Associate Director/Director, Manufacturing & Development
Manages contract manufacturing organizations (CMOs) that produce Heron Drug in support of CTM and commercial supply. Responsibilities include managing CMO business relationship, overseeing production activities at CMOs and providing technical support and troubleshooting.
ESSENTIAL DUTIES & RESPONSIBILITIES:
The primary duties will involve the management of manufacturing activities at CMO’s and/or contract laboratories including but not limited to the following: drug product, clinical and commercial manufacturing of novel formulations, expertise in parenteral process manufacturing activities, technology transfer, process development, change management and coordination of activities at multiple CMO locations.
Additional responsibilities will include:
- Manage, oversee, or develop activities/processes at CMO’s in support of early phase clinical programs through commercial production. Act as company liaison, person in plant, or point of contact for requested activities at CMO or contract laboratories. Support in-house laboratory R&D, process development and investigation efforts. Collaborate with pharmaceutical development teams to transfer development programs to CMO’s.
- Assist in regulatory filings, such as addressing questions from health authorities, and with presentations of materials during regulatory inspections/partner audits, as applicable. Assist in review, implementation, and documentation of change control activities internally and at CMO’s.
- Key contact person on all aspects of the drug substance CMO relationship including:
- Manufacturing: 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.
- Quality: Work with Quality organizations at corporate and suppliers to assure GMP standards are met and execute agreed-to Quality performance/improvement deliverables are completed.
- Legal/contractual: Enforcement of contractual commitments by the company to the supplier and the supplier to the company.
- Financial: Assure that the financial terms and conditions of the company-supplier relationship are being met by both parties.
- Improve manufacturing methods and processes to support existing products by conducting tests to qualify process changes. Shepherding the changes through the appropriate Regulatory path to implementation.
- Preparation of performance objectives for supplier and company. Monitor and report on trending of important performance indicators and interpretation of data summaries.
- 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.
- Requires a degree in Biology, Pharmacy, Chemistry or Engineering- Bachelor’s/ Master’s degree with 10+ years of experience or PhD degree with 5+ years of experience.
- Experience in management of drug product production techniques and processing at CMO sites.
- Experience with sterile and aseptic drug product production in vials and pre-filled syringes.
- 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 a number of projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.
- Ability to travel 10-40% as required to meet project objectives.
The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.