Job Description
R3 Senior Scientist, PCD Outsourcing, Description:
Our Company is a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
Employees within the group provide oversight for outsourcing of regulated clinical and preclinical assay method development, validation, and sample testing in support of biologics and small-molecule programs. This group is seeking a dynamic and collaborative employee with established scientific experience in large and small molecule bioanalytical assay development and validation as well as general project management skills to provide oversight for bioanalytical outsourcing. Oversight will include Pharmacokinetics (PK), Anti-Drug Antibody (ADA), and Neutralizing antibody (NAb) assays. Job responsibilities will support third party lab operational oversight and associated activities including management of assay transfer and validations, study sample analysis contracting, relationship management, meeting organization, and vendor performance to ensure quality, timeliness and compliance of outsourced bioanalytical work.
PLEASE NOTE THAT THIS IS NOT A LABORATORY-BASED POSITION.
Job Summary:
Our company's Regulated PK/ADA Bioanalytical Outsourcing Group is seeking a dynamic and collaborative expert in bioanalytical method development, validation, and assay lifecycle maintenance for large and small molecules, with general project management skills. The ideal candidate will have experience in regulated bioanalytical environments, familiarity with FDA bioanalytical guidance requirements, and the ability to work both independently and within a cross-functional team. This position offers an excellent opportunity to enhance your strong technical, communication, interpersonal and teamwork skills in a fast-paced, scientifically driven environment.
Specific Responsibilities include:
Relationship management of Contract Research Organizations (CROs) to support regulated PK/ADA/Nab bioanalysis across clinical and GLP studies.
Review and provide input on study designs, data files, bioanalytical reports, test methods, study related activities.
Communication of program deliverables and timelines to vendors; setting clear expectations for CRO deliverables and monitoring logistics to ensure timely completion of program deliverables.
Work independently and collaboratively to solve complex problems.
Close collaboration with Subject Matter Experts (SMEs) to guide the science and achieve our company's quality expectations.
Maintains a contemporary knowledge of Regulatory and GLP requirements and ensures externally supported work is following the latest regulatory requirements.
Assist in forecasting annual budget and meeting budget within pre-specified bounds. Align with functional areas to understand future needs and forecast future spend.
Contributes to managing overall vendor relationships with Contract Research Organizations (CROs). Participate in Site Visits providing insight into future strategy and building/maintaining relationships.
Proactive in awareness of vendor talents/abilities and the development of strategic sourcing plans to ensure sustained business continuity.
Facilitating sample reconciliation and data reconciliation through communication and coordination between testing labs and clinical data management
Collaborating and coordinating extensively and effectively across functions, both internally and externally, to achieve program deliverables as part of a team.
Education Minimum Requirement:
Bachelor’s degree in Chemistry, Biochemistry, Biology, Cell Biology, Virology, Immunology, or related field with 4+ years of relevant bioanalytical experience; or Master’s degree with 2+ years of experience as above, or PhD
Required Experience and Skills:
Bioanalytical experience with regulated ligand binding assays (e.g. PK, ADA and Nab), cell-based functional and neutralization assays, molecular assays, and LC/MS assays, with basic knowledge of regulatory agency requirements for operating in a regulated environment.
Ability to work in a collaborative environment.
Ability to work independently and within a cross-functional team.
Excellent technical, communication (oral and written), interpersonal, and teamwork skills.
Self-motivated with a positive attitude and proven performance record.
Preferred Experience and Skills:
2+ years of experience working in a regulated bioanalytical environment and familiarity with FDA bioanalytical guidance requirements.
Project Management Experience
Vendor relationship management experience
Experience with negotiation of timelines and project demands
Travel Requirements: 20%
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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 US salary range:
$111,400.00 - $175,300.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
11/22/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
The University of Vermont Medical Center
Cardlytics
Hempel A/S
Paula's Choice Skincare
