- 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.
- 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)
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Sr. Manager - Petersburg, United States - Civica Rx
Description
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. )
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
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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:
Basic Qualifications and Capabilities:
