Senior Director, Stability Operations and Device Program Management

Job Description Pharmaceutical Analysis and Digital Technologies (PADT) is seeking an exceptional scientific and operational leader for the role of Senior Director, Stability Operations and Device Program Management. This position will provide strategic ownership and end‑to‑end leadership for stability operations across the development portfolio through commercialization, while also leading device program management activities that enable integrated delivery of drug‑device combination products and associated analytical, technical, and regulatory deliverables. The successful candidate will lead a team of scientists, operational experts, and program management professionals responsible for building and executing a robust, compliant, and scalable stability operations model. The role will require strong people leadership, cross‑functional influence, portfolio‑level prioritization, and the ability to translate complex development needs into clear operational plans that support product quality, regulatory submissions, clinical supply, and lifecycle management. The scope of this position includes strategic oversight of stability study design, protocol execution, sample management, stability data governance, operational readiness, and inspection preparedness for development programs across modalities. In addition, the Senior Director will partner with device development, CMC, regulatory, clinical, quality, manufacturing, and external partners to ensure device program plans are integrated with product development strategies, key milestones are delivered, and risks are proactively managed. The Senior Director will oversee the technical writing and change control team, ensuring timely delivery of BLA authoring, global change controls, and technical documentation. The role will set documentation standards, manage portfolio priorities, and partner with the digital team to support digital CMC and modernize the commercial filing strategy. These activities will support regulatory submissions, inspection readiness, and efficient execution of product and process changes. Primary Responsibilities Provide strategic, scientific, operational, and people leadership for stability operations and device program management across the development portfolio. Establish and maintain an integrated operating model for stability study planning, protocol execution, sample logistics, storage, testing coordination, data review, and reporting. Lead device program management activities to ensure clear plans, governance, risk management, decision making, and milestone delivery for drug-device and combination product programs. Partner with cross-functional development teams, including CMC, regulatory, clinical, quality, manufacturing, supply chain, device development, and external partners, to align stability and device deliverables with program objectives. Ensure stability operations and device program management practices are inspection ready, compliant with applicable GxP expectations, and aligned with internal quality systems and regulatory commitments. Develop and implement portfolio‑level metrics, dashboards, and governance routines to monitor delivery, identify risks, drive continuous improvement, and support transparent communication with senior stakeholders. Build, mentor, and develop a high-performing, inclusive team with the scientific, operational, and program management capabilities required to support a complex and evolving development portfolio. Education Minimum Requirements Ph.D. degree in Chemistry, Pharmaceutical Sciences, Engineering, Biology, Biochemistry, or related scientific discipline with 10+ years of relevant experience. MS degree with 13+ years of relevant experience. BS degree with 16+ years of relevant experience. Required Experience and Skills Demonstrated ability to lead large, inclusive, cross‑functional scientific or operational teams and to attract, develop, and retain talent. Extensive experience in pharmaceutical development, stability operations, analytical development, CMC, quality, regulatory, or related technical disciplines. Strong working knowledge of stability requirements, GxP expectations, regulatory guidance, product quality principles, and inspection readiness practices. Experience leading complex programs, managing portfolio‑level priorities, and influencing senior stakeholders across functions and geographies. Ability to integrate scientific, technical, operational, regulatory, and business considerations into clear program strategies and executable plans. Excellent verbal and written communication skills, with the ability to present complex information clearly to technical teams, governance forums, and senior leaders. Preferred Experience and Skills Proven track record leading stability operations, analytical operations, device development, combination product programs, or cross‑functional CMC program management in a regulated pharmaceutical environment. Experience developing operating models, governance processes, metrics, and continuous improvement initiatives that improve delivery, compliance, and portfolio transparency. Experience supporting regulatory submissions, health authority interactions, inspections, or product lifecycle activities related to stability, analytical, device, or combination product deliverables. Position Scope This Senior Director role has enterprise‑impacting scope across PADT and partner functions, with accountability for establishing the strategy, operating model, governance, and performance expectations for stability operations and device program management. The role will ensure that stability and device‑related deliverables are integrated with CMC development plans, regulatory strategies, clinical timelines, supply needs, and quality expectations. The incumbent will be expected to operate as a senior leader, sponsor cross‑functional problem solving, and drive consistent execution across internal and external networks. Required Skills: Analytical Method Development, Analytical Method Development, Analytical Thinking, Bioanalytical Techniques, Biochemistry, Biological Sciences, Chemical Synthesis, Client Relationship Building, Combination Products, Data Governance, Dosage Forms, Immunochemistry, Innovation, Inspection Readiness, Interpersonal Relationships, Manufacturing, Mentoring Staff, Molecular Structure, Operating Models, People Leadership, Pharmaceutical Development, Program Management, Qualitative Analysis, Risk Management, Stakeholder Management {+ 1 more} Preferred Skills: 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. Equal Employment Opportunity Employer 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: EEOC Know Your Rights EEOC GINA Supplement 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 Salary Range The salary range for this role is $173,200.00 - $272,600.00 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 Location and Eligibility Information 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 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. Employment Status Regular Relocation Domestic Visa Sponsorship No Travel Requirements 10% Flexible Work Arrangements Hybrid Shift Not Indicated Valid Driving License No Hazardous Material(s) n/a Job Posting End Date 08/24/2026 *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. Requisition ID

R409737