QC Technology Transfer Manager

Position Summary

Manages activities associated with QC methods transfer for starting materials and drug product disposition. Provide the organization with management of QC method transfers for products ranging from clinical trial material to commercialization. In addition, this position also performs hands on laboratory work to support QC technology transfer projects. This position utilizes experience with technology transfer, CMO/CTO management and a strong knowledge of cGMP/ICH/FDA/EU regulations.

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Duties and Responsibilities*

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Manage the QC Methods department for technology transfer of testing processes to BSM and qualification of methods

• Work with clients to verify, qualify, and validate test methods
• Manage data review, analysis, identification of trends, and complex problem solving
• Manage assay troubleshooting. identify and implement improvements to existing assays
• Review and author QC SOPs, qualification/validation protocols and reports.
• Perform laboratory work including method evaluations, qualification execution, troubleshooting, and training.
• Assess, plan, develop and manage activities and personnel in the Quality Control Technology Transfer Department.
• Ensure all products are Quality Control tested in a timely fashion to meet customer demand.
• Ensure Standard Operating Procedures are in place for all testing procedures and supporting procedures.
• Ensure accurate and timely data submission for Regulatory Authority
• Ensure lab is properly equipped and supplied.
• Identify and implement process/procedural improvements related to Quality Control Methods Transfer functions to improve efficiencies and effectiveness.
• Collect and prepare data for metric reporting to management, such as Key Quality Indicators (KQI).
• Prepare, execute, and review deviations, change controls, CAPAs, OOT/OOS Maintain control and confidentiality of documents and information
• Participate cross-functionally in on-going Continuous Improvement efforts with focus on productivity improvement, implementation of best practice, alignment and harmonization of processes
• Ability to work unscheduled and overtime hours as needed
• Other duties as assigned

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Regulatory Responsibilities*

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Conduct business in a responsible manner that complies with all state, FDA, and OSHA regulations, or otherwise as applicable

• Meet Regulatory requirements and standards set internally and those by Corporate Global Quality
• Comply to pre-clinical and cGMP regulations

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Supervisory Responsibilities*

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Provide leadership in daily operations,

• Ensure employees incorporate compliance practices into their daily routines
• Manage personal and subordinates’ timelines to meet Company goals
• Ensure Quality Control Methods Transfer Department is adequately staffed and properly trained

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Experience*

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At least five (5) years’ experience in a leadership, supervisory or management role in a GMP environment

• Experience in analytical chemistry and familiarity with Quality Control functions
• Experience related to Quality Assurance/Quality Systems with exposure to GMP environment is preferred

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Education*

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Bachelor’s degree in a scientific discipline or equivalent experience

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Knowledge, Skills & Abilities*

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Experience with technology transfer and CTO management

• Strong technical knowledge and skill base
• Experience with HPLC/UPLC preferred
• Leadership skills
• Demonstrated ability to work in a productive and collaborative cross-functional manner
• Strong knowledge of cGMP/ICH/FDA/EU regulations
• Superb written or oral communication skills
• “Do-what-it-takes” attitude
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Proficiency in Microsoft Office Suite applications
• Satisfactory audio-visual acuity
• Ability to read and write English
• Able to travel to customers and/or other contractual facilities as needed

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Physical Requirements*

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Able to sit or stand for prolonged periods of time

• Able to lift up to 10lbs

Job Type: Full-time