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SUMMARY OF POSITION:

The Senior Director of Quality Control is responsible for directing the activities of QC operations at MassBiologics. The Senior Director directs the activities of all functional areas within QC. This includes the supervision and mentoring of staff, capital budgeting and resource analysis. In addition, the Senior Director will provide technical and scientific guidance within QC and in collaboration with other MassBiologics departments and MassBiologics contract manufacturing clients.

ESSENTIAL FUNCTIONS:

• Oversees laboratory operations at MassBiologics to ensure that laboratory operations consistently meet the testing requirements for licensed products, IND products, and client products including the timely completion of assays in accordance with cGMP.
• Oversees animal facility operation and animal testing.
• Oversees the environmental and clean utilities monitoring programs at three manufacturing sites.
• Directs the testing of raw materials, in-process materials and finished products
• Directs the testing of preclinical and clinical samples as required to support MassBiologics INDs
• Responsible for staff allocation and resource planning to support MassBiologics at three manufacturing sites. Provides QC input to key planned capital projects within MassBiologics.
• Responsible for personnel management
• Facilitates the transfer of new methods for MAbs, viral vector, vaccine, and oligonucleotide testing from Product Discovery, Product Development, or directly from the client to MassBiologics Quality Control.
• Identifies, develops and as required, validates new technologies and methods to improve QC operations and QC support of manufacturing in vaccines, cell culture, purification, viral vector manufacturing, oligonucleotides, aseptic fill / finish, visual inspection and packaging, and other emerging pharmaceutical manufacturing processes as appropriate.
• Reviews and approves QC sections of Product License Applications for submission to FDA, EMA, and other appropriate regulatory agencies.
• Provides direction for the review of laboratory procedures, material and product specifications to ensure that they are in compliance with cGMPs, (and where applicable cGLPs and cGCPs) as well as CFRs, other federal and international regulations and applicable regulatory guidance documents. Identifies opportunities for improvement within QC.
• Tracks organizational and departmental objectives, as well as QC related regulatory commitments to ensure timely delivery on key milestones.
• Communicates key issues, and interfaces effectively, at all levels within the organization and provide pertinent input on scientific, technical and compliance issues to other groups and contract manufacturing clients as required.
• Represents QC in discussions with corporate partners in the US and overseas and with regulatory agencies as appropriate.
• Represents QC during regulatory inspections and client audits.
  Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance.
• Perform additional job related duties as required.

REQUIRED QUALIFICATIONS:

• PhD in a scientific discipline with a minimum of 8 years relevant experience or
• Bachelor's Degree in a scientific discipline with a minimum of 12 years relevant experience or equivalnet.
• A combination of experience and/or knowledge of and willingness to adapt to the cGMP environment of a commercial laboratory is required
• Demonstration of initiative and leadership through past experience.
• Relevant experience and technical knowledge in vaccines, monoclonal antibodies, viral vectors preferred.
• Demonstrated ability to interact with senior management and regulatory officials
• Clear, concise, written and verbal communication and presentation skills
• Ability to maintain extensive working knowledge and proficiency in applicable cGMP regulations and procedures
• 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
• Ability to manage performance and motivate personnel to work effectively and efficiently
• Demonstrated problem-solving skills
• Position may require travel
• May require working extended and at times, unusual hours to meet business needs.

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