Associate Scientist jobs at Catalent Pharma Solutions - 934 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

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.

Job Description Associate Scientist/Scientist - Biologics - BDDS Full Time Exton, PA Frontage Laboratories Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Biologics Frontage's biologics teams have an average of 10-15 years in complex drug development and have worked with large molecule applications throughout its evolution in product development. We can handle projects for a range of large molecule development projects including peptides, proteins, monoclonal antibodies, bispecific antibodies, biosimilars, oligonucleotides, biomarkers , and antibody drug conjugates. Gain access to comprehensive biologics services in support of advanced development programs with Frontage's bioanalytical laboratory. We have the capabilities to analyze virtually any peptide, protein, or antibody, and have built a reputation for solving technical challenges related to assay development and validation. Position Summary This is a technical bench scientific position within the Biologics Service Team. The Biologics Service Team is responsible for conducting bioanalytical methods Pharmacokinetics (PK), and Anti-drug Antibody (ADA) related to large molecule biotherapeutic drug development across all therapeutic areas, spanning nonclinical studies to post-market clinical development. The scientist will assist with the interpretation of data resulting from analyses of bioanalytical samples, and work with senior staff to assess, troubleshoot, develop, and validate new assays. They may also perform other duties, as assigned, to meet business needs. Responsibilities Responsible for qualification and preparation of controls and reagents to support PK, and ADA assay methods to quantify concentrations of therapeutic proteins. Required to assist with assay validations, routine lab operations. Responsible for maintaining an electronic lab notebook, participation in GLP compliance activities and other duties as needed. Performs job duties with some supervision. Collaborates effectively with fellow team members following priorities, checkpoints, and timelines in support of objectives set by direct supervisors. Communicates with internal and external team members regarding assigned tasks through written and oral communication. Requirements BS or MS in biochemistry, biomarker, molecular biology, or a related field. Experience in immunoassay development and validation in a GLP lab (21CFR part 11 compliant) is preferred. Experience with Meso Scale Discovery (MSD) immunoassays or ELISA. Experience in a biopharma company, Clinical Research Organization (CRO) or diagnostic lab environment is preferred. Salary And Benefits Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job Description Job Title: Associate Scientist, Drug Metabolism and Pharmacokinetics (DMPK) Reports To: Vivarium Manager / Study Director Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary: A dedicated and detail-oriented Vivarium Associate Scientist to support studies. This role involves the routine care and handling of laboratory animals, preparation for in vivo studies, and collaboration with scientific staff to ensure timely and high-quality data and sample collection in compliance with study protocols and animal welfare regulations. Key Responsibilities: Perform daily husbandry tasks including feeding, watering, cage changing, and health monitoring. Assist with in vivo dosing procedures (e.g., oral, intravenous, subcutaneous) under supervision or upon training certification. Conduct biological sample collection (e.g., blood, urine, feces, tissues) following approved protocols and SOPs. Maintain accurate records of animal health, treatments, and study-specific procedures. Prepare and label dosing and sampling materials and ensure proper sample storage and tracking. Perform minor vascular and major surgical procedures Monitor animals for clinical signs and report any abnormalities to the study team or veterinary staff. Ensure vivarium cleanliness and compliance with IACUC and AAALAC standards. Collaborate with DMPK scientists and project teams to coordinate study timelines and logistics. Assist with inventory and ordering of animal care and dosing supplies. Qualifications: Associate's or Bachelor's degree in Animal Science, Biology, or a related field preferred. ALAT certification or willingness to obtain preferred. Experience working with laboratory animals in a research or CRO environment (rodents required). Familiarity with in vivo DMPK study procedures is a plus. Ability to follow SOPs, protocols, and regulatory guidelines (GLP, IACUC). Strong organizational skills and attention to detail. Ability to work occasional weekends and holidays as study needs require. Physical Requirements: Ability to lift up to 50 lbs and perform physical tasks such as bending, stooping, and prolonged standing. Comfortable working in a controlled environment with laboratory animals. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability

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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. In this role, the candidate will coordinate multi-functional initiatives in the research, creation, and implementation of scientific studies. These studies facilitate developability evaluation of biotherapeutic drug candidates. The candidate will also formulate drug products (DP), perform characterization, and validate commercial parenteral/injectable biologic products. The candidate will lead the development of drug candidates and utilization of in-silico tools in support of developability, pre-candidate selection and formulation and process development. An understanding of protein chemistry, protein engineering, formulation development as well as the ability to run computer simulations or biopharmaceutical assays in a laboratory is necessary. The candidate will establish continuous improvement systems based on lessons learned and implement these improvements in areas of developability assessment, drug formulations, manufacturing technology transfer activities as well as in-silico process simulations. This position is encouraged to interact regularly with multi-functional staff from Research, Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs. Key Responsibilities: Leads drug product development teams with multiple multi-functional collaborators, as well as understand the multi-functional implication of project activities and decisions on project and corporate objectives. Makes scientific/technical proposals based on corporate or project objectives. The candidate must have the ability to communicate effectively with senior management, external partners, and/or regulatory agencies. Actively participates in department and team meetings including assuming ownership and delivering on assign action items. Understands "big pictures" for projects and tasks involved and prioritize work of self and others accordingly. Prioritizes multiple work you're doing and projects and leads project teams consisting of one or more junior team members. The ability to work independently as well as part of the team is essential. Perform in-depth data analysis. Write technical reports and sections of clinical and commercial regulatory filings. These documents cover accomplished studies for Alexion drug product candidates. Be current with the literature about drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations Essential Education, Experience & Skills: PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 0-2 years, a MS with 9+ years or BS with 10+ years of relevant experience. Solid background in protein chemistry, chemistry, biochemistry, or equivalent is highly preferred. Scientific and practical knowledge of protein biochemistry, protein formulation/stability, protein engineering or protein purification as well as biopharmaceutical development is essential. Hands-on experience with developing and utilizing computational tools for protein engineering, protein solution behavior prediction, manufacturing process design and scale-up or automation Experience in biotherapeutics development as well as understanding of the biotechnology products life cycle Understanding of the biotherapeutics engineering, drug development and analytical or in-silico tools used to test drug candidates or processes is desirable. Makes strategic scientific/technical proposals based upon corporate or project objectives and has the ability to take initiative in problem solving and finding solutions to scientific challenges. The individual must be able to work in a collaborative setting and ability to adhere to timelines is essential. Excellent interpersonal skills are required, as is the strong ability to communicate effectively, as well as mentor and motivate others within the department and as part of actively participating in cross-functional teams. The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging Desired Experience & Skills: Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro, would be an advantage. Experience with in-silico tools such as GROMACS, NAMD, BioLuminate, MOE, Python ML libraries, gPROMs or related tools Experience with programming languages such as Python, C++, Fortran, R or related languages Knowledgeable in Global Regulatory guidances, cGMPs, and Quality/Compliance expectations for the development of parenteral drugs The annual base pay (or hourly rate of compensation) for this position ranges from $110,687 to $145,277. 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. At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease. #LI-Hybrid FUSION Date Posted 14-Jan-2026 Closing Date 13-Feb-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.

Interpret complex datasets and translate findings into formulation composition, technical reports, process parameters, control strategies, and regulatory filings. Interact regularly with cross-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Device Development, Manufacturing Technical Services, Quality Assurance, and CMC Regulatory Affairs. You will be responsible for: Leading phase appropriate formulation and process development for injectable biologics, translating program goals into experimental plans, decision criteria, timelines, and risk mitigation from candidate selection through commercial validation and filings. Designing, executing, and troubleshooting laboratory studies using advanced biophysical and analytical methods, with hands on responsibility for high quality data generation. Defining and optimizing drug product processes (fill/finish relevant unit operations, viscosity management, filtration, mixing, hold steps), conducting scaleup and robustness studies, and supporting technology transfer to internal and external manufacturing sites. Integrating complex datasets to establish structure-function relationships, degradation pathways, and mechanism informed stress models; translating insights into robust formulations, control strategies, and phase appropriate specifications. Authoring protocols, technical reports, and contributing to CMC sections of regulatory submissions, including comparability assessments and responses to regulatory queries. Cross functional collaboration with to align development plans and ensure timely program delivery. Mentoring junior team members in matrix teams; reviewing study designs and data; promoting experimental rigor and documentation excellence. Work with senior management, partners, and cross functional teams; presenting program status, risks, and recommendations; taking initiative to solve scientific and operational challenges. You will need to have: PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 5 years of proven experience MS with 14 years or BS with 15+ years of proven experience. Excellent interpersonal skills Ability to mentor and empower others within the team and cross-functionally. Scientific and practical knowledge of protein biochemistry, protein formulation, and stability. Make strategic scientific/technical proposals based upon corporate or project objectives and can take initiative in problem solving and finding solutions to scientific challenges. The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging We would prefer for you to have: Electronic record keeping and data software, (electronic lab notebooks, EndNote) Maintenance of laboratory instrumentation (prioritizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro. Knowledgeable in Global Regulatory guidance, cGMPs, and Quality/Compliance expectations for the development of parenterals. Validated background in protein chemistry, chemistry, biochemistry, or equivalent. Hands-on experience with process development, scale up, and tech transfer to manufacturing sites. Expertise in AUC Why AstraZeneca? When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca offers an environment where innovation thrives. Our commitment to eliminating cancer as a cause of death drives us to challenge the status quo and deliver more effective treatments. With access to industry-leading research, technology, and a pipeline like no other, you will be empowered to accelerate your career while making a meaningful impact on patients' lives. Our entrepreneurial spirit encourages you to step up, take accountability, and lead changes in our dynamic environment. Together, we are reshaping healthcare systems through collaboration, innovation, and advocacy. Ready to make a difference? Apply now and be part of our journey to redefine cancer treatment! Date Posted 12-Jan-2026 Closing Date 29-Apr-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.

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.

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit ******************* for specifics on the pipeline. *All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix Pharmaceuticals is seeking a highly motivated Associate Scientist to join our multidisciplinary R&D team at the Frederick Research & Development Center. This role integrates computational protein structure analysis with hands-on molecular biology and protein biochemistry. The successful candidate will contribute to host-directed therapeutic discovery, antiviral platforms, and vaccine design by combining AI/ML-based protein modeling with molecular biology and protein science to generate, express, and analyze protein targets. Key Responsibilities Perform protein structure modeling and design using platforms such as AlphaFold2/3, ESM, RFdiffusion, ProteinMPNN, and NetMHC. Build and refine bioinformatics workflows for large-scale sequence and structural analysis of host and viral proteins Perform molecular cloning, PCR, DNA and RNA isolation, bacterial transformation, and mutagenesis to generate expression constructs. Carry out protein expression and purification followed by protein characterization Collaborate with Tonix's imaging and cell biology teams to translate computational predictions into testable hypotheses in assays and animal models. Contribute to the development of user-friendly computational pipelines and visualization tools for internal scientists. Document and communicate results in reports, regulatory filings, and presentations to internal teams, collaborators, and external partners. Maintain awareness of emerging computational biology technologies to enhance Tonix's drug discovery capabilities. Required Qualifications B.S. or M.S. in Microbiology, Biochemistry, Bioinformatics, Computational Biology, or related field. Hands-on experience with protein structure prediction and computational protein design tools. Familiarity with core molecular biology and protein biochemistry methods (PCR, cloning, bacterial expression, Western blotting). Strong communication skills and ability to work in cross-functional teams within Tonix's integrated discovery pipeline. Preferred: Experience with cloud computing platforms (Google Cloud, AWS) for large-scale protein modeling. Exposure to machine learning approaches in protein design and immunology. Prior experience with protein engineering for therapeutic applications. Track record of contributions to publications, posters, or conference presentations. Proficiency in Python, especially ML/AI packages. Experience in Linux operating systems and shell programming is desirable. Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $60,000 to $90,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs Pet Insurance Retirement Savings 401k with company match and annual discretionary stock options Generous Paid Time Off, Sick Time, & Paid Holidays Career Development and Training Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.

About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit ******************* for specifics on the pipeline. * All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix Pharmaceuticals is seeking a highly motivated Associate Scientist to join our multidisciplinary R&D team at the Frederick Research & Development Center. This role integrates computational protein structure analysis with hands-on molecular biology and protein biochemistry. The successful candidate will contribute to host-directed therapeutic discovery, antiviral platforms, and vaccine design by combining AI/ML-based protein modeling with molecular biology and protein science to generate, express, and analyze protein targets. Key Responsibilities * Perform protein structure modeling and design using platforms such as AlphaFold2/3, ESM, RFdiffusion, ProteinMPNN, and NetMHC. * Build and refine bioinformatics workflows for large-scale sequence and structural analysis of host and viral proteins * Perform molecular cloning, PCR, DNA and RNA isolation, bacterial transformation, and mutagenesis to generate expression constructs. * Carry out protein expression and purification followed by protein characterization * Collaborate with Tonix's imaging and cell biology teams to translate computational predictions into testable hypotheses in assays and animal models. * Contribute to the development of user-friendly computational pipelines and visualization tools for internal scientists. * Document and communicate results in reports, regulatory filings, and presentations to internal teams, collaborators, and external partners. * Maintain awareness of emerging computational biology technologies to enhance Tonix's drug discovery capabilities. Required Qualifications * B.S. or M.S. in Microbiology, Biochemistry, Bioinformatics, Computational Biology, or related field. * Hands-on experience with protein structure prediction and computational protein design tools. * Familiarity with core molecular biology and protein biochemistry methods (PCR, cloning, bacterial expression, Western blotting). * Strong communication skills and ability to work in cross-functional teams within Tonix's integrated discovery pipeline. Preferred: * Experience with cloud computing platforms (Google Cloud, AWS) for large-scale protein modeling. * Exposure to machine learning approaches in protein design and immunology. * Prior experience with protein engineering for therapeutic applications. * Track record of contributions to publications, posters, or conference presentations. * Proficiency in Python, especially ML/AI packages. Experience in Linux operating systems and shell programming is desirable. Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $60,000 to $90,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: * Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs * Pet Insurance * Retirement Savings 401k with company match and annual discretionary stock options * Generous Paid Time Off, Sick Time, & Paid Holidays * Career Development and Training Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and systems to enable a successful startup into GMP manufacturing operations. Position Overview: The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team that provides the technical support required to achieve reliable and compliant manufacturing of API molecules. This role will be part of the Manufacturing Process Team for its respective area, providing daily oversight to ensure safe and reliable supply of medicines. The Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the manufacturing scientist should be capable and of setting up and executing a variety of experiments at laboratory scale and conducting research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory. Responsibilities: Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment. Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity. Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, etc. Develop and monitor established metrics in real-time to assess process variability and capability. Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose. Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps. Ensure that experiments are well designed with clear objectives. Ability to analyze data and ensure appropriate documentation. Write technical reports and documents. Basic Requirements: Bachelors in STEM Discipline (Chemistry preferred) 3+ years of experience in cGMP manufacturing (pharmaceutical manufacturing experience preferred) Additional Preferences: Demonstrated understanding of process chemistry Demonstrated basic knowledge in small molecule, peptide, or oligonucleotide API Manufacturing. Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development. Familiarity with cGMP manufacturing environment and terminology. Excellent analytical, interpersonal, written and oral communication skills. Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals. Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented. Guidance/mentoring of others through processes. Flexibility to meet business needs. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Job SummaryThe incumbent is responsible for routine calibration and preventative maintenance in the Quality Control laboratories. Hourly Rate: $23.45/hour Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.Responsibilities Performs, monitors, and tracks laboratory calibrations and preventative maintenance. Generates and maintains equipment records from registration through retirement. Purchases minor equipment and supplies to support laboratory function. Develops new Standard Operating Procedures for laboratory testing and equipment administration. Maintains SOPs to assure constant compliance with corporate and regulatory requirements. Supports new equipment commissioning as directed. Completes logbook reviews as required. Assists in equipment troubleshooting. Assists with the execution of equipment and method validation protocols. Assists in Training new department personnel in standard operating procedures. Informs supervisory personnel of all relevant events impacting the operations and performance of the department. Maintains knowledge of cGMPs, GLPs and Quality Systems. Follows safety requirements and maintains good housekeeping of lab areas. Maintains accurate records of all work performed with respect to a given project. Meets facility audit as well as cGMP or GLP requirements. Reviews work performed by department staff for accuracy, completeness and conformance to specifications. Assumes additional duties and responsibilities as assigned by management. Requirements B.S. in Chemistry or related field with 2 years of experience preferred. Background in HPLC and other analytical techniques (GC, AA, UV, ICP and wet chemical methods) desirable. Associates Degree with 5+ years of experience. Excellent verbal and written communication skills are essential. Strong attention to detail, people skills and ability to multitask are essential for success. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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

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.