Organizational Development Specialist, Sr. jobs in Petersburg, VA

Organizational Development Specialist, Sr. analyzes organizational structures, responsibilities, team work, business or operating procedures, reporting relationships and work processes to design efficient methods of accomplishing work. Requires a bachelor's degree in a related area and 2-4 years of experience in the field or in a related area. Being an Organizational Development Specialist, Sr. is familiar with standard concepts, practices, and procedures within a particular field. Relies on limited experience and judgment to plan and accomplish goals. Additionally, Organizational Development Specialist, Sr. performs a variety of tasks. Works under general supervision; typically reports to a manager. A certain degree of creativity and latitude is required. (Copyright 2024 Salary.com)

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Sr. Manager – Formulation & Process Development
  • Civica Rx
  • Petersburg, VA FULL_TIME
  • 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-/)

    Job Description:

    The Sr. Manager – Formulation & Process Development will oversee pharmaceutical product development activities from laboratory scale up till exhibit/PPQ batch manufacturing for sterile injectable products. As Formulation and process development leader, you will champion the process of site technology transfer for multiple aseptic ANDA products starting with engineering batch manufacturing till process validation/PPQ batches. The incumbent is responsible for leading formulation and technology transfer team. This position will be headquartered at Civica’s exciting new plant to be in Petersburg, VA, [greater Richmond area]. 

     

    Essential Duties and Responsibilities:

    • Establish R&D process for technology transfer for transferring lab processes to manufacturing site to support ANDA regulatory filings batches.
    • Work closely with site functions – operations, quality, engineering, validation, supply chain, procurement, and MS&T to bring new products to the site.
    • Establish R&D team capability to scale up products at site, troubleshoot any issues arising during process scale up, and during the manufacturing registration batches to support ANDA regulatory filings.
    • Lead New Product Introduction change control process and work with department functional leads for gap assessments.
    • Define process to update product development reports to include scale up data from engineering and exhibit/PPQ batches.
    • Lead engineering and exhibit batch manufacturing process including batch protocols, sampling, and working with manufacturing and quality team in sample management.
    • Lead product transfer gap assessment, in-process control, and FMEA analysis to identify critical/key process parameters.
    • Represent Civica organization to establish R&D laboratory at the Civica manufacturing site including hiring R&D chemists.
    • Oversight and management of site technology transfer of ANDA aseptic products at the Civica site.
    • 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 combination products and oral solid dosage forms.
    • Work closely with both functional and project managers to identify and mitigate technical issues, manage project milestones to adhere to project timelines.
    • Deliver new drug solutions as a technical leader on a cross-functional project team through all phases of the project lifecycle, from concept through launch.
    • Develop and guide technical design/methodologies to achieve success in developing combination products.  
    • Mentor and motivate team members and junior associates while coaching them through activities such as bench studies, pharmaceutical product development data analysis, FMEAs, combination product development, validation requirements, vendor interactions, material, and component specifications.
    • Ensures that the personal and departmental moral, ethical, legal, and behavioral conduct is following the Civica Code of Conduct.
    • Other duties as required.

     

    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 related industry experience (it may be a combination with advanced degree education).
    • Experience working in FDA and DEA regulated environment.
    • Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.
    • Willingness to travel up to 20% of the time (preferred)



  • 24 Days Ago

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Office Assistant
  • Waukeshaw Development
  • Petersburg, VA PART_TIME
  • Waukeshaw Development seeks a part-time Office Assistant at its Petersburg headquarters. At Waukeshaw, we pioneer multifamily and commercial real estate development projects across Virginia. We also o...
  • 26 Days Ago

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Childcare Provider
  • Fortress Mission Community Development
  • Chester, VA FULL_TIME
  • About us Fortress Mission Community Development is a small business in Chester, VA. We are professional and agile.Overview: We are seeking a dedicated and experienced Childcare Provider to join our te...
  • Just Posted

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Daycare Cook
  • Matoaca Child Development Center
  • Chesterfield, VA PART_TIME
  • We are looking to hire an attentive individual to cook lunch daily for our child care center. During the school year normal hours are 10 a.m. to 1 p.m. daily cooking for about 20 preschoolers. Occasio...
  • 1 Day Ago

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Preschool Teacher
  • Matoaca Child Development Center
  • Chesterfield, VA PART_TIME,FULL_TIME
  • We are looking for a qualified Preschool Teacher to prepare small children for kindergarten by easing them into organized education. You will teach them important elements that they will encounter soo...
  • 7 Days Ago

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Sr. Accountant
  • Robert Half
  • Colonial Heights, VA OTHER
  • Skilled accountants in the are encouraged to submit an application for Robert Half's open Senior Accountant role. Work with a fast-growing company to thrive in your career and expand your knowledge. T...
  • 1 Day Ago

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0 Organizational Development Specialist, Sr. jobs found in Petersburg, VA area

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Manufacturing Specialist - Syringe Filler
  • Civica Rx
  • Petersburg, VA
  • About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies ...
  • 3/28/2024 12:00:00 AM

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Manufacturing Specialist - Vial Line
  • Civica Rx
  • Petersburg, VA
  • About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies ...
  • 3/28/2024 12:00:00 AM

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Patient Access Specialist - NIGHT SHIFT
  • Ensemble Health Partners, Inc.
  • Petersburg, VA
  • Thank you for considering a career at Ensemble Health Partners! Ensemble Health Partners is a leading provider of techno...
  • 3/28/2024 12:00:00 AM

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Recreational Therapist I
  • Virginia Department of Human Resource Management
  • Petersburg, VA
  • Recreational Therapist I Job no: 5012121 Work type: Full-Time (Salaried) Location: Petersburg, Virginia Categories: Heal...
  • 3/28/2024 12:00:00 AM

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Senior Tax Associate
  • Brown Edwards
  • Colonial Heights, VA
  • Description Who We Are A Top 100 Firm, Brown Edwards' provides expert accounting, assurance, tax, and management advisor...
  • 3/28/2024 12:00:00 AM

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US - Call Center Specialist
  • Manpower
  • Colonial Heights, VA
  • Our client in the advanced-technology manufacturing industry is seeking a Call Center Specialist to join their team. As ...
  • 3/27/2024 12:00:00 AM

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Global Customer Support Specialist (Remote)
  • Publicis Group
  • Petersburg, VA
  • **Global Customer Support Specialist (Remote)** * 136 4th St N, St. Petersburg, FL 33701, USA * Employees can work remot...
  • 3/26/2024 12:00:00 AM

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Marketing Specialist
  • District 19 Community Service Board
  • Petersburg, VA
  • Job Description Job Description District 19 Community Services Board is a member of the Virginia Associations of Communi...
  • 3/24/2024 12:00:00 AM

Petersburg is located at 37°12′46″N 77°24′1″W / 37.21278°N 77.40028°W / 37.21278; -77.40028 (37.21295, -77.400417). According to the United States Census Bureau, the city has a total area of 23.2 square miles (60.1 km2), of which 22.9 square miles (59.3 km2) of land and 0.2 square miles (0.5 km2) (1.1%) is water. Petersburg is located on the Appomattox River at the fall line, which marks the area where the Piedmont region (continental bedrock) and the Atlantic coastal plain (unconsolidated sediments) meet. The fall line is typically prominent where a river crosses its rocky boundary, as the...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Organizational Development Specialist, Sr. jobs
$88,208 to $109,795
Petersburg, Virginia area prices
were up 1.2% from a year ago

Organizational Development Specialist, Sr. in Alexandria, VA
Meet or exceed continuing professional education (CPE) requirements.
April 16, 2020
Assist with business development activities, such as proposals, capture, account teams, whitepapers, conferences, and/or other thought leadership materials.
April 18, 2020
Meet or exceed targeted billing hours (utilization).
June 04, 2020