The Principal Scientist will be responsible for providing scientific support to improve our understanding of process/method capabilities, control strategies, identify process changes to improve RFT and costs, and facilitate transfer of new products to our manufacturing sites. This role assures strategic alignment to site vision, strategic, and operational plans to assure achievement of site and business objectives. This position manages the E2E process to get approval of the new products with minimal guidance, including API/drug substance, pre-formulation, formulation/filling, packaging closure, and analytical methods. The Principal Scientist should provide direction and training for employees (production, quality, etc.) for product quality compliance. The holder of this position will have to pursue an intensive collaboration with the Maintenance, Engineering, Quality, Regulatory, and Production Management to ensure production, operation, troubleshooting, non-conformance, and change management. The individual will support the Drug Substance and Drug Product Development teams with their process/analytical expertise and follow up on the progress of the project together with the rest of the Technology Transfer team to assure timely readiness of the manufacturing facility/equipment (IOPQ) and process validation (PV). This position must ensure collaborative and effective working relationships with the manufacturing, quality, and regulatory groups during new product introductions. The role has responsibility for the continuous monitoring to ensure a robust process that stays in compliance with Huvepharma corporate quality policies for all pharmaceutical/biological products. This will require extensive problem-solving of complex technical issues.

EDUCATION & EXPERIENCE

• Master’s Degree in Chemistry, Biology, Engineering, or related field of study with 7 years of experience or, 10 years technical experience in pharmaceutical or related industry
• Expertise in Process Engineering Scale-up, Pack & Label, Process Technology and Manufacturing
• Diverse and demonstrated technical knowledge with strong risk management mindset
• A broad technical background with reference to equipment, facilities, and utilities
• Experience in process validation, technology transfer, and equipment qualification
• Experience with various regulatory agencies, audits, and submission, particularly manufacturing process, methods, and or facility/equipment improvements
• Analytical and statistics proficiency preferred
• Proficiency in Excel, Word, PowerPoint, and Adobe Acrobat
• Experience with regulatory requirements, such as FDA guidance and ICH guidelines.

TECHNICAL SKILLS

• Leadership ability and excellent oral and written communication skills.
• Ability to train and manage people.
• Critical thinker and problem solver, able to think strategically and act tactically.
• In-depth knowledge of GMP standards – 9CFR and/or 21 CFR
• Hands on approach
• Problem solving skills
• Technical writing skills
• Must be a seasoned professional that can be self-sufficient and able to execute without close supervision.
• Project management skills.
• Ability to thrive and to lead in an environment with rapidly changing priorities.
• Adaptable and flexible to deal with varying cultures and executive management styles.
• Ability to travel (15%)

POSITION RESPONSIBILTIES

• Work closely with Operations to implement state of the art technology and to develop robust processes/methods
• Lead process optimization activities to ensure manufacturing processes are robust and cost effective
• Lead technology transfer for new product introductions and process improvements
• Fosters an environment that encourages innovation with respect to identification, evaluation and implementation of new technologies, new products, new analytical tools, and improvement to existing commercial products
• Drive evaluation, planning, schedule adherence, and implementation of improved manufacturing processes for products manufactured from a conceptual idea to a commercial product, in collaboration with key partner functions, including but not limited to Manufacturing, Engineering, Quality, and Product Management
• Develop and execute strategies to improve production throughput efficiencies throughout the new product introduction phase along with seeking opportunities to implement efficiencies of existing processes
• Lead implementation of lean manufacturing projects including, but not limited to, inventory Kanban system, standard work development, Value Stream Mapping, 5S projects, SMED, and Kaizen events
• Support capital projects aimed at reducing overall operational costs and increasing operational efficiencies
• Responsible for maintaining technical expertise on several process unit operations within the manufacturing process
• Evaluates and proposes changes to process/technology to improve compliance or efficiency; implementing strategies relate to new process improvements
• Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues, including complex formulation, stability, and manufacturing issues
• Advise management of new innovations in production/method technologies
• Lead and/or support IQ, OQ and PQ including related tech transfer activities
• Monitor the product portfolio for process capabilities and robustness
• Prepare technical reports, presentations, and documents to support regulatory submissions
• Define scope for new product introduction projects, timeline, and resource needs of functional activities and keep team on schedule
• Lead process and technology introductions, supporting process & product impact assessments for manufacturing event investigations to resolve deviations, understand process trends, and/or improve process performance
• Lead the continuous improvement program related to process optimization
• Identify CapEx projects to improve existing manufacturing processes and equipment
• Support analytical method development, transfer, and validation activities as needed
• Project Management as needed for timely project completion
• Assure compliance with applicable cGMPs
• Assure compliance with corporate quality and site quality policies, standards and programs
• Assure SOPs meet all applicable regulatory and company requirements and are kept current
• Other job responsibilities as deemed necessary by the leadership team