Job Description
At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
The Wilmington Biotech Campus will play a pivotal role in the manufacture of our company's biologics-based medicines, including in the area of immuno-oncology. This site will establish our company's internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029.
This facility will be a significant supplier of Antibody Drug Conjugates and High Potent Compounds and will also be critical in the future supply of new biotechnology products to its global network.
Wilmington Biotech Campus - Analytical Development and Quality Control Laboratory
The Analytical Development and Quality Control Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of our company's pipeline of high potent Biologics including deep pipeline of Antibody Drug Conjugates. This laboratory will bring together late-stage analytical method development and validation with commercial release testing to deliver significantly improved speed through the analytical lifecycle. The laboratory will be supported by locally based advanced analytical subject matter experts and digital tools to enable an enterprise-wide connected laboratory in support of a new approach to analytical commercialization for high potent Biologics. The laboratory will be operated in collaboration by our Research and Development and Manufacturing Divisions.
Reporting to the Vice President, Global Quality Large Molecule Analytical Science (GQMAS), the Site Analytical Development and Quality Control Lead is accountable for establishing a transformational approach to the commercialization of analytical methods for high potent Biologics at the Wilmington Biotech Campus and will be part of the Site Leadership team. The role will work closely with our Research and Development (R&D) and Manufacturing Divisions to create an operating model that integrates late-stage method validation and Quality Control testing for drug candidates manufactured at the Wilmington Biotech Campus. The Laboratory will also support our company's high potent Biologics external network delivering significantly improved speed through the analytical lifecycle.
The role will have overall QC responsibility for the Wilmington Biotech Campus. This will involve managing, planning and directing the Quality Control laboratories ensuring compliant laboratory testing. The role will provide the highest quality analytical support for the Wilmington Biotech Campus, while ensuring achievement of supply commitments and safety regulations.
Primary Responsibilities:
Oversee recruiting and hiring of staff to support analytical development and Quality Control testing.
The site Analytical Development and Quality Control Lead has responsibility for all analytical support to the Wilmington Biotech Campus. This involves analytical support to clinical, validation and commercial activities.
The role assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as human resource management and spending are also responsibilities of the role.
The role will ensure that all necessary support is in place to facilitate laboratory start up and Health Authority approvals.
Key Quality Control responsibilities include:
Strategic Quality Control oversight and leadership at the Wilmington Biotech Campus to meet functional and site goals and objectives.
Responsible for Quality Control related testing for the Wilmington Biotech Campus (Analytical, Biochemistry, Microbiology, Environmental Monitoring and Raw Materials).
Responsible for adhering to domestic and international CGMP regulations, company policies, leadership behaviors, performance and budget management.
Responsible for Quality Control oversight and compliance of laboratory related commissioning, qualification and validation activities.
Responsible for ensuring that the Quality Control laboratory test methods are qualified/validated as per corporate and site procedures.
Accountable for all Quality Control related documents which include Standard Operating Procedures (SOPs), Protocol and Technical Reports.
Responsible for ensuring laboratory investigations including OOS investigations are conducted in compliance with CGMP and best science.
Maintains all laboratories in an inspection-ready, CGMP-compliant state.
The role will lead the set up and management of the stability program for products manufactured at the Wilmington Biotech Campus and in support of the network.
Key Method Development responsibilities include:
In collaboration with Research and Development (R&D) support the transfer and validation of analytical methods and specifications for Biologics drug substance and drug product at the Wilmington Biotech Campus..
Provide site based analytical CMC information for filings and responses to queries from worldwide regulatory agencies to support marketing approvals for Wilmington Biotech Campus products.
Works with R&D to integrate Wilmington Biotech Campus activities into the analytical lifecycle ensuring that feedback is provided in both directions and risks are identified/mitigated to successfully meet analytical timelines.
In partnership with the Quality Organization, formulate and continually update appropriate CGMP procedures for the group, encompassing conduct of work, instrumentation, facilities and CGMP-regulated computer systems.
Ensure Quality Systems support the End-to-End Analytical Lifecycle and are continually audited/reviewed. Ensure new requirements are identified and implement.
Sustain performance through lean leadership, robust learning and development planning, organization talent reviews and communication planning.
Maintain training status in the department at the required level for roles and responsibilities of each job.
Responsible for development, promotion and compensation planning for staff.
Oversees the preparation of the departmental capital and expense budgets and operate within approved funds.
Education:
BSc +15years, MSc +12years or PhD +10years experience in the biotechnology and/or pharmaceutical industry.
Required Experience and Skills:
Significant experience in a comparable role; would typically have experience leading a functional area and contributing to the business at a directional, strategic level; ideally in an Analytical Development and/or Quality Control setting.
Proven ability to lead a QC laboratory team with >5 year experience.
Core Experience and Skills:
Deep experience in analytical method development, validation and transfer in particular in the areas of high potent compounds and biologics products.
Deep understanding of the successful operation of a QC laboratory supporting release testing for multiple products across Chemistry, Microbiology and Potency.
Experience with relevant compendial guidelines, such as USP 1220, ICH Q2/Q14.
Knowledge of regulatory/code requirements to US and International Codes, Standards and Practices regarding analytical activity.
Understanding of business and operations management models and their application.
Recruitment and selection.
Preferred Experience and Skills:
Experience in ADC and Biologics drug product and/or drug substance method validation and technology transfer.
Experience with release testing of clinical materials.
Laboratory experience in the management of potent and sterile drug products.
Experience with commercialization of ADC programs through PPQ and launch.
Drug substance/Conjugation analytical experience.
Business:
Excellent communication, presentation and interpersonal skills
Progressive people management skills
Negotiation skills
Demonstrable analytical and systematic problem-solving skills
Strong influencing skills
Business acumen
Proven financial management skills
Risk management skills
Required Skills:
Biochemistry, Biochemistry, Biological Manufacturing, Budget Management, Business Data Analytics, Change Management, Confidentiality, Corrective Action Management, Cross-Cultural Awareness, GMP Compliance, Human Resources Compliance, Immunochemistry, Key Client Relationships, Laboratory Testing, Leadership, Marketing Data Analytics, Microbiology, Molecular Microbiology, Motivation Management, Operating Models, Operational Quality, Operations Management, People Leadership, Quality Control Management, Quality Management Systems (QMS) {+ 4 more}Preferred Skills:
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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
$206,200.00 - $324,600.00This 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.
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Job Posting End Date:
11/18/2025*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.