Director - Engineering - Acorda - Chelsea

Job description
The Director - Engineering directs the design and scale-up of manufacturing processes, instruments and equipment at the late stage/commercial scale. This individual manages the development, implementation and maintenance of process methods and equipment for the production of pharmaceutical intermediates and products to achieve cost effectiveness and improved product quality. The Director – Engineering plans the implementation of new process formulas, establishes operating equipment specifications and may improve manufacturing techniques and new process equipment production.
Acts as liaison with process development/technical operations to ensure processes and designs are compatible.

*Essential Duties and Responsibilities: include the following. Other duties may be assigned.

Engineering Management
Oversees the development and maintenance of the Engineering Function including the establishment of Good Engineering Practices.
Assumes technical ownership of all Direct Impact processes and utilities including spray drying, capsule filling, blister packaging, and clean utilities.
Responsible for the implementation of capital projects including project specification, engineering design, construction management, and commissioning.
Drives collaboration with the process development/technical operations group during equipment selection, process development activities, technology transfer, scale up, PAR studies, and process validation.
Production Support
Provides technical support for the transformation of raw materials into intermediates, work in process materials, drug substance and drug product.
Manages the troubleshooting and resolution of technical problems to support the manufacturing schedule.
Makes recommendations for continuous improvement of Direct Impact equipment and utilities.

Compliance Management
Provides leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards.
Ensures robust quality event management system execution, including that deviations / investigations are resourced and completed on time, and CAPA are thoughtfully initiated and precisely executed.
Assesses revisions to and conducts gap assessments against manufacturing / production corporate standards; proactively drives actions and projects to close gaps.
Ensures engineering staff is always inspection ready by participating in a comprehensive manufacturing inspection readiness program.
Partners with Manufacturing and Quality leadership to ensure manufacturing instruction set and production records reflect best practices, are aligned to cGMPs and corporate standards, and that executed records are reviewed in a consistent and timely manner.
Safety Management
Ensures the safety of manufacturing areas and work practices in accordance with the site EH&S program.
Provides ongoing feedback, development and performance reviews of staff.
Assists with talent recruitment and leads a highly motivated, efficient and effective team.
Responsible for training and mentoring associates in the Manufacturing department.
Education and/or Experience:
Bachelor’s degree in a scientific or engineering field or related discipline and a minimum of 8-12 years of relevant experience required.
Master’s degree in a scientific or engineering field or related discipline and 5-10 years of relevant experience preferred.
Prior supervisory experience required.
Experience working in a FDA regulated operation required.
Supervisory Responsibilities:
This individual manages a team of engineers.
Qualifications:
Knowledge of Good Engineering Practice requirements required.
Computer Skills:
Must be proficient in MS Office Suite.
Certificates, Licenses, Registrations: none required

Other Skills And Abilities

Excellent written and oral communication and presentation skills.
Ability to manage both day-to-day operations as well as project work in a fast paced environment.
Ability to work both independently and in a collaborative team setting.
Ability to multi-task and adjust priorities, as necessary.
Excellent organization skills with attention to detail.
Demonstrated ability to stay abreast of trends and new information in the profession.
Demonstrated leadership and project management skills.
Demonstrates appropriate safety consciousness.

Physical Demands

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives.
Must have the ability to lift up to 50 pounds.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Must be able to work in a controlled or clean room environment requiring special gowning.

Enter your email address:

Refer This Job To Your Friends And Help Them To Find Jobs!