Hiring company: Merck
Job Description
New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
An exciting opportunity exists for a candidate who wants to be part of creating new ways of working to advance of our Company’s late-stage pipeline. In a newly formed centralized function, the Director of Laboratory Operations will be accountable for developing a team to create, sustain, and improve the essential laboratory systems, processes and ancillary functions that drive the commercialization of new biologics and vaccines products and their associated assets. This position will have oversight of laboratory operations across Global Vaccines and Biologics Commercialization (GVBC) and Biologics and Vaccines (BVA) and will necessitate a highly concerted mindset to effectively simplify systems, streamline conclusion making, and deliver tangible business outcomes. Key laboratory systems and ancillary functions in scope include, but are not limited to:
Laboratory systems validation and qualification
Laboratory systems calibration and maintenance
Sample management, including sample shipping and logistics
Safety
Capital expense management
High-level assignments include:
Direct a team of our Company Employees and our Non-Company Persons with accountability for validation, qualification, calibration, and maintenance of laboratory systems, sample management (including sample shipping and logistics), safety, and capital expense management for GVBC and BVA
Evaluate, design, execute, measure, monitor and control these business processes to enhance productivity and assist the organization in meeting its business objectives
Develop a system to effectively measure the performance of these processes and systems to enable continuous improvement
Direct change management efforts associated with the implementation of new systems and processes
Work in close alliance with laboratory personnel to ensure development, implementation, and management of fit-for-purpose and compliant laboratory assets and systems
Translate various above-site and site wide IT, Quality, and Compliance initiatives into executable strategies that incur minimal impact on the business and laboratory operations strategy
Execute focused work to ensure rapid engagement and troubleshooting of laboratory systems validation, qualification, calibration, and maintenance
Participate in regulatory inspections and internal audits of laboratory systems
Ensure implementation and maintenance of compliant Standard Business Procedures, tools, systems, and training for sample management, shipping, and logistics activities across the departments
Demonstrate accountability and remit for Environmental, Health, Safety, and Sustainability (EHS&S) performance and compliance
Manage capital purchasing across GVBC and BVA
Design, deploy, and continuously improve universal and integrated digital solutions in service of laboratory systems across the departments
Recruit, onboard, and develop the Laboratory Operations team
Education
Bachelor’s Degree in Engineering, Biochemistry, Biology, or related field and 12+ years
Master’s Degree in Engineering, Biochemistry, Biology, or related field and 8+ years
PhD Degree in Engineering, Biochemistry, Biology, or related field and 5+ years
Necessary Skills and Knowledge
5+ years directing others or in a project/program management capacity
Knowledgeable in large molecule manufacturing and testing and/or process or analytical development
Knowledge of GMP/GXP environments and associated compliance expectations
Strong people management skills
Past involvement with organizational change initiatives
Demonstrated ability to manage activities involving laboratory systems
Knowledge of vendor management and ability to effectively address service and/or Quality concerns
Demonstrated ability to participate in aspects of regulatory inspections, internal audits, and/or Quality walkthroughs pertaining to laboratory systems
Proven ability to provide technical guidance for review and approval of incidents, deviations, system commissioning and qualification, change control, and other key automation related processes
Demonstrated ability to generate valuable and relevant ideas, create concepts based on ideas, and develop new solutions based on concepts
Strong executive presence with demonstrated ability to negotiate, influence, and speak at all levels in the organization
Exceptional partnership skills and strong relationship building and stakeholder management abilities
Flexibility to meet business needs while moving key programs and priorities forward
Comfort with ambiguity and highly matrixed organizational structures
Preferred Skills and Knowledge
Versed in Lean, Sigma, and/or agile processes
Ability to anticipate conflictive environments, and manage to facilitate the resolution of complex issues
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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.
For more information about personal rights under Equal Employment Opportunity, visit:
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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not SpecifiedShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
Number of Openings:
1