Job Description

The Associate Director, Quality Assurancewill be responsible for technical leadership and subject matter expertise in Sterile Drug Product Quality Operations. This role will work across internal clinical supply sterile drug product manufacturing sites. The position will lead and/or execute GMP quality assurance activities directly related to internal sterile drug product production and release for clinical trial material supply. The incumbent will assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet our Company's quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations.

Essential Duties and Activities:

• Support operational readiness and future GMP operations of new sterile manufacturing facility, and existing facility upgrades or renovations.

• Lead, perform quality assurance activities related to sterile drug product manufacturing in a complex, clinical supply development. Review and/or approve GMP documents.

• Support sterile drug product manufacturing in compliance with cGMP.

• Lead and perform quality investigations of events or deviations to promote batch release decisions.

• Support planning, execution, and release of process simulation batches (“media fills”)

• Build effective, collaborative working relationships and create effective communications with all stakeholders in all functions and at all levels.

• Identify improvement opportunities and performance or compliance gaps. Implement or propose solutions. Solve complex problems of a technical nature.

• Any activities necessary to achieve GMP compliant and continuous clinical supply.

• On-site support of facility & staff (80% on a weekly basis)

Education:

• Bachelor’s degree in a science, engineering, or related discipline; advanced education preferred.

Required Experience and Skills:

• Minimum of 9 years of experience in Pharmaceutical / Biotechnology industry role(s).

• Working knowledge and application of Current Good Manufacturing Practice (cGMP) to sterile product manufacturing. Ability to interpret regulations, develop and implement solutions.

• Technical understanding or knowledge of manufacturing processes or unit operations for sterile or large molecule products.

• Leadership of cross-functional teams, investigations, or problem-solving situations.

• Interactive skills in verbal and written communications, teamwork, negotiation, conflict resolution.

Preferred Knowledge and Skills:

• Experience in manufacturing operations of sterile drug products, at pilot and/or commercial scale.

• A combination of experiences in sterile product formulation, development, process development, manufacturing, technology transfer, scale-up, facilities, quality systems, and / or quality operations,

• Advanced ability to identify and solve complex problems in a timely and efficient manner.

• Background in R&D or clinical supply areas and processes

• Experience with authoring and/or approving Standard Operating Procedures (SOPs)

• Developing training curricula and training new employees

• Knowledge of Quality Risk Management, including risk assessments

• Investigations related to environmental monitoring and/or particulate matter

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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.

Residents of Colorado

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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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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.

Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R224506