Site Biologics Lead

The Lannett Biologics Program Site Lead will be responsible for oversight of Lannett’s interests in Lannett and HEC’s joint US insulin program, monitoring of day-to-day operations and providing support from development, through commercialization.  The incumbent will act as the liaison between Lannett and HEC management to include oversight of Lannett’s ongoing Quality initiatives and the site’s Quality systems to ensure compliance with regulatory requirements as well as meeting US commercial demands.

•Work with cross-functional teams, including but not limited to HEC management, site QA, Operations, Technical Services, consultants, etc., to develop strategies to maintain and/or improve timelines associated with filing BLAs, preparing for regulatory inspections, launching products and providing commercial supply in line with US requirements;•Communicate project objectives, deliverables, timelines and tasks to HEC team members while offering technical guidance and support;•Communicate with Lannett senior management and appropriate stakeholders of projects’ statuses; engage Lannett and other personnel as appropriate to remove obstacles, resolve disagreements and correct problems;•Acts as a subject matter expert (SME) on Quality compliance in support of FDA inspections and engage with FDA as necessary;•Maintain current with all regulatory expectations associated with biologics, devices, cGMPs and Quality compliance;•Work closely with LCI supply chain and the commercial group to ensure Lannett’s production requests are honored and where shortfalls are expected, facilitate discussions between the two firms and offer suggestions to improve deliveries;•Perform other activities as necessary.

•Work with cross-functional teams to develop strategies to maintain and/or improve approval timelines, commercial supply and facilitate key initiatives;•Communicate project objectives, deliverables, timelines and tasks to team members and management;•Demonstrate leadership qualities while facilitating team meetings to ensure ongoing progress; coordinate follow-up on action items;•Promote continuous improvement of key business processes in all areas ;•Communicate with Lannett senior management and appropriate shareholders of projects’ statuses;•Provide direction and technical guidance to both HEC management and staff;•Participate in and/or call meetings as needed to review progress, discuss problems and share information.•Oversee the review and approval of quality documents including protocols, change controls, deviations, etc.;•Work with the site to develop and/or implement remediation and continuous improvement plans to maintain excellence in quality and ensure compliance with all applicable regulatory requirements and applications;•Acts as a subject matter expert (SME) in Quality compliance in support of FDA inspections and engage with the FDA as necessary.•Work with individuals across various departments to provide required compliance documents and reports to ensure compliance with regulations and procedures;•Generate metrics to support Quality systems and leadership meetings.

•Minimum of six (6) years of quality systems experience in the Pharmaceutical Industry, or equivalent industry•Bachelor’s degree in Chemistry, Biology, Pharmacy, or related science•Firm understanding of pharmaceutical plant operations, ideally from working in a plant environment.•Experience working with executive leadership•Leadership/Management experience is a plus•Strong knowledge of FDA requirements related to quality compliance•Experience interfacing with FDA or aiding in FDA interfacing

•Leadership skills, including mentorship of colleagues•Strong oral and written communicative/negotiation skills•Excellent analytical and problem-solving skills•A high level of integrity•Ability to work independently by planning, scheduling and arranging activities to accomplish objectives •Ability to work in a team environment•Strong organizational skills•Ability to meet internal and external deadlines•Fluent in the Chinese language•Willingness to accept new responsibilities and expand competencies