Senior Director CMC Project Management

Ardelyx

Waltham, MA

Apply

JOB DETAILS

SALARY

$250,000–$306,000 Per Year

JOB TYPE

Full-time

SKILLS

Alliance/Partner Management, Analysis Skills, Analytical Development, Best Practices, Biotech and Pharmaceutical, Budgeting, CMOS, Chemical Engineering, Chemistry, Communication Skills, Continuous Improvement, Cross-Functional, Dosage Forms, Drug Development, Drug Products, Employee Benefits, FDA Requirements, Finance, Financial Planning, Forecasting, GMP (Good Manufacturing Practices), Health Plan, Healthcare Quality, ICH Regulations, Incentive Programs, Insurance, Leadership, Manufacturing Analysis, Meeting Minutes, Metrics, Microsoft PowerPoint, Operational Improvement, Operational Strategy, Operations Research, Organizational Skills, Performance Metrics, Prescription Drugs, Problem Solving Skills, Process Improvement, Product Development, Productivity Management, Program Evaluation, Project Management Software, Project Planning, Project/Program Management, Purchasing/Procurement, Quality Assurance, Regulations, Reporting Dashboards, Resource Utilization, Risk, Risk Management, Strategic Planning, Team Lead/Manager, Team Player, Technical Operations, Technical Research, Time Management

LOCATION

Waltham, MA

POSTED

30+ days ago

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.The Senior Director, CMC Project Management is responsible for leading and coordinating the strategic planning, integration, and execution of the company’s CMC development programs across the portfolio. This role serves as the central program leadership function within Technical Operations and Quality Assurance, driving cross-functional alignment, integrated planning, and disciplined execution from early development through clinical and commercial milestones.Reporting to the Chief Technical Operations & Quality Officer, this individual will partner closely with Technical Operations, Regulatory, Quality, Clinical, and Finance to ensure CMC programs are delivered on time, within scope, and aligned with corporate objectives. This role is best suited for a strong program leader with deep experience in CMC project management, governance, and cross-function team leadership in a matrixed biotech environment. Responsibilities: Strategic Leadership:Lead and manage a portfolio of strategic CMC projects, ensuring alignment with enterprise prioritiesDefine clear strategic priorities, project milestones, performance standards and expectations across a matrixed, cross-functional team of key stakeholdersAct as a trusted liaison between executive leadership and project teams, translating strategic goals into actionable plansEnsure consistent application of project management best practices, including integrated project plans, timelines, risk registers, and governanceReview and challenge project strategies, critical paths, and risk mitigation plans; escalate issues and trade-offs as neededDrive effective transition of projects from Research into Technical Operations and onward to commercial manufacturePartner cross-functionally with Manufacturing, Analytical Development, Quality, Regulatory, External Supply, Procurement, Finance, Clinical, and Commercial stakeholdersPartner with CDMOs and external vendors to ensure aligned execution, transparent communication, and risk managementEnable proactive portfolio visibility through integrated project plans, scenario planning, and resource forecasting Operational ExcellenceIdentify, Establish and continuously improve project management processes, tools, metrics, and operating models across Technical Operations to improve efficiency Identify capability gaps, capacity constraints, and opportunities for operational excellenceDrive adoption of standardized tools and frameworks for program tracking and reportingChampion a culture of inclusion, continuous improvement and operational excellence Financial & Resource ManagementSupport development and accountability to budget and other financial planning deliverables across the functionOptimize resource utilization and monitor KPIs to assess program health and impact Communications & Stakeholder EngagementPrepare executive-level dashboards or MS PowerPoint milestone timelines to communicate progress and escalate risksServe as communications conduit to external partners and internal cross-functional project teams, including executing project tasks and detailsCoordinate and document agenda and meeting notes to ensure smooth execution of functional activities and extended leadership meetingsQualifications:Bachelor’s degree, advanced degree preferred, in Chemistry, Chemical Engineering, or related field 12+ years of experience in pharmaceutical or biotech industry, with at least 3 years in CMC project management or related technical operations role or equivalent experienceStrong understanding of drug substance and drug product development, technology transfer, and GMP manufacturingSmall molecule and solid oral dosage form experience preferred.Experience managing external partners (CMOs/CDMOs)Working knowledge of regulatory CMC requirements (FDA, ICH)Decision Making – has a systematic and methodical approach to making decisions, obtains relevant information, thinks beyond the immediate decision point, challenges assumptions and considers business implications of potential solutionsPeople Leadership - Ability to lead and influence effectivelyStrong analytical, problem-solving, and planning skillsExceptional organizational and communication skills with the ability to work independently and collaboratively across all levels of the organizationPositive Change Agent – curious, adaptable, and energizing leader with a global mindsetCulture Ambassador - champions and models the organization’s values, fostering a culture of quality, inclusion, and continuous improvement across all teamsProficiency with project management tools (Smartsheet strongly preferred)Strong problem-solving, critical thinking, and risk management skillsAbility to thrive in a fast-paced, dynamic environment with shifting prioritiesWork Environment:The position is hybrid, working out of the Waltham, MA or Newark, CA location.Travel is estimated at 15 % but will flex depending on business need.The anticipated annualized base pay range for this full-time position is $250,000 - $306,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.

About the Company

Ardelyx

Resume Resources

Free Resume Templates Free Resume Builder