all new products and platforms</li><li>Work with FAI approvals, Process Capability Study, judging manufacturing deviations and make decisions on deviation acceptance</li></ul> Requirements: <ul><li>Must have a minimum of an Bachelors degree in a discipline of Engineering</li><li>More than 5 years design experience on connector, plug or terminal. Solar or battery energy storage relevant or power / utility design experience is plus,not must</li><li>Ability to develop connectors to meet critical global standards, such as ANSI, UL, IEEE, and IEC</li><li>Component material selection to optimize strength, electrical insulation, stability, and longevity, while meeting the product and standard requirements</li><li>Basic knowledge of product development processes in a stage-gate approach</li><li>A basic understanding of manufacturing processes, such as molding, stamping, plating, and assembly processes</li><li>Possesses high degree of initiative, technical competence, engineering process knowledge and strong communication skills</li><li>Fluent communication with own team, customers, internal business leaders and technology leaders in English (CET-4 or above)</li><li>LDFSS or DMAIC 6-sigma black or green belt an advantage</li><li>Familiarity of engineering software: Creo or Pro/E</li><li>Mastery of office software, such as Word, Excel, PPT, etc.</li></ul>

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88 laboratory software Jobs found

Manager – ADL GMP

CEO Executive Assistant

Reference Standard Coordinator

Solutions Engineer- Public Sector

Engineering Manager

Manufacturing Engineer

Senior Manufacturing Engineer

Senior Manufacturing Engineer

IT Application Specialist

Solar Design Engineer

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Skills

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Jobtitle

88 laboratory software Jobs found

Manager – ADL GMP

CEO Executive Assistant

Reference Standard Coordinator

Solutions Engineer- Public Sector

Engineering Manager

Manufacturing Engineer

Senior Manufacturing Engineer

Senior Manufacturing Engineer

IT Application Specialist

Solar Design Engineer

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

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TALENT

COMPANY

Contact Us

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