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Director, CMC Program Management
Innoviva Specialty Therapeutics, Inc.. Lead the operational and strategic execution of the Chemistry, Manufacturing, and Controls (CMC) portfolio .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Chemistry, Manufacturing, and Controls (CMC) strategy and execution, with a strong focus on regulatory compliance and project management in pharmaceutical development. Proven ability to lead cross-functional teams and manage external partnerships to achieve operational excellence and successful product launches.
Highest-signal resume keywords
Chemistry, Manufacturing, And Controls (CMC)Regulatory ComplianceProject ManagementIND, NDA, And EMA FilingsOperational Excellence
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Pharmaceutical DevelopmentCGMP InterpretationRisk ManagementFinancial ForecastingResource AllocationCross-Functional IntegrationVirtual ManufacturingDrug Substance Supply PlanningDrug Product Supply PlanningComplex Initiative Management
Soft Skills
Effective CommunicationLeadershipProblem-Solving
Industry Keywords
FDAEMAICH Guidelines21 CFRUSP ChaptersSmall MoleculesBiologic ProductsPeptide Drug ProductsClinical TimelinesCommercial Objectives
About the role
Key responsibilities & impact- Lead the operational and strategic execution of the Chemistry, Manufacturing, and Controls (CMC) portfolio
- Establish and oversee CMC strategy, planning, and execution aligned with corporate objectives and clinical/commercial timelines
- Foster cross-functional integration across CMC/Supply Chain, Regulatory Affairs, Quality Assurance, Commercial, Clinical, Alliance Management, and related functions
- Manage external CDMOs and partners and hold them accountable for quality, regulatory, and manufacturing supply goals
- Present program status, milestones, and portfolio risk to leadership teams and external partners
- Manage project-level risk and lead contingency planning
- Promote and use Operational Excellence tools and best practices
- Act as escalation point for complex operational or manufacturing hurdles and drive data-driven decisions
- Support financial forecasting and resource allocation
- Partner with Global Supply and Logistics representatives for long-range drug substance and drug product supply planning
- Communicate effectively with internal and external stakeholders
- Perform other duties as assigned
Requirements
What you’ll need- Bachelor of Science required
- Advanced degree in chemistry, biology, or a related scientific or engineering discipline preferred
- 10 plus years of progressive industry experience, with a solid background in CMC and pharmaceutical development
- Significant experience working in an outsourced “virtual manufacturing” environment
- Experience with small molecules, biologic, and peptide drug products
- Experience in development as well as late stage/product launch/commercial pharmaceutical projects
- Strong track record of successful IND, NDA, and EMA filings
- Ability to interpret, communicate and apply cGMPs, global regulatory requirements, and industry best practices
- Willingness and ability to travel up to 20%
- Deep familiarity with global regulatory frameworks, including FDA, EMA, and ICH guidelines, specifically around 21 CFR and USP chapters
- Excellent project management skills, with experience managing complex, cross-functional initiatives
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Innoviva Specialty Therapeutics, Inc. Website LinkedIn All Job Openings 51 - 200 employees Founded 2023 🏥 Healthcare 🍽️ Food & Beverage 🧬 Biotechnology Healthcare
- Food & Beverage
- Biotechnology Innoviva Specialty Therapeutics, Inc. is a biotechnology company focused on developing and delivering innovative therapies for patients in critical care and infectious diseases. The company markets and develops antibiotics and critical-care medicines—such as GIAPREZA (angiotensin II), NUZOLVENCE (zoliflodacin), XACDURO, XERAVA, and ZEVTERA—targeting serious, life-threatening conditions and drug-resistant infections identified as high public-health priorities. A subsidiary of Innoviva, Inc. , it emphasizes rigorous research, quality standards, and advancing solutions for urgent clinical needs. Director, CMC Program Management 🔥 4 hours ago 🏢 Waltham – Onsite ⏰ Full Time 🔴 Lead 📋 Program Manager 👻 Ghost score 12% Apply Now Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- Lead the operational and strategic execution of the Chemistry, Manufacturing, and Controls (CMC) portfolio
- Establish and oversee CMC strategy, planning, and execution aligned with corporate objectives and clinical/commercial timelines
- Foster cross-functional integration across CMC/Supply Chain, Regulatory Affairs, Quality Assurance, Commercial, Clinical, Alliance Management, and related functions
- Manage external CDMOs and partners and hold them accountable for quality, regulatory, and manufacturing supply goals
- Present program status, milestones, and portfolio risk to leadership teams and external partners
- Manage project-level risk and lead contingency planning
- Promote and use Operational Excellence tools and best practices
- Act as escalation point for complex operational or manufacturing hurdles and drive data-driven decisions
- Support financial forecasting and resource allocation
- Partner with Global Supply and Logistics representatives for long-range drug substance and drug product supply planning
- Communicate effectively with internal and external stakeholders
- Perform other duties as assigned 🎯 Requirements
- Bachelor of Science required
- Advanced degree in chemistry, biology, or a related scientific or engineering discipline preferred
- 10 plus years of progressive industry experience, with a solid background in CMC and pharmaceutical development
- Significant experience working in an outsourced “virtual manufacturing” environment
- Experience with small molecules, biologic, and peptide drug products
- Experience in development as well as late stage/product launch/commercial pharmaceutical projects
- Strong track record of successful IND, NDA, and EMA filings
- Ability to interpret, communicate and apply cGMPs, global regulatory requirements, and industry best practices
- Willingness and ability to travel up to 20%
- Deep familiarity with global regulatory frameworks, including FDA, EMA, and ICH guidelines, specifically around 21 CFR and USP chapters
- Excellent project management skills, with experience managing complex, cross-functional initiatives Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Director, Program Management 🕒 April 23 Trinity Life Sciences 1001 - 5000 🏥 Healthcare 📦 Logistics 📣 Marketing Website LinkedIn All Job Openings Director of Program Management leading complex technology and AI programs for Trinity. Driving client delivery, strategy translation and mentoring program managers in a client-centric environment. 🏢 Waltham – Onsite 💵 $200k / year 💰 Corporate round on 2023-02 ⏰ Full Time 🔴 Lead 📋 Program Manager View More Program Manager Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Remote jobs Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources About us Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course Remote Job Search MasterClass Resume Review AI Apply Copilot OpenClaw job finder API docs Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs