Provides direction and leadership to the Company's operations with oversight of Aseptic Manufacturing (formulation and filling) operations. This position works closely with all levels of Operations (Manufacturing and Finishing), Quality Assurance, Technical Services, Validation, QC (Microbiology and Analytical Chemistry), and Business and Finance teams.
- Key technical leader at the site, assuring that current and upcoming manufacturing processes are robust and efficient. Manages the overall Technical Transfer program at the site and ensures effective technical input regarding equipment and materials is provided early in the TT process.
- Oversees the ‘end to end’ technical success of process transfers and new product launches, effectively integrating technical stewardship with manufacturing activities and priorities established by BMS, while remaining compliant with any current regulations.
- Oversees technical process support activities, leading to successful on time resolution of investigations, and improvement of the manufacturing processes. This includes site activities for optimization of new and existing manufacturing processes, while championing and leveraging the robustness program.
- Accountable for the identification of best practices in our industry related to technology transfers, and process support to manufacturing. Achieves effective introduction of best practices to the site and the network to enable a competitive advantage.
- Represents MS&T internally and externally to BMS, and influences the organization with authority on formulation, processing, filling, secondary packaging & devices for Parenteral products and other relevant areas.
- Drives effective working relationships with other functional organizations, such as Quality, Operations, Engineering, Global Regulatory Sciences, the Microbiology Center of Excellence, Device Development, and others, both internally and externally to the site. Promotes a collaborative and inclusive environment while driving a culture of high performance and mutual accountability.
- In collaboration with other functions, ensures that effective systems and business processes are in place at the site to assure compliance to corporate guidelines for Technology Transfer, Raw Material Qualification, and other relevant areas. For example, supporting finance to develop and control project budgets for the site and the department.
- Leads, motivates, mentors, and develops team members to meet or exceed plant and company goals and objectives.
- Establishes an effective technical and leadership development program for the MS&T site organization. Identifies high potentials and provide leadership to assure their development and incorporation in succession plans, based on business and individual needs.
- Perform other duties as assigned.
- Bachelor’s degree in relevant science or engineering discipline (chemistry, pharmacy, biology, chemical engineering, or a related pharmaceutical science), or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
- 7+ years of experience in the biopharmaceutical or applicable industry in product and process development and commercialization in a global environment.
- Experienced in sterile drug product Technology Transfer & devices (combination products), scale up and technology evaluation.
- Comprehensive experience managing and leading diverse teams and interfacing with multiple stakeholders.
- Expert in biologics/sterile/liquid drug product development and commercialization, process engineering, aseptic processing (Lyo and RTU), fill, finish, inspection, and packaging operations.
- Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals in commercial manufacturing
- Working competency of Statistical Process Control, Computer Modelling, Data Analytics and related tools.
- Strong understanding of project management systems and tools and six sigma green/black belt certification are desirable.
- Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
- Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
- Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
- Must be able to comprehend and follow all applicable SOPs.
- Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
- Demonstrate solid understanding on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Good understanding of cGMPs, industry, and regulatory standards and guidelines.
- Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Demonstrate the ability to portray the appropriate level of integrity and professionalism.
- Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
- Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
- Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results-oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
- Demonstrate the ability to work well in a cross-functional team environment.
- Must communicate fluently in English and have legible handwriting.
- Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to lift up to 40 pounds on occasion.
- Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
Pharmaceutics International IncHunt Valley, MD
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