Director, Manufacturing - ANDA
Civica

Job Info

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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-/)

Position Summary

The Director 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.

Essential Duties and 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.

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