Executive Director, Analytical Development and Quality Control Lead

Merck•Wilmington, DE

2d•Hybrid

About The Position

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.

Requirements

BSc +15years, MSc +12years or PhD +10years experience in the biotechnology and/or pharmaceutical industry.
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.
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.
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

Nice To Haves

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.

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.
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.
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.

Benefits

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

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