Scientist jobs at Catalent Pharma Solutions - 1013 jobs

The role will be responsible for all operations involved with routine manufacturing and quality control testing of radiopharmaceuticals produced in Aktis' GMP laboratory (Boston, MA), including but not limited to the list below. This role will report to the Director of Clinical Trial Manufacturing. Salary Range: $136,800.00 To $189,200.00 Annually Responsibilities Manual and automated production of radiopharmaceuticals in a GMP facility QC testing of radiopharmaceuticals Execution and upkeep of the facilities' environmental monitoring program Accurate and timely preparation and completion of manufacturing and Quality control records (Batch Records, Forms, Logbooks, etc.) Process/analytical method validation for clinical manufacturing Operation and maintenance of equipment in the GMP facility Preparation of products for shipment to other sites Drafting, reviewing and updating GMP documentation including SOPs Upkeep and maintenance of inventory in the GMP Facility Maintenance of the GMP facility including assisting with radioactive waste stream management Perform contamination wipe tests and surveys Performing and maintenance of the facilities' environmental monitoring program Leading manufacturing process and analytical method qualification activities Contribute to writing CMC sections for submission to regulatory agencies Maintain KPI and internal reports Supporting external tech transfer activities Required Skills Proficient with aseptic operations and environmental monitoring Proficient with QC methodologies (HPLC, GC, MS, Gamma Spec, etc.) Proficient with assembly and interpretation of analytical data Expertise with troubleshooting analytical and production equipment High attention to detail and organizational skills to enable working in a fast-paced environment Ability to work in an ISO7 environment with full gowning Adhere to stringent cleanroom protocols and maintain a high level of hygiene Perform precise aseptic manipulations in a restrictive environment Awareness of FDA and EU GMP requirements Ability to lift 60lbs Expertise with GMP radiopharmaceutical manufacturing and quality control Minimum, B.Sc. with 10+ years or M.Sc. with 7+ years of experience in the pharma industry or equivalent research experience Comprehensive knowledge of GMP manufacturing and quality control workflows Excellent verbal, written, and organizational skills Strong desire to be part of a mission‐oriented company leading transformative change for patients Proven demonstration of transparent communication and fostering open and diverse debate Ability to work with agility and manage ambiguity Personifies positive energy and exemplifies respect #J-18808-Ljbffr

Principal Scientist, Innovation Management, Fremont CADescription As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Scientist, Innovation Management will act as a primary expert for upstream/drug substance development and manufacturing with a unique blend of expertise in biopharmaceutical upstream processes, digitalization, and data science. This role will identify and evaluate emerging technologies and companies that can enhance biopharmaceutical manufacturing. The incumbent will provide scientific and technical leadership to the team on both internal and external projects. Duties & Responsibilities Ensures direct report (intern & co-ops) safety, training, and supervision. Responsible for effective management of a team of technical experts. This is an individual contributor Role. Upstream/Drug Substance Development and Manufacturing: Leads the development and optimization of upstream processes for biopharmaceutical production. Oversees cell culture operations, including media development, bioreactor design, and scale-up processes. Ensures compliance with regulatory standards and quality control measures. Collaborates with cross-functional teams to integrate upstream processes with downstream and analytical development. Digitalization and Data Science: Implements digital tools and data analytics to enhance process understanding and control. Develops and applies predictive models for process optimization and troubleshooting. Utilizes machine learning and AI to drive continuous improvement in manufacturing processes. Manages data integrity and ensures robust data management practices. Scouting Technologies and Companies: Identifies and evaluates emerging technologies and companies that can enhance biopharmaceutical manufacturing. Conducts due diligence and feasibility assessments for potential technology acquisitions or partnerships. Collaborates with global teams to integrate new technologies into existing processes. Stays abreast of industry trends and advancements to maintain a competitive edge. Leadership and Team Collaboration: Provides scientific and technical leadership to the upstream development team. Mentors and develops team members, fostering a collaborative and high-performance culture. Manages project timelines, budgets, and resources effectively. Represents the company at industry conferences and scientific meetings. Requirements BS with ten-plus (10+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. OR MS with six-plus (6+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. OR PhD with three-plus (3+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. Thorough knowledge of biotechnology process development methodologies such as cell culture, aseptic techniques, bioreactor operation and development, column chromatography, filtration, and UFDF. Knowledge of GMP biopharmaceutical manufacturing, including process validation and commercial manufacturing support. Four-plus (4+) years' experience in late-stage process development preferred. Two-plus (2+) years' experience leading in a matrixed environment preferred. Two-plus (2+) years' experience in data science, Machine learning, and statistical analysis skills Excellent verbal and written communication skills. Good documentation and presentation skills. Proven skills building and maintaining productive relationships with organizational partners such as Manufacturing and Quality. Ability to troubleshoot and challenge status quo processes and influence in a team environment. Ability to communicate complex results (e.g. hybrid models) to both internal and external stakeholders. Eligibility Requirements Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Compensation Data This position offers a base salary typically between ($115,000) and ($181,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. Please reach out Talent Acquisition or your HR Business Partner for more information. #J-18808-Ljbffr

A leading global healthcare firm in San Diego is seeking a highly motivated scientist to contribute to biotherapeutics development. The successful candidate will discover and engineer antibodies, oversee experiments, and utilize various molecular biology techniques. Applicants should have at least 6 years of relevant experience and a strong background in flow cytometry. This position offers competitive compensation ranging from $110,250 to $187,000 along with comprehensive benefits. #J-18808-Ljbffr

A global healthcare leader in San Diego seeks a highly motivated scientist to contribute to the discovery and development of biotherapeutics. The role involves discovering and optimizing antibodies, utilizing flow cytometry, and requires strong skills in molecular biology and biochemistry. Ideal candidates should have significant industry experience and be detail-oriented, with excellent communication skills. Competitive compensation and benefits include a flexible benefits package and bonus potential. #J-18808-Ljbffr

Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role This role encompasses leading a descriptive sensory panel and maintaining an end-use market as a sensory lead. The position requires strong leadership, technical expertise in sensory science, and the ability to collaborate cross-functionally to support business objectives through high-quality sensory insights. Key responsibilities • Lead and manage a trained sensory panel of 8-16 individuals using the Spectrum Descriptive Analysis (SDA) method. • Develop and implement project-specific training and calibration plans. • Facilitate training, calibration, and testing sessions in compliance with SDA methodology. • Define and maintain reference materials for all attributes of interest. • Monitor and evaluate panel performance; address underperformance through retraining and recalibration. • Maintain panel size through recruitment, screening, and fit-for-purpose assessments. Sensory Testing & Methodology • Design and execute sensory testing using SDA, temporal, and discrimination methods. • Analyze data using relevant sensory software and interpret panel performance metrics. • Communicate findings to sensory leads and project stakeholders. Project Collaboration & Execution • Meet with stakeholders to understand business objectives and define sensory goals. • Collaborate with sensory project leads to select appropriate methodologies and testing logistics. • Coordinate with technicians and technologists to ensure timely preparation of test materials and references. Strategic Sensory Leadership • Act as the sensory lead for an end-use market, maintaining a pipeline of internal and customer-facing projects. • Design, organize, and execute sensory studies aligned with business objectives. • Analyze and interpret test results, providing actionable insights and next steps. • Stay current with sensory science developments and adopt new techniques to enhance capabilities. Qualifications and skills Skills & Competencies: • Expertise in sensory science, particularly descriptive analysis and SDA methodology. • Strong leadership and team management skills. • Proficiency in sensory data analysis tools and statistical interpretation. • Excellent communication skills for both technical and non-technical audiences. • Ability to collaborate across functions including R&D, marketing, and business development. Experience & Qualifications: • Bachelor's, Master's, or PhD in Food Science, Sensory Science, or a related field. • Prior experience leading and managing sensory panels is essential. • Experience with Spectrum Descriptive Analysis is highly preferred. • Familiarity with temporal and discrimination testing methods. • Occasional travel (approximately once a month) may be required for customer visits or panel-related activities. The typical hiring range for this role is $75,602 to $123,432 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements). Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov).

Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role Kerry is seeking a Research, Development and Application Senior Scientist for a key role supporting the growth of the North American Beverage market. This position is based at the KERRY Global Technology & Innovation Centre in Beloit, Wisconsin, USA, reporting to the RD&A Director/Manager and is responsible for executing on the business strategy by creating market relevant and differentiated products that meet the requirements of customers and consumers, utilizing Kerry's broad and industry leading portfolio of technologies. This role is part of a team of RD&A Scientists and Technicians that are responsible for the development of powder and liquid beverage concepts. Strong communication and leadership skills are critical as the day-to-day activities involve significant cross-functional collaboration with Flavorists, Nutrition Scientists, Regulatory, Marketing, Sales, and Finance. Key responsibilities Lead formulation and concept development from end-to-end on internal and customer projects within North America for the Beverage market. Use sound commercial and technical awareness of ingredients, processes, end use market and customer requirements to deliver on project objectives, across powder beverages and liquid beverage product formats. Develop innovative solutions to help grow customers and Kerry's market share within cost parameters and manufacturing capabilities while ensuring all new products are legal within country of use. Manage Pilot Plant validation work and facilitate first production trials of new products internally and with third part manufacturers. Build strong relationships with customer contacts via clear communication, on-site and virtual visits, presentations and supporting trials when required. Support sales and business representatives during customer calls through technical presentations and product demonstrations. Work within cross-functional teams to optimize the strengths of Kerry and deliver the best Taste and Nutrition experience for our customers. Study methods to improve quality of products such as flavour, colour, texture, nutritional value, as well as physical, chemical, and microbiological composition. Qualifications and skills BSc/MSc/PhD in Food Science, Food Engineering, or related field. 5+ years of hands-on experience in product development, preferably beverages products. Experience working with 'functional ingredients' is a plus - probiotics, adaptogens, botanical extracts, etc. Working knowledge of the beverage market in North America. Proven success in product development resulting in successful market launch. Curiosity and a willingness to push creative boundaries. Strong team-player, with excellent interpersonal, organizational, communication and project management skills. Knowledgeable about food chemistry, sensory, microbiology, food packaging systems and food engineering. The pay range for this position is 75,602- 123,432 in Annual Salary. Kerry typically does not hire an individual at the top or near the top of the range, as we are a pay-for-performance company, and this range is set to continue to reward performance annually while in role. Compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate within the above range may be influenced by a variety of factors including skills, qualifications, experience, and internal equity. Kerry offers a competitive benefits package, including medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, Employee Share Plan, Life, disability, and accident insurance, and tuition reimbursement. This job posting is anticipated to expire on Dec 27, 2025. Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov). Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.

Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role We are seeking a passionate and technically skilled Dairy Scientist to join our R&D team. In this role, you will leverage your expertise in dairy science, food technology, microbiology or related fields to develop, optimize, and support innovative dairy products and solutions. You will collaborate closely with cross-functional teams-including product development, process engineering, and commercial teams-to deliver high-quality, market-leading dairy flavors. Key responsibilities Develop and optimize flavor formulations for a variety of dairy products (e.g., yogurt, cheese, beverages, desserts) through the use of cultures, enzymes, materials and processes. Lead application trials and pilot plant runs to validate new concepts and processes. Collaborate with customers and internal teams to understand requirements and deliver tailored solutions. Troubleshoot formulation and processing challenges, providing technical support to both internal stakeholders and customers. Stay current with industry trends, new ingredients, and processing technologies relevant to dairy applications. Document and communicate findings, protocols, and recommendations clearly and effectively. Support commercialization efforts by scaling up successful prototypes and assisting with plant trials. Ensure all work complies with food safety, quality, and regulatory standards. Qualifications and skills Bachelor's or Master's degree in Food Science, Dairy Science, Chemical Engineering, Microbiology or a related field. 3+ years of experience in dairy product development or applications (internships and co-ops considered). Strong knowledge of dairy ingredients, processing technologies, and product functionality. Hands-on experience with pilot plant equipment and laboratory analysis. Excellent problem-solving skills and attention to detail. Strong communication and teamwork abilities. Ability to manage multiple projects and adapt to changing priorities. Willingness to travel as needed (up to 20%)} Experience working directly with customers or in a B2B environment. Familiarity with regulatory requirements for dairy products. The typical hiring range for this role is $91,311 to $149,080 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements). Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov). Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) This role will leverage high-throughput experimentation to drive process optimization, support automated impurity synthesis in process and library synthesis in collaboration with discovery, scale-up manufacturing and generate structured datasets to train AI models for predicting yield, selectivity etc. in process development. Essential Functions of the Job (Key responsibilities) * Execute high-throughput experimentation (HTE) to identify optimal reaction conditions for process development, enabling efficient, scalable, and robust chemical processes. * Operate and maintain HTE and automation equipment, ensuring daily functionality, troubleshooting issues, and coordinating timely repairs with vendors and service providers. * Participate in data integration out of HTE experiments into AI-driven modeling pipelines, continuously refining predictive models for reaction yield, selectivity virtual screening. * Participate in cross-functional collaboration with Process Chemistry, Discovery, QC, QA, and external partners. * Provide scale-up support for drug candidates in both non-GMP early development and cGMP clinical production, including route design, reaction optimization, and cost-effective manufacturing strategies. * Support technology transfer to Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) and review cGMP manufacturing documentation. Qualifications (Minimal acceptable level of education, work experience, and competency) * PhD in organic chemistry, or equivalent relevant industry experience. * Expertise in high-throughput experimentation (HTE), automation and workflows to support AI-driven modeling and decision-making. * Strong proficiency in synthetic organic chemistry, with deep understanding of reaction mechanisms and synthetic methodologies and a proven publication record. * Demonstrated excellence in problem-solving skills, with sound, technically driven decision-making ability. * Outstanding written and verbal communication skills and interpersonal skills. * An innovative team player with high energy for dynamic company environment. * On-site presence required. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact if you have any questions or concerns or would like to exercise your rights.

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview Perrig is currently hiring for an Associate R&D Process Scientist to lead scale-up of new infant formulas from development to full-scale production, overseeing change control, risk assessment, and factory trials while collaborating with cross-functional teams including Product Development, Pilot Plant, Operations, Quality, and Planning. Support manufacturing sites on continuous improvement opportunities in recipe and processing, driving optimization and renovation initiatives through root-cause analysis, cross-functional collaboration, and execution of cost-reduction strategies while ensuring compliance and operational excellence. Develop and implement new process capabilities via feasibility trials and continuous improvement projects to enhance efficiency, reduce costs, and improve overall product quality. Scope of the Role * Realize scale up / industrialization with Manufacturing and Quality departments. Manage change controls - review BOMs/formulations, host risk assessment meetings, setting up manufacturing forms or info, update block flow diagrams, review finished product nutrient data, recipe / process parameterization, support regulatory filings, etc * Support new process evaluations or co-man/pack capabilities or CAPEX projects for new equipments for Perrigo Nutrition business * Support manufacturing sites including root-cause analysis to address identified losses, optimize manufacturing / product quality issues, and support resolve of unscheduled downtime Experience Required * Bachelor's degree in Food or Dairy Science, Chemical or Food Engineering, Chemistry or closely related field preferred. * 1-3 years of experience in product and/or process development in the food industry or closely related is strongly preferred. * Experience in common food and dairy unit operations, infant formula manufacturing and knowledge of spray drying a plus. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about Total Rewards at Perrigo. Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo Nearest Major Market: Eau Claire

Groton, CT, USA Full-time ** Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. **Job Description** + Analysis of powder samples for key physical properties (such as particle size distribution, bulk density, true density, powder flow, particle shape) + Analysis of liquid samples for key physical properties (such as viscosity and surface tension) + Using techniques such as optical microscopy, laser diffraction particle size analysis, electron microscopy, shear cell testing, compaction simulation, etc. **Qualifications** + Bachelor's degree in chemistry or other science related degree concentration, or equivalent directly-related experience + At least one year experience in particle and powder characterization + Strong computer, scientific, and organizational skills + Proficient in learning new techniques, developing and carrying out experimental plans, and performing multiple tasks simultaneously + Experience in data handling and scientific/engineering computations + Excellent communication (oral and written) and attention to detail + Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude + Ability to keep accurate records, follow instructions, and comply with company policies + At least one year experience in particle and powder characterization **Additional Information** + Position is full-time, Monday - Friday 8am to 5 pm + Ability to work overtime as required. + Tasks require repetitive motion and standing for long periods of time. + May be required to respond to off-shift operational issues. + Candidates currently living within a commutable distance of **Groton, CT** are encouraged to apply. + Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options + Life and disability insurance + 401(k) with company match + Paid vacation and holidays + **\#LI-EB1** + Authorization to work in the United States indefinitely without restriction or sponsorship **Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**

Introduction to role Join our dynamic Waltham team within Biologics Engineering, where innovation meets dedication. As part of a global organization, we are committed to discovering and optimizing next-generation biologics across key therapeutic areas. Our mission is to push the boundaries of science and creativity, delivering life-changing medicines to patients. Are you ready to contribute to groundbreaking biologics discovery platforms and novel drug modalities that address unmet medical needs? Accountabilities As a Scientist in our Waltham, MA team, you will play a crucial role in executing well-validated SOPs for high-throughput antibody production and purification. Your focus will be on delivering microgram-to-milligram quantities of antibody therapeutics efficiently and reliably. You will manage scheduled production campaigns, ensure instrumentation readiness, perform routine QC, and compile comprehensive data packages for project teams. Essential Skills/Experience Master's degree with 1+ years of experience in antibody expression/purification, UPLC, or molecular biology Bachelor's degree with 3+ years of experience in antibody expression/purification, UPLC, or molecular biology Demonstrated experience executing standardized high-throughput expression and purification workflows for antibodies or antibody-like proteins at microgram-to-milligram scale. Hands-on operation of liquid handlers (Hamilton or Lynx preferred) using validated methods with integrated automation platforms (Biosero/Green Button Go) a plus. Proficiency in mammalian cell culture (CHO and HEK293), aseptic technique, and transient expression. Experience with sample tracking and laboratory logistics/LIMS software; comfort with barcode-driven workflows. Ability to plan production runs, manage consumables, and meet deadlines in a fast-paced environment. Strong attention to detail, documentation rigor, and adherence to SOPs and QC acceptance criteria. Effective communication and collaboration across cross-functional teams. Desirable Skills/Experience Working knowledge of protein purification technologies and common analytical methods (e.g., SEC-UPLC, LC-MS, SDS-PAGE, CE). Familiarity with lab automation scheduling software; Green Button Go preferred. Basic scripting for data handling (e.g., Python, Jupyter) is a plus, not required. Exposure to imaging or flow cytometry platforms and analysis tools (iQue, Attune, FlowJo) is beneficial for specific assays but not central to the role. AstraZeneca offers an inspiring environment where you can apply your expertise in new ways. We thrive on change and embrace the unknowns, taking calculated risks to deliver new medicines to patients. Our collaborative approach encourages learning from diverse minds, pushing boundaries to find innovative solutions. Here, every challenge is an opportunity for growth, supported by leaders who empower you to make a tangible difference in society. Why AstraZeneca? At AstraZeneca, we push the boundaries of science to deliver life-changing medicines. You'll be part of a globally connected team working at the forefront of innovation-driving advances that impact patients around the world. With a strong emphasis on collaboration, continuous improvement, and scientific excellence, this is your opportunity to lead a team that makes a real difference. Diversity and Inclusion at AstraZeneca We believe that diversity drives innovation. AstraZeneca is committed to building an inclusive culture that celebrates diverse perspectives and fosters belonging. We welcome all qualified applicants and ensure compliance with applicable laws regarding inclusivity and employment eligibility. Individuals with disabilities can request reasonable accommodations throughout the recruitment process. Ready to make an impact? Apply now and join us in our mission to transform patient lives through scientific innovation! The annual base pay (or hourly rate of compensation) for this position ranges from $ 87,200 to $ 130,800. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans Date Posted 15-Jan-2026 Closing Date 20-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us. Hybrid Employee Value Proposition: At Taiho Oncology, we are dedicated to transforming the landscape of cancer treatment and improving patients' lives. As an Associate Director, Clinical Research Scientist, you will play a pivotal role in our mission, leveraging your expertise to drive innovative clinical research and contribute to groundbreaking therapies. We offer a collaborative and inclusive work environment where your ideas and contributions are valued. Join us to advance your career, work with passionate and skilled professionals, and make a meaningful impact on the fight against cancer. At Taiho Oncology, you will find purpose, growth, and the opportunity to be at the forefront of cancer research. Position Summary: The Associate Director, Clinical Research Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3. Additionally, this role serves in assisting the responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, as needed. Performance Objectives: Uses medical/scientific expertise to support the creation of relevant clinical documents of high quality such as study concepts, study protocols, amendments, study reports and investigator brochures. At the asset level, assists the medical lead in the preparations of the clinical content of regulatory submissions/documents (e. g. NDA, MAA, IND, CTA. sNDA, DSUR, PIP, health authority/ethics committee responses, briefing packages). Works with the medical lead to prepare presentations (internal and external), abstracts, manuscripts. Inputs into the of ICF/reviews ICF. Works with data management on CRF design and completion guide. Partners with data management to develop data review plan for review of data and with medical lead for the medical monitoring plan. Reviews protocol deviations, patient eligibility, and patient level and cumulative data per the data review plan across a study, raises queries and coordinates with the medical lead. Reviews safety data with the medical lead, SAE reports (in collaboration with pharmacovigilance), labs, efficacy data, dosing data, withdrawals/discontinuations. Collaborates with the medical lead to provide medical/scientific guidance during the execution of the study. Ensures TMF compliance for clinical development/medical study level TMF documents. Answers specific site protocol questions as needed, after consultation with the medical lead. Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, vendor / CRO staff, in collaboration with the medical lead. Escalates protocol-related issues requiring complex medical expertise to the medical lead, and operational issues to the appropriate operations study team member. Reviews the SAP and statistical outputs, in collaboration with the statistician, medical writer, and medical lead. Education/Certification Requirements: PhD, PharmD or other related Advanced Medical Scientific Degree. Experience in oncology is a must. Knowledge, Skills, and Abilities: At least 3 years in drug development industry in oncology and with previous exposure to clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents. Ability to critically review and interpret Clinical data. Working knowledge of the drug development process in the USA and EU is required. Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members. The pay range for this position at commencement of employment is expected to be between $213,350 - $251,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment. 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. #LI-Hybrid

Clinical Diagnostic Solutions, Inc. (CDS) is a company that provides total hematology solutions for the physician office laboratory, clinic, small hospital, and veterinary office markets. At CDS, our mission is to provide the highest quality experience to our valued customers. Our employees achieve this through our cultural goals of working together through Teamwork, high Quality in the work we do, being Innovative and Courageous, always Results Oriented, and most importantly - being Customer Oriented. Under supervision, uses fundamental concepts, practices, and procedures of particular field of specialization to perform scientific, R&D tasks of some complexity requiring application and adaptation of established techniques, procedures, and criteria. Participates in new product development, optimization, validation, and transfer into production. Prioritizes work schedules to support team objectives. Job Responsibilities: Participates in method development and technical innovation within the research team and supports project timelines Performs method optimizations, validations and participates in technology transfer to production Performs routine operation, maintenance, calibration and troubleshooting of laboratory instruments such as pH, conductivity meters, osmometers, spectrnphotometers, hematology analyzers and nucroscopes Evaluates and selects methods, applies protocols and scientific techniques to accomplish study objectives Drafts and updates protocols, test methods and standard operating procedures as applicable Proactively collaborates and supports the team, communicates problems as they arise Provides solution/s to problem/ s of limited complexity, exercises judgment within defined policies to determine appropriate action Collects, analyzes and compiles data. Summarizes for interpretation and discussion Drafts statistical and narrative reports as applicable Recognizes and reports experimental variances Is able to coordinate a small project or a small component of a larger project according to set deliverables Maintains good laboratory records and documentation for experimental work and results Maintains workplace safety and environmental practices Maintains clean workplace including laboratory bench and glassware Supports the department with QC technical investigation activities as needed Works in the spirit of continuous improvement Engages in inter and intra-departmental activities/studies Performs other related duties as required or as directed. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position. Qualifications: Knowledge of scientific approach and methodologies. Ability to design small studies, gather, organize and analyze statistical data and generate reports Excellent oral and written communication skills Ability to investigate and analyze information and to draw conclusions Skill in the use of personal computers and related software applications such as Word/Excel/Powerpoint/Teams Knowledge of current technological developments/trends in area of expertise is desirable but not required Capable of adjusting to dynamic work environment and changing priorities Willing to take on new challenges and implement new ideas Must be Comfortable handling blood products Willing to embrace a learning environment, is open to suggestions, new ideas and innovation Ability to grasp methods fast and willingness to change course as applicable Familiar with GLP, GMP practices and capable of working in a regulated medical device company (ISO and FDA) Must have strong analytical skills Must be a team player and driven individual Must value innovation, accuracy and accountability Minimum Requirements: Bachelor's degree with 2-5 years or Associates degree with 5-8 years' experience that is directly related to the duties and responsibilities specified. EOE

Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description * Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. * Author abstracts and manuscripts for publication in peer-reviewed journals. * Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. * Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. * Oversee and coordinate the collection of and/or collect pre-study documents * Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. * Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. * Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications * Minimum 2-5 years of pharmaceutical industry clinical trial experience. * Experience in immunology or endocrinology therapeutic areas is a plus. * Primary experience with development of clinical trial protocols. * Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. * Good understanding of FDA regulatory, ICH, and GCP requirements. * Excellent communication skills, written and verbal. * Superior interpersonal communication and the ability to work across company disciplines and functional units. * Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. * Attention to detail and a commitment to high quality and on-time deliverables are key success factors. * Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

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.

Job Description 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.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description * Analysis of powder samples for key physical properties (such as particle size distribution, bulk density, true density, powder flow, particle shape) * Analysis of liquid samples for key physical properties (such as viscosity and surface tension) * Using techniques such as optical microscopy, laser diffraction particle size analysis, electron microscopy, shear cell testing, compaction simulation, etc. Qualifications * Bachelor's degree in chemistry or other science related degree concentration, or equivalent directly-related experience * At least one year experience in particle and powder characterization * Strong computer, scientific, and organizational skills * Proficient in learning new techniques, developing and carrying out experimental plans, and performing multiple tasks simultaneously * Experience in data handling and scientific/engineering computations * Excellent communication (oral and written) and attention to detail * Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude * Ability to keep accurate records, follow instructions, and comply with company policies * At least one year experience in particle and powder characterization Additional Information * Position is full-time, Monday - Friday 8am to 5 pm * Ability to work overtime as required. * Tasks require repetitive motion and standing for long periods of time. * May be required to respond to off-shift operational issues. * Candidates currently living within a commutable distance of Groton, CT are encouraged to apply. * Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays * #LI-EB1 * Authorization to work in the United States indefinitely without restriction or sponsorship Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.