Location: Petersburg, VA
Company: Civica Rx
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 Civica Script, to into the outpatient shop 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. ( 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 Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Job Description: This individual has accountability to manage and deliver affordable drug substance, drug product, and API from Civica’s contract development and manufacturing partners (CDMO) in India and Asia Pacific region. The primary role is to actively manage manufacturing, operational, and quality performance according to those agreements during startup, tech transfer, and commercial phases.
For new products and supply nodes, this individual will partner with Civica Business development, Quality, and Executive Leadership to identify and secure agreements with potential partners in the region for biologics, retail, and hospital products, and lead due diligence efforts. As Civica partners increase over time, this individual may be required to staff a small team of consultants/contingent workers to support local quality, engineering, and subject matter experts during intense phases of startup. This may include tech transfer or Health Authority Inspection readiness.
Essential Duties and Responsibilities: For startup phase, act as Civica Operations counterpart to CMO Leadership, and person-in-plant support (PIP) for critical startup activities, always advocating for on time delivery of quality medicines in the best interest of patients and Civica. Facilitate communication of Civica deliverables in support of the Manufacturing Service Agreement such as demand planning. Ensure the CDMO delivers commitments based on Civica Supply Chain planning requirements. Proactively identify risks to supply based upon ongoing trend performance.
These risks can often only be detected through periodic on-site visits. Work with CDMO project management and Civica program management to build tech transfer and startup schedules, and carefully manage schedule adherence. Participate with Civica Supply Chain in Quarterly supplier reviews. For startup sites, work directly with general management and staff to recommend and implement operational improvements. Ensure CDMO is operating within the agreed Quality agreement. Coordinate QA support resources with Civica quality to enable audit and supplier qualification. Prioritize resources at the CDMO, and within Civica to ensure critical products are released in a timely manner.
Ensure CDMO site master plans and major capital upgrades are executed according to agreements and within the best interest of Civica products. Basic Qualifications and Capabilities: 14 years minimum experience, 5 of which should be in a plant operations environment. Experience in Quality and Operations organizations within GMP manufacturing BS/BA level collegiate degree from accredited university Requires up to 50% travel to partner CDMO’s, however time outside of travel can be conducted as remotely-design.
HR & Recruiting Jobs encompass a range of roles focused on managing an organization's human resources and talent acquisition processes. These positions play a crucial part in shaping company culture, ensuring employee satisfaction, and attracting top-tier candidates. Key responsibilities include developing hiring strategies, overseeing benefit programs, administering personnel policies, and ensuring compliance with labor laws. Characterized by strong interpersonal skills, HR and Recruiting professionals often act as liaisons between management and staff to foster a positive work environment. The field requires a blend of empathy, strategic thinking, and a keen understanding of employment regulations and best practices.
HR & Recruiting Jobs encompass a range of roles focused on managing an organization's human resources and talent acquisition processes. These positions play a crucial part in shaping company culture, ensuring employee satisfaction, and attracting top-tier candidates. Key responsibilities include developing hiring strategies, overseeing benefit programs, administering personnel policies, and ensuring compliance with labor laws. Characterized by strong interpersonal skills, HR and Recruiting professionals often act as liaisons between management and staff to foster a positive work environment. The field requires a blend of empathy, strategic thinking, and a keen understanding of employment regulations and best practices.
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 Civica Script, to into the outpatient shop 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. ( 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 Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Job Description: The Head of Quality Systems leads the deployment and improvement of the Quality Management System (QMS) at Civica that ensures a high state of c GMP compliance and supports the effective execution of Civica objectives, including lifecycle management of policies and procedures for processes that govern all Gx P related activities.
Also, leads the following quality management systems: Documentation, Change Management, Investigation/Deviation and CAPA, Complaints, IT Quality, and Training. Additionally, is the owner of Electronic Systems associated with Documentation Management, Deviations/CAPA Management, Change Management and Learning Management. Essential Duties and Responsibilities: Establish, and maintain the global QMS elements including policies, processes, procedures and controls, enabling successful and efficient development and manufacturing of drug products meeting Civica and regulatory requirements.
Establish and maintain risk-based, fit-for-purpose Quality Management System. Oversee the pharmacovigilance program ensuring robust reporting and investigations. Responsible for the electronic quality management system (VEEVA) and ensuring the system maintains its validated state. Develop robust systems to assure corrective and preventive measures are systematically implemented and controlled. Propose and drive continuous improvements to the Quality Management System to streamline business processes and stay in compliance with external requirements (e. g. regulatory). Design and maintain trending program for quality events/ laboratory controls/ production controls by key indicators (e.
g. dates, categories, root causes, and CAPA) to identify adverse trends/ risk to help drive continuous improvement for manufacturing/ production controls and laboratory controls per Civica Gx P procedures. Ensure Computer System Validation (CSV) processes are fully implemented with the appropriate quality oversight. Develop and implement Medical Device Reporting (MDR) processes for combination products. Support and ensure the governance of any other initiatives as delegated. Establish and maintain Quality Plan.
Basic Qualifications and Capabilities: Minimum 15 years of life science/medical/biologics product manufacturing and development experience. Bachelor’s degree in a science, shop, or engineering discipline. Advanced degree desired. Broad knowledge and experience with quality assurance and quality system, regulatory compliance and understanding of current regulatory requirements and trends for manufacturing drug substance, drug product and combination products, in particular sterile injectable medications. Prior experience managing personnel. Working knowledge of software solutions for QMS.
Strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment. Strong project management skills with an emphasis on critical thinking and problem solving. Demonstrated ability to apply risk-based approaches to Quality Systems implementation, and maintenance. Extensive experience in hosting FDA inspections, keeping pace with ongoing updated regulations and requirements, and as applicable especially 21CFR211, 21CFR820/803/806.
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 Civica Script, to into the outpatient shop 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. ( 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 Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Position Summary Advanced level Manufacturing Technician position with the responsibility to weigh and dispense active medical ingredients (API) and excipients in preparation of compounding. Compound bulk solutions for the filling operations and operate packaging equipment. Essential Duties and Responsibilities Under the Manufacturing Lead and/or Supervisor’s direction, support manufacturing operations to meet strategic department objectives.
Prepare cleaning and sanitizing solutions and perform daily, weekly, monthly cleaning of controlled and classified manufacturing areas. Replenish manufacturing components, materials, and supplies in all processing areas. Transport bright stock and finished product to and from staging as required according to manufacturing schedule. Perform equipment cleaning and preparation for sterilization. Operate sterilizer equipment to provide format parts for filling equipment. Clean, set up, and decontaminate material transfer isolator.
Clean, set up, and operate component processing equipment. Clean, set up, and operate terminal sterilizer equipment. Clean, set up, and operate weighing and compounding equipment. Weigh APIs and excipients according to batch record instructions. Compound bulk drug product per standard operating procedures and batch record instructions. Clean, set up, and operate packaging equipment. Adhere to Civica procedures and policies, conform to current good manufacturing practices and good documentation practices. Adhere to all safety regulations. Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
Perform other duties as assigned by manufacturing management. Minimum Qualifications (Knowledge, Skills, and Abilities) • High school diploma or equivalent. Coursework or bachelor’s degree in a Life Science discipline preferred. • 2-3 years’ experience in medical manufacturing environment preferred. • Good reading and writing skills, and ability to perform basic to advanced mathematical calculations. • Ability to read, understand and follow written procedures.
