Job Description
Job Description Are you ready to lead the future of live virus vaccines? Our company's Manufacturing Division, we're looking for a motivated individual to take on the role of Director, Technical Product Leadership - Live Virus Vaccines (LVVs). This role provides end-to-end support for manufacturing science and technology for some of the most innovative products in our large molecule portfolio.
Why This Role is Important: - Global Reach: Work with manufacturing sites in the US and internationally to ensure our products reach patients worldwide.
- Strategic Leadership: Provide technical direction and leadership, partnering with key business units to implement technical solutions and operational improvements.
- Collaborative Environment: Partner with teams across the Company's Research Laboratories and Manufacturing Division, including Process Development, Commercialization, Operations, Quality, Regulatory-CMC, and Supply Chain.
- Comprehensive Scope: Your expertise will cover Drug Substance, Drug Product, and Analytical aspects.
Key Responsibilities: - Develop deep subject matter expertise in live virus vaccines (Process, Engineering, and Biology) within the team and the manufacturing network.
- Lead strategic and supply initiatives, collaborating with manufacturing sites.
- Utilize scientific and engineering principles to solve problems and implement solutions.
- Support technology transfers, process validation, license applications, and product launches.
- Ensure process and assay robustness through proactive risk management and rapid issue resolution.
- Build strong relationships with site leaders and stakeholders to ensure effective communication and collaboration.
- Drive the development of a Knowledge Management strategy to support regulatory filings and lifecycle management.
Minimum Education Requirement and Experience: - Bachelor of Science (BS) in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with ten (10) years' experience in large molecule, operations, technical operations, or development; OR
- Master of Science (MS) in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with eight (8) years' experience in large molecule, operations, technical operations, or development; OR
- Ph.D. in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with five (5) years' experience in large molecule, operations, technical operations, or development
Required Experience and Skills: - Five (5) or more years' experience in live virus vaccines in a technical process capacity - operations, technical operations, or development
- Strong scientific understanding of live virus vaccine products and processes including biology, process engineering, and process control, and their effective integration with relevant regulatory/GMP requirements
- Demonstrated problem solving, effective verbal and written communication, and strong interpersonal skills
- Proficiency with pharmaceutical industry technical business processes: Change Control, Deviation Management, Technical Protocols/Reports
Preferred Experience and Skills - Experience in vaccine or biologic manufacturing or development
- Authoring BLA/MAA regulatory license documents
- Knowledge of vaccine / chemistry processes (fermentation, purification, formulation, filling, packaging)
- Knowledge of regulatory requirements regarding vaccine and biologics manufacturing.
- Knowledge and experience in DMAIC / LSS methodologies or equivalent
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.
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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".
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
Job Posting End Date: 03/28/2025
*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: R339939
Job Tags
Full time, Work at office, Local area, Remote work, Worldwide, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,