Tech Transfer Project Manager
Company: Civica Rx
Location: Petersburg
Posted on: June 25, 2022
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Job Description:
About CivicaOver the past two decades, shortages of generic,
injectable medications critical to the lifesaving work of hospitals
in the United States have become commonplace. Approximately 200
medically necessary drugs are on the U.S. Food and Drug
Administration's shortage list. Manufacturing challenges and
predatory pricing are both the cause and result. Who suffers most?
Patients. 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. Led by an experienced team of health care and
pharmaceutical industry leaders. Today, more than 50 health systems
have joined Civica. They represent over 1,200 hospitals and over 30
percent 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 is improving patient outcomes and reducing
healthcare costs by making strides to ensure patients and their
needs come first and that essential generic medications are
accessible and affordable. Since established, the #1 Policy for the
Civica team has been Do What Is in the Best Interest of Patients.
Civica is launching a subsidiary to enter the Outpatient pharmacy
market partnering with Blue Cross Blue Shield with the goal of
reducing drug prices, especially high-cost generic drugs where
market forces are not working to control drug costs. To find out
more about how Civica's innovative model is directly impacting
patient care, click below to read a recent article from the New
England Journal of Medicine.
https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189 Video Intro
to Civica: https://vimeo.com/646267406 Position Responsibilities
The Tech Transfer Project Manager will be responsible to develop
and maintain product transfer projects and related project team
activities in all capacities and serve as the primary contact for
both internal and external customers. The role also extends to
similar activity in launching internal products. Working closely
with site functional leaders (R&D, QA, Operations and
Engineering) this role will lead product transfer activities,
coordinate with critical stakeholders, and serve as a liaison to
support new initiatives and tech transfer proposals. Serves as
project leader for multiple, complex projects related to specified
needs and ensure successful product transfers and portfolio
growth.Major AccountabilitiesWe are seeking a highly motivated
Project Manager who is interested in joining our fast-paced,
dynamic start-up environment. In this dynamic role you will,
provide a strategic dimension to Civica's tech transfer process and
portfolio development and be responsible for responsible for
leading new product introduction activities into the Petersburg, VA
facility. You must have a willingness to perform "hands-on" work in
a dynamic, team-oriented work setting. Incumbent provides technical
expertise on Construction, Start-up and Compliance standards and
processes to team members; and provides input on schedule strategy
to key business leaders.--- Responsible for leading new product
introduction activities for new programs' tech transferring into
the Petersburg facility.--- Provide central accountability that all
aspects of product launch are coordinated to lead to a successful
regulatory approval and commercial go-live.--- Provide project
strategic direction of external manufacturing technical transfer
and new product introduction activities coordinating execution of
cross-functional workstreams from Quality, Process Development,
Contracts, Supply Chain, Analytical Sciences, and Regulatory
Affairs.--- Establish full project plans, including timeline,
critical path assessment, risk assessment, contingency planning,
mitigation planning, communication planning, contact listing, and
confirm scope capture during planning phase of a project.---
Controls and monitors project progress to ensure that milestones
are accomplished on time and communicated as needed.--- Evaluates
and adds details to project plan initiated during the proposal in
conjunction with all participating departments for confirmation at
the initiation of the project. Any changes or additions to the
schedule will be first verified against the master schedule and
then agreed upon with the team.--- Work closely with site
Operations, Validation and Quality management to manage and
prioritize the project schedule as it relates to deliverables and
deadlines. Candidate with construction, start-up and/or
commissioning, qualification, and validation experiences
preferred.--- Build and maintain project plans and team assignments
using project planning tools, estimating project cost and adhering
to budget, directing and supervising work efforts on daily basis,
identifying resource needs, performing project reviews, and
advancing functional, quality, timeline and cost issues
appropriately.--- Utilize project management processes, software,
and methodologies to ensure projects are delivered on time, within
budget, adhere to high quality standards, and meet customer
expectations.--- Handle communication with all areas of the
enterprise that impact scope, budget, risk, and resources of the
work being managed and provide project updates and reporting to
executive leadership and internal partners.--- Strong interpersonal
skills as interactions will be both internal and external
facing.--- Lead multiple cross-functional projects of medium to
high complexity.Relevant Skills / Experiences
Experience in pharmaceuticals or cGMP environment, with a
preference for injectable drug products. Experience in closely
related fields such as medical devices or DEA may also be
applicable.
Experience in a broad portfolio of pharmaceutical functional areas
relevant to the role. This may includes but is not limited to
quality assurance, supplier qualification, laboratory testing,
validation, procedures, master batch records, operations, and
regulatory affairs.
Minimum 3 years project management experience with relevant
experience in biotechnology, life sciences, pharmaceutical or
medically related field. Recent college graduates will be
considered if they possess strong technical capabilities and an
ability to articulate a relative project management mindset.
Relevant IT skills - able to work with Visio, Microsoft Project,
PowerPoint, Excel, and/or Oracle Primavera for project management.
Skills such as Gantt charts are required.
Ability to think strategically and tactically
(detail-oriented).
Strong collaborative and influencing skills, and ability to work
well in a cross-functional, matrixed environment.
Demonstrated experience in complex strategic planning, project
execution, and resource management desirable.
Experience in successfully coordinating across several complex
functions to ensure comprehensive and consistent planning.
Proficiency in project management principles, practices, and
tools.
Experience with the preparation of reports and/or presentations/
communications via presentation tools such as PowerPoint, project
dashboards and written reports.
Education (minimum/desirable)
Bachelor's degree from an accredited college/university (a degree
in relevant sciences, engineering or medically related field is
preferred).
Advanced degree or certification, such as an MBA, is desired.
Project Management Professional (PMP) certification is a plus.
Relevant Skills / Experiences
Minimum 3 years of project management experience with relevant
experience in biotechnology, life sciences, pharmaceutical or
medically related field. Recent college graduates will be
considered if they possess strong technical capabilities and an
ability to articulate a relative project management mindset
Experience in pharmaceuticals or cGMP environment, with a
preference for injectable drug products. Experience in closely
related fields such as medical devices or DEA may also be
applicable
Experience in a broad portfolio of pharmaceutical functional areas
relevant to the role. This may include but is not limited to
quality assurance, supplier qualification, laboratory testing,
validation, procedures, master batch records, operations, and
regulatory affairs
Relevant IT skills - able to work with Visio, Microsoft Project,
PowerPoint, Excel, and/or Oracle Primavera for project management
Skills such as Gantt charts are required
Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills, and ability to work
well in a cross-functional, matrixed environment
Demonstrated experience in complex strategic planning, project
execution, and resource management desirable
Experience in successfully coordinating across several complex
functions to ensure comprehensive and consistent planning
Proficiency in project management principles, practices, and
tools
Experience with the preparation of reports and/or presentations/
communications via presentation tools such as PowerPoint, project
dashboards and written reports
Education (minimum/desirable)
Bachelor's degree from an accredited college/university (a degree
in relevant sciences, engineering, or medically related field is
preferred)
An advanced degree or certification, such as an MBA, is desired
Project Management Professional (PMP) certification is a plus
PI183215765
Keywords: Civica Rx, Richmond , Tech Transfer Project Manager, Executive , Petersburg, Virginia
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