TECHNICAL OPERATIONS SUPERVISOR — Bohemia, NY
Jerome Stevens Pharmaceuticals, Inc. is seeking a hardworking, detail-oriented, and experienced Technical Operations Supervisor for Company research & development and GMP production initiatives with experience in process validation, qualification, and regulatory filings.
Job Requirements
Experience with FDA submissions including new product approval and post-approval change applications
Detailed knowledge of drug product manufacturing floor activities
Experienced with use of statistics to analyze process related data
Strong hands-on cGMP and FDA regulatory and SOP knowledge
Proficient in MS Office Suite (Outlook, Word, Excel)
Master’s degree in chemical engineering or pharmaceutical engineering with minimum of 2 years of directly related experience in a Technical Services function within the Pharmaceutical industry or a bachelor’s degree in chemical engineering or pharmaceutical engineering with minimum of 4 years of directly related experience in a Technical Services function within the Pharmaceutical industry
Advanced knowledge of the standards and concepts applicable to a wide range of work in pharmaceutical dosage processing including the areas of tech transfer, commercial manufacturing, and unit operations
Hands on experience in commercial drug product manufacturing/packaging equipment and processes, post-approval change projects and process validation
Willingness to travel periodically as needed
Ability to write, speak and interact clearly and professionally
Extremely organized. Strong follow-up ability, multi-tasking and time-management skills
Persistent and self-starter – working with minimal supervision.
Can handle sensitive information with the highest degree of integrity and confidentiality
Familiarity with both Mac and PC
Current and proficient in trends, concepts, technologies, and best practices within profession
Job Responsibilities
The Technical Operations Supervisor, as appropriate, is responsible for collaborating with quality/regulatory and production staff in supporting research & development, commercial production, quality, and regulatory tasks and projects. Individual must be active and organized both on the floor and office utilizing provided technology and tools to ensure compliant and efficient activities. Active communication and collaboration are essential to the position as well as a willingness to support overall operations.
Prepare and review technical transfer documents, validation protocols and reports
Prepare and review Continued Process Verification (CPV) documents including statistical trending, control charting and process capability analysis and play a significant role in continuous improvement efforts
Provide on-site support and technical leadership for tech transfer and scale up activities and of process performance qualification (PPQ) for new and existent products
Lead and support day-to-day technical operations for commercial drug product manufacturing, ensuring compliance with cGMP, FDA, and ICH guidelines
Provide technical expertise for investigations of OOS/OOT, deviations, identifying root causes and implementing CAPAs
Perform risk assessments and develop mitigation strategies for process changes, equipment modifications, and supplier changes
Support post approval regulatory submissions by writing/reviewing relevant sections of regulatory dossiers
Work with the internal and external teams to leads tech transfer plans
Collaborate with cross-functional teams (QA, QC, Regulatory, R&D, Supply Chain) to resolve technical issues and drive operational excellence
Ensure a high level of current technical knowledge is maintained by evaluating new technical developments and practices in the industry
Design technical projects, interpret diverse data and results, and provide recommendations for project progress
Implement statistical tools for data-driven decision-making and process improvement of new product opportunities and tech transfers
Initiate and review change controls and SOPs as needed
Training:
Current Good Manufacturing Practices (cGMP)
Standard Operating Procedures (SOPs)
FDA Requirements
MS Office Suite (Word, Excel, Outlook)
Statistical programs and platforms (general technology competency)
Full-Time Benefits Include:
Competitive salary (based on experience)
Medical Benefits (including family)
Dental Benefits (including family)
Retirement Planning that includes:
401k
Profit Sharing
Safe Harbor
Accrued Sick and Vacation Time
Annual Bonus (discretionary)
4-Day Work Week (Monday - Thursday)