Principal Scientist, Engineering Full-time

Biologics Drug Substance Commercialization Leader

Are you ready to take your career to the next level?

We are seeking a strategic and technical leader with expertise in cell culture development & commercialization to spearhead our ever growing and dynamic late stage biologics pipeline within the expansive Biologics S&T portfolio.

Reporting directly to the Biologics Cell Culture Commercialization Leader, you will lead a team of approximately 3-5 scientists, who lead multidisciplinary program teams and drive innovation in biologics DS manufacturing and commercialization projects.

Why You'll Love This Role:

As a Biologics Drug Substance commercialization Leader, you'll be at the forefront of scientific advancement, providing strategic and tactical technical direction through cross-functional partnerships with key business units and customers.

Your leadership will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing sites, process validation, second generation process development and health authority licensure.

You'll lead the charge in transforming our late-stage pipeline into reality bringing lifesaving medicines to our patients worldwide.

Global Impact:

Collaborate with colleagues across the US and internationally to elevate standards in biologics commercialization and manufacturing. Your work will shape the future of biologics on a global scale.

Key Responsibilities:

• Technical Strategy: Deliver robust DS strategies for successful commercialization. Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
• Technical leadership: Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.
• CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
• Leadership: Establish, manage and support CMC teams, and align resources to deliver on priorities. Manage and mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff. Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.
• Cross-Functional Collaboration: Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.
• Problem Solving: Remove roadblocks, resolve conflicts, and escalate issues when needed.
• Communication: Foster collaboration, ensure transparency, and engage with governance bodies. Excellent interpersonal and communication skills
• Project Management: Drive project schedules, set clear priorities, and monitor performance metrics. Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.
• Recognition: Celebrate team achievements and foster a culture of appreciation.
• Innovation: Lead business improvement initiatives and leverage your network to drive change.

Education & Experience:

• Bachelor's degree in chemical engineering, Bioengineering, Biological Engineering, or a related field with sixteen (16) years of relevant industry experience. OR
• Master's degree in chemical engineering, Bioengineering, Biological Engineering, or a related field with twelve (12) years of relevant industry experience. OR
• Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum eight (8) years or relevant industry experience.

What You Bring:

• Proven leadership of cross-functional teams in biologics development & commercialization
• Deep expertise in cell culture commercialization and manufacturing operations
• Strong understanding of regulatory requirements
• Ability to lead without authority, build trust, and inspire accountability
• Ethical, resilient, and committed to 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, apply now and be part of a transformative journey in the world of DS commercialization and biomanufacturing!

Required Skills: Cell Cultures, Chemical Engineering, Clinical Manufacturing, Commercialization, Communication, Creativity, Cross-Functional Collaboration, Cross-Functional Teamwork, Decision Making, Driving Continuous Improvement, Mammalian Cell, Mammalian Cell Culture, Manufacturing Scale-Up, Mentorship, Process Characterization, Process Control, Process Design, Process Optimization, Regulatory Submissions, Risk Management, Strategic Thinking, Technical Leadership, Technology Transfer

Preferred Skills:

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 salary range for this role is $173,200.00 – $272,600.00

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: 10%

Flexible Work Arrangements: Not Applicable

Shift: Not Indicate