Director, CMC Project Management

Job Summary

Analytical focused project management role to manage Chemistry, Manufacturing, and Controls (CMC) projects to ensure follow through and completion of all quality requirements and compliance. Collaborate cross-functionally with scientific functions as well as quality assurance, regulatory affairs, and clinical supply chain teams to coordinate drug substance, drug product manufacturing and release. Provide timeline, finance, analytical and strategic guidance to internal teams and external partners, ensuring adherence to industry standards, regulatory requirements, and internal expectations while driving operational excellence in drug development and manufacturing.

Responsibilities

·        Provide project management leadership to facilitate the on-going drug substance and drug product manufacturing activities at the CDMO with focus on analytical perspectives in process validation, stability, and additional GMP production runs.

·        Provide strategy and lead the activities for solving all analytical related OOS at CMOs.

·        Provide scientific, strategic and hands-on project management to move products through drug development, clinical supply, and commercialization phases.

·        Develop and manage timelines for drug substance and drug product manufacturing activities including follow up with CMOs, inventory monitoring, invoice approval and recording, document review, and facilitating team information flow.

·        Facilitate meetings and communications between cross-functional teams including drug substance, drug product, analytical development, quality assurance, regulatory, and clinical development.

·        Actively manage the CMC budget and related activities including contracts, changes of scope, and invoices while working collaboratively with senior management, finance, legal, and CDMOs/CROs.

·        Drive all analytical activities related to technology transfer, process scale-up, validation, and manufacturing at CDMO, including final drug product assembly and release.

·        Support supply chain team to ensure shipping and final process for all drug product batches.

·        Manage the development and execution of analytical plans, master batch records, study protocols and support documentation for all manufacturing productions.  

·        Collaborate with quality assurance and regulatory affairs to facilitate development of specifications and stability programs compliant with ICH guidelines.

·        Support clinical product complaints logistics and investigations.

·        Participate in the review of external reports (batch records, analytical data, validation protocols etc.) and take appropriate action as required with focus on analytical areas.

·        Review and summarize process and batch data, conduct trend analysis, provide feedback and recommendation to assist the timely resolution of technical and/or quality issues.

·        Support authoring technical reports and CMC sections of regulatory submissions.

·        Assist in the responses to health authority questions.

Education Requirement

Bachelor’s degree or higher in Analytical chemistry, Bioengineering, Biology, Cell Biology, Chemical Engineering, Biochemistry, Pharmacology or other relevant scientific discipline or equivalent experience.

Qualifications

·        12 years of related experience in a pharmaceutical or biotechnology company working in an Analytical Development, Quality Control function or Drug Substance/Drug Product manufacturing within an outsourced model partnering with CMOs and/or CDMOs.

·        5 years CMC project management experience involving process development for biologics, preferably monoclonal antibodies including prefilled syringes, vials, and other combination products.

·        Strong analytical background and hands-on experience in managing assay development, transfer, validation and QC activities during biologics manufacturing processes is required.

·        Demonstrated understanding of the principles and practices of biologics manufacturing.

·        Understanding of late phase drug substance and drug product development and process scale-up to support tech transfer activities for biologics. 

·        Strong knowledge and hands-on experience with analytical methods for biologics and device function is required.

·        Working knowledge of GMP, regulatory guidance, and compendial requirements, including FDA, EMA, ICH, WHO, USP-NF and EP.

·        Excellent interpersonal and team collaboration skills.

·        Ability to think critically and work independently.

·        Desire to work in a quickly changing and fast-paced growing business.

·        Dedication to delivering results and a desire to shape the strategic goals of the business.

·        Ability to overcome ambiguity and challenge the status quo.

·        Manage multiple priorities programs with competing and aggressive timelines.

·        Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including executive level stakeholders.

Salary Range: $210,000 - $240,000