Qureos Mentor

WuXi AppTec

We are seeking a skilled and experienced Utilities Superintendent to oversee the operation, maintenance, and reliability of all utilities, facilities, and grounds for our pharmaceutical manufacturing facility in Middletown DE. This role is responsible for ensuring all utilities equipment, automation & controls, and facilities are operated efficiently, safely, and maintained in compliance with Good Engineering Practices. The ideal candidate will lead a team of multi-skilled operators and maintenance technicians, manage vendor service contracts, and implement preventive/predictive maintenance programs, while working closely with cross-functional teams to support production goals and continuous improvement initiatives. <ul><li> Arrange and support routine maintenance activities on all utilities equipment including but not limited to Hurst Boilers, York Chillers, Marley Cooling Towers, Kaeser Air Compressors, BWT PW System, Durr RTO, and Caterpillar Emergency Diesel Generators, </li><li> Develop and implement the Preventive Maintenance programs on all utilities equipment and systems </li><li> Develop and implement a comprehensive Predictive Maintenance program including electrical system thermography, rotating equipment vibration analysis, and oil sampling </li><li> Ensure safe and efficient operation of all utilities equipment and systems </li><li> Ensure all direct reports and contractors work safely and in strict accordance with all WuXi EHS directives, policies and procedures </li><li> Propose new technology, new materials and new equipment to enhance existing utilities maintenance level </li><li> Effectively manage on hand quantities of all necessary spare parts to ensure reliable equipment and systems operation </li><li> Responsible for the development of departmental Standard Operating Procedures (SOP's) and emergency response policies/procedures for utility maintenance operations. </li><li> Organize ongoing training programs for the Utilities Team </li><li> Ensure the optimization of the performance and efficiency of all utilities equipment and systems </li><li> Manage the overall site Energy Efficiency programs including various utility supply contracts for natural gas and electricity with local regulating agencies </li><li> Act as official liaison to the Town of Middletown for all utility related issues - electricity supply, effluent water treatment, etc. </li><li> Act as official liaison to the state regulatory agency DNREC and manage all aspects of the Title V air emissions permitting program for boiler Nox emissions and operation of Regenerative Thermal Oxidizer RTO </li><li> Manage all facilities and grounds contracts including but not limited to lawn care & snow removal, janitorial services, garbage disposal and recycling, uniforms, gas cylinders, universal waste disposal, etc. </li><li> Implement Root Cause Analysis (RCA) or other similar reliability based protocols on all equipment failures </li></ul> Regulatory Compliance & Documentation <ul><li> Maintain accurate records of all maintenance activities, work orders, SOPs, calibration, and validation reports. </li><li> Ensure all equipment and systems are properly qualified and validated per regulatory standards. </li><li> Participate in audits and regulatory inspections, providing necessary maintenance documentation and reports </li><li> Responsible for state of Delaware licensing of high-pressure boiler equipment operators </li><li> Strong working knowledge of all EHS protocols including Safe Work Permitting, Lock Out/Tag Out, Confined Space Entry, Energized Equipment Work, Elevated Work, Hot Work, Lifting Equipment Usage, Underground Excavation </li><li> Working knowledge of electrical systems from 27.3 KV down to 480 Volts </li></ul> Team Leadership & Training <ul><li> Lead and manage a team of multi-skilled maintenance technicians and equipment operators </li><li> Provide technical support and guidance to operations and maintenance personnel including training on utilities equipment operation and maintenance. </li><li> Foster a culture of safety, quality, and continuous improvement within the Utilities department </li><li> Collaborate with cross-functional teams, including Production, Quality Assurance, Engineering, and Safety teams. </li></ul> Continuous Improvement & Cost Management <ul><li> Identify and implement efficiency improvements to optimize operation & maintenance operations and to reduce costs. </li><li> Manage the Utilities Equipment Operating Budget and the associated Maintenance support budget, spare parts inventory, and vendor contracts to ensure cost-effective maintenance solutions. </li><li> Recommend and implement energy-saving and sustainability initiatives to improve overall facility performance </li><li> Manage the ongoing annual Capital Improvement budget for all Utilities equipment and systems </li></ul><ul><li> Bachelor's of Science degree in Engineering (Mechanical, Electrical, Chemical, Industrial, etc.) or a related field required </li><li> 5+ years of specific Utilities equipment operation and maintenance experience in a Life Sciences/Pharmaceuticals/Biotechnology or FDA-regulated environment required </li><li> Strong knowledge of GMP, FDA, OSHA, and industry best practices in Utilities Equipment and systems operation and maintenance </li><li> Hands-on past experience with cleanrooms, HVAC systems, water purification, compressed air, electrical systems, pressure/temperature/flow instrumentation, instrumentation testing & calibration, and automation systems a plus </li><li> Knowledge of PLC's, HMI's, SCADA, Building Management Systems (BMS), and Environmental Management Systems (EMS) a plus. </li><li> Experience with Computerized Maintenance Management Systems (CMMS) - past experience with SAP R/4 HANA EAM module is a definite plus </li><li> Excellent problem-solving, leadership, and project management skills </li><li> Ability to work in a fast-paced, highly regulated environment. </li><li> Certification in Lean Manufacturing, Six Sigma, or Reliability-Centered Maintenance (RCM) is a plus </li><li> Strong hands-on leadership style </li><li> Proficient in oral & written communication skills </li><li> Demonstrated ability to read, write and speak English </li><li> Past experience with AutoCAD or other drawing management system is a plus </li><li> Proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint) </li><li> 10% travel is possible; both domestic and international </li></ul> Physical Requirements: <ul><li> Must be able to work in an office environment with minimal noise conditions </li><li> Must be able to wear appropriate PPE </li><li> Must be able to work in a plant environment with variable noise levels </li><li> Ability to stand/sit/walk for long periods of time </li><li> Ability to lift 10 lbs. routinely </li><li> Ability to crouch, bend, twist, and reach </li><li> Ability to push/pull 10 lbs. routinely / often / occasionally </li><li> Clarity of vision </li><li> Ability to identify and distinguish colors </li><li> Must be able to perform activities with repetitive motions </li><li> Ability to climb ladders / stairs / scaffolding </li><li> Ability to work in variable temperatures (hot, cold, etc.) </li><li> Ability to work both inside and outside in varying working conditions </li></ul>

Utilities Superintendent

The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for WuXi TIDES and STA Pharmaceutical, a WuXi AppTec company, in particular to support the growth of emerging oligonucleotide and peptide (O&P) Contract Development and Manufacture (CDMO) business. The candidate will work within the US business development (BD) team to pursue new clinical to commercial company leads, manage existing clinical to commercial accounts, follow up on critical issues, and aid in resolving customer inquiries. This job is remote in the US. <ul><li> Hunting and Prospecting for oligonucleotide and peptide new drug development contacts and companies that would benefit from WuXi TIDES CDMO services. </li><li> Obtains conferences and meetings to present WuXi TIDES services to prospective and existing clients via email, phone, and web-conferencing systems. Travel to local client meetings where possible. </li><li> Participates in tradeshows to raise the profile of WuXi TIDES and generate leads </li><li> Acts upon, refers and follows-up on leads from both sales and marketing campaigns. </li><li> Increase awareness of WuXi TIDES marketing initiatives, including scheduling meetings at tradeshows and promoting registrations for webinars and seminars. </li><li> Maintains knowledge of industry trends, funding, regulatory influence, mergers and acquisitions, in-out licensing of products/technologies, government/private grants and contacts, new drug development and approvals, related patent grants and notifications, and market growth of small, med, and large cap companies. </li><li> Develops a social network of industry-related contacts via LinkedIn and other social networking platforms. </li><li> Proposes new ideas to increase performance for WuXi TIDES goals. </li><li> Documents information in Client Relationship Management (CRM) including contacts, pre-screened/qualified leads, and new account information as required </li></ul> <ul><li> BA/BS in Chemistry and certain professional training/experience in business (i.e., Marketing, Sales) is required. PhD highly desired. </li><li> 3+ year's relevant experience working in oligonucleotide or peptide new drug development or CRO/CMO industry </li><li> Must be a self-starter, self-motivated, highly flexible, with excellent communication skills (verbal, written, and presentation skills). Must be organized and detail-oriented. </li><li> Must have a proven track record of simultaneously managing several projects and timelines. </li><li> Ability to perform within a professional environment and use judgment as dictated by the complexity of the situation. </li><li> Experience with CRM (Customer Relationship Management) software (i.e., Salesforce and/or Microsoft Dynamics/CRM) is preferred </li></ul> An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Business Development Manager, TIDES Development

This role will design, develop, optimize, and support GMP drug product manufacturing and packaging process, including equipment, facilities, and control systems at our Middletown, Delaware site. This may include support of CQV programs for manufacturing/packaging equipment, instruments, utilities, and processes. The Engineer is also responsible for ensuring external and internal quality standards are applied and followed. <ul><li> Implementing and maintaining manufacturing process automation and control systems. </li><li> Participate as a member of cross functional teams in completion of system impact evaluations and system risk assessments in a multi-product facility. Performs gap assessments and remediates new risks as new equipment and/or products are introduced. </li><li> Assists with the preparation and maintenance of User Requirements Specifications. </li><li> Ensuring compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations. </li><li> Conducting risk assessments and supporting equipment/utilities qualification activities. </li><li> Hands-on experience with troubleshooting and resolving process equipment-related issues during production. </li><li> Experience managing equipment, Preventive Maintenance, Calibration, and reliability programs independently with minimum supervision. </li><li> Experience with OSD equipment but not limited to Wet Granulation systems, Bin Blenders, Encapsulation, Tablet Presses, Tablet Coaters, Roller Compactors, etc. is a must. </li><li> Experience in packaging equipment like bottle packaging, blister packaging, and powder packaging. </li><li> Collaborating with cross-functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs. </li><li> Experience in writing Change Controls, Investigation reports, Work Orders, CAPA, Standard Operating Procedures (SOP), and risk assessments. </li><li> Analyzing process data and driving continuous improvement initiatives to enhance efficiency, reduce costs, and improve product quality. </li><li> Providing technical support and training to production staff on new processes, equipment, and safety protocols. </li><li> Identifies and proposes process improvement ideas and collaborates with cross-functional teams to meet project deliverables and timelines, including scheduling, testing, and deviation resolution. </li><li> Performs other related duties as assigned. </li></ul> <ul><li> 3 - 5 years of experience in a Process or Equipment engineering role, preferably in the pharmaceutical drug products manufacturing industry. </li><li> Ability to read and understand engineering drawings such as P&IDs, equipment/facility layout drawings, electrical/pneumatic drawings, and functional specifications. </li><li> Thorough understanding of cGMP and FDA requirements </li><li> Strong communication and documentation skills </li><li> Proven project management skills </li><li> Experience with equipment qualification following ISPE and ASTM guidelines. </li><li> Proficient with Microsoft Office Suite, Maximo, Calibration program software, MES, etc. </li><li> Preferred Qualifications: </li><li> Prior experience as an equipment or process engineer with process control systems and troubleshooting of pharmaceutical manufacturing processes and packaging equipment. </li><li> Familiarity with Sterile F/F equipment qualification is a plus. </li><li> Familiarity with the IOQ/PQ process/packaging equipment for the pharmaceutical industry. </li><li> Familiarity with Maximo or equivalent Regulatory Asset Manager software. </li></ul> Experience / Education: <ul><li> Bachelor's degree in engineering (Mechanical, Electrical, Industrial) or a related field. </li><li> 3-5 years of maintenance experience in a pharmaceutical, biotechnology, life science, or FDA-regulated manufacturing environment. </li></ul> Knowledge / Skills / Abilities: <ul><li> Technical: Strong understanding of engineering principles, process design and optimization, quality control, pharmaceutical manufacturing technologies, equipment, and relevant software. Knowledge of cGMP guidelines and regulatory compliance is essential. </li><li> Analytical & Problem-Solving: Ability to analyze complex processes and data, identify bottlenecks, troubleshoot issues, and develop effective solutions. </li><li> Soft Skills: Excellent communication (written and verbal), teamwork, leadership, project management, organizational abilities, time management, adaptability, attention to detail, critical thinking, and negotiation skills. Industry Specific: Familiarity with FDA regulations, cGMP guidelines, Lean Manufacturing, and risk assessment techniques (HAZOP, FMEA). </li></ul> An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Process Engineer

The Portfolio Manager plays a pivotal role in managing key accounts, fostering client relationships, and coordinating program workflows to drive the growth and expansion of our comprehensive drug discovery services. Responsible for the strategic oversight and management of the assigned portfolio of projects and programs. This role involves selecting, prioritizing and optimizing initiatives to align with the business goals, maximize return on investment (ROI) and manage risks. The Portfolio Manager collaborates with senior leadership, program managers, and project teams to ensure efficient resource allocation and delivery of strategic outcomes. They play a critical role in balancing competing priorities, monitoring portfolio performance and driving organizational success. Please note this job requires bilingual skills in English and Mandarin. Essential Job Functions : Key Account Management <ul><li> Serve as the primary point of contact for project management and client relationship development in cooperation with Business Development and Technical teams. </li><li> Develop and transition potential accounts into key accounts, driving service penetration across in-vitro and in-vivo services. </li><li> Maintain strong relationships with key stakeholders to ensure client satisfaction and retention. </li></ul> Integrated Drug Discovery Program Management <ul><li> Coordinate program workflows to ensure efficient execution and expansion. </li><li> Deliver customized proposals to clients to increase the win rate for new projects. </li><li> Manage and integrate resources to oversee the program effectively, expanding services to adapt to client needs and market trends. </li></ul> Solution Provider for Other Integrated Collaboration <ul><li> Develop and implement integrated solutions that facilitate collaboration across various segments and enhance project-related initiatives. </li><li> Provide customized services aimed at improving project outcomes and streamlining workflows across different teams and departments. </li><li> Utilize expertise in multiple fields to foster effective integrated cooperation and ensure the successful execution of projects. </li></ul> New Inquiry Allocation and Coordination <ul><li> Serve as a member of the Request Center to effectively coordinate and route business inquiries to the appropriate technical team(s), based on their expertise, experience, and other internal guidelines. </li></ul> Portfolio Governance <ul><li> Establish and maintain portfolio management process, including criteria for project selection, prioritization and termination. </li></ul> Performance Monitoring <ul><li> Track portfolio performance using key metrics and report to senior leadership. </li></ul> Stakeholder Collaboration <ul><li> Work with stakeholders and project teams to ensure clear communication, alignment and conflict resolution. </li></ul> Continuous Improvement <ul><li> Identify opportunities to improve portfolio management process and implement best practices. </li></ul> Other duties as assigned. Qualifications & Experience : <ul><li> Education: A minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience. </li><li> Experience: Proven experience in drug discovery projects, client relationship management, and cross-departmental coordination. Project management experience within the pharmaceutical or biotechnology industry is highly desirable. </li><li> Industry Knowledge: Strong understanding of drug discovery and development processes, particularly in preclinical research and CRO environments. </li></ul> Knowledge / Skills / Abilities : <ul><li> Proficient in drug discovery processes, including in-vitro and in-vivo methodologies </li><li> Proven ability to deliver customized solutions and manage complex projects </li><li> Ability to work independently and collaboratively in a fast-paced environment </li><li> Self-Motivation & Organization: Highly self-motivated, well-organized, and detail-oriented, with a strong commitment to follow-through. </li><li> Communication & Presentation: Outstanding verbal and written communication skills, along with strong presentation, negotiation, and problem-solving abilities ; able to maintain a positive and professional demeanor in all interactions. Fluent in Chinese is a requirement. </li><li> Teamwork & Collaboration: Ability to work effectively in team settings and build strong collaborative relationships with management, R&D leaders, and the BD team from diverse backgrounds to deliver optimal client solutions. </li><li> Prioritization & Independence: Proven ability to prioritize tasks, multitask efficiently, and work effectively with minimal supervision. </li><li> Problem-Solving & Adaptability: Capable of handling challenging situations and developing solutions that drive business success; Ability to thrive in a fast-paced environment while managing multiple projects and priorities simultaneously. </li><li> Technical Proficiency: Proficiency in Microsoft Office Suite; familiarity with CRM/Salesforce tools is a plus . </li><li> Travel Flexibility: Willingness and ability to travel (if this is applicable what travel percentage). </li></ul> Physical Requirements : <ul><li> Must be able to work in an onsite office environment. </li><li> Ability to stand /sit/walk for long periods of time. </li><li> Must be able to perform some activities with repetitive motion, such as keyboarding. </li><li> Must be able to travel for long distances in various methods of transportation (e.g. car, airplane, shuttle bus, train, etc.) </li><li> Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop. </li><li> Must be able to work in environment with variable noise levels. </li></ul> An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Portfolio Manager - WuXi Biology

<div>Overview:
<div>
HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its in vivo Pharmacology Division. We are seeking highly skilled and motivated Research Associate to join the team.</div>
Responsibilities:
<ul><li>Conducting in vivo pharmacology experiments for preclinical contract research with minimal supervision</li><li>Assisting and performing efficacy and PK-PD studies and developing new in vivo/ ex vivo assays and models with minimum supervision, as needed</li><li>Help to design, optimize and execute of pharmacology experiments for compound screening, compound mode of action and efficacy in mechanistic and disease models, e.g. syngeneic and xenograft tumor model, acute and chronic autoimmune/inflammatory conditions, and analyses and reporting of experiments or implantation, blood/tissue collection, etc.</li><li>Assist with and perform other experiments as required</li><li>Working with the team to perform assay development, optimization, and validation projects</li><li>Following SOPs to perform compound receiving, registration, and management</li><li>Help to manage lab coordination</li></ul>
Qualifications:
<ul><li>BA in Biology or related field</li><li>Minimal experience in handling rodents/ mice in in vivo pharmacology studies</li><li>Have experience in troubleshooting experiments and performing data analysis.</li><li>Experience in cell culture, and cell manipulation is a plus</li><li>Detail-oriented with excellent communication skills; able to work in a team-oriented environment.
</li><li>Effectively collaborate across cross functional teams, with excellent organizational and record-keeping skills</li></ul> 

Knowledge / Skills / Abilities: 
<ul><li>Proficient in Oral &amp; Written communication skills</li><li>Need to be able to read, write and understand English
</li><li>Proficient in Microsoft (Excel, Word, Outlook)</li></ul><div></div><div> 
Anticipated salary range: $18.05 to $25.00</div>
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability</div>

Research Associate I