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Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.About ProBioProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. Genscript is seeking a Scientist in Molecular Automation for our Production team in Piscataway, NJ. The estimated salary range is $70,000 - $90,000, depending on experience. Responsibilities: • Conduct feasibility analysis, solution design, and vendor communication for the introduction of automation equipment into molecular biology production lines., • Proficiently operate and develop applications on automated liquid handling workstations such as Tecan EVO/Fluent, Janus G3, and Hamilton; familiar with workflow scheduling software such as PlateWorks, Momentum, and Green Button Go., • Establish stable automated production workflows and implement equipment in real production., • Take overall responsibility for the management of automation equipment in molecular biology production lines., • Learn and optimize existing production processes to improve utilization of automation equipment., • Education: Degree in Biology, Automation, or related disciplines preferred., • Industry Experience: Prior experience in automation within the biotechnology/biological sciences industry preferred., • Skills: Strong communication, problem-solving, logical thinking, and hands-on abilities., • Knowledge: Familiarity with basic molecular biology operations and automation technologies., • Personal Attributes: Proactive, responsible, innovative, diligent, and pragmatic., • Language requirements: English and Chinese., • 3-5 years of experience required. #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.About ProBioProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. Job Summary: We are seeking a detail-oriented and proactive Analytical Associate Scientist or Scientist to join our US Protein Department. This role involves performing analytical testing and characterization of protein products to support research, development, and production activities. The ideal candidate will have a strong background in analytical chemistry, biochemistry, or biotechnology, with practical laboratory experience and familiarity with regulatory standards. Key Responsibilities: • Perform routine and non-routine analytical testing on protein samples using techniques such as HPLC, SDS-PAGE, ELISA, UV-Vis spectroscopy, and others as required., • Prepare reagents, standards, and samples according to established protocols., • Record, analyze, and interpret data with accuracy and integrity; prepare detailed reports and documentation., • Maintain and calibrate laboratory instruments and ensure compliance with quality standards and safety regulations., • Assist in method development, validation, and troubleshooting of analytical procedures., • Collaborate with cross-functional teams to support project timelines and deliverables., • Participate in the review and update of SOPs, batch records, and other quality documentation., • BS/MS in analytical chemistry, biochemistry, biotechnology, or related with 2+ years of relevant experience in protein purification/characterization., • Hands-on experience with analytical instruments such as HPLC, SDS-PAGE, ELISA, UV-Vis, or similar is preferred., • Strong attention to detail, organizational skills, and commitment to data integrity., • Ability to work independently and collaboratively in a fast-paced team environment., • Good communication skills and the ability to clearly document and present data., • Experience working in a CRO or CDMO setting is an advantage. #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.About ProBioProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. Job Title: Research Scientist II, Molecular Biology Supervisor: Director of US Molecular Biology R&D Dept. Location: Piscataway, NJ (Fully Onsite) Salary: $90,000 - $110,000 dependent upon experience Key Responsibilities: • Lead key molecular biology projects including but not limited to DNA synthesis and assembly, cloning, and characterization., • Independently design and execute experiments and analyze the data., • Keep tracking the trend of the latest technological development in both academia and industry., • PhD. degrees in molecular biology, biochemistry, chemistry or related fields., • In-depth knowledge in commonly used DNA assembly, cloning techniques, different methods of DNA amplification., • Broad molecular biology and microbiology knowledge with the ability to apply scientific interpretation to solve problems., • Excellent communication and data interpretation skills and the ability to mentor junior scientists., • Strong collaborative instinct with good time and resource management skills., • Strong data analysis skill is a plus., • Experience with liquid-handling automation operation and development is a strong plus., • A genuine deep interest in technology development and lab work. #LI-EB1 #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job Description Job Summary: Aquestive Therapeutics is a growth-stage pharmaceutical company redefining patient care through transformative patient centric drug delivery technologies and new therapies for patients. Our proprietary PharmFilm® and Adrenaverse™ platforms enable needle-free therapeutics via oral, transdermal, and topical routes. We have brought four prescription products to market and are advancing key pipeline programs, including Anaphylm™ (epinephrine sublingual film) and AQST-108 (topical epinephrine gel). We are seeking a Principal Scientist, Formulation & Innovation to play a hands-on leadership role in developing robust, scalable formulations that enable the delivery and absorption of drugs via oral mucosal and topical routes. Reporting to senior R&D leadership, this individual will drive key formulation development activities for the Rx and Direct to Consumer (DTC) New Product Pipeline (NPP), evaluate new excipients and technologies to fully enable all programs in the NPP, and contribute to rapidly creating and advancing Aquestive’s new product pipeline and platform capabilities. Responsibilities: Formulation Development & Execution • Design, optimize, and execute formulation strategies to support product development from prototype through clinical and commercial scale for Rx and DTC NPPs., • Develop formulations that enable controlled drug delivery through oral mucosa (sublingual, buccal) and topical routes, supporting the PharmFilm® and Adrenaverse™ platform applications for Rx and DTC NPPs, • Assess and implement novel excipients, permeation enhancers, and delivery technologies that will rapidly advance Aquestive’s Rx and DTC new product pipeline and technology/development platforms., • Serve as a subject matter expert (SME) in topical formulation, enteral, sublingual, buccal transdermal and thin film technologies, collaborating cross-functionally to identify and exploit new opportunities to fully enable product ideas in the Rx and DTC NPPs., • Develop robust formulation processes suitable for scale-up to clinical and commercial manufacturing., • Author and execute GMP manufacturing batch records for Phase I clinical supplies., • Write technical reports, protocols, and regulatory support documents., • Prepare and present research data internally and externally, including publications and scientific conferences., • Mentor junior scientists in experimental design, formulation techniques, and data analysis., • Ensure rigorous scientific practices, data integrity, and laboratory compliance with internal standards., • Education: Ph.D. (preferred) or M.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field., • Experience: 6–10 years of experience in pharmaceutical formulation development, with significant exposure to alternate delivery systems (oral thin film, transmucosal, or topical preferred)., • Strong background in formulation design, optimization, and characterization., • Experience with thin film, coating, and related manufacturing processes., • Excellent technical writing and scientific communication abilities., • Proven ability to work cross-functionally within a fast-paced, innovative environment., • Detail-oriented, organized, and driven to deliver high-quality results., • Ability to manage a team for results in a staff role including daily and weekly assessment of performance via select set of KPIs and metrics., • Artificial Intelligence (AI) powered technology experience desirable The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $120,000 to $160,000 USD

Job Description The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population – leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many – by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda – the most effective cancer drug in medical history. We are seeking a Director, Clinical Research / Clinical Investigator. The Clinical Principal Investigator (PI) is a physician-scientist responsible for the overall preparation, conduct, and management of sponsored projects, ensuring compliance with all regulatory requirements and institutional policies. This role will manage the development and execution of clinical trial protocols, contribute to data analysis, and maintain strong communication and alignment with sponsors. This role is based on site in East Brunswick, New Jersey. Essential Responsibilities • Manage early phase clinical trials by providing overarching medical direction and comprehensive medical reviews of protocols in conformance with the investigational plan and good clinical practice., • Provide medical and scientific feasibility of all new sponsor inquiries driving growth through strategic partnerships., • Lead and manage a matrix team of responsible for responsible for the conduct of early phase oncology trials., • Ensure the safety and well-being of all participants in the study at the trial site are protected., • Ensure data collected at the study site is credible and accurate., • Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected., • Develop close personal working relationships with Sponsors and Clinical Research Organizations involved in study conduct., • Provide expert guidance and support to clinical operations research staff and sponsor client., • Lead continuous quality improvement efforts for clinical research services, integrating best practices and fostering a culture of research excellence., • Develop and implement strategies to enhance patient recruitment and retention in clinical trials. Required Education and Experience: • M.D. or equivalent., • Board Certified in Hematology and/or Medical Oncology., • Clinical trials experience with a strong interest in drug development., • Ability to critically analyze clinical scientific data and literature., • Understanding of GCP principles, safety and adverse event reporting, FDA regulations, and biomedical research ethics., • A passion for providing excellent clinical care and for working in a collaborative / team-oriented environment. Preferred Education and Experience: • Previous experience with industry sponsored clinical trials., • Excellent communication skills, with experience in publishing and presenting at scientific meetings., • Translational research experience and familiarity with pharmacokinetics and pharmacodynamics. Best-in-Class Benefits and Perks We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including: • Comprehensive health coverage: Medical, dental, and vision insurance options provided, • Robust retirement planning: 401(k) plan available with employer matching, • Financial security: Company-paid life and disability insurance for added protection, • Flexible financial options: Health savings and flexible spending accounts offered, • Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided, • Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture. More about The START Center for Cancer Research Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Job Description Company Overview: We are a dynamic and innovative small biotechnology company dedicated to advancing oncology research through cutting-edge translational science. Our mission is to translate scientific discoveries into tangible therapeutic solutions that make a meaningful impact on cancer patients' lives. We are seeking a talented and motivated Translational Scientist to join our team and contribute to our mission-driven work. Position Overview: As a manager of clinical pharmacology you will be responsible for providing clinical pharmacology input in early (up to proof-of-concept stage) and late-stage clinical development. You will be responsible for representing clinical pharmacology function on drug development teams, providing input on the dose and the design of early and late-stage clinical trials, and for interacting with the clinicians and the clinical operations group for the execution of the clinical pharmacology components (PK, PD, biomarkers, etc) of the trials. In addition, you will be responsible for performing clinical PK/PD analyses, for providing subject matter leadership related to clinical ADME, pre-clinical to clinical extrapolation and selection of dose/regimen during early development. Additionally, you will be responsible for providing input on study design and leading the selection of doses for late-stage clinical studies. You will contribute to the preparation of the regulatory documents such as briefing books for pre-agency meetings, IBs, INDs, and IMPD dossiers, protocols, and clinical study reports. You will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Pharmacometrics and Physiological PK/PD Modeling and Simulation, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA. You will be responsible for working within the department level budget and resources. Support technical due diligence efforts for business development. Responsibilities: • Responsible for providing support for the preparation of the clinical pharmacology (PK, biomarkers, bioanalytical) sections of early and late-stage clinical protocols, Clin Pharm development plans, modeling & simulation plans, • Contribute to the preparation of the pre-IND, IND, IB and NDA/BLA documents, • Responsible for the pharmacokinetic and PK/PD data analyses using standard industry data analysis software, • Contribute to the design of early phase clinical trials (FIH to POC) and support project goals, • Responsible for recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling, • Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC, • Contribute to the design of late-stage clinical trials (POC-NDA/BLA) and support project goals, • Responsible for leading the dose selection for Phase II and III clinical trials based on PK, PD biomarker and efficacy data analysis from previous studies., • Responsible for the preparation of the PK/PD reports and clinical study reports, • Represent Clin Pharm function for the project team at the regulatory agencies during regulatory meetings., • Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions., • Provide oversight to vendors and ensure high quality deliverables that meet study/project timelines, • 3+ years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry., • Exposure to biologics drug development. Knowledge of basic and clinical immunology is plus., • Hands on knowledge of PK/PD and statistical analyses methods used in analyzing early clinical phase data., • Knowledge of general regulatory process and experience in contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA , EMA and other health authorities., • Excellent written and oral communication skills including good presentation skills. Qualifications: • Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacokinetics, pharmacology, or relevant life science discipline such as biology, immunology., • Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software., • Familiar with PK/PD concepts. principles and applications to support prospective dose/regimen recommendations for planned Phase 1, 2 and 3 trials., • Experience in preparing clinical pharmacology components of clinical study protocols and clinical study reports., • Knowledge of current practices and issues in the bioanalytical and drug metabolism areas., • Proficient in the use of Microsoft Word, Excel and PowerPoint. Travel: • Ability to travel domestic and internationally ≤ 20%. Benefits: Competitive salary commensurate with experience Comprehensive benefits package, including medical, dental, and vision coverage Opportunities for career growth and professional development Collaborative and dynamic work environment with a diverse team of scientists and clinicians Opportunity to make a meaningful impact on cancer patients' lives through innovative translational research

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.About ProBioProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. Genscript is seeking an Associate Scientist, Molecular Biology for our Production team in Piscataway, NJ. The estimated salary range is $60,000 - $70,000, depending on experience. Job Responsibilities: • Perform molecular biology techniques, with a focus on molecular cloning, to support production workflows., • Design and execute experimental plans to optimize processes and meet project goals., • Troubleshoot technical issues in production protocols and propose effective solutions., • Participate in continuous improvement efforts to enhance workflow efficiency and product quality., • Analyze experimental data, document results, and maintain accurate records in accordance with company standards., • Collaborate with cross-functional teams to achieve production targets and timelines., • Master's or PhD degree in Life Sciences (e.g., Molecular Biology, Biochemistry, Biotechnology, or related field) is preferred., • Bachelor's degree in Life Sciences with relevant work experience will also be considered., • Prior experience in molecular cloning techniques (e.g., plasmid construction, restriction digestion, ligation, PCR, transformation) is highly preferred., • Hands-on experience in a laboratory or production setting is a plus., • Fast learner with the ability to quickly adapt to new techniques and protocols., • Strong critical thinking and problem-solving skills to address complex technical challenges., • Results-driven mindset with a focus on delivering high-quality outcomes., • Excellent organizational skills and attention to detail., • Ability to work independently and collaboratively in a team-oriented environment., • Location Requirement: Must be able to work on-site in Piscataway, NJ. #LI-EB1 #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionObjectivePerspective Therapeutics is seeking a highly motivated hands-on scientist with expertise in sterile injectable drug products to join our dynamic CMC drug product team. This role is critical in supporting the development of sterile injectable formulations and drug product process development from early development through scale-up and commercial manufacturing. The successful candidate will play a pivotal role in developing and optimizing injectable radiopharmaceutical formulations and associated manufacturing processes in a cGMP-compliant environment. Working in a fast-paced, integrated, and multidisciplinary environment, the successful candidate is expected to collaborate cross-functionally while also delivering strong independent contributions that support product advancement to late-stage clinical development and commercialization.Objective • Serve as the technical subject matter expert (SME) for formulation and drug product process development., • Conduct formulation/process development studies, including comparability, stability, and compatibility assessments., • Lead scale-up and technology transfer activities to support manufacturing., • Draft detailed study plans to ensure that work is performed efficiently and in a scientifically sound manner, • Monitor experiments (e.g. process development, formulation optimization) and ensure complex data are interpreted in a scientifically correct way, • Support filter and container closure integrity validation studies and other special studies as necessary., • Collaborate with cross-functional teams including Analytical, Quality, Regulatory, and Manufacturing., • Author formulation and process development reports, study protocols, and regulatory CMC module 3 documentation to support late-stage IND and NDA submissions., • Ensure all work is performed in accordance with company policies, procedures and safety standards., • Ensure documents follow relevant regulatory standards (e.g., FDA, USP, ICH) and CMC guidelines., • Troubleshoot and propose scientifically sound solutions in collaboration with internal teams., • Provide technical support during regulatory inspections and audits, as needed.QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.Education/Experience, • Ph.D. or M.S. or B.S. in Pharmaceutics, Chemistry, or related field, • 5-7 years of hands-on experience in formulation development and sterile drug product process development using quality by design (QbD) principles., • Strong understanding of aseptic processing, formulation characterization, excipient compatibility, and container-closure systems, • Experience with QbD principles and risk-based development approaches., • Pharmaceutical product life cycle management, • Deep expertise in regulatory frameworks (FDA, EMA), and clinical/commercial manufacturing., • Familiarity with GMP quality systems and electronic document management systems., • Experience in radiopharmaceuticals or isotope-based therapeutics is strongly preferred.Knowledge / Skill / Ability, • Ability to prepare detailed study protocols and interpret complex data sets across multiple techniques., • Excellent communication skills, including the ability to explain technical concepts to cross-functional teams., • Prior radiochemistry experience and knowledge of radioactive material handling are a plus., • Strong organizational skills, with the ability to manage multiple priorities and meet tight deadlines., • Work independently and proactively in a highly matrixed environment.Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions., • Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels., • May be required to sit or stand for long periods of 8+ hours a day while performing duties., • Willingness to complete safety training within allotted time limits, and work in a team-based environment., • May require travel to Iowa up to 10%. Powered by JazzHR WawpTpaAzu

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description · Set-up and conduct experiments in accordance with Protocol and SOP's. · Conduct laboratory testing on clinical pathology specimens, including automated immunoassay analysis, hematology, coagulation, serum chemistry, and urinalysis, according to established protocols, timelines and established procedures (SOPs) to generate high-quality, error-free, results. · Meticulously maintain precise records of all experiments in accordance with Good Laboratory Practices. · Perform routine maintenance on the lab equipment and troubleshoot with vendor technicians as needed. · Assist in generating and maintaining applicable Standard Operating Procedures. · Assist with the in lab validations of instruments and assays. · Assist in the writing of validation reports. · Meticulously maintains inventory and lab costs, and communicates finding to laboratory manager. · Follow all PSL safety requirements. · Ability to safely wear a respirator required. · Oversees day to day procedures. · Leads training of Clinical Pathology Laboratory Scientists. · Perform other duties as assigned. Qualifications • B.S. or M.S. degree or equivalent experience in laboratory animal medicine, toxicology, animal science or biology is preferred. Additional Information Positions are full-time, working Monday-Friday 8am-5pm, overtime as needed. Candidates currently living within commutable distance to South Brunswick, NJ are encouraged to apply. Compensation: $25-30/hr Excellent full time benefits including comprehensive medical coverage, dental, and vision options • Life and disability insurance, • 401(k) with company match, • Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.