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Research And Development Scientist jobs at Johnson & Johnson

- 1163 jobs
  • Principal Scientist, Preclinical Surgeon

    J&J Family of Companies 4.7company rating

    Research and development scientist job at Johnson & Johnson

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Discovery & Pre-Clinical/Clinical Development **Job Sub** **Function:** Multi-Family Pre-Clinical Development - Medtech **Job Category:** People Leader **All Job Posting Locations:** Cincinnati, Ohio, United States of America **Job Description:** We are searching for the best talent for a Principal Scientist, Nonclinical Surgery located in Cincinnati, OH. Purpose: Functioning as a primary surgeon, with a primary focus on cardiovascular procedures, to provide surgical expertise and technical leadership during research, development, and evaluation of surgical devices using animate, inanimate, and cadaveric models. Performing surgical research & testing which support development of products or procedures in standard and minimally invasive surgery (open, laparoscopic, and robotic). Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will: + Conducting and / or directing surgical investigations for product development and preclinical evidence generation. + Use scientific and surgical expertise to evaluate functionality, efficacy, and safety of medical devices during acquisition, licensure, discovery, development, and product change evaluations. + Provide biomedical expertise by making unbiased recommendations to ETHICON teams regarding new technologies and interaction of device concepts on living tissue. + Provide technical direction and execution within Preclinical Research for surgical investigation and development of medical devices. + Collaborating with Preclinical Research team to apply clinically relevant models for product evaluation, while meeting preclinical study design, execution, and timeline requirements. + Support the Preclinical Research team with the development of animal models. + Responsible for communicating business related issues or opportunities to next management level + For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures + Know & follow ETHICON policies & procedures related to work activities performed in area of responsibility. + Utilize interpersonal skills and collaboration to enhance team processes and drive surgical efficiency/quality within Preclinical Research, ETHICON, and J&J. + Function as key Preclinical Research team member by energetically supporting the goals of the department, ETHICON, and J&J by actively participating in and collaborating with the external scientific community. + Performs other duties assigned as needed Education: + A minimum of a Doctorate degree is highly preferred (DVM/VMD from an (AVMA) American Veterinary Medical Association accredited program; MD is also acceptable with significant preclinical experience) + Surgical residency training and board certification (DACVS) is preferred. + Certification as a Surgical Research Specialist (SRS) through the Academy of Surgical Research may also be considered based on experience level. + Demonstrated knowledge of surgical principles and theory is required, with specific training in cardiovascular procedures also required. + Demonstrated knowledge and experience in performing fluoroscopic angiography in large animals is required + Experience in executing preclinical and/or clinical studies, including GLP, with external contract research organizations is preferred. + Ability to work collaboratively with the preclinical research team is required. + Familiarity with Medical Device Product Development is preferred. + Knowledge of preclinical regulatory requirements for FDA and notified bodies outside the US is preferred. Required Skills & Experience: + Extensive knowledge of cardiovascular surgery as well as interventional procedures. + Deep knowledge of animal and human anatomy and physiology, as well as biological systems. + Demonstrated analytical problem-solving and decision-making skills. + Demonstrated surgical expertise during research, development, & evaluation by utilizing animate, inanimate and cadaveric models. + Ability to work as a technical leader, team member, and role model for preclinical staff. + Excellent communication skills - written/oral/listening. + Working with minimal supervision. + Ability to clearly document and communicate plans and results. + Possess the motivation and work ethic to successfully complete studies/surgical procedures on time and with high quality. + Able to manage multiple tasks and responsibilities. + Serve as a preclinical subject matter expert on technical/surgical evaluation concerning device performance. + Able to bring new scientific principles / innovative technical solutions to projects / studies. + Robust surgical technique & mastery of open and laparoscopic procedures spanning multiple animal models. Robotic surgical experience is desired, but not required. + Knowledge of regulations regarding medical device development and the utilization of live animals in preclinical research. Other: + This position is based in Cincinnati, OH, and requires up to 25% travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.
    $78k-105k yearly est. 60d+ ago
  • Scientist, Analytical R&D (Onsite)

    MSD 4.6company rating

    Rahway, NJ jobs

    Scientist, Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development group has an opening for a Scientist based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. In your role as Scientist, you will be part of a team of Analytical Chemists working on cross-functional scientific teams to enable novel small molecule, peptide, and oligonucleotide drug development through laboratory-based analytical characterization and statistical data analysis. Primary Responsibilities Support execution of Good Manufacturing Practices (GMP) activities such as release and stability testing to support development of active pharmaceutical ingredients (APIs), pharmaceutical formulations, and manufacturing processes using both traditional and advanced analytical tools. Document the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA principals. Troubleshoot and investigate any challenges associated with the GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Validate and implement analytical methods to support release and stability testing of clinical materials. Perform data entry, data review, and author analytical reports or data summaries. Strong collaboration with fellow Analytical Research & Development colleagues as well as cross-functional partners such as Global Development Quality and Process Chemistry. Support internal compliance audit activities. Education Minimum Requirements: Minimum 3+ years relevant industry experience for applicants with a Bachelor of Science degree, or a Master of Science degree in Chemistry, Pharmaceutical Sciences, or other Life Sciences. Required Experience and Skills Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role. Candidates will also be required to work in a team environment with cross-functional interactions. Preferred Experience and Skills Though not required, the ideal applicant would have hands-on experience in in GMP operations, advanced chromatographic separation science, spectroscopy analysis, and other analytical techniques. In addition, experience with Empower, data science, dissolution, and liquid chromatography mass spectrometry (LCMS) are also a plus. #eligiblefor ERP #AR&D Required Skills: Accountability, Accountability, Adaptability, Analytical Characterization, Analytical Development, Analytical Method Development, Cell-Based Assays, Communication, Drug Development, GMP Compliance, Good Manufacturing Practices (GMP), Immunoassays, Interpersonal Relationships, Laboratory Information Management System (LIMS), Laboratory Techniques, Liquid Chromatography-Mass Spectrometry (LC-MS), Mammalian Cell Culture, Manufacturing Processes, Oral Communications, Pharmaceutical Formulations, Pharmaceutical Manufacturing, Process Manufacturing, Production Management, Real Time Polymerase Chain Reaction (qPCR), Self Motivation {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $85,600.00 - $134,800.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a 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.
    $85.6k-134.8k yearly Auto-Apply 4d ago
  • Distinguished Scientist, Analytical R&D

    MSD 4.6company rating

    Point, PA jobs

    The Distinguished Scientist within our company's Vaccines Analytical Research & Development organization (V-AR&D) is accountable for providing scientific research direction and will partner with the executive management team to refine and advance the strategic directions for our Vaccines portfolios. The ideal candidate should be a visionary with extensive experience in human vaccine process and analytical development and be adept at independently directing research and scientific problem solving. They should have demonstrated commitment towards advancing Vaccines products through innovation, strategic decision making, and partnership with Manufacturing, Quality, and Regulatory Affairs. In this role, they will be responsible for steering scientific strategy and policy with broad pipeline oversight. As a scientific leader, they will partner with the respective leadership teams to drive innovation, scientific excellence, and advance strategic initiatives including due diligence activities. Primary Responsibilities: Leveraging experience working on many types of human vaccine candidates, drive an End-to-end Integrated Control Strategy for new programs Build an innovative and strategic scientific vision for the Analytical Research and Development teams through strong scientific leadership. Anticipate Analytical opportunities proactively, including acting as a key interface for collaborating departments. Serve as technical lead for setting specifications and responding to regulatory feedback. Drive Adjuvant strategy through partnership with Strategy and Development teams Advocate and sponsor evaluation of progressive methodologies, driving implementation to the development and commercialization space. Accountable for mentoring the next generation of scientific talent. Serve as a role model and scientific mentor to the department and cross-functional collaborators, with responsibility to develop scientific talent aligned with organizational strategy. Maintaining recognition as an internationally known expert in their field through regular publication in peer reviewed journals and participating actively in scientific meetings, including chairing sessions. May serve on expert committees outside our Company, on editorial boards, planning committees or major scientific meetings. Interface with Discovery interface teams to ensure scientific rigor and strategy for FIH studies Apply principles of predictive stability across the vaccine portfolio. Interface with Manufacturing teams to proactively guide method transfers and serve as POC for any troubleshooting Own Analytical Cross-functional Forum, setting agenda and driving collaboration across the various interfaces Lead Vaccines Analytical Tier Escalation, highlighting wins and areas of current concern to management with the appropriate level of details. Education: Bachelors, Masters, or Ph.D. in biochemistry or other related field with 20+ years of product development experience Required Experience and Skills: The Distinguished Scientist should demonstrate effectiveness in the following key dimensions: Strong experience in Process Development and a willingness to apply learnings to develop relevant Analytical methods Commercialization and licensure of human vaccines products. Strong experience in applying separations techniques and high-throughput automation in process development in a phase-appropriate manner. Provides strategic scientific influence, originates and develops new project/program ideas. Contributes expertise and creativity to the collective knowledge and aids in solving complex pipeline problems. Recognized as a scientific expert, strongly influences senior leaders and helps steer scientific strategy and policy. Recognized nationally/ internationally for scientific expertise in large molecules. Demonstrated experience in Phase Appropriate Validation, data trending, and biological critical reagents used in validated methods. Dynamic mentorship and scientific direction to develop scientific excellence in the team. Strong role model, coach and mentor of junior scientists. A track record of consistently delivering innovations and implementing novel approaches to impact across the pipeline. Interest and experience to adopt and integrate automation and data sciences/machine learning solutions. Demonstrated ability in steering scientific strategy Incumbent must have excellent interpersonal, communication, and collaboration skills. Location: West Point PA, with < 10% travel to other Research and Development sites. Required Skills: Accountability, Accountability, Analytical Chemistry, Analytical Method Development, Business Decisions, Cell-Based Assays, Collaborative Communications, Communication, Cross-Cultural Awareness, Cross-Functional Teamwork, Data Science, Dosage Forms, Exercises Judgment, Foster Innovation, Innovation, Instrumental Analysis, Intellectual Curiosity, Management Process, Mentorship, Molecular Structure, Process Builders, Process Engineering, Product Development, Production Process Development, Professional Networking {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $206,200.00 - $324,600.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 10/21/2025 *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.
    $66k-92k yearly est. Auto-Apply 60d 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 20d ago
  • RD&A Process Scientist

    Kerry 4.7company rating

    Clark, NJ jobs

    Requisition ID 61042 Position Type (US) Full Time Workplace Arrangement #LI-Onsite 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. Recruiter Posting Type DNI
    $107.8k-181.6k yearly 56d ago
  • R&D Scientist Beverage

    Kerry 4.7company rating

    Quincy, MA jobs

    Requisition ID 57820 Position Type (US) Full Time Workplace Arrangement #LI-Onsite 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. What will you do? + Conduct research including new product research and the development of foods. + Develop new and improved methods and systems for food processing, production, quality control and packaging. + Work in pilot plant and support production scale ups and commercialization's. + Field customer requests both internal and external to satisfy project needs from a conceptual phase through commercialization and troubleshooting. + - Participate in ideation/brainstorming + - Develop gold standards while working with Culinary and subject matter experts (SMEs) + - Match competitive products + - Formulation Optimization + - Concept to Commercialization + - Execute internal processes + - Ability to understand and troubleshoot customer processes + Be a strong part of customer facing team to deliver solutions that will "Nourish and Delight" our customers. + Coordinate customer calls with sales/culinary representatives through presentations both technical and culinary based. + Work with cross functional groups to optimize the strengths of Kerry and deliver the best Taste and Nutrition experience for our customers + Develop and protect Intellectual Property by documenting research notes. + Study methods to improve quality of foods such as flavor, color, texture, nutritional value, convenience, or physical, chemical, and microbiological composition of foods + Complete project requests within the time frame required by the customer. + Assist customers with technical issues that may arise. + Travel to Kerry production plants and to customers. + Must be able to taste and smell chemicals, flavors and food products. + Must be able to stand for long periods of time in a laboratory setting and lift 50 pounds. What will you need to be successful? + BS/MS/PhD in Food Science/Engineering/related science or engineering field. + 3+ years of experience in Beverage Product Development. + Knowledgeable about food chemistry, sensory, microbiology, food packaging systems and food engineering. + Problem solving skills. + Ability to work with cross-functional teams at multi levels within the organization. Compensation Data 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 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).
    $74k-101k yearly est. 56d 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. 26d ago
  • R&D Associate Scientist II

    American Regent Laboratories 4.7company rating

    New Albany, OH jobs

    Nature and Scope Responsible for formulation and process development activities associated with parenteral drug product development. Participates in scale-up of manufacturing process. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Conduct laboratory experiments with minimal supervision to support formulation and process development of injectables Execute laboratory studies for characterization, stability studies per ICH guidelines, component selection and scale-up activities Execute and support the formulation team on experiments to support the selection of process parameters and development of manufacturing process. * Prepare formulations to support analytical method development. * Draft protocols/reports on the formulation development experiments and deliver data presentations. * Assist in the general operation of the R & D formulation laboratory including maintenance of Standard Operating Procedures (SOP's) and equipment validation or maintenance. * Maintain clean and safe work environment in the laboratory. * Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health & safety requirements. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * B.S. in Pharmaceutical Science, Chemistry, Chemical Engineering or equivalent required. * 2-3 years, or for M.S. 0-2 year, of experience in drug product development required. * Hands on skills in analytical instrumentals such as HPLC, particle sizer and Karl Fisher titrator is a plus. * Excellent organizational, interpersonal and communication skills required. * Proficiency in Microsoft Office Word and Excel is required. * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. * Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. * Position requires working in the laboratory as well as sitting. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.
    $63k-86k yearly est. Auto-Apply 49d ago
  • Scientist II; Analytical R&D

    Contract Pharmacal Corp 4.3company rating

    Hauppauge, NY jobs

    Job DescriptionDescription: Develop stability-indicating methods. Design and conduct routine laboratory analysis using various analytical instruments and software such as HPLC, UPLC, ICP, and UV-Vis. Responsibilities: Responsibilities include, but are not limited to: Knowledge of USP and FDA requirements. Develop stability-indicating methods for Active Pharmaceutical Ingredients (API) and Dietary Supplement products. Generate method validation protocols. Execute methods validation and methods transfer. Generate method validation reports and analytical methods. Design and conduct full analysis of Dietary supplements and Active Pharmaceutical Ingredients (API) products and their impurities. Conduct assay, content uniformity, dissolution, in-process blend, and blend uniformity of newly developed and stability samples in support of formulation and process development. Prepare result documentation for department and general review. Identify and resolve problems with analytical methods and provide troubleshooting on instrumentation. Conduct Performance Qualification (PQ) on various instruments. Provide leadership, guidance and hands-on training to new employee and provide technical support to other departments. Effectively communicate information in concise reports. Other responsibilities as assigned by Senior Management. Requirements: Education and Experience: Bachelor's degree in chemistry or analytical chemistry with 4-5 years of pharmaceutical experience OR Master's degree or Ph.D. in chemistry or analytical chemistry with 3-4 years of pharmaceutical experience Instrumentation and Computer Experience Instrumentation: HPLC, UPLC, ICP, GC, FT-IR, UV, Dissolution, pH, TOC and Karl Fischer. Computer programs: Empower 1-3, EZ Chrome Elite, WindLab, ChemStation, Microsoft Word, Excel and Outlook. Work Conditions: Hours/Travel maybe subject to changed based on management/company discretion. Work location are subject to change as needed to meet business requirements. While performing the duties of this job, the employee is regularly required to stoop, kneel, crouch, stand, bend, sit, talk, hear or walk for long periods. The employee may lift and/or move up to 50 lbs. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus. Supervisory Responsibilities: None Personal Protective Equipment or Attire Required for Position: As needed Salary Range: $70,000 - $90,000 per year
    $70k-90k yearly 25d ago
  • R&D Scientist

    Kerry 4.7company rating

    Harrisburg, PA jobs

    Requisition ID 60219 Position Type (US) Full Time Workplace Arrangement #LI-Onsite 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 RD&A Process Scientist to join our Coffee Innovation team. This role focuses on developing and optimizing coffee processing technologies, including roasting, extraction, and drying methods. The ideal candidate will contribute to product innovation, process scale-up, and cross-functional collaboration to deliver high-quality coffee solutions. Key responsibilities + To lead and/or participate in Commercial Coffee projects. + To lead and/or participate in scale up, process optimization and innovation projects for coffee with R&D and production. + To support ideation and implementation of PIP projects. + Set clear priorities, goals and objectives for multi-disciplinary cross-functional project teams that create a competitive advantage for the business. + Partner with Innovation, Beverage EUM and Business Development to ensure R&D objectives are aligned with business requirements and evolving market conditions + Ensure technical reports, standard operating procedure (SOP's) and scientific presentations are accurate and kept up to date. + Contribute to training team members on roasting, extraction that can add value to Kerry's coffee team. Qualifications and skills + Food Science, Food Engineering, Chemistry + 3+ years' experience of hands-on Research and Development. + Experience at pilot scale and production environments. + Demonstrate an ability for multi-tasking, in planning and time management + Competence in extraction technology. + Competence in writing technical documents such as research reports, SOPs, etc. Proficiency with Excel or other data processing/visualization software is desirable. The pay range for this position is $75,602 to $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 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. Recruiter Posting Type DNI
    $75.6k-123.4k yearly 56d ago
  • Chemist, R&D Analytical

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ jobs

    1. Maintain the highest standards of scientific professionalism. When in doubt, get feedback from other R&D/Technical professionals. 2. Maintain detailed and comprehensive documentation of all work performed. 3. Stay current with the scientific literature, particularly in areas that may affect companys product line, existing processes or potential commercial opportunities. 4. Evaluate technology packages from external sources for chemical and cost-effective viability, as directed. 5. Perform literature searches for development work, potential projects, and to support QA/QC and Environmental/Health & Safety. 6. Provide ideas for investigation with an emphasis on commercialization, patent opportunity, or publication on a regular basis. 7. Provide support to QA/QC by writing analytical SOPs. 8. Communicate results by providing timely reports and project updates, to include technical reports and summaries for company business units and customers. 9. Provide monthly report on progress of work to the department head. 10. Provide help on preparation of quarterly/yearly R&D summaries of ongoing work to peers and senior management. 11. Plan and develop robust analytical methods including troubleshooting and validation, as appropriate. 12. Work closely with Synthesis group and support on routine analysis. 13. Work closely with Quality Assurance (QA) and Quality Control (QC) to identify project needs and to insure strict compliance with internal quality and/or cGMP/ICH guidelines. 14. Work closely with QA on validation efforts for new API processes to insure strict cGMP compliance, where appropriate. 15. Work closely with R&D team to answer DMF deficiencies and customer queries. 16. Maintain rigorous accountability and documentation of work related to controlled substances in accordance with established SOPs and requirements of federal regulations (21 CFR Part 1300-1399). 17. Adhere to all relevant company SOPs and guidelines, and provide input for correcting and changing existing procedures and processes. 18. Provide technical support as needed for company products, analytical methods and customer-driven issues, as needed. 19. Provide necessary information on cost-saving and time-saving alternatives to current analytical and laboratory practices whenever and wherever possible. 20. Assist in supervision of R&D laboratory operations in general, including troubleshooting of lab systems and instrumentation. 21. Work with Health, Safety and Environmental representative to identify waste stream data and possible hazards for potential products and processes. 22. Assist in the maintenance and cleaning of the R&D laboratory in general and in individual workspace in particular. 23. Seek out opportunities for professional development. 24. Select and purchase R&D chemicals, glassware and supplies, and track these orders using the established R&D purchase requisition system. 25. Execute R&D stability program, to include writing and following stability protocols, and packaging and testing APIs, as well as compiling and reporting stability results to R&D manager. 26. Facilitate the training system within the R&D department in coordination with the requirements set forth by QA. 27. Other duties as assigned. **Position Requirements:** + B.S. degree in Chemistry (preferable), Chemical Engineering, or related discipline. + Ability and attitude to assume a leadership role and work in a productive technical team within an industrial research environment. + Ability to communicate effectively through verbal, written, presentation and computer modes of expression. + Ability to confidently represent company on technical matters to customers, senior management, and at scientific venues (conferences and publications). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $62k-91k yearly est. 60d+ 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
  • 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
  • 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 57d 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 15d 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 41d ago
  • Research Chemist (E&L)

    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 the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Research Chemist (E&L) We are seeking an experienced Research Chemist (E&L) with a minimum of 3-5 years of pharmaceutical industry experience. Responsibilities: Maintain, operate, and troubleshoot LC-MS and GC-MS, GC-FID, and ICP-MS Systems. Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials associated with container closure systems of pharmaceutical drug products as per USP, PQRI, ICH and other regulatory guidelines. Develop and optimize sample preparation techniques for analysis on GC-MS, LC-MS, and ICP-MS systems. Develop and validate LC-MS, GC-MS, and ICP-MS methods for finished product and raw material characterization as well as extractable/leachable testing. Unknown impurity identifications using GC-MS, LC-MS, and LC-MS/MS or other suitable techniques. Interpret complex spectral data and fragmentation patterns. Routine stability testing of API, finished product samples for assay and impurities using various instrumental techniques as suited, and prepare stability data summaries. Generate study designs, write protocols, methods, Datasheets and reports. Provide support in the critical review of analytical data, reports and protocols. Write Instrument-related SOPs and provide training on the instrument and related software. Train new recruits in the lab and support the team as needed. Participate in internal meetings and conferences. Provide support during technical transfer between R&D and QC. Whenever needed, attend SOP, Safety, and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies. Preparation and review of analytical methods, method validation, and related study reports for ANDA/ NDA submissions and support, document preparation for ANDA/ NDA submissions. Any other activities as directed by the supervisor. Qualifications: Education/Experience: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. Knowledge, Skills, and Abilities: Familiarity with the characterization and isolation of impurities. Strong foundation in organic chemistry and structural elucidation, with expertise in small molecule pharmaceutical drug development and peptides, including computational techniques. Proficiency in using standard laboratory equipment, including pipettes, graduated cylinders, and balances. Skilled in laboratory techniques for measuring, weighing, and handling samples. Hands-on experience with HPLC (highly preferred). Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS). Competency in Microsoft Office applications. Experience or familiarity with current Good Manufacturing Practices (cGMP) is preferred. Requirements: Must live or be willing to move to the Sacramento Metropolitan Region (Approximately 40 miles' radius) Benefits: Pay range $70,000 - $85,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401 (k) savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment o retaliation based on any of these factors.
    $70k-85k yearly Auto-Apply 1d 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
  • Drug Product Analytical Development Scientist

    Eurofins Scientific 4.4company rating

    Groton, MA jobs

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description * Design and guide analytical strategies to support manufacturing process development. * Lead the planning, development, execution, and data interpretation performed by other scientists in a collaborative, matrixed environment. * Oversee and review the development, validation, and transfer of analytical methods to ensure robust and reliable data generation. * Manage stability studies to assess degradation pathways and establish shelf-life parameters. * Develop impurity control strategies to ensure product quality and regulatory compliance. * Experience with a wide range of analytical testing including dissolution, HPLC/UPLC, SFC, disintegration, compendial testing (e.g., excipients / packaging release testing), generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methods * Collaborate with cross-functional teams to identify and apply the most effective analytical techniques, including the use of computational modeling, predictive tools, and data visualization platforms. * Evaluate scientific data to draw clear conclusions, guide future work, and communicate findings through presentations, technical reports, and other media. * Contribute to regulatory submissions by authoring relevant sections of the quality modules, ensuring alignment with global standards and expectations. * Maintain compliance with GLP/GMP standard and safety protocols Qualifications * PhD in Chemistry, or related field, with 3+ years of pharmaceutical R&D experience or a B.S./M.S. with 15+ years * Strong oral and written communication skills. * Experience in a regulated laboratory environment (GLP/GMP). * Proven ability to lead scientific projects and mentor team members. * Proficiency in analytical instrumentation and techniques. * Familiarity with regulatory documentation and submission processes. Additional Information * Position is full-time, Monday-Friday, 8:00 am - 5:00 pm. * Candidates currently living within a commutable distance of Groton, CT are encouraged to apply * Excellent full-time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays * #LI-EB1 * Authorization to work in the United States indefinitely without restriction or sponsorship Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
    $72k-94k yearly est. 54d ago

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