Manager/Sr Manager, Contract Manufacturing Management
The Manager/Sr. Manager, Contract Manufacturing Manager, position supports the Manufacturing and Supply group by ensuring the successful manufacture of finished product, printed materials, packaging, samples and other materials for production of Heron’s products.. Manages Heron internal master production schedule to ensure timely batch disposition of products from Third Party vendors, across all programs.
Key responsibilities may include leading efforts in planning supply chain activities, liaison with CMO's, and working closely with internal manufacturing, quality, clinical materials management and project teams to ensure products are available as scheduled. Advise management of any issues which may impact project/production timelines.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Communicates critical path items and priorities to Mfg./QC/QA and provides information that allows for resource planning.
- Manages contract manufacturing and packaging, schedules as well as project management support as needed.
- Collaborates with internal cross-functional teams and CMOs to ensure that manufacturing plans are executed as intended.
- Ensures on-time and predictable delivery of products and projects at CMOs.
- Manages the operational activities (schedule, timelines) of the CMOs, ensuring cost, quality, metrics, delivery and program objectives are met. Manages operational risk at the CMOs.
- Assist the Manufacturing and Quality Team in scheduling and managing the day-to-day manufacturing activities of contract manufacturing site(s).
- Work with Quality Assurance to ensure the manufacturing of products adheres to the implemented quality systems, cGMPs and process specifications at the Contract Service Provider(s).
- Assist the Manufacturing and Technical Services with the transfer of new products/line extensions from the development stage to commercialization.
- Assembling project plans and team assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, and escalating functional, quality, timeline issues appropriately.
- Utilize project management processes and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations.
- Coordinate communication with all areas of the enterprise that impact scope, budget, risk and resources of the work effort being managed.
- BS degree in Engineering, Science or related field with a minimum of 6 years biotechnology/pharmaceutical manufacturing experience.
- Demonstrated ability to work with Contract Service Providers and accomplish company objectives through tactful encouragement and motivation.
- Direct and proven CMO and Manufacturing Operations experience, including tech transfer, validation and commercial scale production.
- Demonstrated success in project planning, resource management, and collaboration with Development, Quality and Manufacturing.
- Strong analytical and creative problem-solving skills.
- Extensive knowledge and expertise in the use of project management methodologies and tools, resource management practices and change management techniques.
- Strong knowledge and demonstrated practice of ICH/cGxP Guidelines.
- Experience preparing business processes.
- Previous experience in API or Drug Product Research, Development, Analytical/QC, Manufacturing or Supply Chain Management.
- Experience managing CMO relationships including contract reviews.
- Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationship.
- Good organizational, communication and presentation skills, effective project and time management skills with the ability to work under pressure.
- Motivated, self-directed, able to work autonomously and have a proven ability to work in a team environment.
- Proficient in Microsoft Project, Microsoft Outlook, Word & Excel.
- Must be highly organized and possess excellent attention to detail, strong oral, written, and interpersonal communication skills.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.