This listing was posted on PrismHR Hiring.
Associate Director Project Manager - Biosimilars
Location:
Petersburg, VA
Description:
About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. ( https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.( https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) POSITION SUMMARY Reporting to the Head of Civica Biologics Program Management, the Associate Director Project Manager, Biosimilars will be responsible for coordinating complex program workstreams and critical activities needed to achieve commercial launch and supply of biosimilars at Civica. This role also involves management of projects involving drug substance, drug product, analytical development, supply chain procurement and logistics, device development/manufacturing, regulatory filing, and clinical development. Will work closely with all Civica functions including R&D, Quality, Regulatory, Supply Chain, Legal, Business Development, Commercial Operations, and others. ESSENTIAL DUTIES AND RESPONSIBILITIES The essential functions include, but are not limited to the following: Lead multi-functional and technical project teams to develop, gain regulatory approval, manufacture, and commercialize biosimilars. Author and maintain the integrated project plan in support of the Program Manager and Insulin core team. Create and support smaller project plans on an as needed basis to support short duration teams. Drive product development, technical transfer, process qualifications/validations, facility construction, manufacturing capacity expansion, process equipment improvements, process scale-up and technical process improvements, contract manufacturing, efficiency improvements, and miscellaneous technical and project planning support. Manage day-to-day execution of program deliverables across multiple workstreams. Intimate working knowledge of the program objectives, deliverables, timeline, dependencies, and schedule activities. Awareness and adherence to program budget and exhibit cost consciousness to ensure we are honoring our commitment to patients. Identify, drive mitigations for, and escalate as appropriate program and workstream risks. Schedule and facilitate meetings, post meeting minutes; Assist workstream leads in documentation and follow-up of action items, decisions, risks, and mitigations. Build strong relationships across program and site-based personnel and workstreams. Utilize experience, expertise, and network to independently resolve issues. Operate with limited supervision and oversight to ensure the program remains on track. Through direct and/or matrix reporting, provide oversight and direction to other team members (internal and external) Providing project management support to assure standard practices are followed and systems utilized in providing all necessary integration of individual projects and/or milestones into overall program management/tracking. Perform other duties as assigned. Ability to effectively communicate program status at all levels of the organization. Take ownership for the assigned scope of work. MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES) 8+ years of relevant project management/related industry experience. BS /BA in a relevant discipline, e.g. project management, engineering, R&D, operations management, or similar is required. Experience in pharmaceutical operations/cGMP environment. Ability to work with a variety of technical disciplines. Knowledge of and significant proficiency in project management software, such as Microsoft Project and others. Demonstrated ability to effectively communicate and negotiate a diversity of issues. Strong interpersonal and communication skills, both verbally and written, at all levels within Civica and external partner organizations. Ability to effectively collaborate with others to achieve team goals and expectations. Effective time management and prioritization skills. Outstanding organization skills and attention to detail. Self-starter, mature, independent, and dependable. Ability to work in a fast-paced environment under pressure, able to multi-task and obtain results. Ability to maintain a high degree of confidentiality and use of appropriate discretion and independent judgment.
Company:
Civica Rx
Posted:
April 18 on PrismHR Hiring
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to PrismHR Hiring
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Associate Director Project Manager - Biosimilars
Associate Director Project Manager - Biosimilars is a Executive Associate Director, Project Manager Job at Civica Rx located in Petersburg VA. Find other listings like Associate Director Project Manager - Biosimilars by searching Oodle for Executive Associate Director, Project Manager Jobs.
Associate Director Project Manager - Biosimilars is a Executive Associate Director, Project Manager Job at Civica Rx located in Petersburg VA. Find other listings like Associate Director Project Manager - Biosimilars by searching Oodle for Executive Associate Director, Project Manager Jobs.