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Associate Director Pharmaceutical Operations
4 months ago
Company Overview:
Innoviva Specialty Therapeutics (IST) is dedicated to bringing innovative therapies for patients in critical care and infectious disease. We endeavor to address unmet needs so physicians can deliver the best treatment for each patient. Innoviva currently has three marketed product medicines - GIAPREZA (angiotensin II), a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock, XERAVA (eravacycline), an anti-bacterial for the treatment of complicated intra-abdominal infections (cIAI), and XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use as the first pathogen-targeted antibacterial approved by the US FDA to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Innoviva Specialty Therapeutics is uniquely positioned to advancing solutions for the most critical and urgent infections identified by the world's leading public health organizations.
Summary of Position:
The Associate Director, Pharmaceutical Operations candidate will provide CMC and GMP oversight of raw material / drug substance / drug product manufacturing and packaging/labeling activities supporting IST's commercial products as part of a virtual manufacturing organization. The position will assist in authorship/review/updates of SOPs and regulatory filings and interact with peer CMC team members from IST's global partners.
Responsibilities:
* Support cGMP manufacturing (RSM, DS, DP), packaging / labeling / serialization, and supply chain logistics;
* Manage CMC aspects of tech transfer, manufacturing and distribution by routinely interfacing with other departments, such as Commercial, Clinical, Regulatory, Quality Assurance and Quality Control
* Perform technical review of drug product and drug substance batch records and batch release documentation to assure GMP compliance prior to QA release;
* Address technical and quality issues / investigations (Deviations, OOS, OOT) at CDMO's to assure GMP compliance prior to QA release; utilize IST quality systems to document review and oversight;
* Support the identification, evaluation, and selection of contract manufacturers with emphasis on GMP compliance and technical expertise; establish KPI's where appropriate to monitor Vendor performance;
* Act as person in plant during manufacturing operations, address technical and quality issues;
* Work closely and collaborate with IST's internal teams and external Vendors to optimize manufacturing processes;
* Communicate effectively and consistently in writing and verbally with all levels of staff both internally and externally;
* Perform other duties as assigned.
Experience & Education:
* B.S., M.S. or advanced degree preferably in chemistry or biology
* Requires -7+years of progressive industry experience, with a solid background in process development, manufacturing, quality assurance, quality control, and CMC regulatory
* Significant experience working in an outsourcing "virtual manufacturing" environment
* Experience with small molecule, antibiotic, and injectable drug products preferred
Skills and Abilities:
* Experience in development stage as well as commercial stage pharmaceutical projects with a strong track record of participation in successful IND, NDA, and EMA filings
* Ability to interpret and effectively communicate technical information
* Ability to interpret and apply cGMPs, global regulatory requirements, and industry best practices
* Ability to travel approximately 10-20% for interactions with CDMOs for critical project activities, and for representing IST in professional conferences
* Self-organizing, self-directing and highly motivated with critical thinking skills
* Ability to initiate and manage external collaborations and engage key opinion leaders
* Excellent project management skills
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.
