Director, CMC Program Mgmt

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare providers in the fields of Critical Care and Infectious Diseases.

Our mission to deliver innovative, life-saving medicines for serious unmet medical conditions drives us every day and contributes to building a sustainable business for the long term. It also inspires our entrepreneurial culture which fosters innovation, collaboration, and a relentless commitment to the people we serve. Patients are at the center of everything we do because everyday matters. Every employee is encouraged to take initiative, explore new ideas, and turn challenges into opportunities that can potentially transform lives, especially those suffering from serious and difficult-to-treat illnesses.

Our products marketed in the U.S. include:

• GIAPREZA® (angiotensin II) is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.
• XACDURO® (sulbactam for injection; durlobactam for injection) is a new treatment designed specifically to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex in adults.
• XERAVA® (eravacycline) is a broad-spectrum antibiotic used to treat patients with complicated intra-abdominal infections (cIAI).
• ZEVTERA® (ceftobiprole) is an approved advanced-generation cephalosporin antibiotic and the only FDA-approved cephalosporin specifically designed to treat adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis. In addition, Zevtera is approved in adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). 
• Nuzolvence® (zoliflodacin) for oral suspension is a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents 15 years of age and older weighing at least 35 kg.

Summary of Position:

The Director, CMC Program Management will lead the operational and strategic execution of our Chemistry, Manufacturing, and Controls (CMC) portfolio. As a key member of the Global Pharmaceutical Development and Supply (GPDS) leadership team, this role will bridge the gap between high-level corporate strategy and technical execution. Operating in a lean, dynamic environment, this role will have a direct hand in shaping the CMC organization, managing end-to-end CMC planning, cross-functional integration, governance, risk management and lifecycle activities. The Director will play an important role in driving alignment, enabling effective decision-making, and advancing key CMC priorities across the portfolio.

Responsibilities:

• Establish and oversee CMC strategy, planning and execution, ensuring portfolio-wide milestones align with corporate objectives and clinical/commercial timelines.
• Foster cross-functional integration between GDPS (CMC/Supply Chain), Regulatory Affairs, Quality Assurance, Commercial, Clinical, Alliance Management, etc. to eliminate silos and accelerate program velocity.
• Collaborate with Pharmaceutical Sciences and Technical Operations (PSTO) to manage external Vendors such as Contract Development Manufacturing Organizations (CDMOs) and Partners and hold them accountable for meeting agreed upon Quality, Regulatory and Manufacturing Supply goals for right first time-on time delivery.
• Serve as the operational voice for CMC, regularly presenting program status, milestones, and portfolio risk to the GPDS-Leadership Team, Executive Leadership Team (ELT), external partners, etc.
• Manage project-level risk with the Core Team by anticipating technical, regulatory, or macroeconomic threats to the supply chain and lead contingency planning. Promote and use Operation Excellence (OpEx) tools and best practices to build a high functioning team. 
• Act as the escalation point for complex operational or manufacturing hurdles, driving, data-driven decisions to keep programs on track.
• Support financial forecasting, resource allocation, and partner with Global Supply and Logistics representatives (GSL) for long-range planning for drug substance and drug product supply.
• Communicate effectively and consistently verbally and in writing with all levels of staff, internally and externally.
• Perform other duties as assigned.

Experience & Education:

• Bachelor of Science required; an advanced degree in chemistry, biology, or a related scientific or engineering discipline is 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

Skills and Abilities:

• Experience in development as well as late stage/product launch/commercial pharmaceutical projects with a strong track record of successful IND, NDA, and EMA filings
• Ability to interpret, communicate and apply cGMPs, global regulatory requirements, and industry best practices
• Excellent interpersonal and communication skills, with the ability to collaborate effectively across functions and levels of the organization.
• Willingness and ability to travel up to 20% for interactions with CDMOs and Partners for critical project activities or to represent IST in professional conferences
• Self-organizing, self-directed and highly motivated, with strong critical thinking and problem-solving skills
• Ability to initiate and manage external collaborations and engage key opinion leaders effectively
• 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

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Innoviva Specialty Therapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.