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Job Description

Our Company's Vaccines Technical Leadership team within the Global Science and Technology (GSEC) organization is seeking a highly motivated Director to lead our Pneumococcal Franchises (PCV) - Development and Commercial Team Leadership (DCT) as well as the technical product leads. This role provides end-to-end technical product leadership and strategic direction for our PCV vaccine products across their product lifecycle-from development through commercialization and sustained supply. The Director will lead a team of specialists and collaborate across multiple functions and global manufacturing sites to ensure robust, compliant, and innovative manufacturing science and technology solutions.

Key Responsibilities

Serve as the primary technical leader for the PCV franchise, owning the product's technical processes and challenges, proactively managing risks, and driving innovative solutions aligned with business goals.
Leads the Development and Commercial Team (DCT), accountable to Development Commercialization Review Committee (DCRC) for delivering a fully integrated stage-appropriate development and commercialization strategy for PCV products.
Critically assesses all team deliverables & fosters a learning and collaborative environment. Prioritizes, interrogates and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen circumstances.
Provide strategic technical leadership and project execution for both strategic initiatives and supply initiatives, partnering with manufacturing sites globally.
Responsible for end-to-end technical product leadership (TPL) and oversight of the on-time execution of deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain toachieve launch on time and uninterrupted commercial supply.
Collaborate with Research Laboratories, Process Development, Commercialization, Operations, Quality, Regulatory-CMC, and Supply Chain teams to ensure seamless technology transfers, process validation, regulatory filings, and product launches.
Ensure process and assay robustness through continuous monitoring, risk identification, and rapid resolution of technical issues within the manufacturing network.
Represent CMC interests in governance bodies, influencing cross-functional strategies to balance speed, cost, and robustness for successful product launch and long-term supply.
Develop and implement Knowledge Management strategies to support regulatory filings and lifecycle management of technical product information.
Provide on-site technical support for critical projects, complex investigations, and specialized requests at manufacturing sites.
Foster strong, trusting relationships with site leaders, functional management, and stakeholders to ensure effective communication and alignment.
Drive a culture of safety, compliance, integrity, and inclusion in all activities.

Core Competencies

Development & Commercialization Expertise:Understanding of technical interdependencies across Drug Substance, Drug Product, Device, Packaging, Analytical, Regulatory, Quality, and Supply Chain from early development through commercial manufacturing.
Technical Leadership:Recognized scientific leadership with the ability to navigate uncertainty and deliver favorable outcomes.
Strategic Thinking:Ability to see the "big picture," ask critical questions, and drive decisions that balance enterprise priorities.
Problem Solving & Innovation:Skilled in analyzing complex data, fostering debate, and developing creative solutions to technical challenges.
Ambiguity Navigation:Comfortable operating in uncertain environments, adapting plans, and making disciplined risk-based decisions.
Communication:Effective at leading complex discussions, influencing stakeholders, and tailoring messages to diverse audiences.
Collaboration & Teamwork:Builds and leads high-performing teams, promotes open communication, and fosters inclusive environments.
Results Orientation:Drives accountability and ensures on-time delivery of projects and commitments.
Influence & Ownership:Inspires action, builds trust, and demonstrates initiative to see challenges through to completion.

Compliance & Culture

Adhere to our company's Global and regulatory requirements and current Good Manufacturing Practices (cGMP).
Promote a safe, compliant, and inclusive culture within the organization and teams.

Minimum Education and Experience Requirement

Bachelor of Science (BS) in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with twelve (12) years of required experience; OR
Master of Science (MS) degree in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with ten (10) years of required experience; OR
Ph.D. in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with seven (7) years relevant experience.

Required Experience & Skills

Extensive experience in vaccine, biologics, or pharmaceutical industries.
Strong scientific understanding of vaccine/biologic products and processes integrated with regulatory and GMP requirements.
Proficiency in technical business processes including Change Control, Deviation Management, and Technical Protocols/Reports.
Demonstrated problem-solving, communication, and interpersonal skills.

Preferred Experience & Skills

Experience in pneumococcal vaccine manufacturing or development.
Experience authoring BLA/MAA regulatory license documents.
Knowledge of vaccine/chemistry processes (fermentation, purification, formulation, filling, packaging).
Familiarity with regulatory requirements for vaccine and biologics manufacturing.
Experience with DMAIC / Lean Six Sigma or equivalent methodologies.

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 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

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

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

$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:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

n/a

Required Skills:

Biopharmaceutical Industry, Biopharmaceutical Industry, Biopharmaceuticals, Business Processes, Capital Management, Change Management, Chemical Process Development, Cross-Cultural Awareness, Cross-Functional Leadership, Decision Making, Decision Making Under Uncertainty, External Manufacturing, GMP Compliance, Innovation, Manufacturing Scale-Up, Mitigated Risks, Process Improvements, Product Commercialization, Product Management Leadership, Regulatory Requirements, Results-Oriented, Sterile Filling, Strategic Thinking, Teamwork, Technical Leadership {+ 1 more}

Preferred Skills:

Job Posting End Date:

09/10/2025

*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.

Requisition ID:R363502