Head of ANDA Manufacturing

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  www.civicarx.org

Purpose of the Position

The Head of ANDA Manufacturing will direct the manufacturing operations for the abbreviated new drug application (ANDA) program at Civica Petersburg and is a member of the site leadership team at Petersburg. Responsibilities of the position include building and leading the manufacturing organization for the Petersburg ANDA program including execution of the new product introduction for small molecule drugs. This position plays a key role in the development of strategic vision and long-range planning for the site as well as team building to ensure compliance with Civica cultural tenets and sustainable and cost-effective manufacturing operations for the site. Champions a safe working environment and compliance with established policies, procedures, and guidelines for the site.

Key Responsibilities

The essential functions include, but are not limited to the following:

• Build and lead the manufacturing operations for Petersburg ANDA program team and drive accountability for deliverables in a matrix environment.
• Provide the manufacturing leadership and management to ensure that the mission, core values and culture of the Company are put into practice at the site.
• Demonstrated ability to act as subject matter expert in manufacturing equipment build and function, as well as in manufacturing processes, including aseptic filling, isolator/RABs technology, terminal sterilization, and packaging.
• Implement manufacturing shifts and support models for the ANDA program in alignment with site, company plans and member needs.
• Review regulatory submissions and drive inspection readiness efforts at the site.
• Support process development/validation, and qualification efforts.
• Establish performance and development plans for department staff, consistent with a culture of individual and team accountability and high performance.
• Establish manufacturing goals, milestones, and objectives as well as key performance metrics.
• Mentors, coaches, and teaches the manufacturing organization in the use of Lean/Six Sigma methodologies and change management techniques to ensure timely completion of projects at the expected results.
• Promotes a strong safety and quality culture.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Must have a college degree in a relevant discipline, such as engineering and/or the sciences, and at least 15 years of experience in a pharmaceutical manufacturing environment.
• Must have 10 years of manufacturing experience with aseptic product manufacturing and/or injectable drugs.
• Demonstrated experience building a culture of continuous improvement by leveraging Operational Excellence methodologies and tools.
• Exceptional leadership abilities to inspire and motivate others to perform well, and accept feedback from others; delegate work assignments, give authority to work independently, set expectations, and monitor delegated activities.
• Ability to involve staff in planning, decision-making, facilitating, and process improvement; be available to staff; provide regular performance feedback; and develop subordinates’ skills and encourage growth.
• Comprehensive knowledge of industry and industry-related trends and forecasts, including direct and comprehensive familiarity with FDA compliance requirements, such as cGMPs, cGLPs, cGDPs, DSCSA, etc.
• Experience reviewing regulatory submissions and supporting regulatory agencies inspections. ANDA experience strongly preferred.
• Ability to identify and resolve problems in a timely manner, as well as skillfully gather and analyze information utilizing appropriate root cause analysis, FMEA, and other tools.
• Demonstrate effective project management skills, including use of appropriate tools and ongoing oversight.
• Speak clearly and persuasively in positive or negative situations, demonstrate group presentation skills, and conduct productive meetings (documented action plans, identified responsibilities, and timing).
• Willingness to explore ways to improve and promote quality and regulatory compliance; demonstrate accuracy and thoroughness; and maintain compliance with legal and regulatory requirements.
• Develop, implement, promote, and enforce site environmental, health, safety and security procedures for all personnel, equipment, materials, and activities at the site.
• Thorough understanding and experience in developing and implementing state-of-the-art technical strategies through knowledge of industry practices, company history, culture, identity, and goals.
• Demonstrated ability to build a strong safety and quality culture.