Drug Product Manufacturing And Cdmo Management

Evive Biotech is a global biologics company developing a portfolio of novel biological therapies for patients worldwide. We leverage our proprietary technology platforms to advance a series of innovative drug candidates for oncology and inflammatory disorders. Founded in 2004, we have ~300 employees today with operations in the US, Singapore, and China. We are seeking a highly motivated research associate to support the antibody discovery efforts for the US R&D center located in Hayward, CA, where we offer exciting career growth and professional development opportunities to work with a highly supportive, skilled, and motivated team, in the joined efforts to develop next-generation therapeutics that benefit patients globally in Oncology, Inflammation, and Metabolism.

Sr. Manager, Drug Product Manufacturing and CDMO Management

Sr Manager, Drug Product Manufacturing and CDMO Management manages contract development and manufacturing organizations (CDMOs) that produce Evive drug products in support of clinical and commercial supply to assure corporate goals regarding product development and supply are met. Responsibilities include managing CDMO business relationship, leading process development and scale up, overseeing production activities at CDMOs and providing technical support to internal and external teams. The position is in the US and works remotely.

Responsibilities

The primary duties will involve the management of manufacturing and testing activities at CDMOs including but not limited to the following: clinical and commercial manufacturing of drug product, expertise in parenteral process manufacturing activities in vials and pre-filled syringes and testing, technology transfer, process development and characterization, change management and coordination of activities at multiple CMO locations.

· Direct, oversee, or develop activities/processes at CDMOs in support of early phase clinical programs through commercial production. Act as company liaison, person in plant, or point of contact for activities at CDMOs. Support in-house laboratory R&D, process development and investigation efforts. Collaborate with development teams to coordinate CDMO support and transfer development programs to CDMOs.

· Define development pathway for CDMO activities to meet corporate goals. Consider contingencies or risk mitigation strategies and allocate resources as appropriate to ensure project milestones are met.

· Propose regulatory strategies for pre- and post-approval changes to manufacturing processes.

· Author required sections of regulatory submissions (such as IND, IMPD, BLA, CBE-30, PAS and MAA), addresses information request from health authorities, and present information at regulatory inspections/partner audits, as applicable.

· Assist in review, implementation, and documentation of change control activities internally and at CDMOs.

· Key contact person on all aspects of the drug product CDMO relationship including:

o Work with supply chain organizations at corporate and supplier to ensure manufacturing schedules and forecasts are aligned to meet corporate needs, prepare requests for proposals and statements of works, source raw materials, identify activities or events that may critically affect supply and act on or relay that information to appropriate level of management.

· Work with Quality organizations at corporate and suppliers to assure CGMP standards are met and execute agreed-to Quality performance/improvement deliverables are completed.

· Improve manufacturing methods and processes to support existing products by conducting tests to qualify process changes and return on investment evaluations. Manage changes through the appropriate Regulatory path to implementation.

· Work with Supply Chain to monitor product metrics and drive applicable improvements.

· Prepare regular written communication via protocols, reports and standard operating procedures, exception and change controls, and other document activities.

· Deliver frequent verbal and/or written communication for internal meetings and external collaborators.

Requirements

· Requires a degree in Biology, Pharmacy, Chemistry or Engineering- Bachelor’s/ Master’s degree with 7+ years of industry experience or PhD degree with 5+ years of industry experience.

· Experience in management of drug product production techniques and processing at CDMO sites.

· Experience with sterile and aseptic drug product production in vials, pre-filled syringes, and combination drug product.

· Ability to work with diverse stakeholders, both internally and at key commercial contract manufacturers.

· Strong knowledge and demonstrated practice of ICH/cGXP Guidelines and regulatory submissions.

· Detail oriented with strong written and oral communication skills, and work with others in a multidisciplinary team environment.

· Ability to troubleshoot problems, work within a team and independently under minimal supervision, and to design, develop, and execute projects. Capable of collecting and presenting statistically valid data.

· Ability to manage several projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.

· Ability to travel 10-25% within and outside of the USA as required to meet project objectives.

· Ability to work with the organizations in different time zones, such as Asia, Europe, and USA.