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. ( ) 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.
( Job Description: The Associate Director of Product Development for Biologics will oversee Civica s medical product development for Biosimilar products starting with Insulin analogs in vials and pen configurations. This role will be responsible for leading drug development of medicals from early phase: scale down batch process, technology transfer through commercialization including the establishment of a development plan with strategic CMC and establish technical direction for the successful product development.
The position will plan, execute drug product development, and CMC strategies in a collaborative manner across internal disciplines and external partners and contractors. Additionally, the position will oversee the preparation of the Biologic License Application (BLA) documentation to support regulatory filings. This candidate will guide the design, development, verification, and validation of medical products in support of Civica s R&D portfolio of sterile Biosimilar injectables. The position will be based in the greater Richmond area.
Essential Duties and Responsibilities: Lead R&D activities for developing products to support BLA enabling product development. Translate product development project requirements into a robust, scalable technical design. Resolve complex problems by applying sound engineering principles, utilizing experimental, and analytical methods to a range of technical product development challenges over a range of products from simple sterile injectable vial products to more complex pre-filled syringe disposable auto-pen injector combination products. Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
Support R&D leadership to build a diverse and capable product development team, supporting the areas of pre-formulation, fill and finish, filtration and filling assembly build up, device assembly, and inspection parenteral operations. Deliver technology Transfer Plan through product life cycle technology transfer, engineering, clinical, PPQ, and process validation, and control strategy development. Participated in and lead the development and implementation of product Failure Modes Effect Analysis (FMEA), particle investigations, filtration and filling assemblies, Root cause analysis.
Support product preapproval inspection. The role has direct interaction with regulatory agencies during site inspections. Understand and implement manufacturing control strategy for various unit operation areas. Define BLA enabling studies necessary for product submission and conduct those internally and externally with collaboration from different departments. Review and approve c GMP documents such as Product Development Report, batch records, technical reports, change controls, validation protocols, and summary reports.
Prepare, review, and approve drug products related IND and BLA documentation necessary for regulatory submissions. Represent the organization to establish an R&D laboratory at the Civica manufacturing site including hiring of R&D process scientists. Oversight and management of the development of Biosimilar aseptic products at the Civica site. Work closely with both functional and project managers to identify and mitigate technical issues, manage project milestones to adhere to project timelines. Improve product development cycles and quality via the application of Quality by Design and Lean Product Development Tools.
Guide multi-function teams comprising of QA, Regulatory Affairs, Hospital network partners, Contract Development and Manufacturing operations team members by facilitating effective communication and engagement. Mentor and motivate team members and junior associates while coaching them through activities such as bench studies, medical product development data analysis, FMEAs, combination product development, validation requirements, vendor interactions, material, and component specifications.
Basic Qualifications and Capabilities: Bachelor of Science Engineering or a similar technical degree. A post graduate degree is desired, but not required. Preferred minimum of 12 years in related industry Experience working in sterile injectables, biologics. Strong working knowledge of current standards and regulatory expectations for medical product development, regulatory filing, and commercialization. Willingness to travel up to 20% of the time (preferred)PI4dc8fefd3f78-31181-#######2 Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality
Management & Executive Jobs refer to positions within an organization that involve overseeing operations and making strategic decisions to guide the company towards its objectives. These roles are characterized by leadership responsibilities, high-level planning, and typically require extensive experience. Executives set the vision and goals, while managers ensure that daily activities align with these directives. Such positions often demand strong communication and interpersonal skills, as well as the ability to solve complex problems and adapt to changing business environments.
Management & Executive Jobs refer to high-level positions within an organization that involve overseeing operations, making strategic decisions, and leading teams towards achieving business objectives. Individuals in these roles typically have significant experience and expertise in their respective fields. They are responsible for setting goals, developing policies, and ensuring the effective management of resources. Executive roles often include titles such as CEO, CFO, COO, and department heads, among others. Characteristically, these jobs demand strong leadership skills, excellent communication abilities, and a capacity to think critically and solve complex problems.
pathways is required to be successful in this role. Essential Duties and Responsibilities: Lead end-to end project management, including initiation, planning, execution, monitoring and project closure. Define scope, objectives, deliverables, and timelines in collaboration with stakeholders.
Develop comprehensive project plans and resource loaded schedules to ensure on-time implementation. Create project dashboards for the monitoring of progress, identifying risk and implementing mitigation strategies. Build strong relationships with stakeholders and effectively communicate project updates and challenges. Manage project-related meetings, document meeting minutes, decisions, and action
items. Prepare project status reports and present to site and above-site leadership. Conduct thorough project reviews to identify lessons learned and areas for continuous improvement.
Promote a culture of continuous improvement throughout the site, fostering innovation and best practices. Basic Qualifications and Capabilities: Bachelor s degree and 7+ years of project management experience. PMP certification preferred. Must be versed in Project Management tools and must have knowledge of related disciplines. Experience working in c GMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices. Demonstrated ability to work in a fast-paced team environment,
meet deadlines, and prioritize work. Start-up experience preferred.
Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges. Advanced computer skills with working knowledge of MS Project, Office, Word, Excel, Power Point, etc. Excellent oral and written communication skills, including presentations. PI19efc6af1741-31181-#######3 Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task
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. ( ) 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.
( Job Purpose Reporting directly to the Senior Maintenance Manager, the Facility Supervisor will play a part in the start-up of our state-of-the-art sterile injectable facility as we move from construction toward commercial operations. The Facility Supervisor works with the Maintenance team to plan, direct, and coordinate the start-up, operations, and maintenance programs to ensure proper safety, sanitation, and mechanical functionality for all buildings, grounds, and non-GMP equipment.
The ideal candidate will have a consistent track record of achieving results in Facilities Management, preferably within Life Sciences. They will support their team through forward-looking plans, effective communication, freedom with accountability, and personal development opportunities. What Will This Person Be Doing? We are seeking an exceptional leader who thrives in a fast-paced environment. The Facility Supervisor will have the ability to make decisions and be capable of setting and balancing priorities. They must be able to coordinate and manage multiple projects with frequent changes that involve cross-functional partners.
They must have a willingness to perform " hands-on" work in a dynamic, fast-paced setting. Throughout construction, oversee electrical and mechanical systems startup and commissioning, and coordinate with subcontractor and construction management activities. Coordinate preventative maintenance, repairs, and troubleshooting of non-GMP systems and utilities. Inspect buildings, sites, and equipment for needed repair and maintenance work. Manage and establish guidelines for preventative maintenance program to ensure life cycle sustainment for real property assets, systems, and equipment.
Negotiate, manage, and administer all contracts relating to building operations, including landscaping, janitorial, HVAC equipment, fire suppression, plumbing, and alarm systems. Support the implementation of a Computerized Maintenance Management System (CMMS). Develop maintenance and calibration programs, with emphasis on planning/scheduling and preventive/predictive maintenance. Maintain accurate paper and electronic records for operations, including supply inventories, reports, mechanical equipment lists, purchase orders, warranties, parts lists, operating instructions, and other documents pertaining to preventive maintenance and repairs.
Assist department head with preparation of the annual operational and capital budget as needed. Contribute to departmental operations, including staffing, budget management/ cost containment, and internal communication. Ability to manage in a manufacturing environment, including capability to perform effectively in high stress, emergency, and crisis situations. Ideal Background Bachelor s degree and 4+ years of facilities/maintenance experience in a biotech, medical, industrial, or military environment.
or Associate s degree and 8+ years of facilities/maintenance experience in a biotech, medical, industrial, or military environment. Previous experience in maintenance supervision/planning or reliability engineering. Knowledge of Enterprise Resource Planning (ERP) systems and as they pertain to maintenance, repair and operations (MRO). Strong verbal, written, analytical and persuasive skills and the ability to interact effectively with all levels of the organization. Ability to give clear and concise presentations and conduct effective meetings. Ability to build consensus and foster positive relationships.
Proficiency in setting priorities and executing multiple assignments in a timely manner. Capacity to solve problems through creative, innovative solutions and challenge traditional methods of accomplishing tasks. Knowledge of sterile injectable or medical manufacturing operations, processes, and customer base. PIcfc4d12c43e5-31181-#######4 Associated topics: business, coordinator, lead, luxury, management, manager i, manager iv, operations manager, property manager, supervise
