Director, Plasmid Production
Location: DC Metro Area
Type: Full-Time
Industry: For-Profit
Job Summary
Our growing client is seeking a Director, Plasmid Production who will report to the Chief Operating Officer. The Director leads the Plasmid Manufacturing department and provides overall leadership for projects and ensuring delivery against work orders, budgets, as well as business plan goals. The Director works cross-functionally with several departments/personnel to ensure the close coordination and planning necessary for GMP plasmid production. Maintain compliance of all systems in the plasmid manufacturing facility.
Responsibilities include but are not limited to oversight of the following areas:
- Provide oversight and supervision of staff and resources performing plasmid production (research grade, GMP-Ready, and GMP Grade Plasmid DNA) such as process and method development and validation, stability, QC, etc.
- Manage the plasmid in-process assays
- Manage and execute the work activities of the group and associates, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff, troubleshooting method and product-related issues, drafting Batch Records, and conducting Good Manufacture Processing compliant with global regulatory requirements
- Ensure the compliance of work performed as well as working with manager to meet the financial goals of the organization
- Work collaboratively with Project Directors/Leads from all functional areas (i.e., Engineering, Quality, Process Development, Validation, Metrology, Materials Management, Regulatory Affairs)
- Lead the development and implementation of all operational procedures and policies related to the company’s plasmid manufacturing operations
- Ensure that production facilities are maintained at a high standard of readiness (validated, calibrated, qualified, continually operational)
- Ensure all staff maintain an appropriate level of training
- Identify and mitigate risks in manufacturing operations that could negatively impact projects and delivery of treatment to patients
- Establish and effectively manage department annual operating budgets for the company’s plasmid manufacturing operations
- Establish robust scheduling systems to maximize the use of facility and staff to optimize the capacity and throughput of operations continually
- Other responsibilities as needed
Knowledge & Other Qualifications
- Master’s degree and 4-6 years of experience that provides the knowledge, skills, and abilities to perform the job; Ph.D. is preferred
- Experience with Process Validation and Commercial Biologic’s manufacture
- Experience in Quality Systems with experience in leading teams in successful through development and launch in various product line in multiple regions
- Excellent understanding of cGMP principles, including validation and the regulatory path for Biologic drug approval
- Experience in risk management and preferably experience in lean manufacturing experience
- Technical/Scientific expertise in biologics and aseptic manufacturing
- Strong communicational influence
Other Characteristics
- Demonstrated Client Interaction and Project Management experience
- Proven ability in managing and coaching experienced research scientists and associated projects
- Strong Molecular Biology knowledge and background
- Relevant experience with research grade plasmid DNA production and GMP Plasmid DNA production and microbial fermentation and purification
- Use strong communication and teamwork skills to build strong relationships with stakeholders
- Demonstrate outstanding technical acumen, operational understanding, and GMP compliance in building and running the Manufacturing Operations Department
- Provide oversight for the maintenance/retrofit of existing plasmid manufacturing facility
- Serve on company’s appropriate Project Teams as the Senior Manufacturing representative for plasmids
- Provide critical leadership for interactions with various agencies (e.g., regulatory agency meetings such as FDA, EMA, etc.)
- Champion the implementation of new technologies and systems
- Strong analytical, strategic thinking and troubleshooting skills
- Provide leadership in the development of strategic Plasmid manufacturing plans
- Authorized to legally work in the United States without visa sponsorship
Physical Requirements/Work Environment/Travel Requirements
- Must be able to lift up to 40 lbs.
- Standing, sitting, pushing, pulling, walking
This role will provide a competitive salary commensurate with experience and a full benefits package.