Job Description
The Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) is seeking a bioanalytical scientist to join our Regulated PK & ADA Bioanalytical group at our Innovation Park in Spring House, PA. We are looking for candidates with experience in bioanalysis of biotherapeutics to support the immunogenicity requirements of regulated drug development studies. Collaboration, innovation, teamwork, and accountability are highly valued within our team. The successful candidate will play a key role in method development, validation, and analysis of neutralizing antibody methods for the company's pipeline.
Main Responsibilities include but are not limited to:
Method development and validation of neutralizing antibody assays for different therapeutics.
Generation of quality data to support clinical studies
Providing timely delivery of high-quality quantitative data to cross-functional collaborators for neutralizing antibody analysis.
Document, track, and communicate scientific findings effectively within cross-functional teams.
Assisting in establishing and managing bioanalytical lab operations, including automation and analytical instrumentation.
Contribution to the 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 3 years of relevant experience
Master's Degree in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 1 to 3 years of experience
Required Experience and Skills:
Demonstrated expertise developing, troubleshooting, and performing bioanalytical assays in plate-based and cell-based neutralizing antibody (NAb) assays for different therapeutics
Experience in different bioanalytical technology platforms, such as ELISA, our company, Ensight, Biacore/SPR etc.
Knowledge of GLP requirements and understanding of current industry trends and regulatory expectations associated with bioanalytical science.
Good verbal and written communication skills
Experience in good documentation practices
Ability to follow procedures and thoroughly document experiments.
Capable of working efficiently and multitasking in a fast-paced environment
Emphasizes a team-based approach and is dedicated to collaborative and harmonious work with others.
Preferred Experience and Skills:
Use of automation platforms to perform preclinical and clinical assays.
Previous work experience in regulated industry environment and a solid understanding of current GLP standards
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 separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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, generally Tuesday, Wednesday and either Monday or 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".
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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:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
YesHazardous Material(s):
n/aJob Posting End Date:
10/5/2024*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:10/05/2024
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.
Requisition ID:R313761
