Senior Manager, Planning & Logistics
Apply NowCompany: Innoviva Specialty Therapeutics
Location: Waltham, MA 02453
Description:
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 serious, 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).
Our latest addition to the Company's expanding antibiotic portfolio is ZEVTERA (ceftobiprole), a newly approved advanced-generation cephalosporin antibiotic. ZEVTERA is the only FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). We anticipate a U.S. launch in mid-2025.
Innoviva Specialty Therapeutics development pipeline includes zoliflodacin, an investigational first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhea infection in patients.
At Innoviva Specialty Therapeutics, Inc., we are building a culture dedicated to delivering products that address critical medical needs. If this is your passion, come and join us to make a difference.
Summary of Position:
The Senior Manager of Planning and Logistics is responsible for the preparation and monitoring of all shipments within IST Pharmaceutical Operations & Pharmaceutical Sciences. This role will interact with CDMO's (Regulatory Starting Material, Drug Substance, Drug Product, Packaging/Labeling) to create purchase orders and supply plans as well as review shipment performance and ensure alignment with global supply chain needs. Additionally, this role will participate in IST's S&OP planning process to ensure alignment of plans to commercial requirements.
Responsibilities:
Experience & Education:
Skills and Abilities:
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.
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 serious, 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).
Our latest addition to the Company's expanding antibiotic portfolio is ZEVTERA (ceftobiprole), a newly approved advanced-generation cephalosporin antibiotic. ZEVTERA is the only FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). We anticipate a U.S. launch in mid-2025.
Innoviva Specialty Therapeutics development pipeline includes zoliflodacin, an investigational first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhea infection in patients.
At Innoviva Specialty Therapeutics, Inc., we are building a culture dedicated to delivering products that address critical medical needs. If this is your passion, come and join us to make a difference.
Summary of Position:
The Senior Manager of Planning and Logistics is responsible for the preparation and monitoring of all shipments within IST Pharmaceutical Operations & Pharmaceutical Sciences. This role will interact with CDMO's (Regulatory Starting Material, Drug Substance, Drug Product, Packaging/Labeling) to create purchase orders and supply plans as well as review shipment performance and ensure alignment with global supply chain needs. Additionally, this role will participate in IST's S&OP planning process to ensure alignment of plans to commercial requirements.
Responsibilities:
- Assist and manage S&OP planning cycle including monthly purchase orders for CDMOs and other suppliers
- Track and manage material shipments and work closely with freight forwarders/brokers on import/export (including, but not limited to, FDA, US Customs & Border Patrol, USDA)
- Provide updated forecasts to Finance for product and shipment cost, approve and track material shipment invoices
- Work closely with IST Pharm Operations, Pharm Sciences, Quality, and CMC Regulatory teams to ensure continuity of supply and implementation of changes into the supply chain
- Liaise with Regulatory Affairs and Quality Assurance on CMC items, regulatory submissions, author/review SOPs and ensure compliance with company procedures and regulatory requirements
- Participate in the evaluation and selection of contract packaging and labeling manufacturers with emphasis on GMP compliance and technical expertise
- Assist with supply plans and requirements to/from ROW partners for products supplied by/to IST
- Collaborate with Commercial team on artwork for product launches and/or product changes
- Perform other duties as assigned on project basis (ERP system implementation, 3PL support)
Experience & Education:
- B.S., M.S. or other advanced degree preferred
- Requires 7 plus years of progressive industry experience, with a solid background in supply chain, planning, logistics (including cold chain), and program management
- Experience working in an outsourcing "virtual manufacturing" environment
- Experience with global supply chain from RSM to Finished Drug Product and 3PL providers
Skills and Abilities:
- Excellent project management skills
- Strong interpersonal skills required for CDMO interactions
- Strong planning and problem-solving skills
- Self-organizing, self-directing and highly motivated with critical thinking skills
- Ability to initiate and manage external collaborations and engage key internal and external opinion leaders
- Ability to travel approximately 10 -15% for critical project activities
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.