Description
Kelly Scientific is actively recruiting for a direct hire (perm) Director of Pharmaceutical Manufacturing Operations in Dallas, TX The Director of Manufacturing Operations will be responsible for the manufacturing and compounding sterile fill finish operations at the new, state-of-the-art sterile fill-finish facility opening Q3 2022 in Dallas, Texas. This role will be responsible for hiring and training the operations team and lead operations to manufacture lifesaving medications at affordable prices. The Director of Manufacturing Operations shall strive to exceed the highest standards of quality and safety in their work. ESSENTIAL FUNCTIONS: * Recruit, hire, onboard and train 10-15 members of the manufacturing operations team * Responsible for aspects of manufacturing operations including but not limited to process, equipment, automation, scheduling, budgeting forecasting, training, regulatory compliance, and improvements * Work closely with the Facilities Engineering team and the Quality Unit to oversee CQV and other startup activities for the Dallas facility * Assist the Quality Unit in the creation and review of any documentation related to sterile fill finish operations such as master documentation, batch records, forms, SOPs, etc. * Troubleshoot production problems, document findings, and implement solutions * Collaborate with the Supply Chain team to ensure inventory and supplies align with production schedules and maintain levels sufficient for unexpected production. Ensure a safe working environment for employees * Plan, conduct, and/or assist with internal department inspections as necessary * Practical expertise with cGMP manufacturing, as well as both state and federal regulations, including the requirements for pharmaceutical manufacturing and compounding activities. * Monitor and analyze manufacturing data as necessary to provide support for process improvement, investigations, and continued process verification * Assist the Quality Unit to complete investigations and corrective actions related to manufacturing personnel and operation * Effectively efficiently communicate manufacturing process performance internally and externally * Maintain a Never willing to sacrifice Quality attitude QUALIFICATIONS * Bachelor s Degree in a technical discipline, preferably chemistry, chemical engineering, or related field. Master s Degree is preferred. * 15+ years of experience in pharmaceutical manufacturing operations including at least: 8+ years of experience directly working in sterile fill-finish operations and 5+ years in a senior operations management role * Sterile fill finish manufacturing and/or Drug Product Ops experience * Extensive automated filling experience preferred * Extensive knowledge of cGMP, 21 CFR 211, Part 11, GAMP, GDP requirements and other FDA regulations * Aseptic gowning experience and training required * Direct experience with regulated environments i.e., cGMP, OSHA, EPA * General understanding of Quality Systems * Working knowledge of pharmaceutical/biotech processes * Computer-savvy with SAP experience preferred Project Management experience required; PM certification preferred * Facility expansion construction and startup experience strongly preferred * Experience interacting with FDA during inspection and audit * Facility startup and CQV experience strongly preferred #TJP2022_SPEC *You should know:* Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process. Why Kelly®? Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly® At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of [benefits]()?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. [Equal Employment Opportunity is The Law.]() ]]
Requirements:
Kelly Services
