Scientist jobs at Frontage Laboratories - 590 jobs

A biopharmaceutical company in San Diego seeks a Principal Scientist to lead an in vitro pharmacology team. Candidates should have a Ph.D. and over 8 years in drug discovery, particularly with GPCRs. Responsibilities include designing assays, managing a team, and collaborating on research projects. The competitive salary ranges from $158,000 to $197,000, with comprehensive benefits including health insurance and PTO. #J-18808-Ljbffr

Principal Scientist, Innovation Management, Fremont CADescription As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Scientist, Innovation Management will act as a primary expert for upstream/drug substance development and manufacturing with a unique blend of expertise in biopharmaceutical upstream processes, digitalization, and data science. This role will identify and evaluate emerging technologies and companies that can enhance biopharmaceutical manufacturing. The incumbent will provide scientific and technical leadership to the team on both internal and external projects. Duties & Responsibilities Ensures direct report (intern & co-ops) safety, training, and supervision. Responsible for effective management of a team of technical experts. This is an individual contributor Role. Upstream/Drug Substance Development and Manufacturing: Leads the development and optimization of upstream processes for biopharmaceutical production. Oversees cell culture operations, including media development, bioreactor design, and scale-up processes. Ensures compliance with regulatory standards and quality control measures. Collaborates with cross-functional teams to integrate upstream processes with downstream and analytical development. Digitalization and Data Science: Implements digital tools and data analytics to enhance process understanding and control. Develops and applies predictive models for process optimization and troubleshooting. Utilizes machine learning and AI to drive continuous improvement in manufacturing processes. Manages data integrity and ensures robust data management practices. Scouting Technologies and Companies: Identifies and evaluates emerging technologies and companies that can enhance biopharmaceutical manufacturing. Conducts due diligence and feasibility assessments for potential technology acquisitions or partnerships. Collaborates with global teams to integrate new technologies into existing processes. Stays abreast of industry trends and advancements to maintain a competitive edge. Leadership and Team Collaboration: Provides scientific and technical leadership to the upstream development team. Mentors and develops team members, fostering a collaborative and high-performance culture. Manages project timelines, budgets, and resources effectively. Represents the company at industry conferences and scientific meetings. Requirements BS with ten-plus (10+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. OR MS with six-plus (6+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. OR PhD with three-plus (3+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. Thorough knowledge of biotechnology process development methodologies such as cell culture, aseptic techniques, bioreactor operation and development, column chromatography, filtration, and UFDF. Knowledge of GMP biopharmaceutical manufacturing, including process validation and commercial manufacturing support. Four-plus (4+) years' experience in late-stage process development preferred. Two-plus (2+) years' experience leading in a matrixed environment preferred. Two-plus (2+) years' experience in data science, Machine learning, and statistical analysis skills Excellent verbal and written communication skills. Good documentation and presentation skills. Proven skills building and maintaining productive relationships with organizational partners such as Manufacturing and Quality. Ability to troubleshoot and challenge status quo processes and influence in a team environment. Ability to communicate complex results (e.g. hybrid models) to both internal and external stakeholders. Eligibility Requirements Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Compensation Data This position offers a base salary typically between ($115,000) and ($181,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. Please reach out Talent Acquisition or your HR Business Partner for more information. #J-18808-Ljbffr

A global biopharmaceutical company is looking for a Principal Scientist in Innovation Management. The role involves the development of upstream processes, oversight of biopharmaceutical production, and integration of digital tools in manufacturing. Candidates must have significant experience in biopharmaceutical manufacturing and possess strong leadership capabilities. This exciting opportunity advocates for collaboration, innovation, and a commitment to high-quality standards in a dynamic working environment. #J-18808-Ljbffr

A leading global healthcare firm in San Diego is seeking a highly motivated scientist to contribute to biotherapeutics development. The successful candidate will discover and engineer antibodies, oversee experiments, and utilize various molecular biology techniques. Applicants should have at least 6 years of relevant experience and a strong background in flow cytometry. This position offers competitive compensation ranging from $110,250 to $187,000 along with comprehensive benefits. #J-18808-Ljbffr

A global healthcare leader in San Diego seeks a highly motivated scientist to contribute to the discovery and development of biotherapeutics. The role involves discovering and optimizing antibodies, utilizing flow cytometry, and requires strong skills in molecular biology and biochemistry. Ideal candidates should have significant industry experience and be detail-oriented, with excellent communication skills. Competitive compensation and benefits include a flexible benefits package and bonus potential. #J-18808-Ljbffr

NeilMed (Santa Rosa, CA) takes pride in delivering quality OTC products from development through manufacturing. We're looking for a Senior Microbiologist to join our team and be the subject-matter expert for microbiological control across our manufacturing, QC and operations functions. Responsibilities Lead and execute advanced microbiology testing of raw materials, in-process samples, finished goods, packaging materials, and utilities in support of OTC drug manufacturing. Drive and oversee the environmental monitoring program (clean-rooms, production areas, utilities) and ensure microbiological integrity of the manufacturing environment. Investigate microbiological failures and out-of-specification (OOS) results; perform root-cause analysis and lead corrective & preventive actions (CAPA). Develop/validate microbiological methods (e.g., microbial enumeration, microbial limits, preservative efficacy, endotoxin/bioburden, sterility if applicable) aligned with compendial standards (USP/EP) and regulatory requirements for OTC drugs. Write and review protocols, reports, deviations, CAPAs, trend analyses, change controls and SOPs relevant to microbiology. Collaborate closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D and Engineering to create and maintain microbiological control strategies across the product/process lifecycle. Monitor and analyze microbial trend data and recommend improvements to facility/processes for risk mitigation and continuous enhancement. Provide technical leadership and mentorship to junior microbiologists/technicians; promote a culture of excellence, data integrity and continuous improvement. Support internal audits, external inspections, supplier/contract-lab evaluations as required. Maintain strict adherence to cGMP, GLP, Good Documentation Practice (GDP), and data integrity standards in the lab and manufacturing environment. Qualifications Required: Bachelor's degree in Microbiology, Biology or a closely related science (Master's/PhD preferred). 5-10+ years' experience in microbiology within a pharmaceutical/OTC drug manufacturing environment (or similarly regulated manufacturing). Hands-on experience with microbiological methods: bioburden, endotoxin, sterility (if applicable), preservative efficacy, microbial identification, environmental monitoring (air, surfaces, utilities). Familiarity with 21 CFR 210/211, OTC monographs, FDA inspections, compendial guidelines such as USP, etc. Proven experience with method validation, protocol/report writing, deviation/CAPA investigations, trend analysis and root-cause resolution. Strong leadership, communication and interpersonal skills; ability to train and mentor team members and influence cross-functional stakeholders. Strong organizational skills, meticulous attention to detail, ability to prioritize tasks and meet manufacturing-driven timelines (including some flexibility for after-hours/weekend support). Proficiency with LIMS and statistical/data review tools; comfort working in a manufacturing laboratory environment with microbiological cultures, incubators, etc. Preferred Skills Experience in vertically-integrated manufacturing operations (raw material → finished goods) and understanding of upstream/downstream impact of microbiology. Demonstrated track record supporting regulatory inspections or audits (e.g., FDA). Experience working in an OTC or consumer health product environment. Strong analytical and problem-solving mindset; ability to influence process improvements based on microbial trend data. Self-starter attitude and ability to work autonomously within a cross-functional team in a fast-paced manufacturing setting. Pay range and compensation package We offer a competitive benefits package including medical/dental/vision. Retirement plan. Paid time off. Opportunities for professional development. 50k Life Insurance Policy (paid by Neilmed).

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

**Scientist II** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Purpose and Scope:** The primary purposes of the Scientist II, in Formulation & Analytical Development, are to design, evaluate and develop suitable formulations and manufacturing processes for rAAV drug product under development, supporting the growing and diversifying portfolio of programs within AGT's pipeline. This position will be based onsite in our South San Francisco, CA location. **Responsibilities** + Evaluate and understand the properties of new rAAV and propose formulations with sufficient stability during storage and suitability for clinical use. + Conduct in-use stability and delivery device compatibility studies to ensure the quality of drug products during administration at clinical sites. + Author regulatory documents such as IND and briefing documents for meetings with healthcare agencies.; prepare responses to Information Requests from agencies. + For preparing PPQ of drug product manufacturing process and BLA, organize necessary activities, plan studies and obtain sufficient data. + Evaluate new medical devices or container-closures for local injection products + Lead the technical discussion cross-functional/divisional to align and enable efficient drug development work + Evaluate and understand analytical tools and methods to develop rAAV formulation appropriately + Participate the program meetings to achieve key milestones in a timely manner + Regularly present data and conclusions in sub-team meetings + Occasionally presents technology summaries to management and program teams **Required Qualifications** + Master's degree (MS) in Biology or Engineering with 8+years of relevant experience in the biopharmaceutical industry + Experience in formulation development for biopharmaceutical products + Experience in authoring IND, BLAor other related regulatory filings, and responding to agency feedback/inquiries + Proven and successful history of taking direction and working independently in a fast-paced environment + Positive, professional attitude with a passion for science + Outstanding collaboration and problem-solving skills; team player with excellent communication and organizational abilities **Preferred Qualifications** + Experience with process development and technology transfer to GMP facilities for drug product manufacturing process + Experience with preparation activities for PPQ of drug product manufacturing processes. + Experience in the development of packaging process and transportation validation for drug products + Experience in operating basic analytical tools, such as chromatography and electrophoresis + Experience working with external vendors, institutions, and other collaborators to develop new and innovative technologies + Experience with handling rAAV gene therapy vectors or other viral particles + Bilingual: ability to communicate in English and Japanese. **Salary Range** : $103,600-$162,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability. \#LI-TR1 Category Gene Therapy Technical Dev Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Scientist II Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: The primary purposes of the Scientist II, in Formulation & Analytical Development, are to design, evaluate and develop suitable formulations and manufacturing processes for rAAV drug product under development, supporting the growing and diversifying portfolio of programs within AGT's pipeline. This position will be based onsite in our South San Francisco, CA location. Responsibilities Evaluate and understand the properties of new rAAV and propose formulations with sufficient stability during storage and suitability for clinical use. Conduct in-use stability and delivery device compatibility studies to ensure the quality of drug products during administration at clinical sites. Author regulatory documents such as IND and briefing documents for meetings with healthcare agencies.; prepare responses to Information Requests from agencies. For preparing PPQ of drug product manufacturing process and BLA, organize necessary activities, plan studies and obtain sufficient data. Evaluate new medical devices or container-closures for local injection products Lead the technical discussion cross-functional/divisional to align and enable efficient drug development work Evaluate and understand analytical tools and methods to develop rAAV formulation appropriately Participate the program meetings to achieve key milestones in a timely manner Regularly present data and conclusions in sub-team meetings Occasionally presents technology summaries to management and program teams

Scientist II Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: The primary purposes of the Scientist II, in Formulation & Analytical Development, are to design, evaluate and develop suitable formulations and manufacturing processes for rAAV drug product under development, supporting the growing and diversifying portfolio of programs within AGT's pipeline. This position will be based onsite in our South San Francisco, CA location. Responsibilities * Evaluate and understand the properties of new rAAV and propose formulations with sufficient stability during storage and suitability for clinical use. * Conduct in-use stability and delivery device compatibility studies to ensure the quality of drug products during administration at clinical sites. * Author regulatory documents such as IND and briefing documents for meetings with healthcare agencies.; prepare responses to Information Requests from agencies. * For preparing PPQ of drug product manufacturing process and BLA, organize necessary activities, plan studies and obtain sufficient data. * Evaluate new medical devices or container-closures for local injection products * Lead the technical discussion cross-functional/divisional to align and enable efficient drug development work * Evaluate and understand analytical tools and methods to develop rAAV formulation appropriately * Participate the program meetings to achieve key milestones in a timely manner * Regularly present data and conclusions in sub-team meetings * Occasionally presents technology summaries to management and program teams

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Analytical Chemistry Scientist to join our Bioanalytical Lab team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities * Develop and validate LC-MS/MS, GC-MS, ICP-MS, HPLC methods for small molecule drugs or drug metabolites and biomarkers; * Draft study protocols/plans, acquisition methods, and study reports; * Supervise all phases of bioassays to support pre-clinical and clinical pharmacokinetics, PD Biomarkers; * Supervise technicians for performing method development, validation, and sample analysis; * Communicate with internal and external resources for sample receiving, quality control, quality assurance, sponsor correspondence etc. Qualifications * PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or related field; * Previous experience with small molecule drug and drug metabolites analysis; * Strong project management, compliance, communication, and people skills; * Experience with various extraction procedures, such as LLE, SPE, SLE+, immune-capture hybrid extraction, etc.; * Experience with LC-MS/MS, GC-MS, ICP-MS, HPLC, etc.; * Direct working experience in Good Laboratory Practices is preferred. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Do you have a passion for Artificial Intelligence (AI) and are looking to make a difference in how the latest clinical trials progress into the market? Do you have a background in data science and/or computer science with experience working with AI tools for interactive AI applications across various IT systems? If so, we have an exciting opportunity for you to help take the reins of a groundbreaking project at Medpace. We are currently seeking a professional with direct experience interacting with artificial intelligence (AI) tools such as NLP, LLM, IA etc. This professional will be expected to lead the programming and fine-tuning of various AI tools and help IT teams to implement them into new applications. This professional will work collaboratively across the organization with multiple teams to help design the roadmap for how AI can improve efficiency of company processes and provide insights and assistance to users. Applicants should have sufficient technical skills to help lead these types of AI projects independently and to train technical teams for support. Responsibilities * Lead the ideation, research, PoC programming and then support programming and fine-tuning of various AI tools with the IT team to implement them into new applications; * Lead the identification and development of AI tools such as NLP, LLM, and IA; * Design, develop, and implement artificial intelligence (AI) models and algorithms for various applications; * Work on a broad set of tasks encompassing various forms of machine intelligence (e.g., machine learning, algorithms, neural networks, computer vision, robotics) to develop AI models for specific applications; * Train AI models using various algorithms and techniques, optimizing for accuracy, efficiency, and interpretability; * Deploy AI solutions into production environments, ensuring scalability, reliability, and integration with existing systems; * Continuously improve models based on feedback and performance metrics; * Lead AI team activities in educating Medpace AI users in the best development, training and deployment of AI tools including various forms of machine intelligence; and * Participate in educating, training and development of more junior team members. Qualifications * PhD in Artificial Intelligence, Computer or Data Science, or related field; * Preferably several years of experience working with different AI capabilities and showcasing your passion both at work and outside work in the development of highly complex AI models (NLP, LLMs, Deep learning etc); * Technical proficiency in programming languages and frameworks commonly used in NLP and AI (e.g., Python, TensorFlow, PyTorch); * Excellent communication skills to collaborate effectively with cross-functional teams; * Demonstrated ability to lead projects independently and mentor technical teams; * A passion for staying up-to-date with the latest advancements in NLP and AI technologies; and * Analytical thinker with great attention to detail. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to 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.

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.

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our AR&D lab is located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced TEMPORARY Analytical Research and Development Scientist III. This is a temp to possible permanent position. Summary The Analytical Research and Development (ARD) Scientist III, under guidance, performs laboratory analyses of raw materials, in process (IP), finished product (FP) and stability (ST) samples, as well as maintenance and calibration of analytical instruments. The incumbent also executes physical characterization studies to facilitate product understanding and performs technical and specialized analytical tasks, conducts research on assigned problems and studies to support product development, method development and technical investigations. She/he supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations. The incumbent also assists and trains lower-level scientists. ESSENTIAL FUNCTIONS Primary duties/responsibilities · Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs), and state, federal and local laws · Sets up and operates analytical instruments (i.e., High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet Visible spectroscopy (UV/Vis), Infra-Red Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, Inductively Coupled Plasma Mass spectrometry (ICP-MS), dissolution apparatus, etc.) to support sample testing · Performs all laboratory analyses of raw materials, IP, FP and ST samples; Prepares standard and sample solutions as required by the test methods. · Performs wet chemistry tests such as Limit of Detection (LOD), pH and titration · Performs physical tests and studies (i.e., particle size, viscosity, density, rheological measurements, microscopies and thermal analysis) · Performs all necessary calculations associated with test analyses · Designs and executes pre-formulation studies (i.e., pH solubility, pH stability and excipients compatibility studies) in collaboration with Product Development (PD) department · Executes designed studies to support laboratory investigations · Performs non-routine testing such as method comparisons and evaluations · Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs) · Assists and trains lower-level scientists · Creates and reviews ARD SOPs as needed · Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and Good Manufacturing Practices (cGMPs) · Cleans and organizes ARD lab areas · Performs related duties, as assigned Requirements Requirements KNOWLEDGE/SKILLS/ABILITIES REQUIRED Minimum education and years of relevant work experience Bachelor's degree in Chemistry or related science field and minimum 8 years' experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR Master's degree in Chemistry or related science field and minimum 5 years' experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR PhD in Chemistry or related science field with 1-3 years' experience in analytical/method development or method validation in the pharmaceutical, biotechnology and/or academic research field. Special knowledge or skills needed and/or licenses or certificates required · Understanding of spectroscopic and chromatographic techniques and concepts · Hands on experience in setting up and operating multiple analytical instrumentation which may include: HPLC, UV/Vis, GC, TLC, ICP-MS and dissolution apparatus · Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements · Ability to perform analytical testing, calculations and data analysis · Ability to perform wet chemistry and physical characterization studies · Ability to train and mentor lower levels scientist · Proficiency with Microsoft Office · Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members · Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines · Planning, organization and time management skills including the ability to support and prioritize multiple projects · Fluent in English (verbal and written) Special knowledge or skills needed and/or licenses or certificates preferred · Proficiency with Empower software Travel requirements 0% Physical requirements Laboratory based position Ability to lift up to 30 lbs Ability to use Personal Protective Equipment (PPE) Ability to stand for extended periods of time Pay rate for temp- $45-55/per hour. Pay rate is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Anticipated salary range for permanent employee: $95k to $115k. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Benefits and bonus are not offered for temp employees. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us. Hybrid Employee Value Proposition: At Taiho Oncology, we are dedicated to transforming the landscape of cancer treatment and improving patients' lives. As an Associate Director, Clinical Research Scientist, you will play a pivotal role in our mission, leveraging your expertise to drive innovative clinical research and contribute to groundbreaking therapies. We offer a collaborative and inclusive work environment where your ideas and contributions are valued. Join us to advance your career, work with passionate and skilled professionals, and make a meaningful impact on the fight against cancer. At Taiho Oncology, you will find purpose, growth, and the opportunity to be at the forefront of cancer research. Position Summary: The Associate Director, Clinical Research Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3. Additionally, this role serves in assisting the responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, as needed. Performance Objectives: Uses medical/scientific expertise to support the creation of relevant clinical documents of high quality such as study concepts, study protocols, amendments, study reports and investigator brochures. At the asset level, assists the medical lead in the preparations of the clinical content of regulatory submissions/documents (e. g. NDA, MAA, IND, CTA. sNDA, DSUR, PIP, health authority/ethics committee responses, briefing packages). Works with the medical lead to prepare presentations (internal and external), abstracts, manuscripts. Inputs into the of ICF/reviews ICF. Works with data management on CRF design and completion guide. Partners with data management to develop data review plan for review of data and with medical lead for the medical monitoring plan. Reviews protocol deviations, patient eligibility, and patient level and cumulative data per the data review plan across a study, raises queries and coordinates with the medical lead. Reviews safety data with the medical lead, SAE reports (in collaboration with pharmacovigilance), labs, efficacy data, dosing data, withdrawals/discontinuations. Collaborates with the medical lead to provide medical/scientific guidance during the execution of the study. Ensures TMF compliance for clinical development/medical study level TMF documents. Answers specific site protocol questions as needed, after consultation with the medical lead. Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, vendor / CRO staff, in collaboration with the medical lead. Escalates protocol-related issues requiring complex medical expertise to the medical lead, and operational issues to the appropriate operations study team member. Reviews the SAP and statistical outputs, in collaboration with the statistician, medical writer, and medical lead. Education/Certification Requirements: PhD, PharmD or other related Advanced Medical Scientific Degree. Experience in oncology is a must. Knowledge, Skills, and Abilities: At least 3 years in drug development industry in oncology and with previous exposure to clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents. Ability to critically review and interpret Clinical data. Working knowledge of the drug development process in the USA and EU is required. Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members. The pay range for this position at commencement of employment is expected to be between $213,350 - $251,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #LI-Hybrid

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description * Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. * Author abstracts and manuscripts for publication in peer-reviewed journals. * Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. * Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. * Oversee and coordinate the collection of and/or collect pre-study documents * Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. * Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. * Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications * Minimum 2-5 years of pharmaceutical industry clinical trial experience. * Experience in immunology or endocrinology therapeutic areas is a plus. * Primary experience with development of clinical trial protocols. * Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. * Good understanding of FDA regulatory, ICH, and GCP requirements. * Excellent communication skills, written and verbal. * Superior interpersonal communication and the ability to work across company disciplines and functional units. * Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. * Attention to detail and a commitment to high quality and on-time deliverables are key success factors. * Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

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

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 will develop analytical techniques and conduct experiments to support the development of commercially viable lipid-peptide and lipid-protein formulations. In addition, the person will support formulation development efforts. This role is crucial for advancing our CMC program for the Gates project, as well as establishing analytical capabilities and in expertise in our expanding portfolio, ensuring products meet rigorous quality and regulatory standards. The person will be hands on in the lab with strong technical knowledge in analytical science and will be mentored to assist in formulation development efforts. What are the key responsibilities? Analytical chemistry: Develop and optimization analytical methods for characterizing and controlling the quality the quality attributes of lipid-peptide and lipid-protein formulations. Support formulation development and design of experiment studies. Formulation science: Support formulation development efforts by participating in formulation runs with guidance form formulation science staff. Regulatory Compliance: Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs) Cross-Functional Collaboration: Work closely with formulation scientists and laboratory management staff, to integrate analytical development within overall project goals. Troubleshooting & Problem Solving: Address and resolve complex analytical issues during development and manufacturing. Continuous Improvement: Stay updated on advancements in analytical techniques and industry trends. What Education and Experience are required? A degree in Chemistry, Analytical chemistry, Biochemistry or related field. 2-5 years of experience in analytical development or quality control. 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 analytical techniques such as UHPLC, mass spectrometry and CAD as they apply to lipid characterization methods. Experience with drug-device combination products is a plus. Understanding of laboratory procedures, equipment, software, and data analysis. Data-driven decisions: Use lab data to make informed decisions about operations, budget, and performance. 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: Ensure up to date training 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.