Chemist jobs at Aurobindo Pharma USA - 77 jobs

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Scientist 3 - Third Shift Analytical Chemist Pilot Plant position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. Description The Scientist III Third Shift - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client. Responsibilities Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data Experience with automated liquid handling systems (Tecan) for high throughput testing Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. Qualifications BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab Desired Skills and Experience Effective organizational, multi-tasking, and oral/written communications skills Ability to work under pressure and provide reliable results with quick turnarounds Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily Proficient in written and spoken English, is required About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Scientist 3 - Analytical Chemist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship. Responsibilities General understanding of analytical method development and method validation Hands-on experience with chromatographic analysis using various ultra-high-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), and gas chromatography (GC) techniques General knowledge of separations science Experience with Empower chromatographic software and with analysis of drug formulations Hand-on experience with Fourier transform infrared (FTIR) spectroscopic analysis and ultraviolet-visible (UV-VIS) spectroscopic analysis Skilled on method and instrument troubleshooting, specifically for HPLC and GC methods and systems Required Skills Strong computer, scientific, and organizational skills Excellent organization to multi-task and manage multiple ongoing projects in parallel including routine testing (for example, assay and impurity testing) and data processing and interpretation Excellent communication (oral and written) and attention to detail Proficient in written and spoken English, is required Desired Skills and Experience Empower software Analysis of drug products Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude Qualifications BS degree and 3-5 years of relevant experience, or MS degree with at least 1-2 years relevant experience About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions. **This is a 2nd shift position; Hours are 3:00pm - 11:30pm | Monday - Friday** **Assistant/Associate Chemist** Performs chemical testing of moderate to advanced complexity within a Quality Control Laboratory in a safe, accurate, and efficient manner following established written procedures while maintaining complete and accurate records of the work and results. This testing is required for the release of raw materials, in-process materials, and final containers. This position will primary support the in-process testing groups. The in-process group is responsible for completing real time testing to directly support the manufacturing process. **Primary Responsibilities:** ● Conducts various routine and non-routine chemical testing (assays) according to procedure. Tests consists of both manual (preparing dilutions which are analyzed spectrophotometrically) and automated (chromatography, atomic absorption spectrophotometry, electrophoresis, etc.) assays. Instruments utilized in the laboratory include basic meters (pH meter, conductivity meters, chloride meters, etc.), Atomic Absorption Spectrophotometers, chromatography equipment (HPLC, GC and IC, which utilize Chromeleon and Waters software), electrophoresis (includes standard electrophoresis, capillary zone electrophoresis and agarose membrane electrophoresis) and moisture titrators (Karl Fischer). ● Follows the requirements of Grifols' Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP). ● Maintains complete and accurate records of work performed and test results. ● Calibrates equipment and performs equipment maintenance ● Performs non-routine duties, housekeeping duties, etc. as assigned ● Learns and follows the methods and the techniques of the chemical tests to be performed. This learning is a continuation of learning that occurred as Assistant Chemist. ● Performs assigned testing in an accurate and efficient manner. Keeps complete and accurate records of the work performed and results. ● Trains Assistant Chemists and other Associate Chemists in areas of this Associate Chemist's knowledge, experience, and expertise. ● May coordinate laboratory activities in the absence of the Laboratory Supervisor. ● Remains compliant with all applicable safety, environmental, regulatory, and training standards, goals, and objectives ● Supports development, validation, and revision of laboratory procedures as assigned ● Conducts all work with a focus on safety, quality, and timely throughput **Additional Responsibilities:** An Assistant Chemist participates in Quality Control studies (blind testing series, validation protocols, precision and accuracy studies) of the tests for which they are trained. Remains compliant with all applicable safety, environmental, regulatory, and training standards, goals, and objectives. Conducts all work with a focus on safety, quality, and timely throughput **Knowledge, Skills, Abilities:** The Assistant Chemist is expected to progress to a performance level requiring less direct supervision (either by the Laboratory Supervisor or the assigned Associate Chemist trainer). The Assistant Chemist position requires basic time/work management skills as the incumbent is expected to complete work assignments accurately and efficiently with only infrequent review by the Lab Supervisor. The Assistant Chemist is expected to have basic verbal and written communication skills. The Assistant Chemist is expected to maintain a professional relationship with peers, to be an effective member of the lab "team" working toward common goals, and to work well in a situation in which most equipment necessary to complete one's daily assignment is also used by others. **Education/Experience:** Assistant Chemist - An associate degree in chemistry or a related curriculum and a minimum of six months of applicable laboratory experience or a BS/BA degree in chemistry or related curriculum is required. Associate Chemist - The Associate Chemist position is normally a progression from the Assistant Chemist position in the Quality Assurance Chemistry Labs. Therefore, the Associate Chemist position also requires knowledge equivalent to a minimum of (2) two years of college level chemistry courses (one year of general chemistry course(s) with associated laboratory work, one or more courses in analytical quantitative chemistry with associated laboratory work, and some other chemistry course(s) with associated laboratory work). While the content of the course work specified above is generally applicable to the Associate Chemist position, the associated laboratory experience is more specifically applicable to the position's work assignments Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. ***Employee Referral Bonus Eligible*** **Location:** **NORTH AMERICA : USA : NC-Clayton** **:** **[[cust_building]]** Learn more about Grifols (************************************************* **Req ID:** 537861 **Type:** Regular Full-Time **Job Category:** OPERATIONAL TECHNICAL AREA

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions. This is a 2nd shift position; Hours are 3:00pm - 11:30pm | Monday - Friday Assistant/Associate Chemist Performs chemical testing of moderate to advanced complexity within a Quality Control Laboratory in a safe, accurate, and efficient manner following established written procedures while maintaining complete and accurate records of the work and results. This testing is required for the release of raw materials, in-process materials, and final containers. This position will primary support the in-process testing groups. The in-process group is responsible for completing real time testing to directly support the manufacturing process. Primary Responsibilities: ● Conducts various routine and non-routine chemical testing (assays) according to procedure. Tests consists of both manual (preparing dilutions which are analyzed spectrophotometrically) and automated (chromatography, atomic absorption spectrophotometry, electrophoresis, etc.) assays. Instruments utilized in the laboratory include basic meters (pH meter, conductivity meters, chloride meters, etc.), Atomic Absorption Spectrophotometers, chromatography equipment (HPLC, GC and IC, which utilize Chromeleon and Waters software), electrophoresis (includes standard electrophoresis, capillary zone electrophoresis and agarose membrane electrophoresis) and moisture titrators (Karl Fischer). ● Follows the requirements of Grifols' Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP). ● Maintains complete and accurate records of work performed and test results. ● Calibrates equipment and performs equipment maintenance ● Performs non-routine duties, housekeeping duties, etc. as assigned ● Learns and follows the methods and the techniques of the chemical tests to be performed. This learning is a continuation of learning that occurred as Assistant Chemist. ● Performs assigned testing in an accurate and efficient manner. Keeps complete and accurate records of the work performed and results. ● Trains Assistant Chemists and other Associate Chemists in areas of this Associate Chemist's knowledge, experience, and expertise. ● May coordinate laboratory activities in the absence of the Laboratory Supervisor. ● Remains compliant with all applicable safety, environmental, regulatory, and training standards, goals, and objectives ● Supports development, validation, and revision of laboratory procedures as assigned ● Conducts all work with a focus on safety, quality, and timely throughput Additional Responsibilities: An Assistant Chemist participates in Quality Control studies (blind testing series, validation protocols, precision and accuracy studies) of the tests for which they are trained. Remains compliant with all applicable safety, environmental, regulatory, and training standards, goals, and objectives. Conducts all work with a focus on safety, quality, and timely throughput Knowledge, Skills, Abilities: The Assistant Chemist is expected to progress to a performance level requiring less direct supervision (either by the Laboratory Supervisor or the assigned Associate Chemist trainer). The Assistant Chemist position requires basic time/work management skills as the incumbent is expected to complete work assignments accurately and efficiently with only infrequent review by the Lab Supervisor. The Assistant Chemist is expected to have basic verbal and written communication skills. The Assistant Chemist is expected to maintain a professional relationship with peers, to be an effective member of the lab "team" working toward common goals, and to work well in a situation in which most equipment necessary to complete one's daily assignment is also used by others. Education/Experience: Assistant Chemist - An associate degree in chemistry or a related curriculum and a minimum of six months of applicable laboratory experience or a BS/BA degree in chemistry or related curriculum is required. Associate Chemist - The Associate Chemist position is normally a progression from the Assistant Chemist position in the Quality Assurance Chemistry Labs. Therefore, the Associate Chemist position also requires knowledge equivalent to a minimum of (2) two years of college level chemistry courses (one year of general chemistry course(s) with associated laboratory work, one or more courses in analytical quantitative chemistry with associated laboratory work, and some other chemistry course(s) with associated laboratory work). While the content of the course work specified above is generally applicable to the Associate Chemist position, the associated laboratory experience is more specifically applicable to the position's work assignments Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. * Employee Referral Bonus Eligible* Location: NORTH AMERICA : USA : NC-Clayton:[[cust_building]]

The Analytical Chemist II is responsible for independently performing routine and non-routine analytical testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements. Under general supervision, the Analytical Chemist II will author standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior team members. **Position Summary** This position is 100% on-site at the Greenville site. Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. This role supports Catalent's Greenville, N.C. facility by performing complex analytical testing and method validation for oral solid dosage forms, ensuring product quality and regulatory compliance. It contributes to efficient formulation development and commercial manufacturing through accurate data analysis, documentation, and cross-functional collaboration. **The Role** + Independently perform routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for excipients, new chemical entities and/or drug products. + Compare laboratory data against specifications and trend data where applicable to determine if results meet requirements. + Interpret data and make recommendations to management for improvement or potential concerns. + Create report templates and/or enter data into established reports/templates or software-based systems. + With guidance, propose applicable specifications based on data obtained in support of certain programs. + Ensure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation. + Ensure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations. + Direct and assist in laboratory personnel training when required. + All other duties as assigned. **The Candidate** + Associate degree in Biotechnology, Chemistry or equivalent science degree with four years of professional experience in pharmaceutical analytical chemistry or; + BS or BA degree in a science-related field (e.g. Biology, Chemistry, Pharmaceutical Sciences) with three years of professional experience in pharmaceutical analytical chemistry or; + Master's degree in a science-related field with two years of professional experience in pharmaceutical analytical chemistry. + Two years HPLC and GC experience required. + Experience in a Catalent analytical laboratory in a role that is independent and proficient in chromatography and data review as well as troubleshooting and technical understanding may be substituted for two years of professional experience. + Position requires the ability to lift 10-50lbs, unassisted. + Majority of the work day is performed while standing, walking, lifting, pulling, and pushing. + Requires bending, squatting, crawling, climbing, and reaching. + Some exposure to hazardous chemicals and other active chemical ingredients. **Why You Should Join Catalent** + Competitive medical benefits and 401K + 152 hours of PTO + 8 Paid Holidays + Dynamic, fast-paced work environment + Opportunity to work on Continuous Improvement Processes **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Analytical Chemist I will primarily perform routine analytical testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements. This position is 100% on-site at the Greenville site. The Role Maintain data integrity and employ good documentation practices when performing experiments. Compare laboratory data against specifications and trend data where applicable to determine if results meet requirements. Ensure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation. Ensure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations. Under general supervision, perform primarily routine testing for chromatographic and spectrophotometric methods of analysis in support of pharmaceutical excipients, API and/or drug product. Testing can include but is not limited to assays (potencies, related substances, residual solvents, metals, etc.), rate of release (dissolution), moisture, identification, and other various wet chemistry-based measurements; HPLC and/or GC based methods are commonly employed along with titrations, UV and IR. Enter data into established reports/templates or software-based systems. All other duties as assigned. The Candidate Bachelor's degree a science-related discipline (e.g. Biology, Chemistry, Pharmaceutical Sciences) or; Associate degree in Biotechnology, Chemistry or equivalent science degree with one year of professional experience in pharmaceutical analytical chemistry. Experience in a Catalent analytical laboratory in a role that is independent and proficient in chromatography and data review as well as troubleshooting and technical understanding may be substituted for two years of professional experience. Position requires the ability to lift 10-50lbs, unassisted. Majority of the work day is performed while standing, walking, lifting, pulling, and pushing. Requires bending, squatting, crawling, climbing, and reaching. Some exposure to hazardous chemicals and other active chemical ingredients. Why You Should Work At Catalent Spearhead exciting and innovative projects Fast-paced, dynamic environment High visibility to members at all levels of the organization 152 hours of PTO + 8 paid holidays Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

The Analytical Chemist II is responsible for independently performing routine and non-routine analytical testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements. Under general supervision, the Analytical Chemist II will author standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior team members. Position Summary This position is 100% on-site at the Greenville site. Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. This role supports Catalent's Greenville, N.C. facility by performing complex analytical testing and method validation for oral solid dosage forms, ensuring product quality and regulatory compliance. It contributes to efficient formulation development and commercial manufacturing through accurate data analysis, documentation, and cross-functional collaboration. The Role Independently perform routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for excipients, new chemical entities and/or drug products. Compare laboratory data against specifications and trend data where applicable to determine if results meet requirements. Interpret data and make recommendations to management for improvement or potential concerns. Create report templates and/or enter data into established reports/templates or software-based systems. With guidance, propose applicable specifications based on data obtained in support of certain programs. Ensure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation. Ensure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations. Direct and assist in laboratory personnel training when required. All other duties as assigned. The Candidate Associate degree in Biotechnology, Chemistry or equivalent science degree with four years of professional experience in pharmaceutical analytical chemistry or; BS or BA degree in a science-related field (e.g. Biology, Chemistry, Pharmaceutical Sciences) with three years of professional experience in pharmaceutical analytical chemistry or; Master's degree in a science-related field with two years of professional experience in pharmaceutical analytical chemistry. Two years HPLC and GC experience required. Experience in a Catalent analytical laboratory in a role that is independent and proficient in chromatography and data review as well as troubleshooting and technical understanding may be substituted for two years of professional experience. Position requires the ability to lift 10-50lbs, unassisted. Majority of the work day is performed while standing, walking, lifting, pulling, and pushing. Requires bending, squatting, crawling, climbing, and reaching. Some exposure to hazardous chemicals and other active chemical ingredients. Why You Should Join Catalent Competitive medical benefits and 401K 152 hours of PTO + 8 Paid Holidays Dynamic, fast-paced work environment Opportunity to work on Continuous Improvement Processes Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

We are looking to fill a **Scientist 3 - Analytical Chemist** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.** **Responsibilities** + General understanding of analytical method development and method validation + Hands-on experience with chromatographic analysis using various ultra-high-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), and gas chromatography (GC) techniques + General knowledge of separations science + Experience with Empower chromatographic software and with analysis of drug formulations + Hand-on experience with Fourier transform infrared (FTIR) spectroscopic analysis and ultraviolet-visible (UV-VIS) spectroscopic analysis + Skilled on method and instrument troubleshooting, specifically for HPLC and GC methods and systems **Required Skills** + Strong computer, scientific, and organizational skills + Excellent organization to multi-task and manage multiple ongoing projects in parallel including routine testing (for example, assay and impurity testing) and data processing and interpretation + Excellent communication (oral and written) and attention to detail + Proficient in written and spoken English, is required **Desired Skills and Experience** + Empower software + Analysis of drug products + Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude **Qualifications** + BS degree and 3-5 years of relevant experience, or + MS degree with at least 1-2 years relevant experience **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are looking to fill a **Scientist 3 -** **Third Shift** **Analytical Chemist Pilot Plant** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ** . This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **Description** The Scientist III **Third Shift** - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client. **Responsibilities** + Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods + Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques + Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy + Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data + Experience with automated liquid handling systems (Tecan) for high throughput testing + Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab + MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab **Desired Skills and Experience** + Effective organizational, multi-tasking, and oral/written communications skills + Ability to work under pressure and provide reliable results with quick turnarounds + Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily + Proficient in written and spoken English, is required **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are looking to fill a **Scientist 3 -** **Third Shift** **Analytical Chemist Pilot Plant** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ** . This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **Description** The Scientist III **Third Shift** - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client. **Responsibilities** + Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods + Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques + Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy + Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data + Experience with automated liquid handling systems (Tecan) for high throughput testing + Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab + MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab **Desired Skills and Experience** + Effective organizational, multi-tasking, and oral/written communications skills + Ability to work under pressure and provide reliable results with quick turnarounds + Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily + Proficient in written and spoken English, is required **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are looking to fill a **Scientist 3 - Analytical Chemist** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.** **Responsibilities** + General understanding of analytical method development and method validation + Hands-on experience with chromatographic analysis using various ultra-high-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), and gas chromatography (GC) techniques + General knowledge of separations science + Experience with Empower chromatographic software and with analysis of drug formulations + Hand-on experience with Fourier transform infrared (FTIR) spectroscopic analysis and ultraviolet-visible (UV-VIS) spectroscopic analysis + Skilled on method and instrument troubleshooting, specifically for HPLC and GC methods and systems **Required Skills** + Strong computer, scientific, and organizational skills + Excellent organization to multi-task and manage multiple ongoing projects in parallel including routine testing (for example, assay and impurity testing) and data processing and interpretation + Excellent communication (oral and written) and attention to detail + Proficient in written and spoken English, is required **Desired Skills and Experience** + Empower software + Analysis of drug products + Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude **Qualifications** + BS degree and 3-5 years of relevant experience, or + MS degree with at least 1-2 years relevant experience **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. Are you passionate about quality and precision in the lab? Join our team as a **QC Chemist** and play a key role in ensuring the highest standards across all departments. This is an exciting opportunity to contribute to method development, support critical QC activities, and drive continuous improvement in a dynamic environment. **Schedule:** 1st Shift: Monday - Friday, 7:30am - 4:00pm **Key Responsibilities** + Provide **analytical support** to all departments. + Assist with **regular QC activities** as needed. + Lead **method development** , including validation and documentation. + Prepare **concise and timely reports** for management on projects and routine activities. + Investigate and resolve **customer complaints** . + Support **technician training** initiatives. + Perform other duties as assigned. **Requirements** + Associate or Bachelors degree in **Chemistry** or a related field. + Hands-on **laboratory experience** . + Working knowledge of **cGMP** as it relates to lab activities. **Why Join Us?** + Be part of a collaborative team committed to excellence. + Opportunity to work on diverse projects and develop new methods. + Competitive compensation and benefits package. **Ready to make an impact? Apply today and help us uphold the highest standards of quality!** The presently-anticipated base compensation pay range for this position is $61,500 to $77,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. **Notice to Agency and Search Firm Representatives:** Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. Are you passionate about quality and precision in the lab? Join our team as a **QC Chemist** and play a key role in ensuring the highest standards across all departments. This is an exciting opportunity to contribute to method development, support critical QC activities, and drive continuous improvement in a dynamic environment. **Schedule:** 3rd Shift: Monday - Friday, 11:30pm - 8:00am **Key Responsibilities** + Provide **analytical support** to all departments. + Assist with **regular QC activities** as needed. + Lead **method development** , including validation and documentation. + Prepare **concise and timely reports** for management on projects and routine activities. + Investigate and resolve **customer complaints** . + Support **technician training** initiatives. + Perform other duties as assigned. **Requirements** + Associate or Bachelors degree in **Chemistry** or a related field. + Hands-on **laboratory experience** . + Working knowledge of **cGMP** as it relates to lab activities. **Why Join Us?** + Be part of a collaborative team committed to excellence. + Opportunity to work on diverse projects and develop new methods. + Competitive compensation and benefits package. **Ready to make an impact? Apply today and help us uphold the highest standards of quality!** The presently-anticipated base compensation pay range for this position is $61,500 to $77,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. **Notice to Agency and Search Firm Representatives:** Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Shift: Monday through Friday, 8:00 AM - 4:30 PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. Associate Scientist I - MS/MS Organic Position Summary: Contribute to the future of innovative therapeutics as an Associate Scientist I in the Organic Spectroscopy group at Pace Life Science's location in Morrisville, NC. The Organic Spectroscopy group performs analyses via a variety of techniques to support our customers' development and manufacture of life-saving medicines. Types of testing conducted by the group include, but are not limited to, nuclear magnetic resonance (NMR), mass spectrometry (MS), high-performance liquid chromatography coupled with mass spectrometry (HPLC-MS or LC-MS), Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), thermal gravitational analysis (TGA), and ultraviolet spectroscopy (UV). Our group has a commitment to continuous improvement and growth of our team members. Our philosophy is that we work together as a team to deliver on-time, high-quality results for our customers and, ultimately, the patient. The nature of our work provides a clear view of how our work matters to help patients live healthier, longer lives. This role offers hands-on experience with advanced techniques and instrumentation with opportunities to grow. Compensation: $23.00 - 25.00 per hour The Role Prepares and analyzes samples according to established procedures. Executes laboratory workplans/schedules and completes work within the expected timelines. Maintains high quality laboratory documentation in accordance with applicable regulatory guidance and SOPs. May draft technical documents such as methods or certificates of analysis. Executes efficiency improvement projects with guidance. Identifies and recommends continuous improvement opportunities. Proactively addresses work issues at both an individual and team level. Required Qualifications Bachelor's degree in chemistry, biochemistry, or closely related field (or equivalent experience). Understanding of standard chemical testing techniques and instrumentation. Ability to learn and retain technical information. Competence in interpreting a variety of instructions furnished in written, oral, diagram, or schedule form. Basic understanding of instrument operations and troubleshooting skills in multiple techniques. Proficiency in standard software (Word, Excel, Outlook). Correct business English, including spelling, grammar, and punctuation. Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. Preferred Qualifications Though not required, special consideration will be given to candidates with any of the following experience: Working under GMP guidelines Experience with instrumental techniques such as NMR, GC-MS, LC-MS, FTIR, UV, DSC, and TGA Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work. Benefits When you join Pace , you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft. Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our Quality Control Department is growing and we have an opening for QC Analytical Senior Chemists I. This is a 1st shift position working Monday-Friday in our Monmouth Junction, NJ laboratories. The Senior Quality Control (QC) Analytical Chemist performs analytical testing of raw materials, packaging components, in-process (IP), finished product (FP), stability samples (ST), analytical method transfers and method verifications following analytical methods, United States Pharmacopeia (USP)/National Formulary Chapters, protocols, Standard Operating Procedures (SOPs) under current Good Manufacturing Practices (cGMPs) and company policies. The incumbent is also responsible for training/ mentoring junior chemists, performing laboratory investigations and root cause determinations, initiating and drafting investigations, SOPs and revising analytical methods etc. Collaborating closely with, and under the direct supervision of Team Leads, and QC Managers, she/he develops and demonstrates advanced analytical knowledge and expertise while carrying out laboratory work to support QC activities and performs special projects, as assigned ESSENTIAL FUNCTIONS * Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws * Performs testing of raw materials, in-process (IP), finished products (FP) and/or stability sample (ST) samples including dissolution, assay, content/blend uniformity, particle size distribution and other tests according to the analytical methods, USP procedures in a regulated laboratory environment. * Performs analytical method transfers and method verifications * Analyzes and interprets test results * Operates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra-Red Spectroscopy (IR), Atomic Absorption (AA), Thin Layer Chromatography (TLC) and dissolution apparatus (Distek) * Assists with the identification and troubleshooting of problems with instrumentation and analytical preparations * Complies with all company policies and procedures, including safety rules and regulations * Adheres to GMPs and current Good Documentation Practices (GDPs) * Hands-on experience with analytical instrumentation (i.e., UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical or biotechnology setting * Strong hands-on experience performing and interpreting Related Compounds analysis (Impurity analysis) * Demonstrated ability to apply good laboratory techniques while maintaining efficiencies required in a QC lab Requirements Minimum education and years of relevant work experience: Senior Chemist I - Bachelors degree in Chemistry or related science field and minimum 4 years lab experience in a cGMP related industry in positions of increasing technical responsibility. Special knowledge or skills needed and/or licenses or certificates required: * In-depth, hands on experience with analytical instrumentation (i.e., UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical or biotechnology setting * In-depth, hands on experience performing and interpreting analytical results and performing laboratory investigations * In-depth, hands on experience with analytical method verifications and method transfers * Demonstrated ability to apply good laboratory techniques while maintaining the efficiencies required in QC lab * Proficiency with Microsoft Office * Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members * Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines * Planning, organization and time management skills including the ability to support and prioritize multiple projects * Fluent in English (verbal and written) * Ability and/or experience training and mentoring lower level chemists * Ability and willingness to work additional hours as required by business needs * Excellent ability to identify and distinguish colors Special knowledge or skills needed and/or licenses or certificates preferred: * Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), cGMPs, and SOPs regulatory rules, regulations and guidelines * Proficiency with Empower software * Experience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis and documentation practices and procedures Travel requirements: 0% Physical requirements: * Laboratory based position * Ability to lift up to 30 lbs * Ability to use Personal Protective Equipment (PPE) * Ability to stand for extended periods of time QC Analytical Senior Chemist I Anticipated Salary range: $85-100k Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, all full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-onsite

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our Quality Control Department is growing and we have openings for QC Analytical Chemists at various levels requiring multiple levels of experience. Title and salary commensurate with experience. These are 1st shift position working Monday-Friday in our Monmouth Junction, NJ laboratories. ESSENTIAL FUNCTIONS * Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws * Performs testing of raw materials, in-process (IP), finished products (FP) and/or stability sample (ST) samples including dissolution, assay, content/blend uniformity, particle size distribution and other tests according to the analytical methods, USP procedures in a regulated laboratory environment. Chemist I also performs analytical method transfers and method verifications * Analyzes and interprets test results * Operates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra-Red Spectroscopy (IR), Atomic Absorption (AA), Thin Layer Chromatography (TLC) and dissolution apparatus (Distek) * Assists with the identification and troubleshooting of problems with instrumentation and analytical preparations * Complies with all company policies and procedures, including safety rules and regulations * Adheres to GMPs and current Good Documentation Practices (GDPs) Requirements Associate QC Analytical Chemist - Bachelors degree in Chemistry or related science field and 0-3 years lab experience in a cGMP related industry. * Hands-on experience with analytical instrumentation (i.e., UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical, biotechnology or academic setting Anticipated salary range: $60-65k/yr. QC Analytical Chemist I -Bachelor's Degree in Chemistry or related science field and minimum 1-5 years lab experience in a cGMP related industry. * Hands-on experience with analytical instrumentation (i.e., UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical or biotechnology setting * Strong hands-on experience performing and interpreting Related Compounds analysis (Impurity analysis) * Demonstrated ability to apply good laboratory techniques while maintaining efficiencies required in a QC lab Anticipated salary range: $65-75k/yr.. Chemist II - Bachelors degree in Chemistry or related science field and minimum 2-6 years lab experience in a cGMP related industry. Anticipated salary range: $75-85k/yr. Chemist III - Bachelors degree in Chemistry or related science field and minimum 3-7 years lab experience in a cGMP related industry. Anticipated salary range: $80-90k/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, all full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-onsite

Job SummaryA Scientist II in Quality Control Microbiology displays an advanced knowledge in microbiological test methods, instrumentation and guides others in routine test methods. A Scientist II participates in the mentoring and training of less experienced analysts in the group. The QC Microbiology department contains four main functional groups. The principal activities vary slightly between the groups. Hourly Range: $29.31 - $41.20 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities Understands department priorities and importance of planning ahead. Performs peer review of data for accuracy, completeness and conformance to specifications. Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department including discrepancies and out of limit conditions. Be able to articulate work related issues clearly and effectively to management and peers. Maintains knowledge of cGMPs and GLPs. Maintains knowledge of current compendial methods. Teach or coordinate teaching of training modules and laboratory techniques to new analysts Assists in authoring basic investigative studies (OOS, OOT, OOL) and other necessary documents for the Quality Control Microbiology department. Supports senior personnel in various projects including investigations, special testing and project work. Investigates deviations from SOP requirements as directed by supervision for potential impact to product and materials and derives root cause of the incident. Investigates nonconforming test results including environmental monitoring for product impact, root cause, and evaluates results to provide conclusions and appropriate corrective action. Identifies additional testing to be performed to resolve these issues in a timely manner. Generates and updates SOPs for microbiology test procedures. Updates and keeps others current. Trains new department personnel in related SOPs. Ensures safety related polices are adhered and makes recommendations to enhance or improve safety policies. Responsible for all aspects of maintenance of equipment and calibrations not performed by metrology or maintenance departments. Performs other duties as assigned. Environmental Monitoring Schedules, initiates, coordinates, performs routine and non-routine environmental monitoring according to established procedures. Must be organized to coordinate activities of multiple filling rooms and associated personnel. Assess environmental conditions using various methods to sample environment, water systems, compressed gas, and personnel in production areas and microbiology laboratory. Recognize out of limit results and initiate OOL investigations. Must successfully execute requirements to achieve ISO Class 5 gowning certification. Processes paperwork, LIMS input and approvals for release by QA Critical Systems. Advanced working knowledge of KabiTrack and recording OOL events. Investigate environmental OOL excursions. Coordinate responses and actions associated with environmental issues Maintain good housekeeping of laboratory areas, environmental chambers and maintain inventory of test media, reagents as assigned. Completes activities required for microbial identification including sub-culture, Gram staining, proper culture maintenance and processing for outside laboratory identification. Assists in training manufacturing personnel in required aseptic techniques, and gowning techniques as assigned by supervisor. Responsible for coordinating the timely completion of routine and project testing. Processes and completes data collection for all critical systems release. Process data and recognize issues and be instrumental in escalating associated results with unexpected results or trending. Finished Products Testing Schedules, initiates, coordinates, performs routine testing of in-process, finished product, raw material. Responsible for coordination and collection of samples for annual testing requirements for component testing. Assures timely testing and result reporting for stability samples. Conduct environmental monitoring during bioburden testing and sterility testing (SKAN isolators) Completes activities required for microbial identification including sub-culture, Gram staining, proper culture maintenance and processing for outside laboratory identification. Maintains testing equipment and coordinates requalification, preventative maintenance and calibration as needed Processes paperwork, LIMS input and approvals for release by QA. Provides data for annual product reviews, investigational requests and validation studies Validations Develops and Validates Microbiological test methods for all new products, including APIs, In-process and Finished Products. Performs studies needed to support incoming new products into the company, justification methods for new stoppers and vials, PFBB validation, raw material bioburden/Bacterial Endotoxin method validations and finished products. Responsible for routine testing of in-process and finished product samples on exhibit/ Process validation batches. Reviews and approves testing results of procedures performed in the department. Writes and revises standard operating procedures (SOP). Develops study protocols to validate production and laboratory methods. Provides support for plant and Lab equipment requalification studies. Supports Tech Transfer's process validation protocols. Performs microbiological testing for product process validation studies. Bacterial Filter Retention (BFR) Laboratory Authors and executes BFR study protocols per established procedures to validate sterilizing grade filters used in manufacturing aseptic fill process of procures Responsible for performing routine testing of validation activities includes viability, spike-flush and filter compatibility studies. Prepares microbial suspensions, media and reagents as needed. Monitors environmental conditions in the laboratory. Reviews and approves testing results of peer work. Assists with laboratory qualification and requalification studies as needed. Reviews standard operating procedures updates related to BFR. Assists investigation of nonconforming test results for validation impact, root cause and strives to derive proper root causes and applicable CAPA's. Maintains laboratory equipment and coordinates preventive maintenance, calibration and requalification REQUIREMENTS Bachelor of Science degree in a biological science with 3-6 years progressive laboratory experience. Equivalent combination of education and experience accepted. Excellent verbal and written communication skills are essential. Planning and organizational skills necessary for primary responsibilities. Must successfully execute requirements to achieve ISO 5 environment gown certification as required by supervision. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our AR&D lab is located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced TEMPORARY Analytical Research and Development Scientist III. This is a temp to possible permanent position. Summary The Analytical Research and Development (ARD) Scientist III, under guidance, performs laboratory analyses of raw materials, in process (IP), finished product (FP) and stability (ST) samples, as well as maintenance and calibration of analytical instruments. The incumbent also executes physical characterization studies to facilitate product understanding and performs technical and specialized analytical tasks, conducts research on assigned problems and studies to support product development, method development and technical investigations. She/he supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations. The incumbent also assists and trains lower-level scientists. ESSENTIAL FUNCTIONS Primary duties/responsibilities · Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs), and state, federal and local laws · Sets up and operates analytical instruments (i.e., High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet Visible spectroscopy (UV/Vis), Infra-Red Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, Inductively Coupled Plasma Mass spectrometry (ICP-MS), dissolution apparatus, etc.) to support sample testing · Performs all laboratory analyses of raw materials, IP, FP and ST samples; Prepares standard and sample solutions as required by the test methods. · Performs wet chemistry tests such as Limit of Detection (LOD), pH and titration · Performs physical tests and studies (i.e., particle size, viscosity, density, rheological measurements, microscopies and thermal analysis) · Performs all necessary calculations associated with test analyses · Designs and executes pre-formulation studies (i.e., pH solubility, pH stability and excipients compatibility studies) in collaboration with Product Development (PD) department · Executes designed studies to support laboratory investigations · Performs non-routine testing such as method comparisons and evaluations · Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs) · Assists and trains lower-level scientists · Creates and reviews ARD SOPs as needed · Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and Good Manufacturing Practices (cGMPs) · Cleans and organizes ARD lab areas · Performs related duties, as assigned Requirements Requirements KNOWLEDGE/SKILLS/ABILITIES REQUIRED Minimum education and years of relevant work experience Bachelor's degree in Chemistry or related science field and minimum 8 years' experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR Master's degree in Chemistry or related science field and minimum 5 years' experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR PhD in Chemistry or related science field with 1-3 years' experience in analytical/method development or method validation in the pharmaceutical, biotechnology and/or academic research field. Special knowledge or skills needed and/or licenses or certificates required · Understanding of spectroscopic and chromatographic techniques and concepts · Hands on experience in setting up and operating multiple analytical instrumentation which may include: HPLC, UV/Vis, GC, TLC, ICP-MS and dissolution apparatus · Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements · Ability to perform analytical testing, calculations and data analysis · Ability to perform wet chemistry and physical characterization studies · Ability to train and mentor lower levels scientist · Proficiency with Microsoft Office · Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members · Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines · Planning, organization and time management skills including the ability to support and prioritize multiple projects · Fluent in English (verbal and written) Special knowledge or skills needed and/or licenses or certificates preferred · Proficiency with Empower software Travel requirements 0% Physical requirements Laboratory based position Ability to lift up to 30 lbs Ability to use Personal Protective Equipment (PPE) Ability to stand for extended periods of time Pay rate for temp- $45-55/per hour. Pay rate is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Anticipated salary range for permanent employee: $95k to $115k. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Benefits and bonus are not offered for temp employees. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Scientist 2 - Quality Control role performs routine analytical testing on raw materials, intermediate, and final products as well as in-process testing; performs data entry; draft deviations, and participates in OOS investigations for their testing. Ensures compliance with applicable Company SOPs and regulatory guidance's. This role will support our pilot plant and other work needed on the weekends. 3 days (12 hour shifts) - 36 hour weekly role with full benefits and shift differential pay on top of full time salary. Responsibilities Perform routine testing of raw materials, intermediate, and final products (may include stability) Provide support to the plant by performing in-process testing and analyzing cleaning samples. Maintain laboratory notebook. Ensure equipment is left in good working order after use. Perform laboratory upkeep (wash glassware, reorder supplies, check for expired chemicals). Draft their deviations. Be an active participant in their laboratory investigations. Qualifications/Skills Analytical Chemistry Knowledge: Some understanding of the principles of Analytical Chemistry or Quality Control Cross Discipline Knowledge: Early practical industry exposure to cross functional technical departments, including organic chemistry GMP/Regulatory Knowledge: With less manager supervision, able to better understand need for SOPs and basic regulatory guidance Instrumentation: Basic understanding of key analytical R&D equipment, can operate independently once instructed Communication: Good oral and written communication skills Problem Solving: May be asked to support peer-led laboratory investigation process with manager support Time Management: Ability to handle key assignments, with supervision Leadership: Shares ideas with peers Technical Documentation and Review: Ability to keep a good laboratory notebook and perform data entry, compliance with GDP External Influence: Ability to work within a matrix team Industry Credibility and Rapport: Willing to learn and grow within the local Cambrex Team Operational Excellence: Strives to engage in group/team improvement projects Change Orientation: Able to understand the importance of Cambrex initiatives Education, Experience & Licensing Requirements M. S. in Chemistry or related field or B. S. degree in Chemistry or related field with 2 years minimum experience, or Technical Degree with 4 years minimum experience, or High School Degree with 6 years minimum experience. Experience with and fundamental understanding of several of the following analytical technologies (* - most important): HPLC* FTIR* Titration Basic wet chemistry* NMR XRPD cKF Working knowledge of other analytical equipment common to the pharmaceutical industry This position works with and handles hazardous materials and wastes at Cambrex. This person has the appropriate qualifications to read, understand, apply and communicate written and verbal information regarding handling and managing hazardous wastes. He/She is also responsible for recognizing emergency situations concerning hazardous materials and wastes. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-RD1M. S. in Chemistry or related field or B. S. degree in Chemistry or related field with 2 years minimum experience, or Technical Degree with 4 years minimum experience, or High School Degree with 6 years minimum experience. Experience with and fundamental understanding of several of the following analytical technologies (* - most important): HPLC* FTIR* Titration Basic wet chemistry* NMR XRPD cKF Working knowledge of other analytical equipment common to the pharmaceutical industry Perform routine testing of raw materials, intermediate, and final products (may include stability) Provide support to the plant by performing in-process testing and analyzing cleaning samples. Maintain laboratory notebook. Ensure equipment is left in good working order after use. Perform laboratory upkeep (wash glassware, reorder supplies, check for expired chemicals). Draft their deviations. Be an active participant in their laboratory investigations.