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Senior Principal Scientist jobs at Novartis - 935 jobs

  • Sr. Scientist - Beverages

    Kerry 4.7company rating

    Clark, NJ jobs

    Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role We are seeking a highly skilled and innovative RD&A Scientist to join our Beverage team. This role is responsible for developing and optimizing beverage formulations across various formats including sparkling, still, juice, and functional beverages. The ideal candidate will bring deep technical expertise, strong sensory capabilities, and a collaborative mindset to drive product innovation and meet customer expectations. Key responsibilities Develop and prepare beverage formulations, syrups, and concentrates at lab and pilot plant scale. Test and refine formulations to meet specific taste profiles and regulatory standards. Customize beverage ingredients independently or within cross-functional teams. Calculate calories and understand the role of sweeteners and nutrients in formulations. Facilitate sample shipments for internal and external stakeholders. Support beverage and taste development under GMP and safety standards. Manage multiple tasks and deadlines with speed and accuracy. Master formulation techniques for RTD (Ready-to-Drink) and RTM (Ready-to-Make) formats. Apply exceptional sensory skills to define and discriminate flavor profiles under tight timelines. Demonstrate a deep understanding of beverage processing techniques and nutritional value calculations. Communicate formulation concepts effectively in commercial settings with customers. Apply mathematical skills to work with dilutions, percentages, and ppm calculations. Exhibit self-motivation and resourcefulness in solving complex formulation challenges. Qualifications and skills Bachelor's Degree in Food Science, Biology, Chemistry, or a related Applied Science. Minimum of 5 years of experience in beverage development and formulation. Strong scientific and analytical aptitude. Proficiency in Microsoft Office; experience with SAP is a plus. Excellent problem-solving skills and ability to work independently and collaboratively. The typical hiring range for this role is $75,602 to $123,432 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements). Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov). 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.
    $75.6k-123.4k yearly 5d ago
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  • Scientist - Downstream Process Development

    Kelly 4.1company rating

    Gaithersburg, MD jobs

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

    Kerry 4.7company rating

    Beloit, WI jobs

    Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role This role encompasses leading a descriptive sensory panel and maintaining an end-use market as a sensory lead. The position requires strong leadership, technical expertise in sensory science, and the ability to collaborate cross-functionally to support business objectives through high-quality sensory insights. Key responsibilities • Lead and manage a trained sensory panel of 8-16 individuals using the Spectrum Descriptive Analysis (SDA) method. • Develop and implement project-specific training and calibration plans. • Facilitate training, calibration, and testing sessions in compliance with SDA methodology. • Define and maintain reference materials for all attributes of interest. • Monitor and evaluate panel performance; address underperformance through retraining and recalibration. • Maintain panel size through recruitment, screening, and fit-for-purpose assessments. Sensory Testing & Methodology • Design and execute sensory testing using SDA, temporal, and discrimination methods. • Analyze data using relevant sensory software and interpret panel performance metrics. • Communicate findings to sensory leads and project stakeholders. Project Collaboration & Execution • Meet with stakeholders to understand business objectives and define sensory goals. • Collaborate with sensory project leads to select appropriate methodologies and testing logistics. • Coordinate with technicians and technologists to ensure timely preparation of test materials and references. Strategic Sensory Leadership • Act as the sensory lead for an end-use market, maintaining a pipeline of internal and customer-facing projects. • Design, organize, and execute sensory studies aligned with business objectives. • Analyze and interpret test results, providing actionable insights and next steps. • Stay current with sensory science developments and adopt new techniques to enhance capabilities. Qualifications and skills Skills & Competencies: • Expertise in sensory science, particularly descriptive analysis and SDA methodology. • Strong leadership and team management skills. • Proficiency in sensory data analysis tools and statistical interpretation. • Excellent communication skills for both technical and non-technical audiences. • Ability to collaborate across functions including R&D, marketing, and business development. Experience & Qualifications: • Bachelor's, Master's, or PhD in Food Science, Sensory Science, or a related field. • Prior experience leading and managing sensory panels is essential. • Experience with Spectrum Descriptive Analysis is highly preferred. • Familiarity with temporal and discrimination testing methods. • Occasional travel (approximately once a month) may be required for customer visits or panel-related activities. The typical hiring range for this role is $75,602 to $123,432 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements). Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov).
    $75.6k-123.4k yearly 5d ago
  • Metallurgical R&D Scientist

    HTI 4.3company rating

    Augusta, GA jobs

    HTI is seeking a Metallurgical R&D Scientist for a brand-new facility in Augusta, GA. This is a great opportunity to work with a state-of-the-art facility and be an important contributor to the growing North American metals supply chain. What They Offer Full Medical, Dental, and Vision Benefits on Day 1 401(k) Match EAP, LTD, STD, and Life Insurance Competitive Vacation Package 12 Paid Holidays Relocation Assistance Available What You Need Bachelor's Degree in Chemical Engineering, Materials Science, Metallurgy, or a related field Minimum of 2 years of experience, ideally in R&D, materials analysis, or process engineering Recent graduates with relevant project or lab experience may be considered Strong understanding of non-ferrous metallurgy and metal extraction principles, especially copper metallurgy. Knowledge of pyrometallurgical, hydrometallurgical, and/or electrometallurgical processes Experience with: Material characterization and analysis Process troubleshooting and optimization Failure analysis and root cause investigation Familiarity with process simulation or thermodynamic modeling tools (FactSage, Thermo-Calc, HSC, etc.) is preferred but not required Experience preparing or interpreting process flow diagrams, phase diagrams, and thermodynamic calculations **Candidates must be eligible to work in the U.S. without sponsorship now AND in the FUTURE** What Your Role Will Look Like As the Metallurgical Research & Development Scientist, you will be integral to the development and enhancement of metallurgical processes, particularly in non-ferrous extractive metallurgy with a focus on copper. Collaborating with various departments, you will lead process improvement initiatives through simulation and modeling, contribute to R&D projects, and support the broader organization in achieving its production and efficiency goals. Key Responsibilities Collaborate closely with cross-functional teams, including Production, Supply Chain, and Maintenance, to develop and optimize metallurgical processes. Design and improve processes through simulation, focusing on enhancing production efficiency and effectiveness. Conduct research and development projects, such as developing new copper alloys and analyzing the impact of using different types of electronic waste. Utilize process simulation software to model and simulate metallurgical processes, implementing improvements to existing operations. Prepare detailed process flow diagrams and perform calculations related to mass balance, heat balance, and phase diagrams. Support other departments by providing expertise on chemical and material compositions and addressing process-related questions. Ensure compliance with environmental, health, and safety standards, contributing to the development of operating instructions and risk assessments. Participate in the ongoing development of R&D labs on-site, with a focus on future process improvements and innovations.
    $52k-74k yearly est. 3d ago
  • R&D Scientist

    EPM Scientific 3.9company rating

    Chicago, IL jobs

    Are you passionate about science and organization? We're looking for a hands-on scientist who can also drive project coordination across R&D and analytical initiatives. This role blends technical expertise with leadership in planning and communication. What You'll Do Track and manage R&D and analytical projects, ensuring timelines and priorities are met. Maintain project dashboards and prepare concise progress updates for leadership. Support formulation experiments, sample prep, and analytical testing (HPLC, dissolution, stability). Collaborate with QA, Regulatory, and Operations to align deliverables. Recommend process improvements and help implement standardized tools. What We're Looking For Education: Bachelor's or Master's in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. Experience: 3-6 years in pharmaceutical R&D, analytical chemistry, or formulation science. Familiarity with HPLC and method development. Strong organizational and communication skills. Comfortable balancing lab work with coordination responsibilities. Why Join Us Competitive salary + comprehensive benefits. Health, dental, vision coverage. Retirement plan with company match. Paid time off and holidays. Collaborative, science-driven environment.
    $70k-96k yearly est. 3d ago
  • Sr. RD&A Scientist - Beverages

    Kerry 4.7company rating

    Beloit, WI jobs

    Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role Kerry is seeking a Research, Development and Application Senior Scientist for a key role supporting the growth of the North American Beverage market. This position is based at the KERRY Global Technology & Innovation Centre in Beloit, Wisconsin, USA, reporting to the RD&A Director/Manager and is responsible for executing on the business strategy by creating market relevant and differentiated products that meet the requirements of customers and consumers, utilizing Kerry's broad and industry leading portfolio of technologies. This role is part of a team of RD&A Scientists and Technicians that are responsible for the development of powder and liquid beverage concepts. Strong communication and leadership skills are critical as the day-to-day activities involve significant cross-functional collaboration with Flavorists, Nutrition Scientists, Regulatory, Marketing, Sales, and Finance. Key responsibilities Lead formulation and concept development from end-to-end on internal and customer projects within North America for the Beverage market. Use sound commercial and technical awareness of ingredients, processes, end use market and customer requirements to deliver on project objectives, across powder beverages and liquid beverage product formats. Develop innovative solutions to help grow customers and Kerry's market share within cost parameters and manufacturing capabilities while ensuring all new products are legal within country of use. Manage Pilot Plant validation work and facilitate first production trials of new products internally and with third part manufacturers. Build strong relationships with customer contacts via clear communication, on-site and virtual visits, presentations and supporting trials when required. Support sales and business representatives during customer calls through technical presentations and product demonstrations. Work within cross-functional teams to optimize the strengths of Kerry and deliver the best Taste and Nutrition experience for our customers. Study methods to improve quality of products such as flavour, colour, texture, nutritional value, as well as physical, chemical, and microbiological composition. Qualifications and skills BSc/MSc/PhD in Food Science, Food Engineering, or related field. 5+ years of hands-on experience in product development, preferably beverages products. Experience working with 'functional ingredients' is a plus - probiotics, adaptogens, botanical extracts, etc. Working knowledge of the beverage market in North America. Proven success in product development resulting in successful market launch. Curiosity and a willingness to push creative boundaries. Strong team-player, with excellent interpersonal, organizational, communication and project management skills. Knowledgeable about food chemistry, sensory, microbiology, food packaging systems and food engineering. The pay range for this position is 75,602- 123,432 in Annual Salary. Kerry typically does not hire an individual at the top or near the top of the range, as we are a pay-for-performance company, and this range is set to continue to reward performance annually while in role. Compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate within the above range may be influenced by a variety of factors including skills, qualifications, experience, and internal equity. Kerry offers a competitive benefits package, including medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, Employee Share Plan, Life, disability, and accident insurance, and tuition reimbursement. This job posting is anticipated to expire on Dec 27, 2025. Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov). Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.
    $80k-108k yearly est. 2d ago
  • Associate Principal Scientist, Clinical Research (Animal Health)

    MSD 4.6company rating

    Rahway, NJ jobs

    Primary activities include but are not limited to: The Associate Principal Scientist is a DVM and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires the candidate be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies. The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study. The Associate Principal Scientist can also be responsible for several effectiveness studies within a project, participating as the clinical representative in project teams as assigned. MAJOR ACTIVITIES AND RESPONSIBILITIES Briefly describe the major activities of the position. Indicate the approximate percentage of time spent on each activity. Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion. Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and the study protocol/related documentation. Provide overall leadership and support to the study team. Identify and select Investigators, laboratories and/or CROs. Apply for the necessary study permits and licenses with support of local regulatory staff within the specified study timeline. Train the study team on the Study Protocol Ensure the timely selection and ordering of study materials. Ensure compliance of administrative aspects of the study (budgets and agreements) with the applicable laws and our Company's policies and procedures | Plan and coordinate the monitoring and data management activities of each study. Ensure that the study is conducted according to legal requirements, GCP, and the applicable internal policies and procedures. Prepare the Final Study Report Maintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed of the study progress. May be the GCR representative in the project team. Assume responsibility for certain monitoring and data management tasks (e.g., User Acceptance Test of electronic CRFs) Monitor clinical studies under the leadership of other Scientists. Develops and maintains a network of internal and external clinical and scientific contacts and key opinion leaders in relevant fields. Conduct quality control inspections of study protocol, study documentation files and reports. Serves as a contact and liaison with other internal departments on specific projects, and with external partners, such as universities or regulatory authorities. Prepares critical summaries and expert reports to management and/or for submission to regulatory agencies. Supervise trainees and provide mentorship and support to other GCR staff. Provides scientific and technical support to the marketing groups for key molecules/products and clinical research expertise upon request. Conducts post-marketing studies. Prepares scientific publications according to the need of the company. Education: Doctor of Veterinary Medicine, OR equivalent veterinary degree Skills Required: Strong scientific writing ability Principled verbal and written communications Proficient in MS Office applications Understanding of GCP Good Clinical Practices guidelines. Competencies Required: Four years in clinical research or similar research role. Experience in a clinical study related role. Required Skills: Accountability, Accountability, Biomarker Assay Development, Clinical Research, Clinical Sciences, Clinical Site Management, Clinical Study Design, Clinical Trials Operations, Computer Science, Design, Detail-Oriented, Ethical Compliance, Ethical Standards, GLP Regulations, Good Clinical Practice (GCP), Machine Learning (ML), Marketing, Medical Laboratories, Medical Writing, Multiple Therapeutic Areas, Patient Recruitment, Regulatory Requirements, Scientific Publications, Scientific Writing, Stakeholder Relationship Management {+ 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: Domestic VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/5/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
    $139.6k-219.7k yearly Auto-Apply 60d+ ago
  • Associate Principal Scientist, Pharmacokinetics, Dynamics, Metabolism & Bioanalytics

    MSD 4.6company rating

    South San Francisco, CA jobs

    At our Company, we are inspired by the belief that a research-driven enterprise dedicated to scientific excellence can create medicines that save and improve lives. Every employee is building on our proud legacy of scientific breakthrough. Our ability to impact the lives of patients worldwide depends on the integrity, creativity, humility, and scientific acumen of our team. We are creating a diverse organization that is inspired by invention and founded on a culture of respect and collaboration. At our Research & Development Division in South San Francisco, you'll have the opportunity to expand your knowledge and skills through collaboration with talented and dedicated colleagues while advancing your career. The SSF Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) group is seeking an Associate Principal Scientist to contribute to our Company's biologics, drug conjugates, and novel modality discovery and development pipeline. The Associate Principal Scientist will be primarily discovery team-facing and is expected to be a key contributor to the multi-disciplinary drug discovery effort for various therapeutics (biologic therapeutics, antibody-drug conjugate, peptide, small molecule). Therapeutic areas will include immunology, oncology, cardiovascular and metabolic disease, and ophthalmology. Key Responsibilities: Project-team representative for biologics or other modality drug discovery and development. Contribute to overall team strategy and lead the formation and execution of team-specific PDMB workflow. Design and execute in vitro and in vivo mechanistic and translational studies to evaluate the pharmacokinetic and metabolic properties of therapeutic proteins, such as drug conjugates and other modalities, to influence drug design, lead selection, and drive PK/PD translations. Be accountable for providing timely and high-quality PDMB data deliverables to teams. Author regulatory documents from FIH through registrational filing. Contribute to departmental scientific initiatives and strategies. Foster a high-performance culture of innovation, collaboration, engagement, self-accountability, and inclusion. Stay abreast of external scientific advancements and contribute to the evaluation and implementation of new technologies and methodologies in DMPK for drug discovery. Position qualifications: Education Minimum Requirement: PhD (3+ year) or MS (+8 years) in a relevant scientific discipline (e.g., Pharmacokinetics, Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, Biology, or related scientific field). Required Experience and Skills: Broad knowledge of ADME science and in depth-knowledge in at least one area (e.g. pharmacokinetics, human dose predictions, TPK/PD, etc.). Has fundamental understanding of drug discovery and/or development of biologic drug candidates. Has basic experience with Certara Phoenix Software. Works independently with some technical & strategic guidance from scientific supervisor. Capable of solving complex problems outside of own area of expertise. Strong leadership, interpersonal, communication, problem solving, and collaboration skills along with strengths in delivering results in fast-paced environment. Demonstrated inclination towards recognition in the field, creativity, and innovation via a strong publication/presentation record. Preferred Experience and Skills: Prior experience with multiple therapeutic modalities (e.g. small molecules, peptides, etc) and/or novel modalities. Prior experience evaluating the biodistribution of biologics in preclinical species. Knowledge in novel and translatable in vitro cellular models and/or in vivo models. Hands-on experience with compartmental PKPD modeling. 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 #EligibleforERP Required Skills: ADME, Antibody Drug Conjugates (ADC), Antibody Therapeutics, Bioanalytical Techniques, Biological Sciences, Biopharmaceuticals, Cell-Based Assays, Communication, Data Analysis, Detail-Oriented, DMPK, Drug Discovery Process, Drug Metabolism, Mentorship, Metabolism, Pharmacokinetics, Pharmacology, PKPD Modeling, Social Collaboration, Strategic Thinking, Therapeutic Proteins 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: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/31/2025 *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.
    $139.6k-219.7k yearly Auto-Apply 60d+ ago
  • Associate Principal Scientist, Continuous & Expression Technologies (Downstream) - Onsite

    MSD 4.6company rating

    Rahway, NJ jobs

    Associate Principal Scientist - Continuous & Expression Technologies in Large Molecule Downstream Processing The Continuous & Expression Technologies (CET) Group within the Process Research & Development, Enabling Technologies department is seeking motivated and creative individuals. This is an opportunity to positively impact our company's manufacturing platforms, while actively supporting drug development in the biologics and vaccine arenas. Specifically, CET is seeking an Associate Principal Scientist specializing in bioprocessing purification technologies for multiple therapeutic classes - at our site in Rahway, NJ. Our Scientists are our Inventors. As a member of the CET Group, you will drive scientific innovation and critically evaluate opportunities to implement enabling technologies. We are seeking a collaborative, self-directed learner with a penchant for problem-solving and expertise in downstream bioprocessing to join the CET group. Our group is tasked with identifying, developing, and deploying continuous manufacturing tools aimed at improving production processes in our company's drug candidate pipeline. Knowledge of intensified unit operations such as multi-column chromatography, single-pass ultrafiltration and in-line diafiltration in addition to applied knowledge of hardware/software integration, process automation systems, and process analytical technologies (PAT) are valued skills within the group. Demonstrated expertise in process development, whether biologics, vaccines, or both, is particularly desirable. As an Associate Principal Scientist, you will have the opportunity to influence the future direction of our company's downstream processing for biologics. You will work with an immensely creative and collaborative team of scientists and engineers to design purification processes while developing technical strategies related to continuous processing and process intensification. As an experienced downstream scientist in the group, you will mentor and coach junior upstream scientists. The chosen candidate should also have excellent interpersonal communication and collaboration skills and exhibit strength in delivering results on firm deadlines. We actively publish and engage with the scientific community to influence the field. RESPONSIBILITIES: As an impactful contributor, shape and realize innovation across biologics' pipeline, strategy, and science Advance best science incorporation into pipeline by collaborating with cross-functional teams, from Research & Manufacturing, in a fast-paced, multidisciplinary environment Lead development of robust and scalable technologies for downstream processes for biologics Identify areas for downstream process innovation/intensification and expand our technologies toolbox to address challenges at different stages of development (clinical, process characterization and commercialization) Contribute to strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams towards its execution Conceptualize, plan, and execute projects with effective organizational, prioritization and problem-solving skills Stay abreast of scientific and regulatory landscape; actively present (premier conferences), publish (peer-reviewed journals) and patent Serve as Subject Matter Expert for intensified and/or continuous bioprocessing Mentor and actively share expertise; guide career development; build strong, collaborative teams MINIMUM EDUCATION REQUIREMENTS: Ph.D. with 3+ years, MS with 5+ years, or BS with 8+ years of industry experience and background in Chemical/Biochemical engineering, or a related field REQUIRED EXPERIENCE, SKILLS, AND COMPETENCIES Strong fundamental knowledge and subject matter expertise in downstream process development Experience in continuous biomanufacturing and experimentation with integrated purification steps Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of downstream process development Track record of accomplishments in downstream bioprocessing with a history of peer-reviewed publications and presentations Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve Demonstrated commitment to coach and mentor staff to maximize talent development and utilization Excellent interpersonal and communication skills PREFERRED EXPERIENCE & SKILLS: Excellent interpersonal and communication skills Experience with purification steps integrated with process-analytical technologies High-throughput experimentation, automation, and process control Experience with single-pass ultrafiltration and in-line diafiltration Experience with high throughput experimentation using automation platforms such as TECAN Experience using and/or programming process control systems such as DeltaV or PCS 7 Experience with multi-column chromatography systems (BioSMB, PCC, or similar) Experience with statistical data analysis tools and design of experiments (JMP, Design Expert) Experience with multivariate data analysis, machine learning, artificial intelligence Experience with process modeling packages such as BioSolve Process, gPROMS, SuperPro Designer, or similar #ET #PRD #eligiblefor ERP To learn more about the PRD team, click: Join Our Process Research & Development Team. Required Skills: Accountability, Accountability, Artificial Intelligence (AI), Automation, Biomanufacturing, Career Development, Cell Line Development, Column Chromatography, Continuous Deployment, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Innovation, Interpersonal Relationships, Leading Project Teams, Machine Learning (ML), Molecular Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Process Automations, Project Prioritization, Software Integration {+ 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 $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: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/16/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
    $139.6k-219.7k yearly Auto-Apply 10d ago
  • Senior Scientist/Principal Scientist- Biotransformation/Met ID

    Frontage Laboratories 3.9company rating

    Exton, PA jobs

    We are seeking a highly motivated and experienced Senior Scientist specializing in Biotransformation and Metabolite Identification to join our dynamic team. This individual will play a pivotal role in the characterization and identification of drug metabolites, contributing to our understanding of drug metabolism and its impact on drug safety and efficacy. Key Responsibilities: Design, execute, and interpret biotransformation studies to characterize drug metabolites in vitro and in vivo. Develop and optimize sample preparation and analytical techniques for metabolite profiling and identification using state-of-the-art LC-MS/MS and high-resolution mass spectrometry (HRMS). Interact with clients to provide actionable insights on metabolism-related challenges. Prepare and review scientific reports, presentations, and regulatory documents to ensure accuracy and compliance with industry standards. Stay updated on advancements in biotransformation and metabolite identification technologies and methodologies. Qualifications: Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field. Strong expertise in drug metabolism and biotransformation, with hands-on experience in metabolite identification using LC-MS/MS and HRMS. Knowledge of in vitro (e.g., hepatocytes, microsomes) and in vivo systems for studying drug metabolism. Familiarity with regulatory guidelines (e.g., FDA, EMA) for metabolite safety testing (MIST). Demonstrated ability to analyze and interpret complex mass spectrometry data and provide detailed reports. Excellent communication skills and ability to work collaboratively in a cross-functional team environment. Preferred Skills: Experience with radiolabeled compounds and metabolite profiling. Track record of publications or presentations in the field of drug metabolism or biotransformation. Hand-on experience on Thermo OrbiTrap or Waters Q-TOF. What We Offer: Competitive salary and benefits package. Opportunities for professional growth and development. A collaborative and innovative work environment. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability
    $75k-109k yearly est. Auto-Apply 60d+ ago
  • Associate Principal Scientist, Data Science - Princeton, NJ

    DSM 4.3company rating

    Princeton, NJ jobs

    Associate Principal Scientist, Data Science We are seeking a highly skilled data scientist specialized in Formulation Performance Modeling and Formulation Creation across a portfolio of Innovation projects, as well as ensuring the team is deploying the latest, state-of-the-art technologies and skills to develop, manage and govern various products in food, perfumery and beauty. The candidate would join dsm-firmenich's Data Science team within Science and Research and with focus on Data Science model development and on the translational task between Data Science and Business Units key users and stakeholders. This role offers the opportunity to drive interdisciplinary science projects that integrate the latest advances in cheminformatics, data science, AI and while working in close collaboration with leading domain perfumery and flavour experts. Your Key Responsibilities: * Use data science and AI to drive a fast-paced ingredient discovery pipeline that generates maximum value for dsm-firmenich's, perfumery and beauty, taste, texture and health segments. * Develop and implement ML and AI models for predicting and optimizing performance of formulations in diverse applications. * Contribute to formula creation and product development tools with Data Science models and data pipelines. * Translate scientific research findings into practical applications that can drive business growth. Identify opportunities for commercialization of research outcomes and collaborate with business units to realize these opportunities. * Contribute to the development and adoption of Data Science best practices and by our global community of data scientists, scientists and experts in perfumery and beaty, taste, texture and health segments. * Stay up to date on the latest advancements in cheminformatics, formulation design, computational biology, molecular AI and modeling approaches. * Apply modern software development and machine learning tools and practices in your daily work, including a high level of proficiency in Python, git, and team co-development workflows. Familiarity with good use of coding agents preferred. * Team-up with other data scientists and chemistry and physics science experts around the globe to drive project success. We Bring: * Highly motivated, professional and committed multicultural and interdisciplinary team. * Opportunity to put your scientific skills into practice with innovations in health, nutrition and beauty. * Grow and develop your skills through our in-house training courses. * Being a part of company shaping a strong legacy heritage through industrial innovations and cutting-edge technology. * A commitment to science-based innovations with 2000 scientists and 700 mm annual S&R investments. You Bring: * Ph.D., master's degree or similar experience in Physics, Chemistry, Engineering, Structural Biology, Computer Science, AI, or a related field. * 3-7 years of additional academic or industry work experience in the chemical industry, bio- and cheminformatics or formulation space. * Record of accomplishments demonstrating high drive and keen entrepreneurial innovation. * Strong skills in computational chemistry, cheminformatics, statistics, structural biology, including hands-on development experience of modern AI tools. * Deep understanding of Data Science methods, formulation performance applications, generative AI technologies in chemistry and physics, science informed ML methods. * Proficiency Python, good code management, git, and working with CI/CD pipelines. * Excellent problem-solving skills and proven ability to work both independently and collaboratively. * Effective communication and collaboration skills with the ability to convey complex concepts to non-experts. * Entrepreneur mindset and ability to provide insights based on data analysis to inform business decisions. The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. This position is also eligible for bonuses and benefits, which are not included in the pay scale provided. Salary $128,000-$183,000. About dsm-firmenich At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. The application process Interested in this position? Please apply online by uploading your resume in English by October 10, 2025. Inclusion, belonging and equal opportunity statement At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency statement We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role
    $128k-183k yearly 21d ago
  • Scientist/Sr. Scientist/Principal Scientist

    Frontage Laboratories 3.9company rating

    Hayward, CA jobs

    Senior/Principal Scientist - Process Chemistry Senior/Principal Scientist - Process Chemistry Discovery Chemistry & API GMP Kilo-Lab Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary: Frontage Laboratories is expanding its API GMP capabilities to support early- and mid-phase development programs for global biotech, pharmaceutical, and academic partners. We are seeking an experienced Process Chemistry Scientist to lead route scouting, process optimization, scale-up, and GMP batch support for small-molecule APIs. This is a hands-on laboratory role with technical leadership responsibilities and potential advancement to Associate Director, depending on experience. Key Responsibilities: Process Development & Scale-Up Design, develop, and optimize scalable synthetic routes for small-molecule APIs and intermediates. Conduct reaction optimization, impurity profiling, and robustness studies. Execute demonstration/engineering batches and support kilogram-scale manufacturing campaigns. GMP Kilo-Lab Technical Support Contribute to batch record drafting, process descriptions, and execute support kilogram-scale manufacturing campaigns. Provide on-the-floor technical support during non-GMP and GMP campaigns. Troubleshoot process deviations and equipment issues in real time. Collaborate with QA, QC, CMC Operations, EHS, and Engineering. Client Interaction & Project Leadership Serve as the technical point-of-contact for client programs. Present data clearly, propose development strategies, and manage timelines. Support CMC planning, risk mitigation, and tech-transfer discussions. Documentation & Regulatory Prepare process development reports, tech-transfer packages, and supporting CMC documentation. Ensure full compliance with non-GMP & GMP requirements and contribute to IND process sections. Team & Capability Development Mentor junior chemists and contribute to building best practices in the new kilo-lab. Support implementation of SOPs, equipment capabilities, and continuous improvement initiatives. Participate in hiring and onboarding as the group expands. Qualifications (Flexible for Senior Scientist → Associate Director) Advanced degree (MS or PhD) in Organic Chemistry, or related field, with significant industry experience in process chemistry, CRO/CDMO, or pharmaceutical development. Strong hands-on expertise in multi-step organic synthesis, route design, process optimization, impurity control, and scale-up. Working understanding of kilo-lab or pilot-plant operations and GMP manufacturing support. Experience with analytical data interpretation and process safety considerations. Demonstrated ability to effectively communicate with cross-functional teams and external clients. Proven leadership ability - ranging from mentoring peers (Senior Scientist) to providing strategic program direction (Principal Scientist / Associate Director). Ability to thrive in a fast-paced CRO environment with multiple concurrent client programs. Salary and Benefits : Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
    $116k-182k yearly est. Auto-Apply 14d ago
  • Associate Principal Scientist, Fermentation - Lexington, MA

    DSM 4.3company rating

    Lexington, MA jobs

    Associate Principal Scientist, Fermentation Are you passionate about advancing fermentation science and making a global impact? Join our purpose-driven team at dsm-firmenich, where innovation, diversity, and sustainability are at the heart of everything we do. We are continuing to build out our best‑in‑class fermentation capability at our Boston, MA Biotechnology Research and Development site to accelerate biotech and microbiome initiatives. As Head of the Bioprocess Team, you will link activities in fermentation and downstream recovery technologies with those in other functional disciplines, including strain engineering, data science, microbiome and analytical chemistry. You'll manage a team of scientists in the Bioprocess Sciences Team, as well as lead close interactions with the Microbiome team and other global dsm-firmenich R&D, piloting, and manufacturing sites. Your Key Responsibilities: * Define the Lexington fermentation strategy and roadmap; champion best practices in aerobic and anaerobic processing from millilitre to 10 L scales. * Drive continuous improvement of methods, experimental setups, and workflows across R&D teams. * Mentor, coach, and empower a diverse team of Scientists and Engineers, fostering an inclusive environment where all voices are values. Serve as a problem-solving consultant to internal and external project team members, including laboratory and biomanufacturing personnel. * Lead communications with internal collaborators, third parties, and strategic partners. * Work closely with the Lexington Strain Engineering Team and Microbiome Team to direct the development and implementation of (an)aerobic fermentation protocols to identify improved organisms and develop novel processes. Coordinate cross‑site experiments and knowledge transfer; clearly communicate progress and risks to stakeholders. * Ensure compliance to quality, environmental, occupational health & safety procedures; uphold aseptic techniques and contamination control. Promote a positive, safe and compliant work environment. * Work setting: Lab‑based leadership role with hands‑on experimentation and on‑the‑shopfloor coaching. We Offer: * Highly motivated, professional and committed multicultural and interdisciplinary team. * An opportunity to put your scientific skills into practice with innovations in nutrition, health and beauty. * A place to grow and develop your skills while you mentor and lead a team. * A globally connected R&D environment with diverse perspectives, advanced facilities, international exposure, and support for professional growth through training and knowledge‑exchange programs. * A commitment to science-based innovations with 2,000 scientists and $700 M annual Science & Research investments. * We welcome applicants from all backgrounds who meet the experience criteria and share our commitment to scientific excellence and teamwork. * Competitive compensation, comprehensive benefits, flexible work arrangements, and support for personal and professional growth. You Bring: * PhD plus 8 years of experience or MSc plus 15 years of experience in Fermentation Science, Biotechnology, Biochemical Engineering, Metabolic Engineering, Microbiology, or related field - or equivalent industry experience. * Extensive experience with bench scale (10 ml to 10 L) anaerobic and aerobic microbial fermentation equipment and technology leveraging yeast, fungi, and bacteria. * Understanding of scale-up / scale-down of fermentation and downstream recovery operations. * Broad microbial physiology and gut microbiome research expertise is a strong plus. * Previous industry and direct team leadership experience with excellent project management and organizational skills (Minimum 5 years of team leadership required). * Exposure to lab automation workflows and digital bioprocess tools; comfort contributing to internal digital platforms. Experience with data analysis and statistical software packages. * Background collaborating with strain engineering and analytical chemistry teams (omics, modelling, protein engineering) to translate strain capabilities into bioprocess wins. * Organized, quality‑minded, problem‑solving orientation; thrives in collaborative, interdisciplinary environments as well as with external collaborator R&D setting. The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. This position is also eligible for bonuses and benefits, which are not included in the pay scale provided. Salary $150,000 -$190,000. About dsm-firmenich At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. The application process Interested in this position? Please apply online by uploading your resume in English by December 1, 2025. Inclusion, belonging and equal opportunity statement At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency statement We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role
    $150k-190k yearly 21d ago
  • Senior Scientist - Formulation Development (R&D)

    Nivagen Pharmaceuticals 3.7company rating

    Sacramento, CA jobs

    About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Type: Full Time Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA About the Job: Title of the Position: Senior Scientist - Formulation Development We are seeking a highly skilled and experienced Senior Scientist to join our Formulation Development team. The successful candidate will play a critical role in the development and optimization of drug formulations from early-stage research through commercialization. This position requires a deep understanding of formulation principles, a strong scientific background, and a proven track record of success in the pharmaceutical industry. Responsibilities: Lead the design, development, and optimization of complex injectable and sterile dosage forms. Develop and implement robust formulation development strategies aligned with regulatory guidelines (e.g., Quality by Design, FDA). Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues Conduct rigorous experimental design studies (e.g., factorial design) to achieve project objectives. Collaborate closely with cross-functional teams, including Technical Services, Operations, and Regulatory Affairs. Define scope, timeline, and resource needs of functional activities and keep team on schedule Participate in evaluation of new product opportunities. Ensure timely and high-quality documentation for regulatory submissions. Stay updated with all FDA and regulatory requirements/guidelines. Provide mentorship and leadership to team members. Stay up to date with the latest scientific advancements in formulation development and applying new technologies to improve product performance. Author and review technical reports, protocols, and regulatory documents. Additional duties and assignments as needed. Qualifications: Education/Experience: Ph.D. or Postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field. 3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development. (Strong candidates with combinations of education and experience will be considered.) Strong understanding of formulation principles, excipients, and drug delivery systems. Hands-on experience with various formulation techniques and equipment. Proven track record of successful formulation development and commercialization. Experience with statistical design of experiments (DOE) and data analysis. Knowledge, Skills, and Abilities: Proven track record of successful formulation development for various sterile dosage forms. Strong leadership, project management, and organizational skills. Expertise in complex injectable and sterile dosage form development. Demonstrated ability to conduct independent research and problem-solving. Requirements: Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius). Benefits: Pay range $70,000-$90,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
    $70k-90k yearly Auto-Apply 8d ago
  • Senior Formulation Scientist - Pharmaceuticals/Nutraceuticals

    Contract Pharmacal Corp 4.3company rating

    Hauppauge, NY jobs

    Job DescriptionDescription: We are seeking a Senior Formulation Scientist to join our dynamic R&D team, where you'll play a key role in developing innovative pharmaceutical and nutraceutical products. In this hands-on role, you'll design formulations, support process improvements, and contribute directly to product development from concept to commercialization. This position offers exposure to oral solid dosage forms. Candidates may specialize in drug formulation or nutraceutical formulation, with the opportunity to grow into broader product development responsibilities. Job Type: Full-Time Location: Hauppauge, NY Works Hours: Monday - Friday, 9:00AM - 5:00PM Pay Range: $85,000 - $125,000 per year, depending on experience Start Date: ASAP What makes this role exciting: Diverse formulation experience - work on nutraceuticals, OTC, and prescription oral solid dosage forms. Hands-on innovation - operate formulation equipment like blenders, high shear granulators, fluid bed dryers, and tablet presses. End-to-end impact - take ideas from early development through regulatory submission and commercialization. Collaborative environment - partner with R&D, production, and regulatory teams, contributing to problem-solving and process improvements. Why Join CPC? At CPC, you'll be part of a team that has set the standard in pharmaceutical development and contract manufacturing since 1971, helping bring high-quality OTC, dietary supplement, and prescription products to market faster and safer than ever. We pride ourselves on quality as a core value, innovative problem-solving, and a collaborative culture where everyone plays a role in advancing formulation and manufacturing excellence. CPC offers an inclusive, respectful workplace with opportunities to grow your skills and career while working with cutting-edge technologies and serving leading global brands. With a commitment to employee success, competitive benefits, and a culture built on teamwork and integrity, CPC is a place where your contributions truly make an impact. Requirements: Responsibilities In this role, you will: Design and develop formulations for oral solid dosage forms across nutraceutical, OTC, and prescription products Manage multiple formulation projects and deliver results on time Write protocols, Master Manufacturing Records (MMRs), and product development reports Provide process improvement support and troubleshoot production issues Stay current with emerging trends in drug delivery technology and regulatory policies Education & Experience MS required; Ph.D. preferred Minimum 5 years of formulation experience in pharmaceutical and/or nutraceutical product development Hands-on experience with formulation equipment such as blenders, fluid bed dryers, high shear granulators, and tablet presses Skills, Knowledge & Abilities Knowledge of cGMPs, US FDA, and EU/EMEA regulatory requirements Familiarity with Quality System standards, ICH guidelines, USP, and EP requirements Experience preparing protocols, Master Manufacturing Records (MMRs), and product development reports Ability to troubleshoot formulation or process issues and recommend practical solutions Strong project management skills, able to prioritize and manage multiple development projects Effective oral and written communication; able to collaborate with R&D, production, and regulatory teams Detail-oriented, organized, and proactive with a strong problem-solving mindset Willingness to learn new technologies and adapt to evolving project needs Experience with regulatory submissions preferred for pharmaceutical candidates Exposure to multi-product development is preferred but not required
    $85k-125k yearly 10d ago
  • Senior Formulation Scientist - Pharmaceuticals/Nutraceuticals

    Contract Pharmacal Corp 4.3company rating

    Hauppauge, NY jobs

    We are seeking a Senior Formulation Scientist to join our dynamic R&D team, where you'll play a key role in developing innovative pharmaceutical and nutraceutical products. In this hands-on role, you'll design formulations, support process improvements, and contribute directly to product development from concept to commercialization. This position offers exposure to oral solid dosage forms. Candidates may specialize in drug formulation or nutraceutical formulation, with the opportunity to grow into broader product development responsibilities. Job Type: Full-Time Location: Hauppauge, NY Works Hours: Monday - Friday, 9:00AM - 5:00PM Pay Range: $85,000 - $125,000 per year, depending on experience Start Date: ASAP What makes this role exciting: Diverse formulation experience - work on nutraceuticals, OTC, and prescription oral solid dosage forms. Hands-on innovation - operate formulation equipment like blenders, high shear granulators, fluid bed dryers, and tablet presses. End-to-end impact - take ideas from early development through regulatory submission and commercialization. Collaborative environment - partner with R&D, production, and regulatory teams, contributing to problem-solving and process improvements. Why Join CPC? At CPC, you'll be part of a team that has set the standard in pharmaceutical development and contract manufacturing since 1971, helping bring high-quality OTC, dietary supplement, and prescription products to market faster and safer than ever. We pride ourselves on quality as a core value, innovative problem-solving, and a collaborative culture where everyone plays a role in advancing formulation and manufacturing excellence. CPC offers an inclusive, respectful workplace with opportunities to grow your skills and career while working with cutting-edge technologies and serving leading global brands. With a commitment to employee success, competitive benefits, and a culture built on teamwork and integrity, CPC is a place where your contributions truly make an impact. Requirements Responsibilities In this role, you will: Design and develop formulations for oral solid dosage forms across nutraceutical, OTC, and prescription products Manage multiple formulation projects and deliver results on time Write protocols, Master Manufacturing Records (MMRs), and product development reports Provide process improvement support and troubleshoot production issues Stay current with emerging trends in drug delivery technology and regulatory policies Education & Experience MS required; Ph.D. preferred Minimum 5 years of formulation experience in pharmaceutical and/or nutraceutical product development Hands-on experience with formulation equipment such as blenders, fluid bed dryers, high shear granulators, and tablet presses Skills, Knowledge & Abilities Knowledge of cGMPs, US FDA, and EU/EMEA regulatory requirements Familiarity with Quality System standards, ICH guidelines, USP, and EP requirements Experience preparing protocols, Master Manufacturing Records (MMRs), and product development reports Ability to troubleshoot formulation or process issues and recommend practical solutions Strong project management skills, able to prioritize and manage multiple development projects Effective oral and written communication; able to collaborate with R&D, production, and regulatory teams Detail-oriented, organized, and proactive with a strong problem-solving mindset Willingness to learn new technologies and adapt to evolving project needs Experience with regulatory submissions preferred for pharmaceutical candidates Exposure to multi-product development is preferred but not required
    $85k-125k yearly 9d ago
  • Senior Scientist/Principal Scientist - Clinical Veterinarian

    Zoetis 4.9company rating

    Kalamazoo, MI jobs

    Role Description Senior Scientist/Principal Scientist - Clinical Veterinarian Kalamazoo Michigan is the world headquarters for Veterinary Medicine Research and Development (VMRD) for Zoetis. The Kalamazoo/Richland Veterinary Service group, within Global Animal Science and Welfare, at Zoetis, has the mission and responsibility of developing and implementing the program of veterinary care and providing veterinary support to VMRD projects at the Richland and Kalamazoo sites. We are seeking an experienced, innovative and highly motivated veterinarian to contribute towards delivering an exceptional animal care program as well as partnering with VMRD researchers to produce high quality research studies. EDUCATION AND EXPERIENCE: * Suitable candidates will have a DVM/VMD from an accredited College of Veterinary Medicine and a minimum of 3 years of experience in clinical veterinary practice with a primary focus on livestock (horses, cattle, swine, small ruminant, poultry), companion animal medicine and surgery, and familiarity with traditional lab animal species (rats, mice, guinea pig) * Licensed to practice in at least one state with the expectation to become licensed in Michigan * Federally accredited or the ability to become federally accredited. * Strong hands-on expertise in a range of animal techniques including handling, restraint, dosing, venipuncture, clinical examination and diagnosis, dental surgery, minor surgical procedures and necropsy. OTHER DESIRABLE ATTRIBUTES * Previous experience in research setting as a clinical veterinarian. * A diplomate of the American College of Laboratory Medicine (DACLAM) * Experience with development of animal models for research. * Experience working in biocontainment facilities and development of biosecurity programs. * Additional academic training in an allied field (infectious diseases, immunology, epidemiology). * Knowledge of animal welfare compliance oversight * Experience working in animal programs regulated by USDA APHIS and visited by AAALAC. * Network of research veterinarians and/or experts in a variety of veterinary disciplines. * High motivation, demonstrated initiative, independent and flexible in thinking, strong interpersonal skills, and attention to detail. * Strong documentation, writing, teaching and oral communication skills. * Experience with multiple software platforms, including electronic data capture and data management. * Experience with livestock and/or traditional lab animal species POSITION RESPONSIBILITIES: Primary responsibility is to provide clinical veterinary support to research animals at the Richland and/or Kalamazoo sites in support of VMRD. Clinical Veterinary responsibility includes but is not limited to: * Development and/or implementation of population medicine programs and preventive medicine procedures * Provision of training to animal care technicians and/or study personnel * Study oversight by reviewing protocols and ensuring compliance with approved procedures * Attendance and participation in pre-study activities * Preparation of health certificates * Assessment of animals prior to shipment and after receipt * Authoring and reviewing SOPs * Performing necropsies * Serving as a non-voting Institutional Animal Care and Use Committee ad hoc member (ex. Animal Use Protocol review, semiannual facility inspections) * Participate in veterinary on-call duty on weekends and holidays on a rotational basis * Participation in facility design/renovation planning Additional responsibilities may include: * Providing support to the Animal Welfare and Compliance Team by assisting with animal welfare audits of animal suppliers and contract research organizations; and participating in internal and external animal welfare audits (AAALAC International, USDA, and internal audits.) ADDITIONAL INFORMATION: * Work environment: The person filling this position will work with research scientists, study monitors, line managers and technical staff. May be required to work with zoonotic and animal pathogens and chemicals. There may be handling of zoonotic organisms and working in BSL-2 and BSL-3 facilities requiring shower in/out procedures. * Veterinary support is about 25% in support of research projects and 75% in support of the animal care program. * Participate in veterinary on-call duty on weekends and holidays on a rotational basis including some work outside of core business hours. * Some travel (10%) to off-site locations may be required * Support for tuition reimbursement, continuing education and career development is available. Full time Regular Colleague 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.
    $75k-106k yearly est. Auto-Apply 19d ago
  • Senior Scientist/Principal Scientist - Biologics Analytical Sciences

    Zoetis 4.9company rating

    Kalamazoo, MI jobs

    Zoetis is the largest animal health company in the world with an industry-leading research and development team. Zoetis Veterinary Medicine Research and Development, Biologics Analytical Sciences in Kalamazoo, MI is seeking an assay development professional at the Senior Scientist/Principal Scientist level. This position requires a highly motivated and independent contributor who can effectively collaborate with other team members to develop fit for purpose analytical methods, advance projects, develop program strategies and answer questions from regulatory authorities. The candidate must be highly motivated to contribute to the characterization of biopharmaceutical products. Agility in data analytics is highly preferred. Self-motivation, excellent problem-solving skills and communication, and an ability to work independently and within a group are essential to this role. Responsibilities Responsibilities include, but are not limited to the following: * Lead, design and conduct laboratory experiments including analytical method development, validation and transfer. Primary assays will be HPLC, mass spectrometry, electrophoresis, spectrophotometric, and microplate assays. * Represent Analytical Sciences at project team meetings and provide analytical support for antigen or antibody characterization in support of process development and establishment of analytical methods for release testing. * Perform analytical methods necessary for the characterization and release of active biological ingredients, vaccine and biopharmaceutical products. * Design, set up, and conduct stability and other hypothesis driven studies. * Trend and report method/critical reagent performance data. * Develop and/or adopt new analytical technology, as appropriate, to advance programs with significant analytical and timeline challenges. * Documentation, reporting, and communication of results in electronic laboratory notebooks, technical reports, PowerPoint presentations, and oral presentations. * Interface with other scientists in a variety of technical disciplines including process development, formulation development, clinical operations, quality control, quality assurance, discovery, and manufacturing. * Have a basic understanding of and utilize the statistical methods employed in process control and method development. Partner with Statistics group to design experiments and report data. * Assist in the preparation and writing of regulatory filings. Minimum Qualifications: * PhD or BS/MS in chemistry, biochemistry, engineering, biology or other related discipline, at least 1-3 years (PhD) or 8+ years (MS or BS) experience preferably in the biopharmaceutical or vaccine industry. * Motivated self-starter with excellent oral and written communication skills * Experience with HPLC, mass spectrometry, electrophoresis * Experience in developing, and validating biopharmaceutical analytical methods * Prepare comprehensive analytical reports and presentations, conveying findings to both technical and non-technical stakeholders. * Strong problem-solving skills and a proactive attitude toward process improvement Desired Qualifications: * Proficiency in data analytics tools such as JMP, Tableau, and Minitab, with the ability to manipulate, analyze, and visualize complex data sets * Individual contributor with experience in multiple analytical techniques (HPLC, mass spectrometry, immunoassays, CGE, cIEF) used to assess quality attributes of biopharmaceutical or vaccines products in development. * Familiarity with peptide mapping by LC-MS/MS (UHPLC and nano LC), intact mass analysis, MS/MS for protein and carbohydrate structural elucidation * Skills and experience in statistical analysis of assays, design of experiments (DOE), technical problem solving and continuous improvement. * Experience with biopharmaceutical development and product licensure. * Familiarity with biopharmaceutical manufacturing processes, including cell culture, purification, and formulation * Knowledge of the regulatory requirements (ICH, FDA, EMA, USDA) that apply to the development of tests for products tested under GMP release. 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.
    $75k-106k yearly est. Auto-Apply 60d+ ago
  • Formulation Development Senior Scientist

    Aerogen 4.4company rating

    Foster City, CA jobs

    Pharma Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system. We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year. Join us as we embark on this breakthrough and become inspired to deliver. What is the role? The person in this role is responsible for establishing and maintaining a state-of-the-art formulation development laboratory, working in close collaboration with the analytical development laboratory manager, to support our efforts in developing commercially viable lipid-peptide and lipid-protein multi laminar vesicle formulations (MLVs). This role is crucial for advancing our CMC program for the Gates project, as well as establishing formulation capabilities and in-house expertise in our expanding portfolio, ensuring products meets rigourous quality and regulatory standards. The person will be both hands on in the lab with deep technical knowledge, as well as mentor and manage direct reports, and will collaborate effectively with our external GMP testing and manufacturing partners. What are the key responsibilities? Lab design, establishment and operations: Establish state-of-the-art process development laboratory that develops lipid-peptide and lipid-proteins MLV formulations. Ensure efficient and safe lab operations. Mentorship and managing direct reports: Hire and mentor staff and manage direct reports. Formulation development: Provide guidance and hands on support for the design and optimization of lipid-peptide and lipid-protein MLV formulations. CDMO/CMO Collaboration: Ensure effective communications and coordination with our GMP partners to meet project timelines and quality expectations. Regulatory Compliance: Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to regulatory requirements. Cross-Functional Collaboration: Work closely with R&D, Regulatory, Quality Assurance, and Manufacturing teams to integrate formulation science efforts within overall project goals. Troubleshooting & Problem Solving: Address and resolve complex process issues during development and manufacturing. Continuous Improvement: Stay updated on advancements in process engineering equipment, techniques and industry trends. What Education and Experience are required? A Ph.D. in Chemistry, Engineering, Biochemistry or related field. 3-10 years of process development experience. Experience in lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus. Experience in technical writing is required. Authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a plus. Knowledge and experience in drug-device development, inhalation drug delivery is a plus. Excellent written and oral communication skills. What key skills will make you great at the role? Technical expertise: Proficiency in formulation design and equipment required for lipid-peptide / lipid-protein formulations. Experience with drug-device combination products is a plus. Deep understanding of laboratory procedures, equipment, software, and data analysis. Data-driven decisions: Use lab data to make informed decisions about operations, budget, and performance. Leadership, management and communication skills: Motivate, inspire, and lead technical staff. Clearly and effectively communicate with team members, other departments, and upper management. Problem-solving and strategic thinking: Quickly and effectively address challenges, from equipment malfunctions to staffing issues. Develop clear strategies and plans to achieve the lab's objectives. Collaboration and adaptability: Foster a collaborative environment where teams can work together seamlessly. Work well under pressure and adapt to changing priorities in a fast-paced environment. Compliance and safety: Ensure a safe and complaint work environment. Training, procedures, quality: Schedule training for staff to ensure they are up-to-date on procedures and best practices. Ensure the lab meets all relevant quality standards and documentation requirements. Why Aerogen Pharma? As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.
    $127k-179k yearly est. 14d 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

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