The Director - Technical Operations leads CMC efforts for Acorda projects/products from phase 2 development through commercialization, collaborating with departments across the organization through Acorda's Project Management system. This individual serves as the primary technical resource working with Acorda Regulatory Affairs (RA) and Quality Assurance (QA) to ensure Acorda drug product quality and CMC regulatory compliance throughout the life of the product. PLEASE REFER TO JOB CODE 1213 WHEN APPLYING FOR THIS POSITION.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.:
• Identifies, plans and implements CMC activities required for the development of drug product from phase 2 through commercialization.
• Responsible for design and management of stability programs as per ICH guidelines for products in development and commercial products.
• Identifies, selects and manages vendors that will perform manufacturing, packaging, testing, storage and distribution for phase 2 and phase 3 development programs.
• Collaborates with R&D on phase 1 and preclinical development, ensuring a smooth transfer into phase 2.
• Partners with colleagues in Technical Operations and RA to prepare information required for IND/NDA/BLA submissions.
• Works together with QA, by providing timely and thorough technical input for investigations of manufacturing/packaging deviations and laboratory OOS reports.
• Establishes drug product specifications, in collaboration with Acorda RA and QA.
• Reviews and approves analytical methods, plans and reports as well as manufacturing and packaging batch records.
• Conducts technical audits of contract manufacturers/packagers and contract laboratories in conjunction with QA ensuring conformance with Acorda policies, regulatory submissions and applicable regulatory requirements.
• Works with Finance and Legal departments ensuring adherence to Acorda procedures used for the management of vendors.
• Conducts thorough technical due diligence on new business development opportunities and, works with an interdisciplinary team, to provide opinions and guidance to senior management.
• Assists the Commercial Team in developing packaging and labeling schemes for products.
• Collaborates with Acorda designees and contractor representatives for the development of technical work plans in conformance with technical and business requirements.
• Contributes to the development of corporate policies and SOPs with impact on Technical Operations responsibilities and related activities.
Education and/or Experience::
• Bachelor's degree in Chemistry, Pharmacy, Engineering or a relevant technical field required.
• Ph.D. degree in Chemistry, Pharmacy, Engineering or a relevant technical field preferred.
• Minimum of six to eight years pharmaceutical or biotechnology industry experience within a technical capacity.
• Advanced understanding of GMP's, GCP's, ICH guidelines and applicable regulatory requirements is required.
• Familiarity of current technical standards applicable to pharmaceutical manufacturing and QC laboratories.
• Ability to apply basic statistical methods for tracking, trending and reporting data on manufacturing metrics.
• Must be proficient in Microsoft Office Suite.
• Proficient in data analysis software such as Excel, Stability System, etc.
• Familiar with the use of document management systems such as DocCompliance.
• Prior experience with Project management software preferred.
Certificates, Licenses, Registrations::
Other Skills and Abilities::
• Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate.
• Excellent writing, communication, and presentation skills
• Ability to handle several projects at once, while paying close attention to details.
• Must be self motivated, able to work autonomously and have a proven ability to work in a team environment.
• Demonstrated leadership and project management skills.
Location: Corporate Office:
This position requires the ability to work on-site 5 days per week in the corporate office located in Ardsley, NY.
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.
• The average travel for this position is 15-20% with some variation based upon time of the year and demands of business imperatives. Travel is for monitoring or audits of vendors and troubleshooting.
• Some site visits may require the use of personal protective equipment.
Work Environment: :
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• No specific work demands.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.