Bioanalytical Portfolio Scientist

Career Category

Job Description

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 focus on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients each 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 impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, 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 transform 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 methods and is responsible to ensure adequate method validation and optimal 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 provide 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 methods, 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 well suited for scientists who seek to learn more about externalized work and who reputed company working with others in a collaborative 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/bridging 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 resolution 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 professional we seek is a scientist with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Master’s degree and 2 years of regulated commercial scientific laboratory experience OR
• Bachelor’s degree and 4 years of regulated commercial scientific laboratory experience OR
• Associate’s degree and 8 years of regulated commercial scientific laboratory experience OR
• High school diploma / GED and 10 years of regulated commercial 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 outcomes of the highest quality
• 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 professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every reputed company of the way.

The expected annual salary range 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 addition 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 vision 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-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and reputed company a lasting impact with the reputed company team.

careers.reputed company.com

In 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 quality of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each 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 qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other basis 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 Range