Senior Specialist, Project Manager, Chemistry Manufacturing & Controls (CMC)

Job Description

Global Project and Alliance Management (GPAM) sits in the Research & Development Division at our company. The Project Managers in GPAM are core members of development teams at our company, driving these cross-functional teams to deliver projects and products that improve human health and business.

Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to enhance our Project & Portfolio management functions which support Development and Commercialization Teams (DCTs) responsible for building and executing CMC development plans.

Under the guidance of the Director & Portfolio Lead, the core responsibility of this individual will be to lead project management efforts to support Chemistry Manufacturing & Controls (CMC) product development from First in Human to Transfer to Supply, driving line of sight across the development lifecycle and maintaining programs in harmony with the portfolio. In addition, the Senior Specialist will be expected to participate in development of tools and processes to support holistic portfolio management and increased integration of CMC and Clinical strategies.

Position Description/Summary:

The Senior Specialist, Project Manager, is a core member of Development and Commercialization Teams (DCTs), partnering with team leads to develop strategies and execute our Companys drug and vaccine development efforts to progress the Research & Development pipeline. The Senior Specialist is expected to provide project management leadership and drive cross-functional teams with sufficient influence and proficiency in project management to take on assignments with minimal guidance. Projects could span the full CMC development continuum from Line of Sight to First in Human to Transfer to Supply stage-gates.

This position may be based in either Rahway, NJ or Upper Gwynedd, PA.

Primary Responsibilities:

Manage the end-to-end development process for projects that are of moderate complexity and/or work effectively with other team members to ensure successful execution of higher complexity development team strategies and project plans, guiding teams to develop comprehensive strategies and ensure successful execution.

Guide teams through the creation, approval, and execution of integrated project plans appropriate to the projects phase of development and complexity.

Build and maintain project schedules and critical project information, using these tools to integrate activities across key functional areas, work with team leads to proactively identify risks, and ensure clear and effective communication with key team, management, and cross-departmental stakeholders.

Leverage relationships and networks to improve and enhance team dynamics, with guidance from senior team members and team leads as needed, to proactively identify and remove obstacles to drive business results.

Navigate process and organizational norms to enable teams to understand corporate governance and business requirements, thereby enabling informed decision-making.

Prepare for and facilitate key team meetings including creating thoughtful agendas, ensuring appropriate participation, contributing project management insights, and following up to ensure the team continues to make progress while holding others accountable.

Participate in and GPAM departmental initiatives and workstreams aimed at improving the way that we work and the way that we interact with one another as well as other departments.

Required Education, Experience, and Skills:

Bachelor’s degree required; concentration in a scientific or applied discipline preferred

Minimum of three (3) years of experience in project management or a related role required

Experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D, manufacturing, or commercial perspective), with demonstrated ability to translate knowledge and expertise to other development teams and areas.

Demonstrated ability to work independently to effectively accomplish goals in a team setting.

Demonstrated ability to serve as a resource for colleagues and program teams.

Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others.

Highly organized and capable of working with attention to detail; Excellent problem-solving skills and ability to build alignment around complex situations.

Strong communication skills, both oral and written. Knows when and how to speak up and appropriately raise issues to team and to management.

Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.

Preferred Experience and Skills:

Experience and knowledge of clinical drug development strongly preferred; including the different phases of development and how the various functional areas contribute to a comprehensive strategy

Project management certification (PMP) and/or formal coursework/training in project management strongly preferred

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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.

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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, Monday – 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$111,400.00 – $175,300.00

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/) .

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

10/21/2024

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: R315419