Location: Petersburg, VA
Company: Civica Rx
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 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
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.
( Position Summary This position will play a crucial role in improving the efficiency, productivity, and overall performance of the Petersburg, VA site. The Operational Excellence Program Manager is responsible for developing, leading, and implementing strategies to enhance the organization s operational processes, improve quality, reduce costs, and drive overall performance improvement. Essential Duties and Responsibilities Develop an Operational Excellence strategy for Civica Petersburg, VA site and assure alignment with Civica Values.
Apply Lean and Six Sigma principles and methodologies to eliminate defects, streamline operations, and drive continuous improvement. Design and implement a tiered meeting structure and performance management boards. Support the development of Operational Excellence capabilities at the site by providing guidance, training, and coaching of Operational Excellence methodologies. Lead the development and implementation of site KPI s and analytics. Use data analysis and metrics to backss process performance, identify opportunities for improvement, and make data-driven decisions.
Manage Operational Excellence projects through the application of Lean manufacturing strategies and methodologies to improve production efficiency, reduce waste, and increase quality. Lead root cause analysis sessions. Develop training and education strategies and tools to ensure Lean and Six Sigma expertise. Coach and mentor Lean Six Sigma practitioners in developing improvement strategies and using the Lean Six Sigma tools in-line with problem complexity. Promote a culture of continuous improvement throughout the site, fostering innovation and best practices.
Minimum Qualifications (Knowledge, Skills, and Abilities) A minimum of 7 years of relevant industry experience including demonstrated experience in creating Operational Excellence strategies and implementing Six Sigma and Lean programs across a manufacturing site. Minimum of Bachelor s degree from a fully accredited institution. Certification in Lean and Six Sigma, or other related methodologies. Black Belt certification is preferred. Experience working in regulated environments. Preferred experience in c GMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
Prior experience coaching for transformational change in the area of Operational Excellence and Lean improvements. Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work. Start-up experience preferred. Excellent oral and written communication skills, including presentations. Advanced computer skills with working knowledge of MS Project, Office, Word, Excel, Power Point, Etc. PI40c78acaec55-31181-#######2 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
to $10,000! - State-of-the-art medical and training facilities - Paid parental leave for birth/adoption of a child - Retirement benefits with match from day one - Sign - on bonus available for those that qualify! The MRI Imaging Clinical Coordinator assists in continuous performance improvement within the department in order to maintain optimal quality patient care.
Coordinates the overall workflow of the department to ensure quality patient care, efficient and timely processes, and customer satisfaction. Demonstrates a thorough knowledge and understanding of radiation protection and safety principles and procedures. Demonstrates a thorough understanding of Imaging principles and techniques.
Manages the overall operations of the section. Job Responsibilities - Assists in the development, review, and implementation of policies and procedures. - Ensures adequate staffing plans on a 24-hour basis and ensures equitable staffing requirements.
- Demonstrates proper technique for injection of IV contrast under the American College of Radiology (ACR) guidelines. - Works effectively with the staff/consulting physicists in all matters of the hospital pertaining to radiation protection/safety. - Demonstrates a thorough knowledge and understanding of radiation protection/safety principles and procedures. - Accurately monitors radiation sources, in all aspects of the scope of work, as
evidenced by acceptable compliance with NRC and hospital regulations.
Demonstrates the initiative to conduct successful and timely radiation safety meetings. - Ensures that all appropriate hospital staff are educated in radiation protection procedures. Manages radiation monitoring program to ensure that all staff are appropriately monitored. - Ensures that all appropriate hospital staff are educated in radiation protection procedures. Manages radiation monitoring program to ensure that all staff are appropriately monitored. - Oversees and assists team members in assigned functional area, which may include but is not limited to, ensuring the team is meeting key deliverables and quality standards, addressing and resolving challenges, managing and tracking performance, and assisting in time management and scheduling; escalates issues to senior leaders as needed.
- May perform additional duties as assigned. Requirements - Work schedule: Monday - Friday, FT - Education: Associate degree or Graduate of an accredited school/program of Radiology or Nuclear Medicine with a valid certification. - Experience: Three years of imaging experience in a hospital/healthcare environment with experience in an applicable imaging modality. Preferred: Three years leadership experience in a hospital/healthcare environment with a diagnostic testing department.
- Certification: Must be certified by at least one of the following: ARRT or ARDMS or CNT or CVT or NMTCB or RVT or CAMRT or NMTCB; as applicable with additional certification in an applicable imaging modality required. Inova Job ID #649360. Posted job title: mri imaging clinical supervisor - mt. vernon For more details: jobs-search. org/supervisor_alexandria-c449899/job_i1974666644
center.
Primary duties and responsibilities: Develop RFPs, create proposal comparisons and negotiate contracts for various services/venues to include hotel, audiovisual, transportation, venues, catering, etc. Create individual meeting budgets and keep track of revenue and expenses to meet budget requirements.
Prepare meeting requirements and orders for F&B, room setup, AV, virtual needs, housing, exhibits, internet, signs, security, badges, transportation, offsite venues, etc. Communicate with speakers, attendees, exhibitors, and sponsors Plan and execute virtual meetings to include producing, executing speaker dry runs, creating run-of-shows and setting up the meeting environment
in the virtual platform. Update and maintain meeting websites, including setting up online registration Monitor registration and housing pick up and make adjustments to alleviate potential liabilities Maintain weekly hotel and registration reports for all meetings and distribute report to staff Run in-house conference center operations to include maintaining and ordering supplies, setting up/tearing-down and liaising with in-house customers to order catering Assist in exhibition/tradeshow management and sponsorship deliverables Collaborate with marketing and content leaders on strategy and promotion for events Provide timely and accurate meeting status reports, post event and final reports Recommend
improvements and innovations to event capabilities and processes to enhance attendee experience and improve efficiency Review and reconcile various vendor invoices for accuracy and payment Collaborate with cross-functional teams to create a cohesive event experience Keep up to date on industry and technology trends Provide on-site staff support as needed at meetings Perform other duties as required Requirements: Bachelor s degree, CMP preferred5-7 years of experience in planning meetings At ease with learning new technology quickly.
Self-motivated, able to take initiative, and work independently with minimal direction. Takes personal responsibility and accountability for their work - maintains high standards despite pressing deadlines.
Creative, innovative, resourceful, with a get-it-done mentality. Exceptional project manager with experience gaining team consensus and driving deliverables. Ability to handle competing priorities seamlessly and efficiently prioritize tasks. Detail oriented, highly organized, team player who thrives in a fast-paced environment. Excellent time-management skills, manage multiple tasks and projects, track details, and ensure timely and accurate results. Excellent verbal and written communication skills.
Impeccable attention to detail, excellent proofreading skills. Strong financial management and negotiation skills Proficient in Microsoft Office Suite; experience in i MIS, Steam Yard and Vimeo a plus. Able and willing to work flexible hours as needed; work hours may require some evenings, early mornings and/or weekends. AAAE is an equal opportunity/affirmative action employer. Pando Logic. Category: Hospitality & Tourism, Keywords: Meeting and Convention Manager, Location: Alexandria, VA-22314 Associated topics: business coach, district manager, executive team leader, fire marshal, manager, manager in training, petty officer, police commander, shift lead, shift supervisor
to identify problems and develop unique solutions in the learning space? Do you enjoy collaborating with trainers, facilitators, and speakers to hone their content to maximize the potential for learning to occur? If the answer to all these questions is yes, this may be the opportunity you have been looking for.
In addition, this position has the potential to grow the role into new areas. We re looking for someone with a vision to propel our online learning programs to the next level. Our team is small, flexible, and dedicated to providing the best, most-effective learning programs to our member organizations. The role will require finesse in dealing with industry subject-matter experts,
trainers, executives, and owners as well as technical know-how in ensuring the content follows best practices in instructional design. Your day will vary. One day you may spend the morning performing LMS maintenance followed by a strategic planning meeting, a content planning call, writing marketing copy, and hosting a webinar.
The next day you may be tasked with designing new curricula and gaining stakeholder buy-in for an identified industry skill gap. Although we work as a team, you will need to be able to own your role and be accountable for its growth and results. Who is ASA? Well, we empower and advocate for the U. S. staffing, recruiting, and talent solutions industry helping companies
thrive and connect people with opportunities. Our vision is to lead and elevate the talent solutions industry as it enables people and businesses to achieve their full potential creating better lives, better businesses, and a better economy.
We value: service (to our members, communities and each other), community (create inclusive staff and member communities), integrity (respectable, accountable and build trust with others) andgrowth (for people, our organization and members)! We are a dedicated group of professionals who work in various roles to provide value to our members and ensure we are an indispensable part of the talent solutions industry.
If this sounds like you, please apply today! Equal Opportunity Employer ASA is an equal opportunity employer and encourages applications from women, people of color, people of all gender identities and interactionual orientations, veterans, and people with disabilities. Pando Logic. Category: Education, Keywords: Distance Education Manager, Location: Alexandria, VA-22314 Associated topics: district manager, editor in chief, manager in training, petty officer, police chief, police commander, sergeant, shift supervisor, supervisor, team lead
close, managing all accounts payable functions for the organization, developing, and maintaining accounting principles, practices, and procedures to ensure timely financial reports and statements, and supervising accounting staff responsible for accounts receivable function.
This position works closely with the CFO to execute tight deadlines and a multitude of accounting activities to manage the organization s finance and accounting functions. Position requires a bachelor s degree in accounting, finance or related field and minimum five years experience in finance and accounting. Must have strong experience/knowledge of GAAP, financial reporting, accounts payable, month and year-end close
processes, external audits, and 1099s and sales tax filings. Experience with accounting software packages and Microsoft Office including advanced Excel skills required.
Ability to communicate effectively, exceptional organizational and analytical skills, and the ability to meet deadlines needed to successfully perform this position. Pando Logic. Category: Finance, Keywords: Finance Director, Location: Alexandria, VA-22314 Associated topics: chief financial officer, controller, financial director, general operations manager, manage, operational manager, president finance, recruit, staff, supply
