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Merck · 2 months ago

Executive Director, Analytical Development and Quality Control Lead

USA - Delaware - Wilmington (Biotech)

Full-time

Hybrid

Director/Executive

$206K/yr - $325K/yr

10+ years exp

Merck is a leading company in the biotechnology sector, committed to addressing challenging healthcare needs. They are seeking an Executive Director for their Analytical Development and Quality Control Lead role at the Wilmington Biotech Campus, responsible for overseeing the quality control laboratories and ensuring compliance with safety regulations while leading the analytical support for high potent biologics.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

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

Qualification

Analytical Method DevelopmentQuality Control ManagementBiologics ProductsRegulatory ComplianceBudget ManagementMicrobiologyGMP ComplianceLeadershipPeople ManagementCommunication SkillsNegotiation SkillsProblem-Solving Skills

Required

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