Merck Jobs

Job Description

The Executive Director of Materials and Biophysical Characterization is responsible for providing strategic and technical leadership for materials characterization methodologies, phase screening platforms, and biophysical characterization to enable deep understanding of drug substances and drug products and successful advancement of small molecules, biologics, and vaccines from discovery through development and commercial launch.

The Executive Director reports to the Associate Vice President, Analytical Enabling Capabilities and will be directly responsible for a multidisciplinary team of people managers and scientists, approximately 50-60 people across our West Point, PA, Rahway, NJ, and WAG, Switzerland sites. The team works closely with leaders and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical insights and support for our portfolio of projects from candidate nomination to marketing authorization.

The Executive Director manages the work within their group to ensure that the goals of the project teams are met in a timely, cost-sensitive, phase-appropriate and compliant manner. The Executive Director would be accountable for the growth/career development and performance of the team with a demonstrated ability to collaborate, build high-performing teams, develop diverse talent, set and achieve a strategic direction for the team, and implement and manage change to enable process improvement and optimal workflows.

Responsibilities include, but are not limited to, the following:

Scientific Excellence & Innovation : Responsible for leading the overall scientific, technical and operational efforts of a department within Analytical Enabling Capabilities with delivery of analytical characterization data, methods, and process knowledge in a timely manner needed to meet project milestones and associated regulatory requirements. This includes development of novel tools and processes to position Analytical Enabling Capabilities to deliver against future pipeline needs.

Quality and Regulatory Standards : Develops and implements quality standards and specifications for drug substance and drug product when required. Ensures the delivery of high-quality CMC sections for IND/CTA/NDA filings. Addresses measurement and quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications.

Compliance Systems : Sets a high compliance standard and ensures that systems and resources are in place to conduct the activities of the laboratories in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, and OSHA safety standards and in accordance with corporate requirements. Partners with colleagues to ensure overall laboratory readiness for regulatory inspections and internal audits.

Project Management and Teamwork : Responsible for managing quality and timelines for development projects and bringing analytical representation and expertise to CMC, project teams and task forces as appropriate. Facilitates teamwork and coordinates execution of plans with key stakeholders. Allocates resources and ensures tracking and follow-up as necessary. Ensures the department works as a partner with collaborators and teams.

Building Teams & Talent : Responsible for setting high standards, building and managing a high performing team. Sets department goals and performance objectives, supports talent development and proactively addresses performance issues. Identifies department needs and recruits/hires/promotes talent as appropriate to grow and progress the organization. Allocates proper resources for meeting goals and objectives.

Communications : Maintains productive communications with staff, colleagues across CMC development, Quality Assurance, and CMC Regulatory Affairs as needed to ensure understanding of needs, proper prioritization and timely delivery of product knowledge, customer-oriented data and documentation. Regularly exchanges ideas and information to develop effective plans and strategies to meet business needs.

Education:

• PhD in relevant scientific discipline with 12+ years’ experience; MS in relevant scientific discipline with 15+ years’ experience; or BS in relevant scientific discipline with 18+ years' experience;

Required Experience and Skills:

• 12 + years of development experience

• Demonstrated ability in leading large teams and mentoring and developing talent.

• Incumbent must have excellent interpersonal, communication, and collaboration skills.

• Strength in delivering results on firm deadlines in support of drug/vaccine development.

Preferred Experience and Skills:

• Experience with physical, biophysical and/or materials characterization along with multi-modality drug substance and/or drug product development experience

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 (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

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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”.

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:

$243,500.00 - $383,300.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/18/2024

*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.

Job Posting End Date: 06/18/2024

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: R299239