Quality Operations Laboratory Manager
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
Summary, Focus and Purpose
The Quality Operations Laboratory Manager is accountable to support day-to-day operation of the Potency laboratory and will support testing, provide troubleshooting to test method and equipment related issues. The Manager will also be expected to review and authorize testing results, collaborate in day to day lab scheduling, provide leadership in lean lab initiatives, have a strong understand of Labware LIMS, handle Quality Notification, Change Controls, authoring SOPs and protocols and provide audit support.
Schedule daily testing of laboratory samples based on internal metrics and production needs
Serve as a Subject Matter Expert (SME) for internal and regulatory inspections
Provides active support during audits and inspections (regulatory, internal, safety)
Participate in routine audits of Quality Operations laboratory to ensure compliance and inspection readiness
Train and mentor laboratory analysts on test methods, techniques and good documentation practices
Author and implement test method qualifications and final reports for assays
Lead and support troubleshooting OOS and invalid assays. Provide scientific guidance for investigation
Authors standard operating procedures (SOPs) for the performance of laboratory methods
Trouble-shoots equipment issues
Collaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirements
Supports our Manufacturing Division divisional and Quality initiatives
Bench work support
Bachelor degree in Chemical Engineering, or Scientific Field preferably biology, biochemistry or life sciences
Five years laboratory testing with a minimum three years in QC laboratory in a GMP settings
Effective and principled technical writing skills with high attention to details
Various laboratory instrumentation
Work independently and within a team environment
Deviation support, change controls or method validation
Principled communication skills
Proven track record of successfully planning, executing, and troubleshooting projects and experiments
Proficient with Microsoft Office: Word, Excel, PowerPoint
Mammalian cell culture (aseptic technique) | BSL-2 organisms
Vaccine potency testing
Trained in root cause analysis methodology
Analytical method transfer
Knowledge of method development and validation for use within the QC laboratory
Working knowledge of international regulatory guidelines, such as ICH, EP, JP
Statistical data analysis with JMP or other software
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted 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., Rahway, 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.
For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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US and Puerto Rico Residents Only:
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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.
Residents of Colorado:
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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.
Travel Requirements:No Travel Required
Flexible Work Arrangements:Not Specified
Shift:1st - Day
Valid Driving License:No
Number of Openings:1