Sr. Manager – Formulation

4 days ago

Petersburg, United States Civica Rx Full time

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress at

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)

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