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Madrigal Pharmaceuticals · 1 day ago

Executive Director, Pharmaceutical Science

Pennsylvania Furnace, PA

Full-time

Onsite

Director/Executive

$270K/yr - $332K/yr

10+ years exp

Madrigal Pharmaceuticals is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). The Executive Director of Pharmaceutical Science will lead the CMC strategy for drug candidate molecules, overseeing formulation development and ensuring compliance with regulatory standards.

BiopharmaBiotechnologyMedical DevicePharmaceutical

Responsibilities

Strategic oversight for all drug product teams and their activities from API Final Form selection, development of preclinical formulations, definition and development of fit for purpose formulations to support early clinical development through definition of robust commercial formulations that meet the Target Patient Profile

Oversee all aspects of the lifecycle of formulation development including drug product definition, process development and characterization, DOE and robustness studies through to partnering with MS&T for successful process validation

Partner with the Executive Director of Organic Chemistry in the generation, evaluation, selection and development of final API forms

Provide strategic guidance to enable empowered CMC and Pharmaceutical Science teams to define stage appropriate processes and control strategies that are Fit for Purpose for stage of development

Ensure that syntheses align with the company’s Quality, Regulatory, and Supply Chain standards

Insure development of robust, scalable and cost-effective formulations and drug product processes for commercial manufacture

Implement Quality-by-Design (QbD) and Quality Risk Management (QRM) principles throughout the development lifecycle

Development of timely budget submissions that insure achievement of all project team goals for formulation needs

Drive innovation in partnership with the Manufacturing Science and Technology team to enhance product robustness, supply resilience, and cost efficiency

Define and deliver a Fit for Purpose Pharmaceutical Science organization that balances internal and external resources to deliver on all Drug Product objectives in a timely and cost-efficient manner

Collaborate with Global Procurement to define a set of CROs and CMOs that can both define products & processes for CMC teams and deliver formulations with systems and processes in compliance with all relevant regulatory standards

Through CROs and CDMOs, execute plans for the validation and registration of formulations as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations

Insure Intellectual Property Coverage is obtained to both enhance pipeline value and to insure Freedom to Operate

Provide direction and oversight of the authoring and reviewing of Pharmaceutical Science documents for INDs, NDAs and other regulatory section submissions

Review and author CMC regulatory and Quality documents as required

Review Quality Agreements, participate in audit programs, and ensure risk-based CMC oversight for all external partners

Champion a culture of Right First Time, data integrity, and continuous improvement across CMC and technical operations

Collaborate with Quality Assurance to support inspection readiness and represent the company as a API/CMC subject matter expert during US and ROW regulatory inspections and audits

Qualification

Pharmaceutical ScienceCMC leadershipDrug Product developmentCGMPICH guidelinesProcess validationRegulatory approvalQuality Risk ManagementLeadership skillsProblem-solving skillsCommunication skillsInterpersonal skills

Required

PhD degree in Pharmaceutical or Material Sciences, Organic or Inorganic or Analytical or Polymer Chemistry or a Master's Degree and commensurate Pharmaceutical Science development and leadership experience

Minimum of 10 years of experience in Pharmaceutical Science and CMC leadership within the biopharmaceutical industry, with a strong background in CMC and Drug Product development

Proven experience in working with CROs and CMOs and driving technical solutions in a external environment

Demonstrated success in transitioning programs from clinical development to commercial manufacturing, including process validation and regulatory approval

Strong knowledge of cGMP and ICH guidelines and global regulatory requirements

Strategic and operational leader with a balance of scientific depth and business acumen

Strong Leadership skills with an ability to both influence and empower

Strong technical expertise in Pharmaceutical Science, pharmaceutical development, processes and technologies

Excellent problem-solving and risk management skills to address complex issues

Strong written and verbal communication and interpersonal skills with the ability to collaborate across functions, with external partners, and present to executive stakeholders

Detail-oriented with a focus on maintaining high standards of quality and compliance

Proactive and strategic thinker with an empowering approach to solving technical challenges

Aptitude for identifying inefficiencies and driving process improvements within CMC, SC, and QA

Meticulous in review of documentation to ensure regulatory and quality robustness

Ability to mentor others in quality and best practices

Initiative in shaping compliance culture across the organization