Principal Engineer - Formulation & Process Development (557)

About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at

Job Description:

The Principal Engineering – Drug Product Formulation & Process Development will oversee pharmaceutical product development for sterile injectable products in Civica portfolio. This role will be a hands-on technical leadership on a cross-functional project team for drug development from the early phase, scale down batch process, through scale-up including technology transfer activity support to commercialization As Formulation and process development leader, you will champion the process of site technology transfer for multiple aseptic (A)NDA products, site transfers, and BLA enabling product batches 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:

• Lead the design and development of drug product formulation and process development, characterization, and robustness studies.
• Lead scale-up and technology transfer activities of products for internal and external manufacturing studies.
• Troubleshoot any issues arising during process scale up, and during the manufacturing engineering studies, shake-down runs, feasibility runs, and registration batches to support product scale up and regulatory filings.
• Lead New Product Introduction change control process and work with department functional leads for gap assessments.
• Author, review, and update the process to update product development reports and update them through engineering and exhibit/PPQ batches.
• Lead engineering and registration batch manufacturing process including batch protocols, sampling plan, and batch record writing working with MSAT, quality, and operations team.
• Participate in and lead the development and implementation of product Failure Modes Effect Analysis (FMEA), risk assessments, investigations, process development and implementation, Master Batch Record preparation, filtration and filling assemblies, root cause analysis for investigations and troubleshooting.
• Manage preparation of the CMC section of the Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA) Investigational New Drug Applications (IND) and Biologic License Applications (BLA) to support regulatory filings. 
• Represent the organization to support establishment of an R&D laboratory near the Civica manufacturing site including hiring of R&D process scientists as necessary.
• Oversight and management of site technology transfer of aseptic and terminally sterilized products at the Civica site.
• 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 and cartridge-based 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, QbD, DoE, validation requirements, vendor interactions, material, and component specifications.
• Stay up to date with aseptic filling technology requirements, including filling profile studies, fill volume optimization, and support validation and MSAT in line filling PQ, as necessary.
• 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.
• Stays abreast of current technology by reading appropriate journals and attending conferences and courses, and identifies opportunities to bring new or improved processing technologies to Civica.
• 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.

Basic Qualifications and Capabilities:

• Bachelors, Masters, or PhD degree in chemical engineering, or related disciplines with a minimum of 10 years in relevant industrial experience.
• Proven ability to solve critical scientific problems.
• Experience working in sterile injectables, biologics/Bio-Similar, and medical device development is preferred.
• Experience with the Design of Experiments (DoE), multivariate statistical analyses, and data visualization tools.
• 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)

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. Furthermore, the employee must be capable of successfully passing aseptic gowning requirements, procedures, and certification. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.