Kelly Services is hiring a Systems Analyst / Quality Management Systems Analyst for a project in Carlsbad, CA. For immediate consideration, please email your updated resume to the recruiter at tauri.hayes@kellyservices.com or apply online today! Systems Analyst 5 month project – W2 Carlsbad, CA (onsite only – no remote) Pay: $55/hr We are seeking a knowledgeable Systems Analyst/Quality Management Systems Analyst to join a growing Corporate IT team. Key Responsibilities: Maintains the integrity of the Quality Management System performance by proactively monitoring system performance, provide second level support, troubleshoots all application, configuration and infrastructure related issues and escalates to the vendor. Coordinates and manages Functional, User Acceptance, validations and performance testing. Assist in preparing Functional and Technical specifications Experience with ServiceNow IT Service Management: Change Management, Major Incident Management and Problem Management is most desirable Ability to configure and design Informatica Workflows Performs application data migration activities using Data Import/Export tools sets Designs and executes workflows, including but not limited to developing InfoCard types, packet types, and workflow processes within MasterControl Must be familiar with Web Technologies (HTML, CSS and JavaScript) and Services (REST/SOAP) Participates and drive continual process improvements. Seeks ways to automate and streamline internal processes and procedures. Design and develops various custom reports using Power BI Exposure working with Environmental Health and Safety Systems (EHS) systems like WERCS and the SHED is highly desirable but will train. Experience working with QMS Systems MasterControl and Trackwise Digital is strongly desired. Must have knowledge in gathering requirements, maintaining operational instructions to support computer systems validation testing and end user training Knowledge of industry best practice such as GxP, GAMP, knowledge of 21 CFR Part 11, Quality Assurance/Regulatory Affairs. Experience working in Quality Management Systems maintaining a validated state is highly desired. Experience Requirements: Office 365, MS SharePoint, Windows Server 2012/2016, Windows 7, 10, Terminal Services, TCP/IP, WAN, DNS, DHCP, VMware, VB.NET for development and debugging activities, Command Line Interface (CLI) and PowerShell scripting. WERCS Docloader, FTP Client and JCL. Must have experience with Oracle PL/SQL and MS-SQL and automated testing tools like SOAPUI for integration testing. Minimum Requirements/Qualifications: Bachelor’s degree in Computer Science or Information Technology or equivalent experience may be accepted in lieu of a degree. 3-5 years’ experience working as a system support analyst/administrator is strongly desired. Possess strong analytical, troubleshooting and problem-solving abilities. Ability to work in a fast-paced environment and meet tight deadlines Effective verbal, written and communication skills Why Kelly ® ? As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined. About Kelly ® At Kelly , we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. #KellyGTS ]]
QA & Testing Jobs
Senior Software Engineer If you are a Sr. Software Engineer with at least 8 years experience, please read on! Since our start at the turn of the century, we have been a leader in transaction solutions, including payment processing, virtual and remote terminals, cashless solutions, and mobile payments. We strive to make your payments more simple, much safer, and a lot faster. We are trusted worldwide by leaders in healthcare, education, gaming, education, and hospitality industries to bring unparalleled value and security services. We are looking for an elite Sr. Software Engineer with experience in the Microsoft Tech Stack with an emphasis on middleware products and hardware devices to join our team. Top Reasons to Work with Us – Excellent benefits including but not limited to dental, medical, prescription, vision, life insurance and 401k – Fantastic modern office space – Catered breakfast and lunch daily – Frequent growth opportunities What You Will Be Doing You will be working directly with 3rd party hardware devices and building structured, well-commented solutions for intricate integrations and multi-faceted problems. You will be working within a scrum team to create estimates, tasks, stories, and delivery for every sprint. You will have multiple responsibilities including solution and software design and architecting, software development, n-tier solutions, high performing transaction handling, and complex secure system integrations. You will leverage various frameworks, patterns, and tools. You will have shared accountability for the quality of the solution and ensure seamless integration and implementations. You will report to the Director of Software Development. Help create application frameworks and libraries for a variety of solutions, finding anyway to reuse code and core frameworks when you can. You will be working with our quality assurance team to make certain that the correct test plan, coverage, execution and defect remediation. You will maintain and expand our middleware solutions and practice thorough unit and system testing. What You Need for this Position – 8 Years Experience minimum holding the title of software engineer/developer – .NET 4.0+ – VS 2012+ – C# – Object-Oriented Design and Programming – Windows Servers/Services – Transactional processing software – Direct interaction with hardware devices -Working knowledge of current network hardware, protocols, and standards, including TCP/IP socket programming, HTTP and HTTPS handling, WiFi, GPRS, SSH, SSL Nice to have skills with the following: – Experience in high volume transactional processing environments, preferably financial or payment related – C, C++ – SQL and SQLite – GIT – Linux -VMWare or VirtualBox What’s In It for You – Excellent benefits including but not limited to dental, medical, prescription, vision, life insurance and 401k – Fantastic modern office space – Catered breakfast and lunch daily – Frequent growth opportunities So, if you are a Senior Software Engineer with experience, please apply today! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
SunIRef:it Microsoft .Net Developer NTT DATA Services 2,334 reviews – Albany, NY NTT DATA Services 2,334 reviews Read what people are saying about working here. At NTT DATA Services, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees are key factors in our company’s growth, market presence and our ability to help our clients stay a step ahead of the competition. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA Services and for the people who work here. NTT DATA Services currently seeks a Microsoft .NET Developer to join our team working full-time, on-site in Albany, NY. This is not a remote position. Daily Tasks include: Provide solution design, create functional and technical documents. Develop, implement, manage and maintain applications using Microsoft .NET technology in support of NYBE. Analyze, design and configure changes within the system to incorporate portal functionality. Work with architects and developers to configure and support various back office and Oracle integration points and activities. Detail daily tasks will include but are not limited to the following: Guide development team for project including reviewing and reporting on team progress and assigning Developer’s tasks Analyze and interpret business rules and workflows for application design Workflow analysis Performance Metrics/Data Analysis Developing Applications using SDLC with Java [J2EE1.6] including EJBs, JSP development using custom tags, Structs2, Hibernate 4, and Java Frameworks / Packages such as JQuery 1.7, and Apache Commons. Mandatory Qualifications Expert 84+ Months: IT Specialist who works in the field of Information Technology Experienced in the usage and support of a collection of development platforms, technical architectures or business applications and products that run on those platforms – beyond that of a Programmer. Able to provide guidance to large teams and/or has extensive industry experience and is considered at the top of his/her field. 84 months of experience: Designing and developing enterprise applications in J2EE ( JSP, Servlets, EJB, Struts, Spring, Hibernate, JMS, MQ Service, MDB, JCA). Requested Qualifications: 84 months of experience: In IT in the areas of Application Design and Implementation, with Lead Software Engineer/Architect role. In analysis, application solution designing, requirement gathering, development, requirements planning, quality assurance of enterprise grade applications and successfully led multiple releases to completion. Working on XSLT transformations, and transaction management using EJB, JPA and Hibernate, and interfacing with Edge applications using SOAP, RESTfull Web Services. Building Web Applications using Vue JS, Angular, Microsoft .Net Core, .Net Core MVC, C#, Entity Framework as well as J2EE technologies EJB, Servlets, JSP, JMS, MDB, Open Java Frameworks Spring, struts, Hibernate. 60 months of experience: Designing and implementing web applications in responsive web design using Bootstrap, HTML 5, CSS 3, AngularJS, Less framework, memory management and CPU profiling using JProfiler. In Oracle Policy Automation (OPA) writing rules, designing interviews and Interface Java with OPA using OPA 10.x Asses Service, OPA 12.2.2 Interview Service and Web Connector. Developing SOA composite applications using Oracle SOA Suite OSB (Oracle Service Bus), BPEL, Mediator, BPM, Human Tasks. Developing Dynamic Components, Modules, Services and Custom Filters using Vue JS, Angular, AXIOS and VUEX to access REST API’s. About NTT DATA Services NTT DATA Services partners with clients to navigate and simplify the modern complexities of business and technology, delivering the insights, solutions and outcomes that matter most. We deliver tangible business results by combining deep industry expertise with applied innovations in digital, cloud and automation across a comprehensive portfolio of consulting, applications, infrastructure and business process services. NTT DATA Services, headquartered in Plano, Texas, is a division of NTT DATA Corporation, a top 10 global business and IT services provider with 118,000+ professionals in more than 50 countries, and NTT Group, a partner to 88 percent of the Fortune 100. Visit to learn more. NTT DATA, Inc. (the Company) is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result. Job Types: Full-time, Contract Salary: $116,900.00 /year Experience: software development: 1 year (Required) app development of applications w/Microsoft .NET technology: 1 year (Required) Oracle Policy Automation (OPA) writing rules: 1 year (Preferred) Oracle integration points and activities: 1 year (Required) designing and developing enterprise applications in J2EE: 1 year (Required) Education: High school or equivalent (Required) Location: Albany, NY (Required) Work authorization: United States (Required) Full Time Opportunity: No Work Location: One location Benefits: Health insurance Dental insurance Vision insurance Retirement plan Paid time off Other Visa Sponsorship Potentially Available: Yes: H-1B work authorization Yes: Immigrant visa sponsorship (e.g., green card sponsorship) This Job Is: A job for which military experienced candidates are encouraged to apply A job for which all ages, including older job seekers, are encouraged to apply Schedule: Monday to Friday 8 hour shift – Just posted report job If you require alternative methods of application or screening, you must approach the employer directly to request this as Indeed is not responsible for the employer’s application process.
Project Manager Material Handling System Projects required We have been in business since 1982, and have grown to serve major clients in multiple industries by providing material handling solutions that are custom crafted for their need. We’ve built a reputation for delivering challenging projects on-time, and offer turnkey solutions for our clients. If you are a Project Manager with Material Handling System Projects that is required, please read on! Top Reasons to Work with Us 1. Tremendous growth opportunities in this company for the right person 2. Remote position possible 3. Ethical company with great people to work with! What You Will Be Doing Overall responsibility for a Project Manager is to successfully lead complex distribution design, implementation, and operational programs, projects – inclusive of material handling systems implementation, system design, logistics strategy, warehouse management and control systems, new or expanded building construction, new or redesigned processes, and training end users, managing change across stakeholder groups, and driving distribution center operational performance. Ability to lead medium to large scale material handling integration projects. Leading project scope, schedule, budget, as well as, quality assurance and risk management initiatives. Manages & controls scope, schedule and budget. Lead project quality assurance and risk management initiatives Follows company PMO methodologies, standard, process and procedures to ensure milestones are reached and deadlines are met throughout project lifecycle. Managing the pre-project development of project proposals or statements of work, time- phased resource/vendor plans, material handling and cost estimates, project schedules, and customer contracts and commitments Demonstrates subject matter expertise on distribution center operational concepts, processes, control systems, execution systems, material handling solutions, and implementation. What You Need for this Position More Than 5 Years of experience and knowledge of: – Managed material handling systems is required – MS Office Suite and MS Project – Background in project based efforts – Travel up to 50% and some weekends – Manage Multiple Projects Simultaneously – PMP preferred – People Skills – Leadership skills – Project Management Skills – Delivery Management Skills So, if you are a Project Manager-Material Handling System Projects required with experience, please apply today! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Global Company InfoClient is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened their leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Company employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Company focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.A Pharmaceutical, also known as a company in New York, is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. Job DetailsExperience 10 – 15 YearsAnnual Salary Mid 100k-High 100k USDWork Location USADomainPharmaceuticals/Biotechnology/Clinical ResearchJob DescriptionThe Therapeutics business offers an opportunity to transform a generics company into an innovation-driven specialty business. This role is a unique opportunity to build a business with the backing of an 80-year-old legacy of sophisticated dosage forms expertise, CMC expertise, large scale manufacturing, and drug delivery. Company has a proven performance track record in 100 countries with over 1000+ products across various therapeutic categories. Company is known for creating businesses that are sustainable with a high focus on continuous innovation in R&D (with 20+ world firsts so far). Therapeutics will focus on Anti-infectives, Pain, Neurology and Respiratory therapies and building out a Branded business. Its Neurology pipeline has two early-stage assets in Spasticity, while in Respiratory, it has a Phase 2 ongoing asset for Aspergillosis in Asthma patients. It also has a Phase 3 completed “opioid-sparing” program for mild to moderate pain in hospital patients. It recently acquired an approved new generation intravenous aminoglycoside for cUTI.JOB DESCRIPTION The Director, R&D, Synthetic Organic Small Molecule Analytical Sciences position will lead all analytical sciences research and development (R&D) activities at Therapeutics. In this role the Director may lead a small team comprised of internal resources and/or contractors. The focus is on all topics analytical chemistry as applied to synthetic organic small molecule active pharmaceutical ingredient (API), formulation, process development and technology transfer. This position will report into the Senior Vice President and Head of R&D, North America. This position is based out of Warren, NJ or Long Island, NY. The job duties for this position include but are not limited to the following: · – Lead all Analytical Sciences, R&D activities as related to development and registration of synthetic organic small molecule products via 505(b)(1) and 505(b)(2) new drug application (NDA) pathways.· – Manage a team of scientists (internal and/or contractors) on all topics Analytical Sciences as applied to API, per-formulation, formulation, manufacturing process development, technology transfer, and established product support.· – – Lead technical deliverables as related to API, excipients, intermediates and finished products.· – Spearhead and/or contribute towards internal pipeline projects and collaborations with development partners (strategic development partners, CROs, CDMOs etc.).· – Operate as the subject matter expert (SME) on analytical sciences including process analytical technologies (PAT). Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner. – Lead and/or contribute towards API, excipient, packaging characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.· – Generate, review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.· -Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Quality Control, Quality Assurance, Supply Chain Management, Procurement etc.) on analytical method transfers from R&D to commercial functions.· -Contribute towards process development, process verification/qualification, process pre-validation, process validation, site and equipment qualification in collaboration with relevant stakeholders. · -Operate as the subject matter expert (SME) on analytical methods for various internal and external projects. Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices and drug products using industry standard methodologies including QbD principles for analytical methods; US FDA or EU guidance’s and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LC-MS/MS, NMR, SS-NMR etc.· — Act as SME on extractable and leachable strategies and methodology.· – Responsible to be single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). Collaborate with project management (PM) function to lead execution of activities against approved plan.· – Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CROs, CDMOs etc.) · – Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).· -Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions. · -Independently draft and/or review standard operating procedures (SOPs).· – Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.· -Draft and/or participate in drafting relevant sections of NDA dossiers towards 505(b)(1) and 505(b)(2) submissions. Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.· -Train staff, peers and junior staff members on new techniques. TYPICAL DAY-TO-DAY ACTIVES · New product development· R&D activities such analytical method development and validation· New Analytical Method Development· Method Validations· Technical Troubleshooting· Technology Transfer· Leading activities at CROs and CMOs· Drafting new drug application (NDA) dossier supportive documents· Drafting and responding to r
REJECTAssociate Director of Research & Development Pharmaceuticals/Biotechnology/Clinical ResearchCentral Islip, New York, USAClient DetailsLEADING ARMACEUTICAL COMPANY In the last 80+ years, CO. has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. CO. is a fast-growing pharmaceutical company which the view to preserve our strong legacy and carve out a stronger future, we articulated our 2022 winning aspiration to double the number of patients we serve and hence double the impact we create as a global pharmaceutical company. Job DetailsExperience 10 – 15 YearsAnnual Salary 130000.00-150000.00 USDWork Location Central Islip, New York, USADomain Pharmaceuticals/Biotechnology/Clinical ResearchNO H1B employment sponsorship. Due to the amount of time required with H-1B transfer petitions and other related activities, it is our preference to not provide employment sponsorship. Please request the recruiters to provide resumes of candidates who do not require employment sponsorship. Thanks. Please find below the difference between the two Associate Director R&D Scientist roles. One position is to oversee the R&D team and activities for the Cipla New York (InvaGen Pharmaceuticals, Inc.) business unit. The other position is to oversee the R&D team and activities for the Cipla USA Exelan business unit which will also be located at the Cipla New York site.Other informations Both positions will report to the SVP of R&D.PhD is mandatory. JOB DESCRIPTION The Associate Director, R&D position will lead all research and development (R&D) activities at co. NY Pharmaceuticals Inc. In this role the Associate Director will lead a team of scientists comprised of formulation, process development, technology transfer and analytical sciences. This position will report into the Senior Vice President and Head of R&D, North America. This position is based out of Long Island, NY. The job duties for this position include but are not limited to the following: · Lead all R&D activities as related to development and registration of products via 505(b)(1), 505(b)(2) and 505(j) pathways.· Lead a team of scientists comprised of pre-formulation, formulation, manufacturing process development, technology transfer, established product support, analytical sciences with a focus on active pharmaceutical ingredient (API), excipients, intermediates and finished products.· Lead internal pipeline projects and collaborations with development partners (strategic development partners, CROs, CDMOs etc.).· Manage scope, cost, time of projects as related to delivery against business objectives.· Operate as the subject matter expert (SME) on pre-formulation and formulation, process development and technology transfer or analytical sciences as applied to development, characterization, process analytical technologies (PAT) and incorporation of active pharmaceutical ingredients (APIs), excipients, packaging material and devices to develop finished products. Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner. · Conduct API, excipient, packaging characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.· Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required.· Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.· Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Quality Control, Quality Assurance etc.) on scale-up and technology transfer of processes from R&D to commercial functions.· Lead and/or participate in activities related to process development, process verification/qualification, process pre-validation, process validation, site and equipment qualification in collaboration with relevant stakeholders. · Operate as the subject matter expert (SME) on analytical methods for various internal and external projects. Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices and drug products using industry standard methodologies including QbD principles for analytical methods; US FDA or EU guidance’s and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LS-MS/MS, NMR, SS-NMR, Synchrotron etc.· Act as single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). Collaborate with project management (PM) function to lead execution of activities against approved plan.· Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CROs, CDMOs etc.) · Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).· Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions. · Independently draft and/or review standard operating procedures (SOPs).· Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.· Draft and/or participate in drafting relevant sections of dossiers towards 505(b)(1), 505(b)(2) or 505(j) submissions. Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.· Train staff, peers and junior staff members on new techniques. TYPICAL DAY-TO-DAY ACTIVIES · New product development· R&D activities such as pre-formulation, formulation, process development or analytical method development· Technical Troubleshooting· Technology Transfer· Process Validations· Method Validations· New Analytical Method Development· Leading activities at CROs and CMOs· Drafting dossier supportive documents· Drafting and responding to relevant requests from the US FDA or EU authorities· Working with external partners on technical activities· Technical Management· Functional Group Management EDUCATION AND EXPERIENCE · Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry. Decorate in Biochemistry, Peptide Chemistry or Protein Chemistry is preferred.· Successful candidate must have a strong analytical and formulation background.· In-depth understanding of UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and
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