Job Description
The Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) is seeking a bioanalytical scientist to join our Regulated PK & ADA Bioanalytical group located in West Point, PA. Experience in the field of the bioanalysis of biotherapeutics via ligand binding methods to support the PK and immunogenicity components of regulated drug development studies is highly preferred. Knowledge of quantitative LC/MS-based bioanalysis of therapeutic peptides, small molecules, and proteins is advantageous. In this position, you will be responsible for developing bioanalytical methods for measuring biotherapeutics, such as monoclonal antibodies, proteins, and antibody-drug conjugates, and assessing their immunogenicity in support of Good Laboratory Practice (GLP) and clinical studies.
Main Responsibilities include but are not limited to:
Method development, validation, and sample analysis for the quantitation of drug candidates in biological matrices and immunogenicity characterization (e.g., serum, plasma)
Delivering high-quality quantitative data in a timely manner to cross-functional collaborators for PK analysis.
Effectively documenting, tracking, and communicating scientific findings and recommendations within cross-functional teams
Contributing to establishing and maintaining bioanalytical lab operations including automation and analytical instrumentation.
Contributing to authoring of method development reports, test methods, qualification and validation reports, and study reports
Education Minimum Requirements:
B.A./B.S. in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with a minimum of 1+ years of relevant experience
Master’s Degree in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline
Required Experience and Skills:
Knowledge of the basic principles of regulated bioanalysis and Good Laboratory Practice (GLP)
Good verbal and written communication skills
Ability to follow procedures and thoroughly document experiments
Strong direct experience with ligand binding assay methodologies for quantitative and qualitative analysis of biotherapeutics
Understanding of the drug discovery and/or development process and DMPK science
Ability to work efficiently and multitask in a fast-paced environment
Fosters team-based approach to research; committed to working synergistically and harmoniously with others
Preferred Experience and Skills:
Experience with antibody-drug conjugate (ADC) bioanalysis is advantageous.
Prior work with quantitative LC/MS-based bioanalysis of therapeutic peptides, small molecules, or proteins.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
#eligibleforerp #EBRG #vetjobs
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:
EEOC Know Your Rights
EEOC GINA Supplement
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”.
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:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/19/2024
*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.
