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Job Description

Manages the Manufacturing Division (MD) Durham Quality Laboratory functions in accordance with worldwide Health Authority regulations, cGMPs, and our Company policies.

Primary Responsibilities:

The Manager of Environmental Monitoring is responsible for overseeing the lab and sampling groups. Responsible for supporting manufacturing activities at Hilleman Site by environmental monitoring of classified areas and facility utilities, maintaining high standards of excellence for Good Manufacturing Practices (GMP), continuous process improvements, functional expertise, planning and forecasting to align with operational demands, management of performance metrics, employee coaching/development & staffing, and managing a high performing, high functioning team of 7+.

Environmental Monitoring / Microbiology Laboratory Management and Sampling/Testing:

• Assist with development and implementation of programs for trending of EM and utility data. Manages the preparation of reports and analyzes to identify adverse trends.

• Responsible for reporting and investigation of environmental excursions for all classified areas as well as utilities. Executes organizational and training strategies to provide maximum testing efficiency.

• Manages performance and established metrics for Quality Operations Environmental Monitoring to manage the efficiency and effectiveness of the group and/or individual while fostering a culture of continuous improvement.

• Managing test methods within the QC Laboratory including management of analytical change control and introduction of new methods (including compendial updates) and managing method validations and method transfers

• Managing laboratory investigations, including OOS investigations

• Managing laboratory instruments/equipment and laboratory computerized systems

• All aspects of data integrity and adherence to ALCOA principles for both electronic and hard copy records

• Overseeing training of EM personnel on both laboratory/sampling specific as well as GMP training

• Responsible for inspection/audit readiness and driving continuous improvement initiatives.

• Responsible for classified rooms sampling for RQs, Verifications, Incursions, and Routine EM, and the 8000 utility ports that are sampled yearly.

• Responsible for Data/Orphan Data Review/Identify Adverse Trends for site - Quarterly, Monthly and Annual Reports are completed on time and in full.

• Maintain Comp Gas, WFI and SMA Decon logbooks (review and retention).

• Responsible for all EM Sampling Laboratory Information Management System data with the inclusion of Particle Count Raw data (complete, approved, and retained).

• Accountable for Utility Incursions, Special Projects and RQs (complete and on time).

• Managing equipment used by EM and VMF Operations and new products.

Education Minimum Requirements

• Bachelor’s Degree (or higher) in Chemistry, Biology, Microbiology, Engineering or equivalent and a minimum six (6) years' experience in related pharmaceutical analytics, quality, and/or management functions and at least three (3) years of direct people management

Required Experience and Skills

• Prior work experience in a laboratory setting.

• Demonstrated expertise in analytics and related cGMPs

• Effective decision making and communication skills

• Demonstrated ability to manage large organization and complex projects

• Strong contemporary knowledge of relevant cGMPs, compendia, regulations and current industry trends

• Demonstrated knowledge of Quality systems

Preferred Experience and Skills

• Prior work experience in a microbiology laboratory setting.

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Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

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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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/2/2025

*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: R340817