Development Scientist jobs at Takeda Pharmaceuticals U.S.A., Inc. - 1043 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 global biopharmaceutical company is looking for a Principal Scientist in Innovation Management. The role involves the development of upstream processes, oversight of biopharmaceutical production, and integration of digital tools in manufacturing. Candidates must have significant experience in biopharmaceutical manufacturing and possess strong leadership capabilities. This exciting opportunity advocates for collaboration, innovation, and a commitment to high-quality standards in a dynamic working environment. #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

HTI is seeking a Metallurgical R&D Scientist for a brand-new facility in Augusta, GA. This is a great opportunity to work with a state-of-the-art facility and be an important contributor to the growing North American metals supply chain. What They Offer Full Medical, Dental, and Vision Benefits on Day 1 401(k) Match EAP, LTD, STD, and Life Insurance Competitive Vacation Package 12 Paid Holidays Relocation Assistance Available What You Need Bachelor's Degree in Chemical Engineering, Materials Science, Metallurgy, or a related field Minimum of 2 years of experience, ideally in R&D, materials analysis, or process engineering Recent graduates with relevant project or lab experience may be considered Strong understanding of non-ferrous metallurgy and metal extraction principles, especially copper metallurgy. Knowledge of pyrometallurgical, hydrometallurgical, and/or electrometallurgical processes Experience with: Material characterization and analysis Process troubleshooting and optimization Failure analysis and root cause investigation Familiarity with process simulation or thermodynamic modeling tools (FactSage, Thermo-Calc, HSC, etc.) is preferred but not required Experience preparing or interpreting process flow diagrams, phase diagrams, and thermodynamic calculations **Candidates must be eligible to work in the U.S. without sponsorship now AND in the FUTURE** What Your Role Will Look Like As the Metallurgical Research & Development Scientist, you will be integral to the development and enhancement of metallurgical processes, particularly in non-ferrous extractive metallurgy with a focus on copper. Collaborating with various departments, you will lead process improvement initiatives through simulation and modeling, contribute to R&D projects, and support the broader organization in achieving its production and efficiency goals. Key Responsibilities Collaborate closely with cross-functional teams, including Production, Supply Chain, and Maintenance, to develop and optimize metallurgical processes. Design and improve processes through simulation, focusing on enhancing production efficiency and effectiveness. Conduct research and development projects, such as developing new copper alloys and analyzing the impact of using different types of electronic waste. Utilize process simulation software to model and simulate metallurgical processes, implementing improvements to existing operations. Prepare detailed process flow diagrams and perform calculations related to mass balance, heat balance, and phase diagrams. Support other departments by providing expertise on chemical and material compositions and addressing process-related questions. Ensure compliance with environmental, health, and safety standards, contributing to the development of operating instructions and risk assessments. Participate in the ongoing development of R&D labs on-site, with a focus on future process improvements and innovations.

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

A global healthcare company is hiring a Senior Medical Science Liaison for Solid Tumor Oncology in the Northeast. This role involves developing territory plans, engaging with KOLs, and addressing educational needs in the field. Candidates should have a doctorate and 2+ years of MSL experience, with a preference for oncology expertise. The position offers a competitive salary range, annual performance bonus, and a comprehensive benefits package including health insurance and retirement plans. #J-18808-Ljbffr

Senior Analytical Scientist (R&D/Product Development) position with a large, well-established pharmaceutical manufacturing company in Greenville, SC. This is a direct hire, full time, onsite role. Relocation assistance is available for candidates located outside of the greater Greenville, SC area. Salary is dependent upon education and experience. This company offers fantastic benefits, and a positive, team-oriented work environment. Requirements: Bachelor's degree in Chemistry 6+ years of experience as an Analytical Chemist or Scientist working in pharmaceutical product development/R&D with responsibility for the job duties listed below Must have experience developing and completing validation/verification of analytical methods to support product release and stability testing, and submitting products to the FDA Strong knowledge of cGMP and FDA regulations; USP and ICH are a plus HPLC, UPLC, GC, TLC, dissolution, particle size analysis, UV/Vis, FTIR, spectroscopy, titrations experience Chromatography software experience (Empower, OpenLab, etc.) Strong MS Office and document management skills (Word, Excel, Adobe Acrobat for PDF editing) Must have professional verbal and written communication skills, with strong technical writing abilities for creating SOP's, reports and FDA submittals Ability and desire to mentor and train junior team members Must be authorized to work in the United States without visa sponsorship (both now and in the future) Additional experience that is a plus: Liquid oral solution/suspension experience ICP experience Mass spectrometry experience (MS, LC-MS, GC-MS, ICP-MS) Extractables/leachables identification for N-nitrosamines Previous experience in a Senior Scientist role Master's degree in Chemistry Job Summary: Responsible for developing, validating, and verifying complex analytical methods to support drug product release and stability testing. This role includes designing and executing method validation/verification protocols and reports, preparing technical documentation (SOP's, test methods, etc.) and independently managing projects all the way through to FDA submission. This team member will troubleshoot analytical challenges, provide technical solutions, and ensure compliance with FDA/ICH regulations. Job Duties: Develop and complete validation/verification of complex analytical methods to support product release and stability testing Design, prepare, and execute method validation/verification and transfer protocols, reports, analytical methods, and SOPs, etc. Independently manage assigned projects Perform laboratory investigations and prepare necessary reports as needed Support timely deficiency responses Evaluating, troubleshooting, and improving existing analytical methods when necessary Maintain consistency with organizational objectives while providing imaginative and practicable technical solutions to an array of difficult problems Provide and receive peer reviews Train and mentor junior scientists on analytical techniques This employee will spend approximately 50% of their work time in the lab and the other 50% developing and writing SOP's, technical documentation, FDA submittals, and reports Support other duties as assigned

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 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.

Scientist - Container Closure Integrity Development Our company's Device Product & Process Development (DPPD) Team focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection. The DPPD within our Company Research Labs is seeking a talented, self-motivated, and highly collaborative Scientist with knowledge of container closure integrity (CCI) technology and experience with test method development, testing, and method validation for various product images (vials, syringes, cartridges, and injectors) and secondary packaging. The candidate will develop methods for our company's device and combination product pipeline, inclusive of small molecule, biologics, and vaccine products. Key Responsibilities Function as an analytical subject matter expert (SME), troubleshooting and optimizing analytical methods, with a focus on container closure integrity methods Provide technical leadership and mentorship to junior scientists and team members. Develop, validate, and execute feasibility container closure integrity (CCI) studies for complex combination devices & delivery systems Author technical reports and testing protocols Review technical data to ensure compliance with cGMP standards Collaborate with cross-functional teams to ensure successful tech transfer of analytical methods between QC labs Minimum Education Requirement B.S./M.S in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with a minimum of 1 year of relevant work experience in the pharmaceutical, biotechnology, or medical device industries Required Experience | Knowledge | Skills: Relevant analytical execution, development, validation, and/or quality control (QC) for container closure integrity as it pertains to small molecule, biologics, and vaccine products. Ability to learn new techniques, troubleshooting assays, author and review technical documents Excellent organizational skills to manage multiple projects Preferred Experience | Knowledge | Skills: Hands-on experience in container closure integrity technology (CCIT) method development, validation, and troubleshooting for injectable therapeutics. Candidate should be familiar with the following CCIT technologies for this purpose: dye ingress, high voltage leak detection, vacuum and pressure decay, laser headspace analysis Good technical understanding of USP Good technical, communication (oral and written), interpersonal, and teamwork skills. Ability to effectively identify and communicate risks. Experience with other analytical methodologies #eligiblefor ERP AR&D Required Skills: Accountability, Accountability, Analytical Chemistry, Biocompatibility, Biomedical Engineering, Biomedical Sciences, Biopharmaceutical Industry, Biotechnology, Clinical Supply Chain Management, Combination Products, Cross-Functional Planning, Data Analysis, Human Factor Engineering, Innovation, Interpersonal Relationships, Machine Learning (ML), Manufacturing Processes, Materials Science, Mechanical Engineering, Mechanical Testing, Medical Device Technologies, Medical Product Development, Pharmacology, Production Process Development, Prototyping {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/28/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Applications are sought for an opportunity in the Vaccine and Advanced Biotechnologies (VAX) Process R&D department, which is part of the our Research & Development Division. The individual will support our Company's downstream process development efforts for Vaccine programs at West Point, PA. Vaccines and Advanced Biotechnologies (VAX) Process R&D is responsible for the development and clinical manufacturing of Drug Substance (DS) and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality-agnostic DS/DPI process development and clinical manufacturing for our company's pipeline. Our vaccines downstream process development team develops safe, scalable, robust, cost-effective downstream processes that enable clinical and commercial manufacture of vaccines and adjuvants across all vaccine modalities. We are seeking an innovative, highly motivated, and experienced Associate Principal Scientist to join us at our research and development site in West Point, PA. The candidate will be responsible for scientific/technical leadership of a bioconjugation process development team, and will also be a critical member of cross-functional program/project teams. This role will require frequent collaboration with cross-functional teams including Analytical, Formulation, Process Chemistry, Enabling Technologies, and Manufacturing colleagues. The candidate should have a strong background in downstream bioprocess/bioconjugation design, including reaction steps, filtration (tangential and normal flow) and column chromatography. Preferably, the candidate will have a strong background in biomolecule conjugation techniques and conjugate modalities (e.g., conjugate vaccines, antibody-drug conjugates). Primary responsibilities include, but are not limited to: Lead downstream process design and development for conjugate vaccine candidates. Design, execute, and analyze process development experiments to maximize conjugate vaccine production processes, thereby de-risking later stage development and tech transfer. Represent functional area in cross-functional and strategic teams engaged in vaccine development. Lead tech transfer of vaccine bioconjugation processes for clinical and commercial manufacture. Serve as scientific/technical mentor for junior staff, providing technical guidance in the various aspects of downstream bioprocess/bioconjugation development. Support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development. Analysis of experiments through analytical techniques including HPLC, light scattering, and spectroscopy. Data interpretation and presentation, manuscript/patent preparation. Education Minimum Requirement: BS, MS or PhD in engineering or bio/chemical sciences: Chemical Engineering, Bioengineering, Biomedical Engineering, Chemistry, Biochemistry, Molecular Biology, Biotechnology For BS candidates, at least eight (8) years of experience in a pharmaceutical or biotechnology-related position For MS candidates, at least five (5) years of experience in a pharmaceutical or biotechnology-related position For PhD candidates, at least three (3) years of experience in a pharmaceutical or biotechnology-related position Required Experience and Skills: Strong scientific and hands-on understanding of downstream bioprocess/bioconjugation unit operations, biotherapeutic and/or vaccine process development and sound understanding of scale-up principles. At least five (5) years of hands-on laboratory experience in downstream bioprocess/bioconjugation development. Prior experience with statistical design of experiments (DOE) and/or algorithmic process optimization. Strong understanding of, or hands-on experience in, cGMP manufacturing. Ability to work effectively both independently and in a team-focused environment. Well-developed organizational, record-keeping, and timeline/resource-mapping skills. Preferred Experience and Skills: Experience with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates), conjugation chemistry and downstream bioconjugate processing. Experience in leading technical development teams and mentoring others. Experience in authoring and reviewing CMC regulatory documentation. Experience with process and technology transfer. The successful candidate will be expected to demonstrate the ability to communicate results of their work in both verbal and written formats. They are also expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to comply with all required training and maintain a focused attention on laboratory safety for themselves and their team. Position may require working with infectious agents, pathogens, and/or potent compounds with appropriate engineering controls and PPE. Some travel or off-hours work may be required. #PRD Required Skills: Accountability, Accountability, Animal Vaccination, Antibody Drug Conjugates (ADC), Bioconjugation, Biomedical Engineering, Biomedical Sciences, Biotechnology, Cell Line Development, Chemical Engineering, Chemical Technology, Column Chromatography, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Immunochemistry, Innovation, Interpersonal Relationships, Laboratory Safety, Leading Project Teams, Machine Learning (ML), Molecular Biology, Pharmaceutical Formulations {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 02/10/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Technical Services & Manufacturing Science (TSMS) Associate -Pilot Scale The Technical Services & Manufacturing Science (TSMS) Associate is responsible for providing operational and technical support for commercial and pilot laboratory operations at the Elwood, Kansas, monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting, and continuous improvement activities. Your Responsibilities: Support the execution and troubleshooting of upstream and/or downstream manufacturing processes for biologics (e.g., mammalian cell culture, purification). Collaborate with Manufacturing, Development, and Quality teams in the execution of technical / development studies, investigations, validation activities, and technical transfer programs, and collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and likelihood of technical success. Provide on-floor support during manufacturing campaigns, including troubleshooting and deviation investigations. Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements. Author and provide critical review of technical documents, including, but not limited to: batch records, SOPs, PFDs, risk assessments, investigations, technical studies, commissioning and qualification protocols, and reports. Assist in implementing changes through the change control system (e.g., BOM updates, process changes). What You Need to Succeed (minimum qualifications): Education: Bachelor's degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. Experience: 0 - 2 years' experience in the Biotech / Pharmaceutical industry. Familiarity with tools such as JMP or Excel for data analysis is a plus. Ability to work in a team environment and support manufacturing activities on the production floor, including occasional off-shift or weekend support if required. Detailed understanding of biopharmaceutical production processes and technologies with working knowledge of cGMP standards and experience working in a regulated environment. What will give you a competitive edge (preferred qualifications): MSc in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. 3+ years' experience in the Biotech / Pharmaceutical industry. Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes. Experience in tech transfer, scale-up, and validation of biopharmaceutical processes. Experience in capital project design, development, validation, and execution. Experience with electronic quality systems (e.g., Veeva QMS, TrackWise) and MES platforms. Additional Information: Location: Elwood, Kansas Day shift position. Weekend and evening work is not usual, although it may be required to provide process support to ongoing operations. Minimal travel requirements < 10%. Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: Multiple relocation packages Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 8-week parental leave 9 Employee Resource Groups Annual bonus offering Flexible work arrangements Up to 6% 401K matching Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Technical Services Manufacturing Scientist - Downstream The Technical Services & Manufacturing Science (TS/MS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial downstream operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects. Your Responsibilities: Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events. Act as the Process Teams product and process subject matter expert for purification processes which may include chromatography, tangential flow filtration, and centrifugation. Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements. Develop / execute projects to address process performance issues and deliver improvement opportunities. Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports. What You Need to Succeed (minimum qualifications): Education: Bachelor's degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. Experience: Experience in the Biotech / Pharmaceutical industry. Detailed understanding of biopharmaceutical production processes and technologies. Working knowledge of cGMP standards and experience working in a regulated environment. Proven analytical thinking and problem-solving skills. What will give you a competitive edge (preferred qualifications): MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline. Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes. Experience in tech transfer, scale up, and validation of biopharmaceutical processes. Experience with SAP, JMP, Veeva Vault, RCI, FMEA and QRM tools. Working knowledge of USDA and/or EU GMP regulations for veterinary biologics. Additional Information: Location: Elwood, Kansas. Day shift position. Weekend work on a rotation to provide process support to ongoing operations. Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: Multiple relocation packages for eligible roles Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 8-week parental leave 9 Employee Resource Groups Annual bonus offering Up to 6% 401K matching #LI_MNLC Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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.

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 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 Type: Full Time Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA About the Job: Title of the Position: Senior Scientist - Formulation Development We are seeking a highly skilled and experienced Senior Scientist to join our Formulation Development team. The successful candidate will play a critical role in the development and optimization of drug formulations from early-stage research through commercialization. This position requires a deep understanding of formulation principles, a strong scientific background, and a proven track record of success in the pharmaceutical industry. Responsibilities: Lead the design, development, and optimization of complex injectable and sterile dosage forms. Develop and implement robust formulation development strategies aligned with regulatory guidelines (e.g., Quality by Design, FDA). Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues Conduct rigorous experimental design studies (e.g., factorial design) to achieve project objectives. Collaborate closely with cross-functional teams, including Technical Services, Operations, and Regulatory Affairs. Define scope, timeline, and resource needs of functional activities and keep team on schedule Participate in evaluation of new product opportunities. Ensure timely and high-quality documentation for regulatory submissions. Stay updated with all FDA and regulatory requirements/guidelines. Provide mentorship and leadership to team members. Stay up to date with the latest scientific advancements in formulation development and applying new technologies to improve product performance. Author and review technical reports, protocols, and regulatory documents. Additional duties and assignments as needed. Qualifications: Education/Experience: Ph.D. or Postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field. 3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development. (Strong candidates with combinations of education and experience will be considered.) Strong understanding of formulation principles, excipients, and drug delivery systems. Hands-on experience with various formulation techniques and equipment. Proven track record of successful formulation development and commercialization. Experience with statistical design of experiments (DOE) and data analysis. Knowledge, Skills, and Abilities: Proven track record of successful formulation development for various sterile dosage forms. Strong leadership, project management, and organizational skills. Expertise in complex injectable and sterile dosage form development. Demonstrated ability to conduct independent research and problem-solving. Requirements: Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius). Benefits: Pay range $70,000-$90,000 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 401k 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 or retaliation based on any of these factors.

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Manufacturing Scientist Location: 450 Elanco Circle, Indianapolis, IN 46221 / Global Elanco Headquarters 15-25% domestic travel required for accompany validations, tech-transfers of manufacturing process, deviation investigations, and external site meetings. Job Description: Your day-to-day will include: Ensure technical oversight of products within Elanco External Manufacturing (EEM)-Americas (North and Latin America) scope. Ensure technical excellence and effective supply production across a portfolio of products (specifically medicated feed and nutritional health) produced at external contract manufacturers and suppliers. Maintain and improve product process capability, quality, and compliance as well as drive gross margin improvement through a technical productivity agenda are all part of this role. Participate in Joint Process Team (JPT) meetings with contract manufacturers and external suppliers as primary technical manufacturing science point of contact. Ensure technical requirements of global standards and oversight are met using Change Management, Deviation, and Investigation Management. Maintain oversight of key batch processing records used at CMs, including SOP's, Master Production Records, Standard Packaging Instruction's. Write technical reports to convey status of product performance, capability and to communicate process metrics. Act as the technical point of contact and subject matter expert for lifecycle aspects for Elanco External Manufacturing (EEM) managed products. You have the following technical skills and qualifications: Requirement - Bachelor's degree in Chemical Engineering, Mechanical Engineering, Chemistry and Pharmaceutical Science, a related field, or a foreign equivalent Relevant experience - 5 years of progressively responsible post-baccalaureate experience in job offered or any engineering related job titles. Applicants must possess 5 years of experience in the following: (1) Scientific data collection and documentation (JMP's - statistical tool); (2) Root Cause Analysis including defining problem statement, data collection and analysis, 5 whys, fish bone diagrams, identifying causal factors & root causes, and DMAIC (Define/measure/Analyze, improve and control) protocol; (3) cGMP and FDA regulations; (4) systematic troubleshooting for manufacturing issues including using statistical tools to define the operating parameters for a manufacturing process and analytical test; (5) analyzing manufacturing process failures; troubleshooting stability failures and raw materials issues (i.e. particle size change); (6) solid dosage processes; and (7) technical writing. 15-25% domestic travel required for accompany validations, tech-transfers of manufacturing process, deviation investigations, and external site meetings. Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected 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