Director of Scientific Affairs - 185K-210K
Responsible for overseeing manufacturing operations at the Company. Directs and oversees manufacturing including scheduling, staffing, and budget, and ensures manufacturing performance and quality goals are met. Working cross-functionally with Quality, Engineering, PD, Supply Chain, HR and Operational Excellence, the Senior Director is responsible for organizing, managing and improving Operations activities in support of the manufacture of clinical and commercial products according to cGMPs and Right First Time. Develops and leads a culture of learning, respect, and employee growth.
- Lead the manufacturing department, and ensure cGMP compliant operations including hiring of qualified personnel and execution of relevant safety and quality trainings. Ensure adherence to Compnay policies and SOPs.
- Direct manufacturing staff to ensure the timely delivery and Right First Time execution of manufacturing operations. Champion a culture of continuous improvement.
- Develop and monitor performance criteria so as to allow measurement and continuous improvement of manufacturing efficiency and quality, thereby ensuring on-time and error-free performance.
- Lead, assess, coach, and develop departmental leaders and staff. Manage performance to ensure team meets department, site, and corporate objectives for quality and performance. Guide the professional growth of team members by providing personal guidance and relevant proficiency, safety, and quality training relative to responsibilities.
- Represent Manufacturing Operations on site governance teams. Participate in the cross-functional management of site business activities in support of successful delivery of client and company objectives.
- Support Business Development as required to produce product manufacturing proposals for potential customers. Assist in evaluation of material, equipment, and personnel requirements. Participate in presentation of proposals as required.
- Develop and maintain budgets for the manufacturing area. Monitor performance against budgets, and identify and lead efforts to improve financial performance.
- Oversee the development and ongoing implementation of safety programs to ensure a safe working environment and compliance with all applicable state and federal requirements.
- Serve as SME as required during regulatory inspections for deviations, change controls, and process documentation.
- Maintain the operational facility in the highest level of cGMP compliance per FDA, EMA and customer expectations.
- Must be able to react to change productively and handle other essential tasks as assigned.
Minimum of Bachelor’s degree in a scientific or biochemical engineering discipline and ten or more years experience manufacturing recombinant proteins in a fermentation, cell culture, or purification environment. At least five or more years experience at a managerial level.
Also requires a demonstrated track record in the following key areas:
- Attainment of aggressive growth and profit objectives.
- Strong orientation for Quality and Customer Service
- Demonstrated level of respect for individuals
- High level of integrity and personal responsibility
- Record of innovation
- Strong collaboration and team building skills
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