Share Email Opening Title Manager, Parenteral Drug Manufacturing  About the Organization kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions.   Description The Manager of Parenteral Drug Manufacturing is responsible for working with Sterile Fill Contract Manufacturing Organizations (CMOs) and kaleo stakeholders to ensure efficient and effective commercial fill/finish operations. The Manager is a proactive partner, driving a science and risk-based, quality compliant manufacturing culture. The Manager is responsible for Fill/Finish CMO process and performance management, Fill/Finish CMO drug product and inventory management, and troubleshooting / resolution of routine operational issues and investigations with a hands of approach and willingness to travel to sites to ensure collaborative environment. PRINCIPAL DUTIES AND RESPONSIBILITIES: Provides leadership for manufacturing and operational activities for commercial fill/finish operations in the kaleo Contract Manufacturing Organization (CMO) network Collaboratively manages key projects with CMO project management, driving projects to completion balancing commercial production needs with project objectives Coordinates all aspects of manufacturing operations including the oversight of day-to-day operations to ensure timely completion of associated operations/documentation and assist in the monitoring and adherence of cGMP requirements at CMO locations Monitors Manufacturing, Quality Assurance, and Compliance to meet appropriate Regulations to assure timely product delivery Works with the Production Coordinator and CMO resources for the scheduling of all batches, supply of materials, and direct shipment of bulk drug product to manufacturing sites Work closely with internal partners in Quality, Supply Chain and Regulatory to ensure production objectives are met and issues are resolved quickly Experience in cold chain shipping and working with temperature and time sensitive products Tracks and monitors Key Performance Indicators (KPIs), schedule adherence, and cycle-times Escalates and supports issue resolution with Fill/Finish CMO's and other partners to ensure that all issues which may have an adverse effect on the quality of the product are escalated in an appropriate manner Develops solutions for a diverse range of challenges that require complex judgements, using highly developed levels of conceptual thought, strategic vision and statistical analysis   Open Date 9/14/2018   Position Requirements EMPLOYMENT REQUIREMENTS: A Bachelor’s degree in a science or technical field is required Project Management certification or experience preferred A minimum of 3 – 5 years manufacturing operations in pharmaceutical sterile drug fill/finish operations Advanced training or experience with cGMPs, CFR Title 21, ISO and relevant Guidance(s) for Industry Must be able to obtain feedback from stakeholders and implement improvements Travel up to 30% POSITION QUALIFICATIONS: Hands-on experience with cGMP and ISO Quality standards with demonstrated success in project management and process improvement initiatives in the manufacture of sterile drug products for combination product medical devices Experience in collaborating with Fill/Finish CMOs Experience in sterile fill/finish operations for cartridge or vial manufacturing utilizing crimped container closure systems Experience with the production of aseptic pre-filled syringes or vial filling Experience in project management and risk management / mitigation Ability to gather statistical data from multiple sources for use in troubleshooting and investigations Ability to create and improve systems, processes, tools, policies, and SOPs to insure compliance with requisite regulatory, contractual and financial requirements Ability to work within a team to resolve product issues and investigations Understands and listens to cross-functional team member and stakeholder needs while supporting productive team environments toward one common objective Proven problem-solving skills in the proactive resolution of technical challenges with tact, diplomacy and composure Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments Strong interpersonal, written and oral communication skills Experience with SPC (Statistical Process Control) or SQC (Statistical Quality Control) is a plus ACCOUNTABILITY: Responsible for compliance to company’s Quality System Manual Responsible for compliance with company’s safety policies Responsible for knowing and adhering to policies and procedures in the company’s Employee Handbook Responsible for compliance of corporate Code of Conduct   Exempt/Non-Exempt Exempt   Full-Time/Part-Time   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Location Corporate   This position is currently not accepting applications. To search for an open position, please go to http://KaleoPharma.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found -- Follow us See who works here:

 

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