Associate Chemist jobs at Eurofins - 381 jobs

NeilMed (Santa Rosa, CA) takes pride in delivering quality OTC products from development through manufacturing. We're looking for a Senior Microbiologist to join our team and be the subject-matter expert for microbiological control across our manufacturing, QC and operations functions. Responsibilities Lead and execute advanced microbiology testing of raw materials, in-process samples, finished goods, packaging materials, and utilities in support of OTC drug manufacturing. Drive and oversee the environmental monitoring program (clean-rooms, production areas, utilities) and ensure microbiological integrity of the manufacturing environment. Investigate microbiological failures and out-of-specification (OOS) results; perform root-cause analysis and lead corrective & preventive actions (CAPA). Develop/validate microbiological methods (e.g., microbial enumeration, microbial limits, preservative efficacy, endotoxin/bioburden, sterility if applicable) aligned with compendial standards (USP/EP) and regulatory requirements for OTC drugs. Write and review protocols, reports, deviations, CAPAs, trend analyses, change controls and SOPs relevant to microbiology. Collaborate closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D and Engineering to create and maintain microbiological control strategies across the product/process lifecycle. Monitor and analyze microbial trend data and recommend improvements to facility/processes for risk mitigation and continuous enhancement. Provide technical leadership and mentorship to junior microbiologists/technicians; promote a culture of excellence, data integrity and continuous improvement. Support internal audits, external inspections, supplier/contract-lab evaluations as required. Maintain strict adherence to cGMP, GLP, Good Documentation Practice (GDP), and data integrity standards in the lab and manufacturing environment. Qualifications Required: Bachelor's degree in Microbiology, Biology or a closely related science (Master's/PhD preferred). 5-10+ years' experience in microbiology within a pharmaceutical/OTC drug manufacturing environment (or similarly regulated manufacturing). Hands-on experience with microbiological methods: bioburden, endotoxin, sterility (if applicable), preservative efficacy, microbial identification, environmental monitoring (air, surfaces, utilities). Familiarity with 21 CFR 210/211, OTC monographs, FDA inspections, compendial guidelines such as USP, etc. Proven experience with method validation, protocol/report writing, deviation/CAPA investigations, trend analysis and root-cause resolution. Strong leadership, communication and interpersonal skills; ability to train and mentor team members and influence cross-functional stakeholders. Strong organizational skills, meticulous attention to detail, ability to prioritize tasks and meet manufacturing-driven timelines (including some flexibility for after-hours/weekend support). Proficiency with LIMS and statistical/data review tools; comfort working in a manufacturing laboratory environment with microbiological cultures, incubators, etc. Preferred Skills Experience in vertically-integrated manufacturing operations (raw material → finished goods) and understanding of upstream/downstream impact of microbiology. Demonstrated track record supporting regulatory inspections or audits (e.g., FDA). Experience working in an OTC or consumer health product environment. Strong analytical and problem-solving mindset; ability to influence process improvements based on microbial trend data. Self-starter attitude and ability to work autonomously within a cross-functional team in a fast-paced manufacturing setting. Pay range and compensation package We offer a competitive benefits package including medical/dental/vision. Retirement plan. Paid time off. Opportunities for professional development. 50k Life Insurance Policy (paid by Neilmed).

This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including overtime and/or weekends, may be required. Hours of Work: 8-hour shift Monday through Friday. 0600-1430 or 1400-2230. Safety and Responsibilities SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for filling operations. Responsible for acquiring and maintaining classified area gowning qualification. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Values and Behaviors Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. Required Qualifications and Education High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Preferred Skills Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability. 10am - until work is complete

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.

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Research Chemist (E&L) We are seeking an experienced Research Chemist (E&L) with a minimum of 3-5 years of pharmaceutical industry experience. Responsibilities: Maintain, operate, and troubleshoot LC-MS and GC-MS, GC-FID, and ICP-MS Systems. Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials associated with container closure systems of pharmaceutical drug products as per USP, PQRI, ICH and other regulatory guidelines. Develop and optimize sample preparation techniques for analysis on GC-MS, LC-MS, and ICP-MS systems. Develop and validate LC-MS, GC-MS, and ICP-MS methods for finished product and raw material characterization as well as extractable/leachable testing. Unknown impurity identifications using GC-MS, LC-MS, and LC-MS/MS or other suitable techniques. Interpret complex spectral data and fragmentation patterns. Routine stability testing of API, finished product samples for assay and impurities using various instrumental techniques as suited, and prepare stability data summaries. Generate study designs, write protocols, methods, Datasheets and reports. Provide support in the critical review of analytical data, reports and protocols. Write Instrument-related SOPs and provide training on the instrument and related software. Train new recruits in the lab and support the team as needed. Participate in internal meetings and conferences. Provide support during technical transfer between R&D and QC. Whenever needed, attend SOP, Safety, and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies. Preparation and review of analytical methods, method validation, and related study reports for ANDA/ NDA submissions and support, document preparation for ANDA/ NDA submissions. Any other activities as directed by the supervisor. Qualifications: Education/Experience: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. Knowledge, Skills, and Abilities: Familiarity with the characterization and isolation of impurities. Strong foundation in organic chemistry and structural elucidation, with expertise in small molecule pharmaceutical drug development and peptides, including computational techniques. Proficiency in using standard laboratory equipment, including pipettes, graduated cylinders, and balances. Skilled in laboratory techniques for measuring, weighing, and handling samples. Hands-on experience with HPLC (highly preferred). Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS). Competency in Microsoft Office applications. Experience or familiarity with current Good Manufacturing Practices (cGMP) is preferred. Requirements: Must live or be willing to move to the Sacramento Metropolitan Region (Approximately 40 miles' radius) Benefits: Pay range $70,000 - $85,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401 (k) savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment o retaliation based on any of these factors.

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.

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.

This position is responsible for support of CMC activities as well as working with Scientists and management for specific compound development at CritiTech in support of CritiTech product development and associated affiliates/partners for the global development and regulatory approval of New Chemical Entities (NCE's), Active Pharmaceutical Ingredients (APIs) and support of research and development of any/all product activities. RESPONSIBILITIES Participates in lab development in support of Chemistry, Manufacturing and Controls (CMC) section of NDA or SNDA by direction and interaction with Quality Operations/Regulatory Affairs and CritiTech. Provides analytical support for proof of concept studies, feasibility studies, routine manufacturing, and troubleshooting using CritiTech's Supercritical Precipitation equipment. Provides analytical support for proof of concept studies, feasibility studies, routine manufacturing, and troubleshooting using CritiTech's spray drying equipment. Perform production activities in support of clinical trials, including filling, environmental monitoring, visual inspection, and packaging of vials for further processing. Suggest changes and improvements to CritiTech's analytical services and product characterization, facilities, utilities, and other systems. Performs preventative maintenance and calibration checks on analytical equipment. Participates in the qualification of new equipment and facilities. Generates support data for CritiTech to be used in 3rd party development activities. Generates data in support of CMC documents, including out-of-specification (OOS) or deviation investigations, and helps execute action plans to meet sound scientific practices. Provides technical support for QO on complaint samples and manufacturing/packaging problems. Performs and assists in CritiTech compatibility and feasibility assessments for compounds being considered for development. Participate in the onsite review of data, facilities and laboratory operations of contract manufacturing and analytical laboratory. Suggests changes or edits to appropriate SOP's for CritiTech. Performs release and stability analytical testing with QO in the coordination and management of retest/expiration dating. Executes testing and lab work in support of technology transfer and stability protocols, stability packaging and manufacturing jobs for CritiTech activities. Other duties as assigned. EDUCATION, EXPERIENCE AND SKILLS Required BS in chemistry, biology, engineering or related pharmaceutical field with 3+ years industry background in pharmaceutical product development - or - MS in chemistry, biology, engineering or related pharmaceutical field with 2+ years industry background in pharmaceutical product development. 2+ years preparing and supporting CMC documentation for IND's and NDA's. Experience in working with people in a multi-disciplinary team environment. Preferred Advanced degree in chemistry or pharmacy or equivalent experience. Experience in pharmaceutics, analytical and organic chemistry. Experience in technology transfers to contract facilities. Experience with interactions with regulatory agencies. Experience in preparing and supporting Chemistry, Manufacturing and Control (CMC) documentation regulatory filings. KNOWLEDGE AND SKILLS Knowledgeable (including hands-on experience) in the use of analytical methods for active pharmaceutical ingredients and drug product (i.e. HPLC, GC, IR, etc.) and formulation development/manufacturing and the relation of these to overall pharmaceutical development. Knowledge and understanding of current Good Manufacturing Practices (cGMP) as well as other pertinent national regulations. Current knowledge of CMC regulatory and ICH guidelines. Knowledgeable in the overall drug development process. Knowledgeable in the application of compendia requirements and procedures to testing and developing pharmaceutical products. Leadership Skills - knowledge and interpersonal skills to help others towards the accomplishment of CritiTech's goals and objectives. Analytical and Problem-Solving Skills - ability to identify problems or opportunities using appropriate information; determines the causes and possible solutions to the problem. Teamwork - the ability to work well and manage personnel in a highly cross-functional team environment. Communication Skills - ability to express one's self clearly and concisely to CritiTech personnel over the phone or with others within the team; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience. Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement. Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, an deliverables through the use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use. Resource Management - ability to work with internal and external resources and to coordinate individual goals and objectives to align with business imperatives.

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.

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.

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. The Scientist I will perform analytical testing on various sample types using established methods and instrumentation, contributing to accurate and timely data generation in a laboratory setting. Compensation: $60,000.00 - 65,000.00 per year Job Responsibilities * Conduct chemical and/or physical analyses on environmental, pharmaceutical, or other relevant samples according to Standard Operating Procedures (SOPs) and client requirements. * Operate and maintain laboratory instrumentation, including but not limited to GC, LC, GC/MS, LC/MS, ICP, ICP/MS, and wet chemistry apparatus. * Prepare samples for analysis, including extractions, dilutions, and digestions, ensuring proper technique and documentation. * Interpret and report analytical results, maintaining accurate and detailed laboratory records, notebooks, and LIMS entries. * Troubleshoot analytical issues and instrument malfunctions, escalating complex problems to senior staff. * Adhere to all safety protocols, quality control procedures, and regulatory guidelines (e.g., GLP, GMP, ISO 17025). * Participate in instrument calibration, preventative maintenance, and method validation activities as assigned. * Collaborate with team members to optimize workflow and meet project deadlines. * Assist in the training of new laboratory personnel on basic analytical techniques and procedures. Job Qualifications * Bachelor's degree in Chemistry, Biochemistry, Environmental Science, Biology, or a related scientific field. * 2-3 years of experience in a laboratory setting, preferably in an analytical testing environment. * Basic understanding of analytical chemistry principles and laboratory techniques. * Familiarity with laboratory instrumentation and data acquisition software is a plus. * Strong attention to detail and ability to follow precise instructions and SOPs. * Excellent written and verbal communication skills. * Ability to work independently and as part of a team in a fast-paced environment. * Proficiency in Microsoft Office Suite (Word, Excel). * Ability to lift up to 25 pounds and stand for extended periods. 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.

Job Requisition Name Quality Analytical Chemist Job Requisition No VN8368 USA - Sarasota Worker Basis Full Time Worker Type Employee Contract Type Permanent Applications Close Date Mar 31, 2026 Purpose As a Quality Control Analytical Chemist, you will be responsible for performing analytical testing of incoming materials, in-process samples, and finished materials within a regulated medical device manufacturing environment. You will ensure that materials meet defined specifications and regulatory requirements through accurate chemical analysis, thorough documentation, and close collaboration with internal and external stakeholders. * Perform analytical testing of incoming, in-process, and finished materials using techniques such as HPLC, GC, FTIR, UV-Vis, pH, titration, and conductivity * Inspect materials visually and dimensionally and approve or reject them based on specifications and test results * Accurately document analytical results and quality data in quality systems and databases * Prepare and maintain Certificates of Analysis, Nonconformance Reports, and related quality documentation * Ensure compliance with GMP, ISO 13485, and FDA regulatory requirements * Support internal and external audits by providing analytical data and documentation * Collaborate with internal teams and suppliers on quality issues, root cause analysis, CAPA, and continuous improvement * Associate or Bachelor's degree in Chemistry, Chemical Engineering, or a related field * Minimum 3 years of experience in analytical testing or quality inspection within a regulated industry * Proficiency in analytical techniques and laboratory instruments such as HPLC, GC, FTIR, UV-Vis spectroscopy, pH measurement, titration, and conductivity testing * Strong understanding of GMP, ISO 13485, and FDA regulatory requirements * Ability to interpret technical drawings, specifications, and tolerances * High attention to detail with strong documentation and communication skills Preferred Skills * Knowledge of statistical process control (SPC) * Familiarity with risk management and validation protocols BVI is refocusing the future of vision. As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium IOLs), and spans more than 90 countries. We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept - taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus. Learn more at ******************

Shift: Monday through Friday, 8:00AM - 5:00PM 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. Make an impact. Build a career. At Pace , everything we do is built upon an unwavering commitment to making the world a safer, healthier place. We continually work to develop innovative practices that drive sustainability and empower our partners with accurate, quality data at every critical moment and milestone. That's why we need you - your curiosity, your talents, and your drive - to help us advance this important work, and your career. Find your place at Pace Join us as a Analytical Chemist, where you'll put your love of science to work in the Scientific Insourcing Solutions division. You'll receive all the training you need to successfully take on your new role and grow an exciting laboratory sciences career at Pace . A candidate for this role will support an organics laboratory in environmental services and equipment management. Compensation: $27.00 - 30.00 per hour NOTE: Location is Portsmouth, VA Responsibilities: Prepare chemical samples for analytical procedures (volatiles/non-volatiles) Conduct sample analysis using Gas Chromatography-Mass Spectrometry (GC-MS) and Gas Chromatography (GC) Clean, maintain, and calibrate laboratory instruments to ensure optimal performance Support the administration of air, water, and soil sample analysis using standard chemistry and biochemistry techniques Maintain accurate, detailed, and organized documentation of all laboratory activities and results Requirements: Minimum requirement: BS degree in Chemistry, Biology, Biochemistry, or a related degree 1-2 years of GC (Gas Chromatography) and ICP (Inductively Coupled Plasma) experience Able to handle multiple projects concurrently, self-motivated, and results driven Mechanically inclined with experience using common hand tools Proficiency in Office 365 and other software preferred Able to communicate effectively Excellent organizational and task management skills 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.

Pharma Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system. We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year. Join us as we embark on this breakthrough and become inspired to deliver. What is the role? The person in this role will develop analytical techniques and conduct experiments to support the development of commercially viable lipid-peptide and lipid-protein formulations. In addition, the person will support formulation development efforts. This role is crucial for advancing our CMC program for the Gates project, as well as establishing analytical capabilities and in expertise in our expanding portfolio, ensuring products meet rigorous quality and regulatory standards. The person will be hands on in the lab with strong technical knowledge in analytical science and will be mentored to assist in formulation development efforts. What are the key responsibilities? Analytical chemistry: Develop and optimization analytical methods for characterizing and controlling the quality the quality attributes of lipid-peptide and lipid-protein formulations. Support formulation development and design of experiment studies. Formulation science: Support formulation development efforts by participating in formulation runs with guidance form formulation science staff. Regulatory Compliance: Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs) Cross-Functional Collaboration: Work closely with formulation scientists and laboratory management staff, to integrate analytical development within overall project goals. Troubleshooting & Problem Solving: Address and resolve complex analytical issues during development and manufacturing. Continuous Improvement: Stay updated on advancements in analytical techniques and industry trends. What Education and Experience are required? A degree in Chemistry, Analytical chemistry, Biochemistry or related field. 2-5 years of experience in analytical development or quality control. Experience in lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus. Experience in technical writing is required. Authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a plus. Knowledge and experience in drug-device development, inhalation drug delivery is a plus. Excellent written and oral communication skills. What key skills will make you great at the role? Technical expertise: Proficiency in analytical techniques such as UHPLC, mass spectrometry and CAD as they apply to lipid characterization methods. Experience with drug-device combination products is a plus. Understanding of laboratory procedures, equipment, software, and data analysis. Data-driven decisions: Use lab data to make informed decisions about operations, budget, and performance. Problem-solving and strategic thinking: Quickly and effectively address challenges, from equipment malfunctions to staffing issues. Develop clear strategies and plans to achieve the lab's objectives. Collaboration and adaptability: Foster a collaborative environment where teams can work together seamlessly. Work well under pressure and adapt to changing priorities in a fast-paced environment. Compliance and safety: Ensure a safe and complaint work environment. Training, procedures, quality: Ensure up to date training on procedures and best practices. Ensure the lab meets all relevant quality standards and documentation requirements. Why Aerogen Pharma? As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.

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.

This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including overtime and/or weekends, may be required. Hours of Work: Tuesday to Friday, 3 PM to 1:30 AM Safety and Responsibilities SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for filling operations. Responsible for acquiring and maintaining classified area gowning qualification. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Values and Behaviors Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. Required Qualifications and Education High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Preferred Skills Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability.