Description

Job Description

PLEASE NOTE THAT THIS IS NOT A LABORATORY-BASED POSITION.

Specific Responsibilities include:

• Management of group members including setting objectives, holding team meetings, providing candid real time feedback, conducting formal reviews, fostering meaningful and actionable employee development plans, engaging and retaining staff, managing performance issues and ensuring appropriate staffing and balancing of resources.
• Support PPDM's and our Research & Development Division'sobjectives by supporting a portion of the late-stage drug development pipeline. Responsibilities would include managing bioanalytical activities at select Contract Research Organizations (CROs) with a focus on PK, ADA and nAb assays.
• Participate in regular group meetings with the vendors across the globe. Working-hour flexibility is expected to accommodate global meetings, especially with our company in China and some vendors located in China.
• As the senior scientist in the group, mentor junior scientists on solving complex problems independently while helping them gain confidence in decision making.
• Represent the Outsourcing Group as a Scientific Lead for select drug modalities.
• Maintain vendor relationships with select CROs. Participate in Site Visits to review ongoing work, provide insight into future strategy, and build/maintain relationships.
• 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.
• Build and maintain relationships with Subject Matter Experts (SMEs) and other stakeholders that guide the science and achieve our company'squality expectations.
• Contribute to overall group strategy in line with PPDM and our Research & Development Division's strategies. Deliver on annual group objectives in line with strategy.
• 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 7+ years of relevant bioanalytical experience; or Master's degree with 10+ years of relevant experience, or Bachelor's degree with 14+ 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.
• 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 coaching and mentoring skills required.

Preferred Experience and Skills:

• 10+ 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 remote work arrangement

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".

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:
$159,200.00 - $250,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R271470