Senior Director, Drug Substance and Process Development

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Management Waltham, MA, US

6 days ago Requisition

Company Overview:

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‑spectr um 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 12 years of age and older weighing at least 35 kg.

Summary of Position:

The Senior Director, Drug Substance Process Development supports drug substance process development, manufacturing, technical oversight, and product lifecycle activities in collaboration with our external manufacturing partners. In this role, the Senior Director will provide active management of small molecule drug substance contract manufacturers worldwide to ensure the successful manufacture and tech transfer of drug substance processes supporting IST’s commercial products as part of a virtual manufacturing organization.

Responsibilities include supporting commercial product disposition activities as well as deviations, CAPAs, and change controls as well as process optimization, preparing and reviewing regulatory filings, and life cycle management (CPV) to support development and commercial requirements in collaboration with CMC team members from IST’s internal and global partners.

Responsibilities:

• Lead and coordinate CMO cGMP manufacturing activities including but not limited to scheduling, production, process transfer, validation, cleaning, and supply chain logistics.
• Support and lead chemistry and engineering development of drug substance processes with focus on manufacturing process development, scale‑up, process optimization, technology transfer and validation for commercial manufacturing.
• Review commercial & clinical batch records, investigations related to manufacturing deviations, out‑of‑specification (OOS) results, and other quality‑related incidents.
• Establish and maintain continued process verification (CPV) programs and KPIs to ensure proactive control and monitoring utilizing process data analytics.
• Addr…