R4 Associate Principal Scientist, PCD Outsourcing Job in Pennsylvania (PA), Research and Development Career, Full Time Jobs in Merck & Co.
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Life Science Career Fair

R4 Associate Principal Scientist, PCD Outsourcing job in West Point

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Merck & Co. jobs
Pennsylvania (PA), West Point
Job Code:  MERCUSR291160ENUS
Employer:  Merck & Co.
Category:  Research and Development
Job Type:  Full Time

Location
Country:  United States
State:  Pennsylvania (PA)
City:  West Point
04/23/2024

Description
Job 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 Regulated PK/ADA Bioanalytical Outsourcing 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 people management/mentoring experience and general project management skills to provide operational and logistical 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.

Specific Responsibilities include:
  • Contribute to overall group strategy in line with PCD and our Research and Development Division strategies.- Set and deliver on annual group objectives in line with strategy.
  • As a senior scientist in the group, mentor junior scientists on solving complex problems independently while helping them gain confidence in decision making.- Help team members to build relationships with Subject Matter Experts (SMEs) which guide the science and achieve company 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, reporting quarterly actuals vs. plan, and meeting budget within pre-specified bounds.- Align with functional areas to understand needs and align with finance.
  • Contribute in 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.
  • Ensure team members understand and comply with all safety and company policies/procedures.-
  • Collaborating and coordinating extensively and effectively across functions, both internally and externally, to achieve program deliverables as part of a team.

Education Minimum Requirement:-
  • PhD in Biology, Cell Biology, Virology, Immunology, Biochemistry, Chemistry or related field with 4+ years of relevant bioanalytical experience; or Master's degree with 8+ years of relevant experience, or Bachelor's degree with 12+ years of relevant experience.

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 knowledge of regulatory agency requirements for operating in a regulated environment.-
  • Employee management or mentoring experience.
  • Ability to work independently and within a cross-functional team.
  • Excellent leadership, technical, communication (oral and written), interpersonal, and teamwork skills.•-
  • Self-motivated with a positive attitude and proven performance record.
  • Demonstrated leadership, coaching and mentoring skills required.

Preferred Experience and Skills:
  • 8+ 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

Location:
  • West Point, Pennsylvania or Kenilworth, New Jersey
  • Travel Requirements:- 20%

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.

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, 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".

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R291160
ref: (MERCUSR291160ENUS)
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