Post job

Development Scientist jobs at Takeda Pharmaceuticals U.S.A., Inc.

- 882 jobs
  • RD&A Process Scientist - Food Industry

    Kerry 4.7company rating

    Clark, NJ jobs

    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 The RDA Process Scientist performs research and development work with an operations focus which bridges the gap between RD&A Taste Innovation and KERRY's commercialization process. He/she will focus on process optimizations, scale-ups, solving regulatory and other hurdles to new products and technologies introductions. He/she will collaborate with other scientists (especially Taste Innovation team), engineers, maintenance, QC, sanitation, etc. Key responsibilities Work closely with Taste Innovation team to develop and scale up taste modulation products Focus on solving the regulatory hurdles Liaising with cross functional teams: engineering, research, technical, QC, sanitation, maintenance, and/or production staff, regulatory, procurement, etc. Planning, organizing, and overseeing process or production trials Suggests improvements or modifications to current processes Generates ideas for new products and researches feasibility in terms of profitability, resource availability and compliance with regulations. Adheres to Standard Operating Procedures (SOPs) and Cleaning In Place (CIP) Keeps recording data log (flow rate, pressure, temperature, etc) and analyzing data Writes and reads technical papers, reports, reviews, and specifications. Qualifications and skills Bachelor's or Master's in food process science, food engineering, agricultural science, engineering, material science or related science fields. Experience in a food production environment or industrial laboratory Experience with upscaling of food manufacturing processes is a plus: moving from lab scale to industrial scale. Knowledge of good manufacturing practice Problem-solving skills, analytical skills, and attention to detail Strong communication and interpersonal skills, able to work effectively as part of a team. Excellent analytical, organizational, and multi-tasking skills. The pay range for this position is $107,757 to $181,563 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 Jan 30th, 2026. 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.
    $107.8k-181.6k yearly 5d ago
  • Scientist - Downstream Process Development

    Kelly 4.1company rating

    Gaithersburg, MD jobs

    Kelly Government Solutions is seeking a Scientist - Downstream Process Development to work on-site with the Vaccine Production Program at the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) in Gaithersburg, MD. KEY TASKS/SERVICES (1) Support the Purification group of the Vaccine Production Program (VPP) Labs of the Vaccine Research Center (VRC). (2) Develop downstream (purification) processes, under the supervision of a project lead scientist, for recombinant proteins, virus vaccines, and virus-like particles (VLP) that may be used as clinical vaccine candidates. (3) Serve as a functional lead in chromatography process development unit operations. (4) Provide critical process step assessment and experimental design to define optimal process parameters for chromatography unit operations. (5) Train team members in large-scale unit operation such as AxiChrom column packing and Pilot-scale chromatography execution. (6) Work independently and collaboratively within the purification group to design, develop and optimize chromatography and filtration step unit operations to support process development of clinical trial vaccine candidates and mAb products. (7) Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles in support of other groups at the VRC. (8) Work to prepare necessary materials (buffers, packed columns, etc.) in support of downstream process activities. (9) Perform protein/small molecule conjugation experiments to support method development or conjugate-based vaccine candidates. (10) Support technology transfer of processes to VRC Pilot Plant for manufacture of clinical products including authoring process descriptions, reports, and on-floor support. (11) Author training documents, process documents and summaries, instrument SOPs, technical reports, protocols, and other supporting documentation. KEY REQUIREMENTS (1) Ph.D. in a scientific field with at least 5 years of experience. MS with at least 10 years of specialized experience may also be considered. (2) Deep understanding of challenges and method development approaches of mAb, vaccine and mRNA scientific field. (3) Familiarity with monoclonal antibody and multi-specific antibodies, recombinant protein vaccine and nanoparticles; mRNA and mRNA/LNP vaccines. (4) Analytical skills and applications such as developing release and characterization methods using reversed phase HPLC/or UPLC -UV methods or HPLC/or UPLC - MS methods for pipeline project support. (5) Experience with other bio-separation techniques such as electrophoresis and lab-on-chip separation.
    $68k-93k yearly est. 2d ago
  • Sr. RD&A Scientist - Beverages

    Kerry 4.7company rating

    Beloit, WI jobs

    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.
    $80k-108k yearly est. 1d ago
  • Sensory Scientist/Panel Leader

    Kerry 4.7company rating

    Beloit, WI jobs

    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).
    $75.6k-123.4k yearly 4d ago
  • Food Scientist - Dairy flavor

    Kerry 4.7company rating

    Beloit, WI jobs

    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.
    $47k-73k yearly est. 2d ago
  • Associate Principal Scientist, Downstream Vaccines and Advanced Biotechnologies Process R&D

    MSD 4.6company rating

    Point, PA jobs

    Associate Principal Scientist - Downstream Vaccines and Advanced Biotechnologies Process R&D 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 all of our company's pipeline. Our Discovery Interface team works closely with our Discovery organizations across Infectious Disease and Vaccines, Oncology, Neuroscience, and Immunology, and seeks to embed developability/manufacturability considerations into early research discussions in order to enable more seamless and rapid progression of candidates from Discovery into Process Development and Clinical Supply Manufacturing. 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 (outside Philadelphia). The candidate will be responsible for scientific/technical leadership of a downstream/bio-purification process development team, and will also be a critical member of cross-functional program/project teams. This will require frequent collaboration with cross-functional teams including colleagues in Discovery, Analytical, Formulation, and Enabling Technologies. The candidate should have a strong background in recombinant protein therapeutic/vaccine process design and understanding of various purification modalities, including but not limited to column chromatography (SEC, IEX, Affinity, MMC, HIC, etc.) and filtration unit operations (depth filtration, sterile filtration, viral filtration, TFF), as well as advanced knowledge in peptide/protein handling and purification techniques. Alternatively, the candidate will have a strong background in biomolecule conjugation techniques and conjugate modalities (e.g., conjugate vaccines, antibody-drug conjugates). Preferably, the candidate will have experience with both recombinant protein purification and conjugation process development. Primary responsibilities include, but are not limited to: Lead early downstream process design and development for recombinant subunit and/or conjugate vaccine products. Contribute to the development of new principles, concepts, methods, and workflows to enable rapid early process development for new molecules emerging from Discovery. Design, execute, and analyze process development experiments to maximize understanding of recombinant subunit and/or conjugate vaccine production processes, thereby de-risking later stage process/product development. Represent functional area in cross-functional and strategic teams engaged in novel vaccine development. Serve as the scientific/technical mentor for junior staff. Provide technical guidance in the various aspects of downstream/bio-purification process development for vaccines and advanced biotechnologies. Support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development. Analysis of downstream/bio-purification experiments through basic analytical techniques including SDS-PAGE, UV-Vis, HPLC, Light Scattering Data interpretation and presentation, manuscript/patent preparation Education Minimum Requirement: Must have a BS or MS or PhD in engineering or biological sciences Engineering: Chemical Engineering, Bioengineering, Biomedical Engineering Science and Technology: Cell Biology, Biological Sciences, Biotechnology For BS candidates, at least seven (7) 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: Must have strong scientific and hands-on understanding of a wide variety of common downstream unit operations for large molecule purification (e.g., depth filtration, chromatography, tangential flow filtration), biotherapeutic and/or vaccine production, and purification process development and sound understanding of scale-up principles. At least 5 years of hands-on experience in the optimization of downstream processes Some 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 in purification unit operations using AKTA platform (or similar FPLC system) Experience with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates) Demonstrated knowledge of peptide and protein biochemistry (e.g., structure, function, immunology), and cutting-edge methodologies related to protein isolation/purification Experience in mentoring others and leading small technical development teams 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 his/her 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 him/herself and his/her team. Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds. Some travel may be required. This position may require occasional off-hour and weekend work. PRD Required Skills: Accountability, Accountability, Animal Vaccination, Antibody Drug Conjugates (ADC), Biomedical Engineering, Biomedical Sciences, Biomedical Technologies, Cell Line Development, Column Chromatography, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Immunoassays, Innovation, Interpersonal Relationships, Laboratory Safety, Leading Project Teams, Machine Learning (ML), Mechatronics, Molecular Biology, Neurotrophins, Pharmaceutical Formulations, Pharmaceutical Process Development {+ 3 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 $139,600.00 - $219,700.00 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 12/26/2025 *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.
    $62k-87k yearly est. Auto-Apply 18d ago
  • Associate R&D Process Scientist

    Perrigo Company Corporate 4.9company rating

    Eau Claire, WI jobs

    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
    $62k-84k yearly est. 24d ago
  • Technical Services Manufacturing Scientist (TSMS) Associate- Pilot Scale

    Elanco 4.9company rating

    Elwood, KS jobs

    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
    $59k-78k yearly est. Auto-Apply 60d+ ago
  • Technical Services Manufacturing Scientist - Downstream

    Elanco 4.9company rating

    Elwood, KS jobs

    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
    $59k-78k yearly est. Auto-Apply 33d ago
  • Senior Scientist - Formulation Development

    Nivagen Pharmaceuticals 3.7company rating

    Sacramento, CA jobs

    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.
    $70k-90k yearly Auto-Apply 52d ago
  • Toxicologist

    Zoetis 4.9company rating

    Remote

    Zoetis Veterinary Medicine Research and Development (VMRD) seeks a skilled Toxicologist to join the Toxicology Group within Clinical Pharmacology and Safety Sciences based in Kalamazoo, MI. This challenging and dynamic role provides global toxicology and safety assessment support. The successful candidate will collaborate across VMRD and Global Manufacturing and Supply (GMS) to develop scientifically rigorous safety assessments supporting product safety across therapeutic areas, veterinary species, human health, and manufacturing processes. Responsibilities: Toxicological Assessment for Drug Products: Conduct safety assessments for formulation excipients, degradants, raw materials, and residual solvents in active pharmaceutical ingredients (APIs) and drug products Toxicological Assessment for Manufacturing: Qualify impurities in the manufacturing process of APIs and drug products; conduct safety assessments for extractables and leachables, cross-contamination of products in shared facilities, and establish cleaning limits. Occupational Safety: Develop Occupational Exposure Limits (OELs/ OEBs) following Zoetis processes and procedures. User and Worker Safety: Provide product user and worker safety support for project teams, including risk assessments, exposure scenario calculations, risk mitigation proposals, packaging recommendations and label language development. Safe Exposure Level Development: Establish Threshold of Toxicological Concern (TTC) and health-based exposure limits, including Permitted Daily Exposure (PDE), Acceptable Daily Intake (ADI), and Margin of Exposure (MoE). Health Hazard/ Medical Assessments: Support pharmacovigilance, product quality, and qualification of out-of-specification batches. Regulatory Support: Assist with REACH registration for API intermediates and raw materials, and address global regulatory queries related to the safety of registered products. Toxicology Data Analysis & Literature Review: Perform rigorous toxicology gap analysis, literature data mining, and critical evaluation of toxicological information to support product development and registration. Hazard Communication and Chemical Regulatory Compliance (Preferred): Experience in preparing Safety Data Sheets (SDS), classifying drug substances and process intermediates according to the Globally Harmonized System (GHS) and national requirements, and horizon scanning and monitoring of chemical regulations. Cross-Collaboration and Technical Leadership: Engage in multidisciplinary collaboration within R&D, and with Manufacturing, Product Quality, and Sustainability, to develop and integrate key knowledge areas and expertise into actionable business insights. Regulatory & Scientific Engagement: Support regulatory compliance, trade association participation, and involvement in professional organizations relevant to toxicology. Travel Requirement: This role involves up to 10% travel for collaborations, regulatory engagements, or conferences as needed. Minimum Qualifications Ph.D. (or equivalent) plus at least 2-3 years of experience in toxicology or closely related discipline is critical. Master's degree in toxicology or closely related discipline with 8 years of relevant experience shall be considered. Demonstrated experience in preparing regulatory-quality technical documents or toxicology dossiers, with strong technical writing skills (e.g., protocols, reports, journal articles) Experience in study design, implementation, and interpretation of studies evaluating in vivo and in vitro toxicity or similar experience. Highly organized with strong problem-solving skills, capable of performing rigorous scientific assessments. Ability to prioritize tasks, make informed decisions, and collaborate effectively in a global matrix environment. Excellent verbal and written communication skills in English. Proficiency in MS Office, and toxicology databases for literature research and data analysis Desirable Skills, Experience, and Attributes: Board certification in toxicology (e.g., DABT, ERT) and/or DVM. Knowledge of global regulatory requirements for toxicology risk assessment and documentation to support product safety and chemical registrations. Experience in preparing safety data sheets. The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors. Base Pay Range: $91,000 - $131,000 The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and other factors. Base Pay Range: $103,000 - $148,000 [This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.] We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $103k-148k yearly Auto-Apply 60d+ ago
  • Scientist- Biologics

    Frontage Lab 3.9company rating

    Exton, PA jobs

    Scientist, Biologics Full-time 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. Responsibilities: Primary responsibilities include, but are not limited to the following: * Perform analytical and biological sample testing * Conduct method development and validation studies * Perform immunoassay techniques: (ligand binding assays, ELISA, MSD, and/or RIA applicable to Pharmacokinetic and Immunogenicity studies), with proficiency * Prepare and handle various cell lines, tissue culture media and other reagents for cell-based assays such as Neutralizing Antibody (NAb) assays * Maintenance of instruments, and address technical and instrumental issues * Assist the Principal Investigator with study conduct * Maintain study documentation * Meet regulatory compliance requirements * Maintain a safe work environment Requirements: * Bachelor's degree in related scientific discipline or Bachelors degree with relevant experience * At least 2 years working in a laboratory 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. *
    $52k-78k yearly est. 60d+ ago
  • Research Associate, Assay Development Returnship

    Recursion 4.2company rating

    Salt Lake City, UT jobs

    Your work will change lives. Including your own. We are leveraging new technology to create virtuous cycles of learning around datasets to build a next-generation biopharmaceutical company. It's complex biology, decoded. Recursion is a digital biology company industrializing drug discovery. We are working to solve some of the hardest, most meaningful problems facing human health today. Come join us in our mission to decode biology to radically improve lives, while doing the most impactful work of your life. Recursion's Returnship Program Our Returnship program is sponsored by the Women at Recursion Employee Resource Group. The program is aimed at helping those who have taken a hiatus (2+ years) from the STEM industry have the opportunity to return to the workforce in a learning environment with support from teams and mentors. This allows our company to tap into an underutilized pool of talent in Utah, and leverage the experience and skills of previous work and life experiences, while also providing opportunity to learn and develop experience in new cutting-edge tools and technology. This sixteen-week program will enable you to have ownership of projects that can deeply impact the company's mission to radically decode biology and serve patients, while having the guidance, support and mentorship has you re-enter the workforce. Each Returner will be assigned a mentor who will meet with them weekly, as well as weekly seminars on workplace culture, communication and technology. Our returner program lasts 4 months, running from February 2026 through the end of May 2026, with potential for transition into full-time employment depending on performance and availability. This position is mainly based in our Salt Lake City, UT headquarters, with some hybrid working flexibility available. MOAD Returnship Are you a talented scientific professional looking to re-enter the workforce after a career break? The Multi-Omics Assay Development (MOAD) team is excited to announce our MOAD Research Associate Returnship. This unique opportunity is designed for individuals with a passion for cutting-edge biological research and a desire to contribute to groundbreaking scientific and innovative projects. The MOAD team is a group of Scientists that work together to develop novel assays and onboard them to the HTS platform. This team interacts with many cross functional teams including a group of exceptional biologists, automation and software engineers, assay operations, machine learning scientists, computational biologists, and data scientists. We work rapidly and as a team on a project-by-project basis to prove or disprove the value and feasibility of new biological assays as Scientist and Project Managers. As a Research Associate, you will work under the direction of a Senior Scientist, collaborating closely with our MOAD team and crossfunctional teams. We are seeking an individual with excellent time management skills, a bias for action, strong troubleshooting abilities, and a minimal viable product mindset. A strong desire to learn new skills, techniques, and industry approaches is essential to thrive in our fast-paced environment. Working alongside Recursion's MOAD within the OS Hub. You will work on projects to: Perform tissue culture activities: This includes media preparation, cell thawing, counting, lipofection, plating, and changing media, utilizing good sterile laboratory techniques. Execute drug treatment experiments on cells, leveraging lab automation tools. Conduct diverse experiments: Including but not limited to immunofluorescence, high-content imaging, and other relevant assays (e.g., -omics assays). Capture data via automated imaging runs and set up basic image analyses. Document project activities using an electronic laboratory notebook (ELN) and interact with a laboratory information system (LIMS) for reagent tracking, SOPs, and QC. Deliver robust data and establish baseline protocols to drive progress on complicated and exciting scientific projects. Learn about assay development, including experiment design and validation. The Experience You'll Need Must have 3 years of working experience in a research laboratory, preferably with mammalian cell culture. Bachelor's Degree or higher in Biology, Biochemistry, Bioengineering, or a related major. Including understanding of molecular biology techniques. Must have taken a 2+ year break from employment. A strong desire to learn with excellent written and verbal communication skills. Attentive to detail and possess the ability to accurately record experimental details and results. Enjoy working both independently and collaboratively with a team in a laboratory setting. The Recursion Community While we offer cutting-edge tools, the secret sauce is our people. Our organization structure and culture isn't driven by politics or ego, it is designed first and foremost to help you do your best work. We live and work by values that we see as the strategic differentiators that give us a competitive advantage, allowing for better and faster work that isn't predicated on burnout and encourages us to make leaps where others take steps. This is a place where people in every role and every level make the bold bets that create large leaps forward on a regular basis! The Perks You'll Enjoy as a Returner Recursionaut Paid sick pay and additional flexibility as needed. Complimentary chef-prepared lunches and well-stocked snack bars (Salt Lake City). One-of-a-kind 100,000 square foot headquarters complete with a 70-foot climbing wall, showers, lockers and bike parking (Salt Lake City). Weekly Returners Skill Development Classes. 1:1 Weekly Mentorship with a member of your team and a member of the Returnship ERG. The Values We Hope You Share: We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust. We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action. We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection. We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day. We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together. We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities. Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively. More About Recursion Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine. Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn. Recursion is 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, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation. Accommodations are available on request for candidates taking part in all aspects of the selection process. Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
    $61k-100k yearly est. Auto-Apply 51d ago
  • Associate Scientist - R&D

    Clinical Diagnostic Solutions 4.8company rating

    Plantation, FL jobs

    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
    $49k-76k yearly est. 60d+ ago
  • Process Development Associate II

    AGC Biologics 3.6company rating

    Bothell, WA jobs

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. Job Summary We are looking for a Process Development Associate II to join our Analytical and Formulation Development (AFD) team. AFD develops robust analytical methods to support drug release testing, upstream and downstream development, and non-GMP studies. The team also provides molecular characterization and scientific expertise for deviation investigations. In this role, you'll focus on executing analytical methods - primarily HPLC/UHPLC and capillary electrophoresis (CE-SDS, ic IEF)-to support process development activities. You'll work closely with experienced scientists, contribute to method optimization, and help drive continuous improvement projects within the department. This position is a great fit for someone who enjoys hands-on lab work, collaborating with teammates, and learning in a supportive environment. Location: Bothell, WA Schedule: Monday through Friday, onsite Compensation Range: $66,960 - $92,070 Essential Job Duties / Responsibilities Perform analytical testing in support of process development following established protocols. Assist in the development and optimization of analytical methods. Support method transfer to Quality Control. Coordinate and perform instrument maintenance and troubleshooting. Ensure accurate and complete documentation of results. Author, review, and edit analytical protocols and reports. Contribute to laboratory operations and continuous improvement efforts. Leadership Skills Communicates clearly and effectively with colleagues and customers. Solves straightforward problems and explains logic and decisions to others. Collaborates with teammates to support project and department goals. Qualifications BS/BA degree in biochemistry, protein chemistry, or related field, plus 2+ years of experience in an analytical lab. Required: Experience in chromatography (HPLC/UHPLC), preferably across multiple modes (SEC, IEX, RP, affinity). Preferred: Experience with capillary electrophoresis (CE-SDS, ic IEF). Strong interpersonal and teamwork skills; able to thrive in a fast-paced environment. Ability to adapt quickly to changing priorities or technical challenges. Strong data management skills and attention to detail in documentation and execution. Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit *************** W ant to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
    $67k-92.1k yearly Auto-Apply 55d ago
  • Process Development, Associate Director - Cell Line Development (CLD), Biologics

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead and manage activities related to cell line development (CLD) for the production of monoclonal antibodies and other therapeutic biologics, with a strong focus on overseeing programs conducted at external CDMOs. This role is critical in advancing our pipeline of innovative biologics from early development through to commercial readiness. The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of Biologics, Cell and Genetic therapeutics. The successful candidate will bring deep technical knowledge in cell line development and act as the technical lead for CLD work. This is a highly cross-functional role that will work closely with drug substance development, analytical development, external manufacturing and supply chain management in CMC teams to drive technical and strategic decision-making. Key Duties and Responsibilities: * Lead phase-appropriate strategies to develop, select, and characterize stable, high-producing cell lines for monoclonal antibodies, ADCs and other biologics modalities. * Evaluate, select and manage external capabilities for cell line development. * Oversee and review all aspects of the CLD process, including vector design, transfection, clone screening, characterization and cell line stability studies. * Ensure regulatory-compliant cell line development workflows, including clonality documentation and cell bank generation. * Develop and manage project timelines and budget for CLD activites. * Ensure project deliverables, quality standards, and timelines are met in alignment with internal program goals. * Collaborate with internal cross-functional teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs to ensure alignment and knowledge transfer. * Review and approve technical protocols, development reports, and data packages provided by CDMOs. * Provide scientific and strategic input into cell line platform development, technology evaluation, and implementation of innovation from external partners. * Support regulatory submissions (IND/IMPD/BLA) by contributing to or authoring relevant sections and responding to agency queries related to CLD. * Serve as a subject matter expert in regulatory agency interactions, audits, and inspections. * Expected travel: 10-20% (domestic and international) Required Education: * PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline with commensurate years of education and experience. * Minimum of 8 years of experience in drug substance development and manufacturing. MS with 12+ years of relevant experience may be considered. Required Experience and Skills: * Demonstrated expertise in cell line development for therapeutic proteins including antibodies, ADCs, and fusion proteins. * Strong understanding of molecular biology techniques, vector construction, clone selection strategies, and cell line characterization methods. Familiarity with industry-leading expression platforms (e.g., GS, CHOZN, CHEF1, etc.) is strongly preferred. * Knowledge of upstream process development and analytical methods related to CLD. * Hands-on experience managing external CDMOs and navigating cross-functional and cross-organizational workflows. * Experience in authoring and reviewing relevant CMC sections of regulatory filings (IND, BLA, etc.). * Proven track record of delivering on complex biologics development programs. * Excellent interpersonal, communication, and organizational skills. * Ability to work independently, manage multiple projects simultaneously, and operate in a fast-paced environment. #LI-LE1 Pay Range: $166,800 - $250,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $73k-88k yearly est. Auto-Apply 39d ago
  • Analytical Development Principal Research Associate

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    Employer: Vertex Pharmaceuticals Incorporated JOB TITLE: Analytical Development Principal Research Associate OPENINGS: 1 * Design, develop, execute and analyze characterization and release assays for identity, purity, strength and potency of cell- based products. Multiple analytical platforms will be employed including RT-qPCR, SDS-PAGE, ELISA, Western blots, Flow cytometry, Flow-cam, dd PCR, Alphalisa and cell- based functional/ potency assays. * Execute test methods in support of pluripotent stem cell Process Development activities. * Troubleshoot, optimize, and trend assay performance. * Report on project progress, write analytical development protocols and reports, provide recommendations to management. * Identify, qualify, and manage analytical reagents as per regulatory standards. * Establish assay design criteria using Design of Experiments (DOE) and other contemporary development tools. * Perform statistical analysis to establish specificity, sensitivity, linear range, precision, and accuracy of test methods. * Establish reference standard materials as required to support assay validation. * Transfer assays to QC and provide SME support for assay qualification, author transfer/qualification protocols and reports. * Maintain excellent written documentation (e.g. lab notebook and test forms). REQUIREMENTS: Employer will accept a Master's degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 2 years of experience in the job offered or in an Analytical Development Principal Research Associate-related occupation. Alternatively, employer will accept a Bachelor's degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 6 years of experience in the job offered or in an Analytical Development Principal Research Associate-related occupation. Position requires demonstrable experience in the following: Developing analytical methods in compliance with ICH guidelines. Assisting with the following assay platforms: RT-qPCR, ELISA, Western blots, Flow cytometry or cell- based functional/ potency assays. Assisting with the culture of multiple mammalian cell types and combination drug product (Cells + device) Using literature to design proof of concept studies. Writing technical documents including development reports, qualification protocols and qualification reports. Rate of Pay: $88300.00 - $132400.00 CONTACT: Send Resume to *********************. Reference 12140.579. EOE. #LI-DNI Pay Range: $0 - $0 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $88.3k-132.4k yearly Auto-Apply 13d ago
  • Scientist I, Production

    Cole-Parmer Instrument Company 4.2company rating

    North Charleston, SC jobs

    Job Title: Scientist, Production Reports To: Manager, Operations Work Type: Onsite FLSA Status: Non-exempt Individuals serving in this position will be working in manufacturing, product development, and Quality testing at the Diagnostics business units. Employees will be trained in a variety of lab techniques specific to the department assigned as well as document generation and completion. The incumbent must be a dynamic individual who can multi-task and perform various activities associated with manufacturing operations while adhering to all safety policies and high quality Standard Operating Procedures. This position requires hands on lab work and will report to the Lab or Production Manager. Key Responsibilities: · Execution of quality system procedures · Proper execution of SOPs, safety guidelines, and work instructions for manufacturing procedures assigned by supervisor · Ability to work individually as well as part of a team towards completion of specific projects · Use of manufacturing related equipment as required by work instructions and SOPs · Data analysis · Demonstration of sound problem-solving skills and troubleshooting abilities · Communicate exceptions to established/agreed upon schedules to all affected parties internal and external. · Adherence to quality systems with special regard to FDA, ISO 13485 and GMP / OSHA compliance · QC testing of components and finished products including organization of inventory, weighing actual hands-on inventory and updating systems. · Inventory management of materials and supplies · Focus on continual process improvement · Cleaning and maintenance of equipment · Guided experimental design and product testing assigned by supervisor · Preparation of reagents, media, and buffers · Performs other duties as assigned Department Specific Potential Duties: Chemistry · Assist and manufacture inorganic or organic products using knowledge of chemistry principles. · Experience with general chemistry glassware, lab supplies and concentrated acid handling · Experience with hot block digestion, auto pipettes, and sample preparation preferred. · Basic mathematics and familiarity with general chemistry calculations Experience: · 4-year B.S. degree required in biology, microbiology, chemistry, or other life sciences program · Relevant experience in laboratory skills/cGMP preferred. Including but not limited to pipetting, preparing reagents, centrifugation, recording observations, etc. Qualifications: · Ability to analyze and interpret data and results · Proficiency in Microsoft Office · Strong analytical, problem solving, process improvement skills · Attention to detail · Ability to multitask and adapt to changing priorities · Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints · Excellent communication skills, both written and verbal, to communicate to all levels of the organization clearly and concisely · Strong work ethic and an ability to excel within a rapidly changing and growing organization · Willingness to cross train and support other teams as needed for our medium sized business. Physical Requirements/Working Conditions: · Potential Hazards: solvents, acids, bases, infectious organisms, carcinogens, combustibles, fast paced environment, repetitive motion, · Recommended PPE: Closed toe shoes, lab coats, gloves, safety goggles, Tyvek suits in level three biohazard laboratories Compensation & Benefits: Salary Range: $20/hr-$36/hr, depending on location, experience, and qualifications. Benefits coverage begins day 1, including the following: Medical, Dental, Vision Insurance Disability Insurance Life Insurance 401(k) company match Paid Time Off (15 days annually) Paid Holiday time (10 company-designated days) Tuition Assistance Additional benefits available with company package This position has not been approved for Relocation Assistance. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
    $20 hourly Auto-Apply 60d+ ago
  • Toxicologist

    Zoetis 4.9company rating

    Kalamazoo, MI jobs

    Zoetis Veterinary Medicine Research and Development (VMRD) seeks a skilled Toxicologist to join the Toxicology Group within Clinical Pharmacology and Safety Sciences based in Kalamazoo, MI. This challenging and dynamic role provides global toxicology and safety assessment support. The successful candidate will collaborate across VMRD and Global Manufacturing and Supply (GMS) to develop scientifically rigorous safety assessments supporting product safety across therapeutic areas, veterinary species, human health, and manufacturing processes. Responsibilities: Toxicological Assessment for Drug Products: Conduct safety assessments for formulation excipients, degradants, raw materials, and residual solvents in active pharmaceutical ingredients (APIs) and drug products Toxicological Assessment for Manufacturing: Qualify impurities in the manufacturing process of APIs and drug products; conduct safety assessments for extractables and leachables, cross-contamination of products in shared facilities, and establish cleaning limits. Occupational Safety: Develop Occupational Exposure Limits (OELs/ OEBs) following Zoetis processes and procedures. User and Worker Safety: Provide product user and worker safety support for project teams, including risk assessments, exposure scenario calculations, risk mitigation proposals, packaging recommendations and label language development. Safe Exposure Level Development: Establish Threshold of Toxicological Concern (TTC) and health-based exposure limits, including Permitted Daily Exposure (PDE), Acceptable Daily Intake (ADI), and Margin of Exposure (MoE). Health Hazard/ Medical Assessments: Support pharmacovigilance, product quality, and qualification of out-of-specification batches. Regulatory Support: Assist with REACH registration for API intermediates and raw materials, and address global regulatory queries related to the safety of registered products. Toxicology Data Analysis & Literature Review: Perform rigorous toxicology gap analysis, literature data mining, and critical evaluation of toxicological information to support product development and registration. Hazard Communication and Chemical Regulatory Compliance (Preferred): Experience in preparing Safety Data Sheets (SDS), classifying drug substances and process intermediates according to the Globally Harmonized System (GHS) and national requirements, and horizon scanning and monitoring of chemical regulations. Cross-Collaboration and Technical Leadership: Engage in multidisciplinary collaboration within R&D, and with Manufacturing, Product Quality, and Sustainability, to develop and integrate key knowledge areas and expertise into actionable business insights. Regulatory & Scientific Engagement: Support regulatory compliance, trade association participation, and involvement in professional organizations relevant to toxicology. Travel Requirement: This role involves up to 10% travel for collaborations, regulatory engagements, or conferences as needed. Minimum Qualifications Ph.D. (or equivalent) plus at least 2-3 years of experience in toxicology or closely related discipline is critical. Master's degree in toxicology or closely related discipline with 8 years of relevant experience shall be considered. Demonstrated experience in preparing regulatory-quality technical documents or toxicology dossiers, with strong technical writing skills (e.g., protocols, reports, journal articles) Experience in study design, implementation, and interpretation of studies evaluating in vivo and in vitro toxicity or similar experience. Highly organized with strong problem-solving skills, capable of performing rigorous scientific assessments. Ability to prioritize tasks, make informed decisions, and collaborate effectively in a global matrix environment. Excellent verbal and written communication skills in English. Proficiency in MS Office, and toxicology databases for literature research and data analysis Desirable Skills, Experience, and Attributes: Board certification in toxicology (e.g., DABT, ERT) and/or DVM. Knowledge of global regulatory requirements for toxicology risk assessment and documentation to support product safety and chemical registrations. Experience in preparing safety data sheets. The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors. Base Pay Range: $91,000 - $131,000 The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and other factors. Base Pay Range: $103,000 - $148,000 [This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.] We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $103k-148k yearly Auto-Apply 60d+ ago
  • TALENT PIPELINE - Scientist II (Analytical R&D)- Future Opportunities

    Cambrex 4.4company rating

    Durham, NC jobs

    Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview Thank you for considering a future opportunity with Cambrex! If you are interested in joining our team but don't see a current role that fits your background, please submit your resume here. If we have future opportunities that match your skillset, we will contact you. While we are not currently hiring for a role linked to this specific posting, we would love to connect with talented individuals who are interested in potential future positions. By joining this talent pipeline, you will be the first to be notified when suitable opportunities arise within our Analytical R&D function. Cambrex's Analytical R&D positions will be on-site at our Durham, NC site. Responsibilities Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work with supervision and to evaluate and interpret generated data. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Qualifications/Skills Duties and Responsibilities • Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines • Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability. • Maintains compliant records with little or no supervision • Able to write technical documents with assistance • Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks • Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions • Sets up various instrumentation for testing according to written test methods and with little to no supervision. • As needed, troubleshoots laboratory instrumentation • Leads a sample project with assistance • May participate in client level meetings, with approval • Responsible for ensuring compliance with cGMP and other regulatory guidelines. • Analyze information for technical correctness and accuracy • Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor • Perform routine laboratory procedures in a timely and efficient manner • Gain familiarization with analytical techniques • Participate cGMP activities • Maintain laboratory equipment and supplies as directed • May support peer-led laboratory investigations process with assistance • Maintain a clean and safe work-space • Maintain laboratory notebook and/or computer files (i. e. LIMS) according to standard, accepted practices • Participate in group and project meetings as required • Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems • Attend seminars as required • Participate in and comply with all current safety, health and environmental programs • Shows initiative and interest in learning new techniques and tests • Participates in technical discussions and brainstorming sessions • Communicates issues or challenges to senior staff and/or management • May review test data acquired by others and witness others' notebooks • Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs • Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed • With guidance, prepares well written and organized development reports • Performs other related duties as assigned. Education, Experience & Licensing Requirements Skills and Competencies • Working knowledge of experimental design, including chemistry supporting method development • Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC. • Working exposure to cross functional techniques including organic chemistry. • Able to comply to SOPs and basic regulatory compliance • Working knowledge of scientific concepts, principles and procedures • Actively and positively engages with team and supports process improvements • Ability to read and execute compendial methodologies • Strong understanding of current FDA and cGMP regulations • General knowledge of chemistry and scientific calculations • Hands on experience in analytical techniques such as HPLC, GC, etc • Good computer skills • Ability to operate laboratory equipment and computers • Ability to take direction from experienced scientists and contributes in a team environment • Good problem-solving skills • Good attention to details • Can repeat and follow detailed scientific procedures with supervision • Able to clearly present results verbally in group meetings and in written progress reports • Good interpersonal skills and is willing to ask questions about procedures and concepts • Aptitude and willingness to gain more skills and knowledge in support of GMP regulations • Good written and verbal communication skills • Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel. • Aptitude and willingness to gain more skills & knowledge. • Good attention to detail and good problem-solving skills. Education, Experience, and Other Qualifications • B. S. /B. A. Chemistry with 4+ years of experience in related industry or MS with 0+ years related experience Supervision Received: Works under limited supervision. Physical Demands, Work Environment, and Travel Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required. Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. Travel: Little to no expected travel time. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-SK1Skills and Competencies • Working knowledge of experimental design, including chemistry supporting method development • Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC. • Working exposure to cross functional techniques including organic chemistry. • Able to comply to SOPs and basic regulatory compliance • Working knowledge of scientific concepts, principles and procedures • Actively and positively engages with team and supports process improvements • Ability to read and execute compendial methodologies • Strong understanding of current FDA and cGMP regulations • General knowledge of chemistry and scientific calculations • Hands on experience in analytical techniques such as HPLC, GC, etc • Good computer skills • Ability to operate laboratory equipment and computers • Ability to take direction from experienced scientists and contributes in a team environment • Good problem-solving skills • Good attention to details • Can repeat and follow detailed scientific procedures with supervision • Able to clearly present results verbally in group meetings and in written progress reports • Good interpersonal skills and is willing to ask questions about procedures and concepts • Aptitude and willingness to gain more skills and knowledge in support of GMP regulations • Good written and verbal communication skills • Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel. • Aptitude and willingness to gain more skills & knowledge. • Good attention to detail and good problem-solving skills. Education, Experience, and Other Qualifications • B. S. /B. A. Chemistry with 4+ years of experience in related industry or MS with 0+ years related experience Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work with supervision and to evaluate and interpret generated data. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
    $58k-82k yearly est. Auto-Apply 60d+ ago

Learn more about Takeda Pharmaceuticals U.S.A., Inc. jobs

Most common jobs at Takeda Pharmaceuticals U.S.A., Inc.

View all jobs