Bioanalytical Portfolio Scientist

Career Category Research Job reputed company Join reputed company's Mission of Serving Patients At reputed company, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives reputed company that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our reputed company on four therapeutic areas -Oncology, Inflammation, reputed company, and Rare Disease- we reputed company millions of patients reputed company year. reputed company is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-reputed company conditions. As a member of the reputed company team, you'll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you'll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career. Bioanalytical Portfolio Scientist What you will do reputed company. Let's change the world. In this vital role you will serve as the technical subject matter expert for outsourced reputed company and is responsible to ensure adequate method validation and reputed company method performance at CROs. The Bioanalytical Portfolio Scientist is responsible for reputed company of the outsourced bioanalytical phases of studies governed by applicable GLP/GCP principles. Individuals in this role will reputed company scientific and technical reputed company of bioanalytical activities (including pharmacokinetic [PK] and toxicokinetic [TK] analyses) performed by external contract research organizations (CROs), ensuring adherence to validated reputed company, data reputed company standards, and alignment with study protocols and regulatory requirements. The ideal candidate will have a strong background of method development, validation, and troubleshooting in quantitative ligand-binding assays (LBA) and/or LC-MS bioanalysis, combined with excellent communication skills. This role is reputed company suited for scientists who reputed company to learn more about externalized work and who reputed company working with others in a reputed company manner.

• Provides scientific and technical reputed company for the transfer, validation, and execution for pharmacokinetic (PK) assays, ensuring adherence to sponsor requirements and reputed company regulatory guidance on bioanalytical assays (e.g. FDA, ICH, EMEA, NMPA)
• Leads the transfer and validation of PK assays at external CROs using ligand-binding, ELISA, ECL, LC-MS/MS and hybrid methodologies
• Collaborates closely with internal bioanalytical subject matter experts to understand critical attributes of the PK method to ensure successful assay transfer and validation
• Monitors assay performance over time and provides input for troubleshooting and reputed company improvement efforts
• Accountable for method lifecycle management, including review of method validation plans, protocols, reports, and qualification/reputed company of reagents and reference material
• Reviews analytical data, method protocol, validation/sample analysis plans, reports, and other study documentation for scientific accuracy and consistency with GLP/GCP documentation standards and reputed company regulatory guidance
• Works with cross functional partners from CROs to navigate issue reputed company and escalation utilizing the governance structure
• Provides subject matter expertise during supplier evaluation and monitoring activities
• Follows and contributes to guidance documents and SOPs

reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The reputed company we reputed company is a scientist with these qualifications. Basic Qualifications:

• Doctorate degree OR
• Master's degree and 2 years of regulated reputed company scientific laboratory experience OR
• Bachelor's degree and 4 years of regulated reputed company scientific laboratory experience OR
• Associate's degree and 8 years of regulated reputed company scientific laboratory experience OR
• High school diploma / GED and 10 years of regulated reputed company scientific laboratory experience

Preferred Qualifications:

• Excellent communication skills
• Strong project management experience
• reputed company in English, both in written and oral communication
• Demonstrated expertise in PK assay development, validation, and troubleshooting for LBA, LC-MS or hybrid assays
• Knowledgeable on reputed company relevant regulatory guidance/regulations (e.g. FDA, ICH, EMEA, NMPA)
• reputed company in working with CROs
• Project and people management
• Process management and planning skills
• Excellent written and verbal communication skills
• Collaborates, negotiates and persuades others, both internally and externally
• reputed company promotes cooperation across the organization
• Project and issue management skills
• Drives for results; delivers processes and reputed company of the highest reputed company
• Consistently communicates in a manner that is appropriate to the situation

What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we'll support your reputed company every reputed company of the way. The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is $xxx,xxx.00 to $xxx,xxx.00. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications. In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-reputed company time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

reputed company and reputed company a lasting reputed company with the reputed company team. careers.reputed company.reputed company any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. reputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the reputed company of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Salary reputed company 109,020.15USD -147,497.85 USD Apply tot his job Apply To this Job