Senior Scientist, Cell Culture Sciences, Biologics Drug Substance Commercialization

Job Description

Join Our Team as a Biologics Cell Culture Senior Scientist!

Are you ready to take your career to the next level

We are seeking a strategic and technical scientist 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.

Why Youll Love This Role:

As a Sr. Scientist in Biologics Cell Culture Commercialization youll be at the forefront of scientific advancement providing strategic and tactical technical direction through cross-functional partnerships with key business units and customers.

Your participation 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.

Youll be supporting 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 companys pipeline.

• Technical knowledge: Fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products) recent advances and challenges in the field. Experience 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:Support Cell Culture CMC teams and align resources to deliver on priorities. 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 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: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:

• Bachelors degree in Chemical Engineering Bioengineering Biological Engineering or a related field with six (6) years of relevant industry experience. OR

• Masters degree in Chemical Engineering Bioengineering Biological Engineering or a related field with four (4) years of relevant industry experience. OR

• Ph.D. in Chemical Engineering Bioengineering Biological Engineering or a related field with a no minimum relevant knowledge.

What You Bring:

Expertise in cell culture commercialization and manufacturing operations

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 youre 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:

Preferred Skills:

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.

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 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

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 anothers 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 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

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 employees 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 can apply for this role through (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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.