Principal Scientist, Regulated Pk & Ada Bioanalytical Group

Job Description

Position Description:

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Department of our company's Research Laboratories is seeking an experienced scientist to join our Regulated PK & ADA Bioanalytical group located in West Point, PA. 

The position requires demonstrated expertise in the field of the bioanalysis of biotherapeutics via liquid chromatography/mass spectrometric (LC-MS) and ligand binding methods to support the PK of clinical and non-clinical studies.

In this position, you will be responsible for developing bioanalytical strategies to support the projects throughout the development phase including development of bioanalytical methods for measuring biotherapeutics, such as monoclonal antibodies, fusion proteins, and antibody-drug conjugates, in addition to small molecules and peptides.

Responsibilities also include authoring and contributing to regulatory filing documents.

The successful candidate:

• Uses comprehensive knowledge of principles, concepts and practices and/or techniques to lead complex projects within a department/group/team or across departments.

• Applies technical and departmental knowledge to design experiments/projects that contribute to overall direction of department/discipline.

• Is recognized as a technical expert and significant scientific contributor.

Responsibilities include but are not limited to:

• Conduct bioanalytical work to a high degree of quality and rigor, ensuring compliance with regulatory guidelines and SOPs

• Expert review of bioanalytical data and reports

• Provide guidance and develop regulated bioanalytical methods for the quantitation of biotherapeutic drug candidates using LC-MS and ligand binding assay-based platforms in addition to emerging technologies.

• Represent the group on cross-functional project teams by serving as the bioanalytical subject matter expert (SME)

• Communicate and present bioanalytical data to stakeholders and internal scientific forums.

• Author bioanalytical reports and the bioanalytical components of regulatory submissions and drafting responses to regulatory questions

Education Requirements:

• Ph.D. in Biology, Immunology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with a minimum of 8 years of relevant industry experience or

• M.S. in chemistry/biochemistry/biology with a minimum of 10 years of relevant industry experience, or

• B.S. in chemistry/biochemistry/biology with a minimum of 15 years of relevant industry experience in a drug discovery and development setting.

Required Experience and Skills:

• Expertise in developing and managing the development and utilization of LC-MS and ligand binding assays in support of regulated (GLP and clinical) pharmacokinetic and immunogenicity studies for drug development candidates.

• Prior experience with scientific supervision of staff

• In-depth understanding of the drug development process

• Expert knowledge of the principles of regulated bioanalysis and Good Laboratory Practice (GLP)

• Excellent verbal and written communication skills

• 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.

• Knowledge of regulatory guidelines pertaining to regulated bioanalytical assays (PK and immunogenicity) is expected.

• Proven record of scientific publications and presentations at scientific meetings

Preferred Experience and Skills:

• Experience with antibody drug conjugate (ADC) bioanalysis is advantageous.

• A thorough knowledge of regulated bioanalysis.

• Prior work with quantitative LC/MS-based bioanalysis of therapeutic peptides, small molecules, and proteins is highly desirable.

• Experience in authoring the Integrated Summary of Immunogenicity

• Experience with immunogenicity, ADA and nAb assay development.

This position will be located at WP PA sites and is an on-site position.

NOTICEFORINTERNALAPPLICANTS

InaccordancewithManagers'Policy-JobPostingandEmployeePlacement,allemployees subjecttothispolicyarerequiredtohaveaminimumoftwelve(12)monthsofserviceincurrent positionprior toapplyingfor openpositions.

 

If youhavebeenofferedaseparationbenefitspackage,buthavenotyetreachedyour separationdateandareofferedapositionwithinthesalaryandgeographicalparametersasset forthintheSummaryPlanDescription(SPD)ofyourseparation package,thenyouarenolonger eligible foryourseparationbenefitspackage.Todiscussinmoredetail,pleasecontactyour 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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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, 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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID:R282951