Job Description

Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes.  dCMC intends to deliver:

• Increased productivity and speed to clinic/market

• Accelerated timelines for site, filing, and launch readiness

• Improved access to product and process data

• Streamlined transfer of process and product knowledge with reduced error rates

A key enabler of these outcomes is implementation of digital solutions that will install the foundational capabilities needed to realize dCMC’s vision of the frictionless flow of data from development to commercialization and supply. Under the broad guidance of dCMC leadership, the Associate Director, dCMC Site Implementation Lead, will be accountable for implementing improved business processes and driving tactical deployment of digital solutions at sites across our Company network.

The responsibilities of the dCMC Site Implementation Lead include:

• Project Management: develop a comprehensive project plan for site-specific implementation of digital solutions, inclusive of scope, objectives, timelines, milestones, and resources.  Ensures appropriate prioritization of critical tasks.

• Stakeholder Management & Communication: identifies and engages key cross-functional partners and stakeholders across the site and global teams to ensure execution meets the needs of the business.  Facilitates regular project team meetings and workshops as needed.

• Cross-Functional Team Leadership: leads the cross-functional project team to ensure successful implementation of digital solutions at the sites.  Fosters a learning and collaborative team environment.

• Resource Management: in partnership with the sites, identifies and manages project resources (internal and external) to ensure completion on-time and within budget, escalating risks or issues in a timely manner to drive resolution.

• Implementation Oversight: oversees the on-time execution of all deliverables associated with the introduction of digital solutions at the sites, ensuring they meet operational and quality requirements.  Ensures deployment of training for site teams.

• Risk Management & Issue Resolution: proactively identifies and interrogates risks and develops appropriate mitigation strategies to ensure successful implementation of digital solutions at the sites.  Escalates issues through the tier process and drives problem-solving and resolution within the team.

• Operating Model Improvement: contribute to the development and improvement of standard work, knowledge management playbooks, and project management tools and dashboards to support deployment of digital solutions across the network.

Required Skills and Experience:

• Knowledge of manufacturing, testing, quality, and supply processes from late clinical development through commercialization and supply.

• Experience in drug development or manufacturing, including process or analytical development, characterization, technology transfer, validation/PPQ, commercial manufacturing, process and plant modeling, and/or regulatory filings.

• Experience with planning and execution of process tech transfer and/or life-cycle management (development or manufacturing).

• General understanding of data sources and IT systems (e.g., LIMS, Signals, MES, DeltaV, SAP, etc.).

• Demonstrated ability to create and analyze detailed, cross-functional project plans (including interdependencies) and manage execution against those plans with disciplined urgency.  Drives accountability within teams to follow through on commitments.

• Effective team facilitation, interpersonal, and leadership skills, with the ability to establish and maintain inclusive team environments.

• Strong collaboration, critical thinking, and problem-solving skills.  Ability to resolve conflict and drive ownership and accountability.

• Excellent oral and written communication skills, with demonstrated ability to tailor communications for diverse audiences.  Active listener who consistently strives to understand others’ perspectives, concerns, and ideas.

• Demonstrated stakeholder management skills and ability to lead and influence across functions and divisions.

• Highly organized and able to prioritize activities across the team to ensure success.

Preferred Experience and Skills

• Technical operations experience in drug substance or drug product manufacturing at either pilot or commercial facilities

• Automation experience or knowledge

Minimum Education/Experience Requirement:

• B.S. in chemistry, engineering, or related field with a minimum of 8 years of experience in the pharmaceutical industry;

• Or M.S. in chemistry, engineering, or related field with a minimum of 6 years of experience in the pharmaceutical industry;

• Or Ph.D. in chemistry, engineering, or related field with a minimum of 3 years of experience in the pharmaceutical industry.

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, 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:

$139,600.00 - $219,700.00

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.

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:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Measurement Analysis, Portfolio, Programme, and Project Support, Program Management, Risk Management, Stakeholder Relationship Management, Waterfall Model

Preferred Skills:

Job Posting End Date:

04/3/2025

*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.