• Training on all analytical chemistry and cGMP procedures
• Manages performance for the direct reports. 
• Potentially directly manage one or two specified direct reports.
• Directs and reviews the work of other analytical chemists and scientists.
• Analyses research and production samples.
• Documents all analyses per SOPs.
• Prepares SOPs, test methods, and other GMP documentation.
• Detects and solves complex problems of high technical difficulty.
• Applies knowledge and expertise from multi-disciplines (including QA, QC, Analytical and production) to achieve project goals.
• Conducts investigations independently.
• Troubleshoots analyses and instruments.
• Supports qualification of reference materials.

Skills: Analytical Chemistry Expertise, Leadership and Management, Team Oversight, Problem Solving, Interdisciplinary Knowledge, Independent Investigation, Method Development and Validation, Communication and Client Interaction.

• Execution of laboratory work in the area of Process Analytics supporting analytical testing on antibodies and other therapeutic recombinant proteins.
• Perform data interpretation to support laboratory studies.
• Test methods employed include, but are not limited to, techniques using capillary electrophoresis, HPLC/UPLC, oligosaccharides profiling, ELISAs, etc, including high throughput versions (Bravo, Gyros, GXII, etc).
• Collaborate with other functions in the analytical team by contributing to analytical validation studies alongside Product Stability and Reference Standard activities by performing supporting analytical work.
• Contribute to customer projects by generating and interpreting scientific data from experimental work and not limiting to performing methods suitability assessments stages.
• Deliver high quality communication to ensure an outstanding customer experience (written reports, teleconferences and face-to-face meetings).
• Working as part of a site and global project team, coordinate multiple projects and ensure timely delivery of project work stages.
• Become established as a Subject Matter Expert in a specific area.
• Facilitate communication between other departments (eg USP/DSP/QC/QA) and across the global Lonza network.
• Able to guide and coach junior scientists.

Skills: Laboratory Skills, Data Interpretation, Analytical Techniques, Collaboration, Project Management, Communication Skills, Global Team Coordination, Subject Matter Expertise and Mentorship

• Perform analytical cGMP testing activities including support of clinical product release and stability for new investigational medicinal products
• Provide technical evaluation and feedback of analytical methods.
• Independently plan and perform analytical method validation
• Provides technical expertise and troubleshooting for technical problems and investigations
• Coordinate technology transfer of analytical methods to BMS external partners.
• Provide input into audit readiness for internal and external regulatory inspections.
• Identify opportunities and/or implement solutions to improve efficiency, productivity, quality or reduce costs.
• Expected to advance into an analytical leadership role overseeing GxP analytical deliverables on a project for small molecule chemical entities.
• Carry out testing of biopharmaceutical products using techniques such as HPLC and UPLC, enzyme activity assays and UV spectroscopy.
• Take responsibility for the preparation and documentation of reagents.
• Responsible for adopting new analytical methods 
• Analyze novel materials and assist in the development and implementation of new analytical methods.

Skills: Analytical Testing, Method Validation, Technical Evaluation and Feedback, Troubleshooting and Investigations, Technology Transfer, Regulatory Compliance, Continuous Improvement, Leadership Potential

• Lead short to medium term projects of varying complexity, many having significant impact on revenue potential.
• Ensure results and reports are delivered on time, effectively communicate the results, and collaborate with customers on areas for improvement.
• Interface with multiple technology groups across the globe.
• Responsible for ensuring achievement of appropriate quality, quantity, cost-effectiveness, reproducibility, and timeliness of results as related to projects.
• Actively develops, improves, and disseminates new technologies/solutions in support of projects and customers.
• Proactively leads activities that provide general support to the department and company.
• Proactively brings new technology and processes into the technical community.
• Promotes safety and may lead in the development of new lab safety procedures.
• Requires travel within the US, with possible international travel

Skills: Project Management, Communication Skills, Cross-functional Collaboration, Quality Assurance, Innovation and Technology Development, Initiative and Leadership, Safety Awareness, Travel Flexibility

• Planning and execution of laboratory analytical projects, from definition of customer needs through assistance with timely analysis and report generation of analytical results.
• Effective management of multiple analytical projects in a cross-functional global team environment, ensuring clear alignment of goals and deliverables with business and market needs
• Providing technical insights and acting as a knowledge source to offer technical guidance to project teams, resolving deadlock situations by constructive dialogue.
• Clear communication and reporting of laboratory activities
• Use product and testing expertise to collaborate with internal and external customers to determine root causes in product development and quality problems
• Respond to customers’ feedback on technical problems and improve product value as well as customer satisfaction
• Perform material characterizations using analytical instruments
• Solve customers’ quality complaints and provide solutions to their technical issues
• Participate in technology exchanges with customers by visiting and teleconferencing
• Promote Entegris’ image by participating in industrial conferences and seminars
• Continuous training on the various analytical techniques and methods

Skills: Project Management, Cross-functional Collaboration, Technical Expertise, Clear Communication, Problem-solving and Root Cause Analysis, Customer Focus, Analytical Instrumentation, Continuous Learning and Development

• Execute large panel multicolor flow cytometric testing (8 or more colors) on a regular basis, in support of process development and product characterization
• Perform gating, data analysis, and data reporting using analysis software
• Maintain, operate, and troubleshoot flow cytometry analytical equipment
• Assist in data verification to ensure data integrity
• Implement lot-checking and inventory tracking
• Participate in transfer of flow cytometry assays from the method development group to analytical testing group
• Help develop improved documentation for standard operating procedures and analytical test methods
• Develops new analytical procedures.
• Validates analytical methods.
• Prepares and reviews scientific reports.
• Interfaces with internal and external clients.
• Document work in internal reporting systems, external publications, and patent applications

Skills: Proficiency in Multicolor Flow Cytometric Testing, Data Analysis and Reporting, Equipment Maintenance and Troubleshooting, Data Integrity and Verification, Inventory Tracking and Lot-Checking, Assay Transfer and Documentation, Analytical Method Development and Validation, Scientific Reporting and Client Interaction

• Translate requests from the business into sensible experiments
• Reconstruct unknown fragrances based on analytical, olfaction and supplementary data
• Carry out analyses on known fragrances in and delivered by consumer products, especially in fabric care applications
• Co-develop analytical methods for known fragrances and write protocols
• Equipment maintenance and troubleshooting
• Organize lab supplies
• Support the generation foundational data for analytical and fragrance reconstruction tools and databases.
• Contribute to the development of strategic plans for the chromatography area. 
• Advance those plans by introducing new techniques to support product, process, and application development projects on materials of interest to the business.

Skills: Experimental Design, Fragrance Reconstruction, Analytical Skills, Method Development, Equipment Management, Supply Chain Management, Data Generation, Strategic Planning

• Apply chromatography expertise to evaluate the composition, structure, and properties of polymeric and oligomer systems and their related small molecules. 
• Serve as a chromatography (separations sciences) subject matter expert.
• Collaborate proactively with local and global project teams, manufacturing, and other analytical scientists to identify and articulate technical problems, establish the most effective route to solve them, recommend appropriate testing, coordinate efforts within the team, and articulate any needs for new method or capability development.
• Execute required routine and non-routine chromatographic techniques, method/capability development work, provide statistically sound analysis and interpretation of data, and recommend next steps.
• Communicate key findings to colleagues via written reports and/or oral presentations and document the results using knowledge management systems.
• Proactively maintain a productive laboratory workspace, which includes managing workflows, processes and systems for the lab, maintaining/troubleshooting equipment, and providing recommendations for continuous improvement.
• Be responsible for all safety activities related to the chromatography laboratory, including relentless attention to safe laboratory practices and conditions, management of change (MOC) procedures, Safety Risk Assessments (SRAs), and proper chemical management.
• Actively participate in department life, including department meetings, cross-functional teams, shared laboratory upkeep duties, and other related activities.

Skills: Chromatography Expertise, Subject Matter Expertise, Collaboration, Method Development, Communication, Laboratory Management, Safety Management, Team Participation

• Provide analytical chemical testing/laboratory work in support of the QAS department, Operations and Quality where required for commercial product support including but not limited to method development, method validation, product testing, degradation profiles, impurity identification, extractable leachable testing, and material contact studies. 
• Material scope includes but is not limited to API, in process testing and finished drug products of the product forms noted in the company summary
• In coordination with other QAS personnel design investigation schemes to support commercial product troubleshooting and execute designed lab experiments
• Troubleshoot and remediate analytical test methods for a wide range of API, excipients and finished products
• Design and execute test method development
• In association with maintenance and analytical vendors install, qualify and maintain the required laboratory equipment within the Technical Services laboratory
• Perform the analytical laboratory work to serve as the sending lab for test method transfer within Akorn sites, contract manufacturing facilities and contract laboratories
• Document and maintain data/test results according to GMP.
• Produce reports and present results for management updates
• Operate and maintain the QAS Laboratory within GMP and SOP requirements and within budget
• Ensure that all data comply with cGMP, FDA and/or other appropriate regulatory guidelines

Skills: Analytical Chemistry Expertise, Method Development and Validation, Troubleshooting Skills, Laboratory Experiment Design, Equipment Qualification and Maintenance, Test Method Transfer, Documentation and Compliance, Regulatory Compliance

• Planning and execution of laboratory analytical projects, from definition of customer needs through assistance with timely analysis and report generation of analytical results.
• Effective management of multiple analytical projects in a cross-functional global team environment, ensuring clear alignment of goals and deliverables with business and market needs
• Providing technical insights and acting as a knowledge source to offer technical guidance to project teams, resolving deadlock situations by constructive dialogue.
• Clear communication and reporting of laboratory activities
• Design/develop and execute method development, validation, transfer and verification activities for pharmaceutical drug API and finished products, based on USP, FDA and ICH guidelines
• Provide technical expertise on analytical methods for drug substance and drug product to assist with trouble shooting and investigations.
• Expertise in analytical techniques, such as HPLC, U-HPLC, GC, and dissolution.
• Write and review technical documentation for contributing to regulatory filings.
• Support corporate efforts to industrialize drug discovery and development.
• Develop processes and systems that will facilitate the advancement of drug candidates through clinical trials and commercialized products.
• Contribute to the development and validation of reliable test methods, the design and implementation of effective characterization stability or other studies through appropriate protocols, meaningful data reviews and accurate reports.

Skills: Project Management, Technical Expertise, Problem Solving and Technical Guidance, Communication and Reporting, Regulatory Compliance, Process Improvement, Collaboration and Teamwork, Attention to Detail and Accuracy

• Experience in multiple analytical techniques related to protein/mAb characterization
• Experience with method transfer, qualification, and validation
• Knowledge of cGMP environment as applied to analytical sample testing
• Experience working with monoclonal antibody and protein therapeutics as applied to mammalian cell lines in a bioprocessing environment
• Strong analytical experience with bio-process residual impurities (HCP, Protein A, DNA) using ELISA and PCR.
• Working knowledge of enzyme activity/kinetic assays 
• Knowledge of common mammalian cell culture and protein purification processes
• Team player, participating on cross-functional teams
• Good communication skills (both verbal and technical) and interpersonal skills, must be able to work in highly flexible and effective teams.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.

Qualifications: BA in Chemistry with 5 years of Experience 

• Experience in the biotech or pharmaceutical industry.
• Experience in analytical separations methods such as HPLC, cIEF, and CGE.
• Experience working with teams and communicating to key stakeholders
• Hands-on experience and knowledge in method development of separations assays supporting biopharmaceuticals.
• Experience with protein biochemistry along with assay development/qualification/validation, pharmacopeia compliance and analytical life cycle management
• Understanding of the biopharm product development life cycle including analytical method qualification, validation and transfer.
• Experience in protein analytical and biochemical techniques such as HPLC, UPLC, capillary electrophoresis, spectroscopy, and other bioanalytical technologies
•  Demonstrates high attention to detail, ability to recognize anomalous and inconsistent results and interpret experimental outcomes. 
• Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy. 
• Experience with GMP validation and testing.

Qualifications: BS in Biochemistry with 2 years of Experience 

• Strong knowledge of required principals and concepts with understanding of context for application.
• Strong knowledge of flow cytometry principles, method development and optimization and data analysis.
• Familiarity with development and /or qualification of cell-based and gene therapy therapeutics, including the development of analytical methods.
• Prior experience in development and execution of assays to characterize and measure proteins and DNA using a variety of methodologies including flow qPCR, ddPCR, electrophoresis, and ELISA.
• Excellent bench skills with attention to detail and high standards for data integrity and quality.
• Able to critically analyze data and troubleshoot methods and equipment.
• Highly organized with excellent communication skills, and demonstrate scientific rigor and excellent problem-solving skills.
• Demonstrated effective management of scientists and/or research associates.
• Experience with cell-based viral titration assays (e.g. flow cytometry, PCR, ELISA).
• Experience with viral vector systems, production and/or purification.
• Experience with liquid handler automation platforms (e.g. Integra, Hamilton, Tecan)

Qualifications: BS in Chemical Engineering with 3 years of Experience 

• Familiarity with GxP principles and regulations as demonstrated by assay and/or technology transfer to GxP manufacturing, or significant laboratory support of IND/BLA submissions.
• Experience in authoring and reviewing documentation including technical documents, protocols and reports connected to assay development, validation and sample testing in IND filing documents.
• Strong scientific and practical knowledge of general test methods for analyzing protein therapeutics including monoclonal antibodies and glycoproteins such as IEX, SEC, Labchip, N-glycan, HCP, Pro A, DNA and cell-based assays.
• Strong hands on experience in the development, validation and transfer of analytical methods for biological products, especially in cGMP environment 
• Ability to conduct critical evaluation of scientific documentation and testing data
• Excellent written and verbal communication skills
• Excellent collaboration skills and experience working in cross functional teams
• Ability to motivate employees and build team morale
• Support employees, executing against established guidelines and common procedures and policies
• Coordinate, organize and assign daily activities of operations
• Ability to identify problems and escalate accordingly
• Continuously drive to improve processes for improved performance

Qualifications: BS in Pharmaceutical Sciences with 6 years of Experience 

• Active membership of the RSC at MSRC level and evidence of pro-active continuing professional development
• Good analytical knowledge for a range of active substances found in consumer products, for example caffeine, theanine, taurine
• Demonstrable competency in the chemical analysis of natural extracts and related products is a primary requirement and experience of working in an ISO 17025 accredited and/or GLP compliant environment 
• Skilled use and understanding of preparative and instrumental techniques applicable to the isolation and measurement of the physical properties of, or trace level analytes in complex matrices
• Relevant technical experience resulting in thorough knowledge and application of best analytical method development and validation using complex instrumental analysis techniques (e.g. GC/MS, GC/MS/MS, HPLC/MS, HPLC/MS/MS, ICP/MS) with associated high-level problem-solving skills
• Experience of project management system i.e. PRINCE2
• Ability to influence and communicate across the team and within the RandD
• Creative, flexible, receptive to change, focused and able to deliver
• Ability to analyze and identify trends.
• Develop and deliver effective presentations
• Strong written communication
• Ability to work in an ever-changing environment
• Critical thinking skills

Qualifications: BS in Biotechnology with 4 years of Experience 

• Experience working in an analytical laboratory in an industry setting.
• Extensive hands-on experience with a variety of modern analytical techniques including GC, GCMS, HPLC, LCMS, and UV spectroscopy.
• Broad knowledge and experience with small molecule analytical development and a strong ability to troubleshoot technical problems.
• Additional analytical experience with large molecules including proteins and peptides.
• Team player with the ability to work under own initiative.
• Strong organizational, data analysis, communication, interpersonal, and written skills.
• Experience with writing and reviewing SOPs.
• Critical thinking and problem-solving skills along with multitasking.
• Experience with LC/Q-TOF MS and ICP-OES/MS.
• Previous hands-on experience with automation equipment.

Qualifications: BA in Environmental Science with 5 years of Experience 

• Advanced knowledge and hands-on practical experience with the operation and troubleshooting of analytical instrumentation spanning (HPLC, IC, GC, LC-MS, GC-MS, NMR)
• Experience working in a chemical/gas manufacturing industry or related industry
• Experience in the chemical analysis of complex matrices and air and moisture sensitive material 
• Knowledge of proper safe handling/disposal of chemicals and ability to maintain a clean and safe workspace 
• Experience with applicable quality tools such as Pareto, FMEA’s, SPC/SQC, histograms, trend analysis, process mapping, design of experiments, cause and effect diagrams, 8D problem-solving methodology.
• Experience in pharmaceutical drug product development.
• Strong technical problem-solving skills and advanced knowledge of regulatory requirements in drug product development along
• Excellent communication and interpersonal skills 
• Experience leading scientific staff.
• Some experience in large molecule development (i.e. peptides, nucleotides), dissolution characterization, and knowledge in statistical data processing

Qualifications: BS in Materials Science with 2 years of Experience 

• Work effectively in a dynamic and high-stress environment while eagerly tackling unexpected challenges.
• Expert knowledge of analytical testing of small molecules including HPLC, LCMS, dissolution, GC, KF, DSC, including data processing and reporting software
• A demonstrated ability to work independently and utilize practical knowledge of liquid chromatography and mass spectrometry to solve problems
• Understanding of organic chemistry principles, degradation pathways, impurity identification, process chemistry, and pharmaceutical development
• Working knowledge of ICH guidance documents, and GMP requirements
• Significant experience in a GMP manufacturing environment
• Theoretical and practical knowledge of method development and validation principles
• Good documentation practices (GDP)
• Enthusiasm in science with a motivation for making contributions in a team environment
• Strong leadership ability, exceptional communication, and interpersonal skills are able to work in a dynamic environment and prioritize work as assigned
• Highly motivated and self-directed, detail-oriented and schedule-driven
• Strong analytical and problem-solving skills

Qualifications: BA in Physics with 2 years of Experience 

• Thorough knowledge of all relevant ICH Guidelines and Pharmacopoeias
• Good knowledge/experience of analytical instrumentation and qualification procedures
• Transnational/international educational or work experience
• Experience working in an international team or with international clients 
• Knowledge of QbD principles in relation to Analytical Method Development & Validation
• Knowledge of basic statistics and experimental design
• Excellent decision-making and problem-solving skills
• Excellent planning and organizational skills
• Ability to work as part of a team and on own initiative
• Excellent verbal and written skills
• Knowledge and experience in GLP environments, experience with LC-MS 
• Experience with small molecules, transfer of analytical methods, and collaboration with CMOs 
• Excellent collaboration skills, be structured and reliable, and have the ability to stay calm and make the right decisions in a dynamic work environment. 
• A team player and have a feel for communicating essential information to the right stakeholders at the right time.

Qualifications: BS in Analytical Chemistry with 4 years of Experience 

• Experience in an industrial laboratory environment or other science labs
• Demonstrated experience in the development of methods for the analysis of pharmaceuticals, method validation, and understanding of the pharmaceutical product development process
• Demonstrated success working with regulatory and cGMP requirements
• Proven experience carrying out HPLC and using techniques for the analysis of proteins and enzymes.
• Proven experience working to GMP or ISO9001 regulations.
• Good understanding of bioanalytical processes used in the laboratory.
• Must demonstrate good computer skills, especially in the utilization of Microsoft Word, Excel, and analytical software.
• Knowledge of chromatography software.
• Experience in the regulatory context.
• Experience in managing analytical activities covering early-phase to late-phase clinical development. 
• Scientific experience in analytical development 

Qualifications: BA in Applied Mathematics with 7 years of Experience