Associate Director, Manufacturing Science and Technology (Drug Product)

Overview:

Aviceda Therapeutics is seeking an Associate Director of Manufacturing science and Technology – Drug Product to play operational and strategic leadership to the Drug product programs within Technical Operations to support the development and optimization of Aviceda’s clinical and commercial programs. The candidate will report to the Head of Technical Development and will coordinate process development, scale-up, and technology transfer to manufacturing sites, including managing operations and coordinating with Contract Manufacturing Organizations. Their responsibilities are critical to ensuring the consistent delivery of high-quality drug products for clinical and commercial use, adhering to stringent regulatory standards.

Summary of Key Responsibilities:

·       Evaluates external vendors/resources necessary to ensure the successful execution of drug product supply plans, creates Requests for Proposals (RFPs), participates in contract negotiations and facilitates the execution of legal documents required to engage the vendor’s services.

·       Coordinates activities related to manufacturing, packaging, and labeling, ensuring adherence to GMP and ICH guidelines.

·       Accountable for person-in-plant (PIP) technical support staff during manufacturing. Provides production process troubleshooting including travel to CMOs to monitor production of drug product; interfaces with CMOs and internal departments to facilitate the manufacture and release of drug product.

·       Manages and executes activities related to drug product technology transfer, validation and process improvements to manufacturing partners.

·       Leads process validation lifecycle initiatives, including process performance qualification and continued process verification studies. Collaborates with Process Development in establishing risk assessments, process design/characterization, and process control strategies.

·       In close collaboration with the internal and external manufacturing teams, assists with troubleshooting or investigations related to the manufacturing processes. Works directly with manufacturing and quality teams to author deviations, non-conformances, and CAPAs as required. Partners with Quality function(s) to address these issues efficiently, effectively, and compliantly.

·       Monitors existing vendors' activities. This includes, but is not limited to, reviewing vendor batch records, randomization files, label copies, variable text documentation, change orders, distribution procedures and invoices.

·       Assists in the identification, development and implementation of policies, procedures and standards which impact the department, while working to ensure compliance with applicable regulatory requirements.

·       Coordinates the authoring, reviewing, execution and issuance of drug product process development, registration and validation protocols and reports; supports the authoring and review of the manufacturing-related sections of regulatory submissions (domestic and international).

·       Manages the execution of experiments and studies in support of root cause investigations and product/process impact assessments.

·       Ensures documentation (batch records and SOPs) is accurate and updated as required.

·       Authors and reviews relevant drug product CMC sections for global regulatory submissions (IND/CTA, NDA, MAA etc).

·       Monitors, analyzes, trends, and reports process performance and manufacturing data to identify continuous improvement and robustness initiatives.

·       Actively identifies, recommends, and implements opportunities for continuous improvement.

·       Performs other tasks and assignments as needed and specified by management.

Qualifications:

·       MS or PhD in Pharmaceutical sciences, Chemical Engineering or related field with minimum of 5 years of experience in the pharmaceutical or biotech industry.

·       Demonstrated knowledge/experience with development and manufacturing of sterile dosage formulations, including direct experience with nanoparticles, microparticles, and related drug delivery technologies strongly preferred.

·       Excellent knowledge of GMP and ICH guidelines related to clinical and commercial labeling, and packaging operations and the overall drug development process.

·       Demonstrated experience with process validation and regulatory requirements. NDA / MAA/ ANDA filing experience is preferred.  

·       Demonstrated experience with scale-up and optimization of lab procedures up to commercial scale under GMP conditions.

·       Demonstrated knowledge and application of Pharmaceutical Quality by Design (QbD) principles.

·       Experience overseeing/managing CDMOs conducting clinical and commercial manufacturing.

·       Demonstrated ability to motivate and mentor peers and technical staff at CDMOs by fostering a culture of continuous improvement and operational excellence.

·       Demonstrated expertise in the development of project plans for manufacturing transfers, including the ability to manage multiple projects.

·       Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

·       Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

·       Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

·       Experience working with both domestic and international CMOs.

·       Travel requirements: up to 25%

Aviceda Therapeutics is an equal opportunity employer offering competitive cash and stock compensation, excellent employee benefits, and the opportunity for personal and professional growth in an outstanding and intellectually challenging environment.

Salary : $160,000