Job Description

The Associate Director of Laboratory Operations is responsible for providing operational direction and oversight to a team of Managers, Specialists and Laboratory Technicians.This team is responsible for performing microbiology, sterility, and environmental monitoring and quality control testing.

Primary activities include, but are not limited to:

• Responsible for ensuring compliance in accordance with cGMPs, regulations and our company's guidelines, policies, and procedures.

• Advocate for maintaining a safe work environment.

• Responsible for meeting customer testing needs including schedule adherence and right the first-time execution of testing while working with their staff on employee development.

• Lead key projects for the site aimed at elevating the compliance and performance of analytical methods.

• As the lead, 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, understanding of capacity and demand, participates and drives the tier process, as appropriate, and uses this forum to escalate concerns and best practices.

• Proactively partners with Laboratory Quality Assurance personnel to ensure compliance with regulations, guidelines, and procedures.

• Ensures that all process improvements and capital projects are timely, robust and in alignment with corporate goals.

Education Minimum Requirement and Experience:

• Bachelor of Science (BS) degree in life science, science discipline, or engineering with ten (10) years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations in a laboratory, manufacturing, science related, or regulated setting. OR

• Master of Science (MS) degree in life science, science discipline, or engineering with eight (8) years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations in a laboratory, manufacturing, science related, or regulated setting.

Required Experience and Skills:

• Previous people management experience: ability to develop staff.

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

• Familiar with aseptic technique.

• In-depth working knowledge and application of GMPs.

• Progressive and demonstrated Quality decision-making responsibility.

• Proven ability to manage multiple projects/tasks simultaneously.

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

• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.

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

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

• Speaks with courage and candor.

• Strong written and verbal communication 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.

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.

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".

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.

Requisition ID:R329945