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GENERAL SUMMARY OF POSITION:

The Director of Quality Control is responsible for directing activities within the Quality Control department at MassBiologics.  The Director of QC is responsible for meeting the organization’s priorities and goals in a timely and efficient fashion, maintaining continuous quality improvement of existing programs and leading the development of quality control methods and protocols to address the needs of the investigational new drug program.  In addition, the Director will provide technical and scientific guidance within QC and in collaboration with other MassBiologics departments including Manufacturing, Technical Services, Quality Assurance and R&D.  

MAJOR RESPONSIBILITIES:

• Directs assay development and data analysis activities within Quality Control; oversees the transfer of new methods for MAbs testing from Product Discovery or Development to Quality Control.
• Will be required to direct or manage projects related to some or all of the following functions within the Quality Control Laboratories
• Animal facility operation and animal testing.
• The environmental and clean utilities monitoring programs at two manufacturing sites.
• The testing of raw materials, in-process materials and finished products for both licensed and IND products.
• Preclinical and clinical sample testing as required to support MBL INDs
• Develop, review and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation and stability studies; Design and implement methods to increase efficiencies and productivity.  Design and implement methods to improve knowledge of safety, purity, efficacy, potency and stability of biologics.
• Identifies, develops and as required, validates new technologies and methods to improve QC operations and QC support of manufacturing in vaccines, cell culture, purification, aseptic fill / finish, visual inspection and packaging.
• Supports pre-clinical scientific initiatives as appropriate and required.
• Assure operations are conducted in accordance with regulatory requirements and expectations, accommodating FDA and ICH guidelines as appropriate.
• Reviews QC sections of Product License Applications for submission to FDA.
• Identifies opportunities for improvement within QC. Maintains knowledge of regulatory requirements in order to manage risk.
• Tracks organizational and departmental objectives, as well as QC related regulatory commitments to ensure timely delivery on key milestones.
• Responsible for interfacing with regulators as required.
• Under the guidance of the Senior Director, responsible for staff allocation and resource planning to support MBL commercial and IND operations at two plant sites. Provides QC input to key planned capital projects within MBL.
• Communicates key issues, and interfaces effectively, at all levels within the organization including participation at regular senior management meetings to include pertinent input on scientific, technical and compliance issues to other groups as required
• Initiate hiring, performance reviews, and staff development activities to improve technical and management capabilities, maintaining career development for QC Analysts and professional development for QC Managers.
• Perform additional job related duties as required.

REQUIRED QUALIFICATIONS:

• Requires a PhD and demonstrated senior leadership experience or Bachelor's Degree in a scientific discipline and a minimum of 10 years of relevant experience or equivalent
• Demonstration of initiative and leadership through past experience.
• Relevant experience and technical knowledge in vaccines and / or  monoclonal antibodies preferred.
• Demonstrated ability to interact with senior management and regulatory officials
• Demonstrates potential for technical proficiency, scientific creativity, productive collaboration with others, and independent thought
• Strong organizational skills, demonstrated ability to prioritize projects, and to meet deadlines with minimal supervision are required
• Clear, concise, written and verbal communication and presentation skills 
• Adept understanding of applicable FDA and cGMP regulations in order to manage risk. Demonstrated ability to interpret and apply regulations to complex issues in order to manage risk
• Ability to manage performance and motivate personnel to work effectively and efficiently
• Demonstrated problem-solving skills
• Position may require travel
• Requires ability to work flexible and, at times, extended hours to meet business needs