FULL_TIME

FEED

YEAR

Perform method validation activities in accordance with regulatory guidelines (e.g., FDA, EMA), including accuracy, precision, selectivity, sensitivity, reproducibility, and stability assessments. This position plays a critical role in generating high-quality bioanalytical data to support clinical trials, regulatory submissions, and drug development programs.

Some relocation assistance is available for this role. The Senior Research Associate 2, CB is responsible for executing experiments, immunoassays, and technical procedures. Working under the supervision of the Manager, this role supports clinical pharmacokinetic (PK) assay development, validation, and clinical sample analysis in compliance with regulatory guidelines. This position plays a critical role in generating high-quality bioanalytical data to support clinical trials, regulatory submissions, and drug development programs. The ideal candidate possesses strong knowledge of, and hands-on experience with, ligand-binding assays and flow cytometry platforms within a regulated (GCLP) environment. Duties and Responsibilities (Include but are not limited to):<ul><li>Design, develop, optimize, and troubleshoot bioanalytical assays for quantification of drugs in biological matrices (e.g., plasma, serum).</li><li>Perform method validation activities in accordance with regulatory guidelines (e.g., FDA, EMA), including accuracy, precision, selectivity, sensitivity, reproducibility, and stability assessments.</li><li>Conduct PK analysis of clinical study samples while ensuring data integrity and compliance with GCLP standards.</li><li>Maintain detailed and accurate electro laboratory notebook, including protocols, raw data, and reports.</li><li>Analyze and interpret experimental data; and summarize results.</li><li>Support preparation of study reports, validation reports, and regulatory documentation.</li><li>Manage general laboratory operations, including ordering supplies and equipment maintenance.</li><li>Other duties/responsibilities as assigned.</li></ul>Education/Experience/Skills:<ul><li>M.S. in a relevant field with 2-5 years of experience or a Bachelor's degree with 5+ years of experience in life sciences  related field. </li><li>Strong written and verbal communication skills.  Writing skills include routine communications and technical reports detailing procedures, outcomes, and observations.  Ability to effectively present information in one-on-one, small groups and lab meetings.</li><li>Demonstrated proficiency  using Microsoft Office applications (Word, Excel, PPT) as well as job related electronic systems/applications.</li><li>Proficient in applying established mathematical and scientific techniques to compile and analyze data.</li><li>Knowledge of laboratory techniques and protocol development, with adherence to Good Clinical Laboratory Practice (GCLP) standards.</li></ul>Physical Demands:    While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee will be able to use the pipettes for long periods at any given time. The employee must regularly  lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus. Working Environment and Travel: Normal laboratory working conditions.  Business travel is not typical for this position. ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets  Powered by JazzHR

Senior Research Associate 2, Bioanalytical Assays

Analysis Skills

Assay Development

Assays

Biology

Clinical Assessment

Clinical Data

Clinical Practices/Protocols

Clinical Support

Clinical Trial

Clinical Validation

Communication Skills

Data Analysis

Data Collection

Data Quality

Develop Methodologies

Documentation

Drug Development

Equipment Maintenance/Repair

FDA (Food and Drug Administration)

GCP (Good Clinical Practices)

GLP (Good Laboratory Practices)

Identify Issues

Immunoassays

Laboratory Management

Laboratory Notebook

Laboratory Operations

Laboratory Techniques

Ligand Binding

Mathematics

Microsoft Excel

Microsoft Office

Microsoft Word

Operations Management

Order Supplies

Pharmacokinetics

Physical Demands

Plasma

Presentation/Verbal Skills

Regulations

Regulatory Compliance

Regulatory Reports

Regulatory Submissions

Stability Analysis

Writing Skills

partner JazzHR

UNKNOWN

The Global Integrated Evidence Operations, Associate Director role oversees and coordinates the operational processes, digital system support, and governance for Global Integrated Evidence & Innovation (GIE&I), which includes responsibility for operating models, system readiness, and process adherence for integrated evidence planning (IEP) and generation programs across the enterprise. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States.

Summary:The Global Integrated Evidence Operations, Associate Director role oversees and coordinates the operational processes, digital system support, and governance for Global Integrated Evidence & Innovation (GIE&I), which includes responsibility for operating models, system readiness, and process adherence for integrated evidence planning (IEP) and generation programs across the enterprise. In addition, the role will play a crucial role in enhancing the efficiency and effectiveness of general department operations to support timely and transparent delivery of high impact evidence.Responsibilities:<ul><li>Support the creation and management ofIEPprogramwith a focus on operational efficiency by building out andmaintainingdigital planning platform/repository</li><li>Track and reportIEP programupdatesto leadership</li><li>Overseethe digitalIEPplanning platform/repository andmonitordata quality</li><li>Ensure operational excellence through the continued development and implementation of standardized processes, tools, and governance forIEPand generation?</li><li>Contribute to the development of operational KPIs and dashboards tomonitorperformance and drive continuous improvement forIEPplanning and generation</li><li>Lead enterprise training,change management, and capability building forsystems, process, and governance</li><li>Supportevidence planning governance to ensure alignment with asset vision and strategic objectives</li><li>Supportevidence generation governance to oversee the execution of evidence generation activities.</li><li>Contribute strategic thinking and thought partnership forevidenceoperations,systemsand governance</li><li>Recommend process improvements and efficiencies toleadership</li><li>Develop andmaintainrelationships with colleagues involved in theIEP, evidencegenerationand governance processes.</li></ul>Requirements:<ul><li>Bachelor's degree in drug development or business management.</li><li>5+ years of experience in life sciences or project management supporting research needs.</li><li>Proventrack recordin program management with matrixed teams in health or life sciences.</li><li>Strategic mindset with the ability to prioritize tasks andfocuswork accordingly.</li><li>Capability to synthesizelarge amountsof data into meaningful content.</li><li>Strong written, verbal, and presentation skills for diverse stakeholders.</li><li>Excellent project, time management, and organizational skills.</li><li>Ability to thrive under pressure, meet deadlines, and lead parallel projects.</li><li>Competence in drug development lifecycle and scientific understanding of assets.</li></ul>Preferred:<ul><li>Formal training or certification in project management methodologies (PMP, Six Sigma, Agile).</li><li>Experience in developing IEPs or managing complex processes across cross-functional stakeholders.</li><li>Experience in leading or working closely with leadership governance</li><li>Successful execution and management of multiple projects supporting life sciences research.</li><li>Technical experience in drugdevelopment/commercialization.</li><li>Knowledge of drug development lifecycle functions such as Discovery, Clinical Trials, and Regulatory.</li><li>Experience with digital technology to support management of planning and research</li></ul>CompetenciesAccountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.Empowered Development - Play an active role in professional development as a business imperative.Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.Application Deadline : This will be posted for a minimum of 5 business days.Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.Come discover more about Otsuka and our benefit offerings; .Disclaimer:This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .Statement Regarding Job Recruiting Fraud ScamsAt Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka 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.

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Senior Research Associate 2, Bioanalytical Assays SAB

Associate Director, Global Integrated Evidence Operations Otsuka America Pharmaceutical

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