Director, Manufacturing - Insulin
Company: Civica RX
Posted on: November 17, 2023
The Director Manufacturing will direct the manufacturing
operations for the Petersburg Insulin program at Civica 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 Insulin program including
supporting the newly announced facility expansion that includes a
dedicated high-speed cartridge filling line. This includes
assisting in development of strategic vision and long-range
planning for the site, as well as a focus on execution and 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
engineering department and the overall site. -
Essential Duties and Responsibilities
The essential functions include, but are not limited to the
- Build and lead the manufacturing operations for Petersburg
Insulin program team and drive accountability for deliverables in a
- 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
Insulin program in alignment with site, company plans and member
- Support the facility and equipment design, construction,
process development/validation, and qualification.
- Establish performance and development plans for department
staff, as standardized by the site and company, consistent with a
culture of individual and team accountability and high
- Establish manufacturing goals, milestones, objectives and key
- Mentors and coaches Manufacturing personnel in the use of
Lean/Six Sigma methodologies and change management techniques to
ensure timely completion of projects at the expected results.
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 biologics manufacturing experience with
aseptic product manufacturing and/or injectable drugs.
- Demonstrated experience building a culture of continuous
improvement by leveraging Operational Excellence methodologies and
- 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,
- Ability to identify and resolve problems promptly and
skillfully gather and analyze information using 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
- 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. -
Keywords: Civica RX, Richmond , Director, Manufacturing - Insulin, Executive , Petersburg, Virginia
Didn't find what you're looking for? Search again!