Job Description

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Position Responsibilities:

* Responsible for providing quality and technical leadership to a team of Laboratory Managers, Data Analysts, and Laboratory Technicians.

* This individual is responsible for ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and our Company guidelines, policies and procedures.

* The individual will support key projects for Laboratory Operations aimed at elevating the compliance, assay robustness, and overall performance of virology, cell culture, and potency assays. As such, strong partnership with Laboratory Operations, Laboratory Quality Assurance, Divisional Analytical groups, and manufacturing areas is required.

* The Associate Director is expected to be a subject matter expert in LVV, cell culture, and potency testing and to leverage this expertise to provide guidance for analytical changes, work standardization, and process improvements.

* As the direct technical support in the area, the individual is expected to fully manage all aspects of assigned projects and run the business activities, including but not limited to: decision making, stakeholder management, issue identification and resolution, and understanding of capacity and demand.

* This individual participates in and drives the tier process, as appropriate, and uses this forum to escalate concerns and share best practices.

* The Associate Director must be an advocate for maintaining a safe work environment and is responsible for ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and our Company guidelines, policies and procedures.

Education Minimum Requirement:

* Bachelors degree in life science, biochemistry, science discipline or engineering.

* Degree in Biology, Molecular Biology, or Biochemistry preferred. Masters degree or Ph.D is beneficial.

Required Experience and Skills:

* For candidates with a Bachelors degree, a minimum or 8 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting.

* For candidates with a Masters degree, a minimum or 6 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting.

* For candidates with a Ph.D. degree, a minimum of 4 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting

Preferred Experience and Skills:

* Progressive and demonstrated Quality decision making responsibility.

* Project Management, Change Execution Management and Team Leadership experience in a Quality function.

* Demonstrated interpersonal skills including collaboration and inclusion skills and ability to work in a team environment.

* Demonstrated self-starter with capability to develop innovative solutions to challenges.

* Demonstrated facilitative leadership skills and able to lead teams to deliver results.

* Ability to effect and influence change across multiple groups to achieve business goals.

* Proven analytical aptitude, critical thinking skills and ability to apply key concepts.

* Speaks with courage and candor.

* Strong written and verbal communication skills.

* Skilled in writing and critical review of scientific documentation

* In-depth working knowledge and application of GMPs/GLPs.

* Experience with the creation, management, and use of ELN

* Experience in pharmaceutical laboratory operations or related environment.

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 thats 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

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:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

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 anothers 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R108083