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Job Description

Lead the Future of Biologics Drug Substance Commercialization!

Are you a bold, strategic thinker with a passion for biologics? We’re looking for a dynamic and visionary Director, Drug Substance Leader to drive innovation and excellence across our Biologics Science & Technology (S&T) portfolio. In this high-impact role, you’ll lead the Drug Substance Working Group (DSWG), mentor scientific talent, and partner cross-functionally to bring transformative therapies to patients worldwide.

What You’ll Do:

+ Establish and lead Drug Substance working groups (DSWG) across the Biologics Commercialization portfolio

+ Support CMC teams and align resources to deliver on program priorities

+ Mentor and develop a team of scientists focused on biologics commercialization

+ Foster a culture of initiative, creativity, and problem-solving

+ Deliver robust DS process and analytical strategies to enable successful commercialization

+ Provide technical oversight for DS process development, characterization, and regulatory filings

+ Ensure smooth execution of PPQs and BLAs for pipeline assets

+ Bring deep expertise in biologics DS processing (large molecule products)

+ Lead planning, execution, analysis, and documentation of cell culture process commercialization

+ Drive risk assessments, control strategies, comparability reports, PPQ, and regulatory submissions

+ Support and contribute to regulatory filings (IND, MAA, BLA)

+ Prepare for and support inspections with global health authorities (FDA, EMA, JNDA, TGA)

+ Unite diverse internal and external teams to deliver as One Team

+ Champion compliance, safety, and a culture of diversity, equity, and inclusion

+ Foster transparency and collaboration across stakeholders and governance bodies

+ Communicate effectively across all levels of the organization

+ Drive project schedules, set clear priorities, and monitor performance metrics

+ Recognize team achievements and promote a culture of appreciation

+ Lead business improvement initiatives and leverage networks to drive change

+ Enhance data monitoring capabilities and manufacturing robustness

+ Collaborate with colleagues across the U.S. and internationally to elevate standards in cell banking, manufacturing, testing, and storage. Your leadership will shape the future of biologics on a global scale.

Minimum Education Required & Experience:

+ Bachelor’s Degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with sixteen (16) years of relevant experience. **OR**

+ Master’s Degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with twelve (12) years of relevant experience. **OR**

+ Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or related field with eight (8) years of relevant industry experience

What You Bring:

+ Proven leadership of cross-functional teams in biologics development & commercialization

+ Deep expertise in DS manufacturing operations (cell culture and purification)

+ Strong understanding of regulatory requirements and inspection readiness

+ Ability to lead without authority, build trust, and inspire accountability

+ Ethical, resilient, and committed to scientific and operational excellence

+ Skilled in risk management, team facilitation, and strategic planning

+ Experience in commercial manufacturing and CMC development

+ Exceptional communication and stakeholder engagement skills

Be a Catalyst for Innovation!

+ If you’re passionate about biologics and ready to lead a high-impact team, this is your moment. Join us and be part of a transformative journey in DS commercialization and biomanufacturing.

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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 salary range for this role is

$169,700.00 - $267,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

**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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Biodesign, Biodesign, Biological Engineering, Biological Sciences, Biomedical Engineering, Building Trust, Cell Cultures, Cell Physiology, Change Agility, Chemical Engineering, Consulting, Cross-Cultural Awareness, Cross-Functional Team Leadership, Cross-Functional Teamwork, Digital Transformation Initiatives, Downstream Process Development, Engineering Standards, Estimation and Planning, Immunochemistry, Maintenance Supervision, Mammalian Cell Culture, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems, Regulatory Compliance {+ 2 more}

Preferred Skills:

Job Posting End Date:

06/19/2025

*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.

**Requisition ID:** R352380