Associate Director, Drug Product Manufacturing & CDMO Management
Our client is a global biologics company. They have asked us to assist them in a search for an Associate Director, Drug Product Manufacturing & CDMO Management.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Directs, oversees, or develops activities/processes at CDMOs in support of early phase clinical programs through commercial production. Acts as company liaison, person in plant, or point of contact for activities at CDMOs. Supports in-house laboratory R&D, process development and investigation efforts. Collaborates with development teams to coordinate CDMO support and transfer development programs to CDMOs.
- Proposes regulatory strategies for pre- and post-approval changes to manufacturing processes.
- Authors required sections of regulatory submissions (such as IND, IMPD, BLA, CBE-30, PAS and MAA), addresses information request from health authorities, and presents information at regulatory inspections/partner audits, as applicable.
- Assists in review, implementation, and documentation of change control activities internally and at CDMOs.
- Works with supply chain organizations at corporate and supplier to ensure manufacturing schedules and forecasts are aligned to meet corporate needs, prepares requests for proposals and statements of works, sources raw materials, identifies activities or events that may critically affect supply and acts on or relays that information to appropriate level of management.
- Works with Quality organizations at corporate and suppliers to assure CGMP standards are met and execute agreed-to Quality performance/improvement deliverables are completed.
- Improves manufacturing methods and processes to support existing products by conducting tests to qualify process changes and return on investment evaluations. Manages changes through the appropriate Regulatory path to implementation.
- Works with Supply Chain to monitor product metrics and drive applicable improvements.
- Prepares regular written communication via protocols, reports and standard operating procedures, exception and change controls, and other document activities.
- Delivers frequent verbal and/or written communication for internal meetings and external collaborators.
- Requires a degree in Biology, Pharmacy, Chemistry or Engineering. Master’s degree with at least seven years of industry experience or a PhD degree with at least five years of industry experience is required.
- Experience in management of drug product production techniques and processing at CDMO sites is required.
- Must have experience with sterile and aseptic drug product production in vials, pre-filled syringes, and combination drug product.
- The ability to work with diverse stakeholders, both internally and at key commercial contract manufacturers is required.
- Strong knowledge and demonstrated practice of ICH/cGXP Guidelines and regulatory submissions is required.
- Must be detail oriented with strong written and oral communication skills, and work with others in a multidisciplinary team environment.
- Requires the ability to troubleshoot problems, work within a team and independently under minimal supervision, and to design, develop, and execute projects. Must be capable of collecting and presenting statistically valid data.
- Must have the ability to manage several projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.
- Must have the ability to travel 10-25% within and outside of the USA as required to meet project objectives.
- The ability to work with the organizations in different time zones, such as Asia, Europe, and USA is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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