Bioanalytical Scientist

The Position
**This position can be 100% remote in the US**
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Scientist, Bioanalytical
located at our Jersey City office. A remote location may be considered.
As a member of Translational Medicine and Early Development (TMED), the Bioanalytical Scientist will liaise with bioanalytical vendors and serve as the technical and scientific expert point of contact for all bioanalytical assay method development and analyses associated with both nonclinical and clinical studies. The Bioanalytical Scientist will serve as the subject matter expert to trouble-shoot bioanalytical technical challenges during method development and bioanalysis. Additionally, the Bioanalytical Scientist will coordinate and oversee the outsourced bioanalytical activities across all projects in Organon's portfolio to ensure a timely bioanalytical support for both clinical and nonclinical programs. The Bioanalytical Scientist will be responsible reporting of bioanalytical methods in accordance with regulatory guidelines for submissions and respond to agency questions as the subject matter expert. Specific responsibilities include the following:
Responsibilities
Serve as the point of contact between internal study teams and bioanalytical vendors for communication regarding sample logistics and availability, batching and testing timelines, reanalysis, and tracking of data and associated bioanalytical reports.
Manage bioanalytical vendors by reviewing scope of work (SOWs) and liaise with Organon clinical business operations to support contracting and payments, as necessary.
Work closely with bioanalytical vendors to oversee the outsourced bioanalytical activities for method development and validation, sample receipt, shipment, handling, analysis, storage, and data delivery and archiving. Communicate and confirm that bioanalytical samples are shipped and tested according to study timelines, data is returned in the specified format, and all SOW specified deliverables are met.
Serve as the subject matter expert (SME) for all bioanalytical activities, review and approve technical documents for bioanalysis (e.g., method validation plans and reports; sample analysis reports), and assess technical capability of bioanalytical vendors to support study protocol implementation and ensure the outsourced bioanalyses are conducted with highest quality and scientific integrity in compliance with the protocol, ICH/GCP/GLP, and applicable regulatory requirements.
Provide forecast to budgeting and timeline for bioanalysis to support design and implementation of clinical and nonclinical studies.
Author and review bioanalysis-related sections in technical documents supporting regulatory filings (eg, NDA, MAA, IND) or clinical studies (e.g., CTA, CSR).
Core Competencies
Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively.
Exercise good judgment and make decision that is appropriate for the organization.
Results-driven, take initiative and ownership to accomplish work.
Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment.
Strive for continuous improvement and embrace innovative ideas in daily work.
High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.
Strong analytical background in bioanalytical assay method development, validation, operation, and troubleshooting, specifically for detecting compounds in biological matrices using HPLC, LC-MS/MS and/or other bioanalytical methods.Solid understanding of current regulatory requirements, guidelines and standards of bioanalytical assays, particularly ICH, GCP, and GLP.
Experience interacting with clinical and/or nonclinical study teams with involvement of the processing and/or analysis of biological samples.
Ability to manage multiple competing priorities with complex timelines in a positive and collaborative manner.
Excellent communication skills.
Excellent interpersonal and organizational with attention to detail.
Experience in writing technical reports and documents to support regulatory filings or clinical studies.
Required Education, Experience and Skills
PhD/MS degree in analytical chemistry, pharmaceutics, or related field.
Five years of experience in pharmaceutical industry (or related industry) with bioanalysis, especially using HPLC and LC-MS/MS techniques.
Secondary Language(s) Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
US and PR Residents Only
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Organon LLC., 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.
Applicable to United States Positions Only:
Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Annualized Salary Range (US)
$76,000.00 - $129,400.00
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID:
R529561