Associate Director, Quality Control

Job Description

Organizational context:

Within our company's Manufacturing Division, the Micro Analytical Sciences (MAS) section within the Global Quality Large Molecule Analytical Sciences (GQLMAS) organization, located in Wilmington, Dunboyne and Oss, scientifically support the microbiological laboratories in the commercial production sites for vaccines, biologics and small molecules. The MAS team plays a crucial role in supporting the transfer, troubleshooting and life cycle management of the microbiological test methods (including equipment) for all modalities. This includes compendial test methods, non-compendial test methods, and alternative microbiological methods. Furthermore, MAS is seen as the owner for global microbiological methods and equipment packages to ensure a structured transfer of the methods.

Job purpose:

The individual will support US-based sites and play an important role in developing the Microbial laboratory at Wilmington Biotech Campus. The individual is responsible for several microbiological/virological methods, and will serve as a Subject Matter Expert for some. Their role includes assisting with method transfers for commercial products, regulatory interaction such as response to questions, and providing training to the network.

Their responsibilities include ensuring that methods are properly introduced and qualified by the receiving unit during the transfer process in accordance with established guidelines. They are also tasked with overseeing methods for complex products on a global scale and coordinating the involvement of relevant Subject Matter Experts.

The Associate Director supports microbiological studies essential to production sites by providing both practical and scientific expertise as needed. In this capacity, the Subject Matter Expert contributes technical and scientific insights to these processes and is required to travel for at least 20% of their time.

In addition to their responsibilities, the Associate Director will serve as the point of contact for commercial production sites on microbiological methods and will act as a global method or equipment package owner.

The Associate Director will support the Micro Analytical Sciences leads by coaching Senior Specialists, Specialists and associate specialists in the team and taking up a senior role in the team.

Position in the organization:

Manager (reporting): Reports to Lead Micro Analytical Sciences

Staff: not applicable

Key activities

Scientific and Technical leadership

• Deep technical expertise as a Microbiological / Virological SME, with deep scientific understanding of the microbial /virological techniques used in pharmaceutical industry.

• Responsible for best scientific practices within the lab space and supports from an SME perspective, troubleshooting, network and life cycle management activities for methods in their expertise at the network sites.

• Leads the implementation of microbiological / virological methods (compendial/alternative microbiological methods) in a harmonized way to secure efficient implementation at the receiving unit (internally and/or externally).

• Provides scientific and practical support to analytical investigation during validation, method suitability and routine use.

• Accountable for scientific and practical support for microbiological tests on an as-needed basis for methods and studies in their expertise on an as-needed basis for the transfer of Biologicals, Vaccines and/or Small Molecules.

• Leads the evaluation, method development, method validation of alternative microbiological technology (Rapid Microbiology Methods).

• Responsible for authoring primary and secondary source documents used for regulatory filings.

• Recruitment and supervision of MSc students

• Project Member and/or lead

• Recruitment and supervision of MSc students

• Acts analytical lead in the implementation / deployment of alternative microbiological technology (Rapid Microbiology Methods)

• Root Cause Analysis lead for significant investigations.

• Participates as Analytical lead in multidisciplinary teams solving technical problems at global or multisite level.

• Participates in global change control processes as an SME or Impact accessor.

• Serves as the point of contact for microbiological / virological methods for the commercial production sites based in the US.

• Analytical lead for global methods or equipment package in their expertise, driving the standardization of microbiological / virological methods in the network together with relevant SME’s.

Compliance

• Takes GMP requirements into account when setting up experiments and protocols.

• Ensures compliance of protocols and reports.

• Contributes to the regulatory (CMC) teams to ensure that the required documentation is in place for product submission (Licensing application) to authorities (e.g. FDA, EMA, China) including response to questions from agency in a timely manner.

• Participates as SME in or leads multidisciplinary teams supporting compliance topics ensuring global policies are in place for the network.

Qualifications & Experience:

• Minimum Bachelors degree/ Master preferred

• Minimum of 7 – 10 years relevant experience in preferably Pharmaceutical Microbiology/Virology.

• Proven ability to work as part of a team but also on own initiative.

• Strong project management skills & proven ability to manage complex projects.

• Demonstrated initiative, and innovative process-oriented thinking within a team environment.

• Ability to lead and coach others to solve problems and take new perspectives on existing solutions.

• Demonstrated experience of technical leadership.

• Knowledge of regulatory and quality guidelines (GMP).

• Excellent analytical and technical skills.

• Preferably broad knowledge of manufacturing, analytical development and validation processes in Microbiology/Virology.

VETJOBS

Required Skills:

Analytical Method Development, Analytical Method Development, Analytical Problem Solving, Analytical Thinking, Biological Analysis, Clinical Microbiology, Communication, Continuous Improvement Tools, Corporate Productions, Counterfeit Detection, Cross-Functional Teamwork, Global Compliance, GMP Compliance, Identifying Customer Needs, Innovation, Leadership, Management Process, Microbiological Analysis, Microbiological Cultures, Microbiological Test, Microbiology, Molecular Microbiology, People Management, Pharmaceutical Management, Pharmaceutical Microbiology {+ 5 more}

Preferred 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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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”.

The salary range for this role is

$129,000.00 - $203,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

n/a

Job Posting End Date:

03/12/2026

*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.