We are seeking a Director or Sr. Director-level Biologics CMC Lead to drive the company's biologics pipeline projects related to neurological disorders. It is a new function established to plan, coordinate, and deliver large molecular CMC activities in line with project requirements and company prioritization. This position partners with Project Leaders, and other functions such as Research, Clinical, Operations, and Regulatory to manage CMC activities globally. Successful candidate is expected to use a variety of cellular, molecular biology and biochemical knowledge, and the latest CMC technical, regulatory and project management experience to transition new candidates into CMC development to enable human clinical trials.
What you will love about this Opportunity A fast-growing company with great career advancement potential.
Great team and great science. You will be working with world-renowned neuroscientists and senior leaders from large pharma/top CRO/CDMO and top academic medical centers with solid scientific, industrial, and managerial experience.
A company operating mainly in the US with a global footprint which could be a great learning experience to develop skills in a multi-national environment.
A collaborative organization with cross-team communications internally covering different business units, and locations and externally with vendors, partners, etc.
Key responsibilities: Partner with the Executive Team for overall CMC strategic planning
Be accountable for delivering Biologics programs in line with both CMC strategies and Portfolio priorities
Manage all CMC activities such as CMC project planning, budgeting, CMC vendor sourcing and contracting, capability building, IND preparation and filing, CTM supplies etc.
Utilize project management approaches to manage CMC project timelines, coordinate planning, preparation, and resources for CMC campaigns, evaluate timing, risks, and issue management, ensuring project deadlines and performance metrics are met
Subject matter expert (SME) for CDMO vendor assessments, vendor management and quality audits
Act as the sponsor representative collaborating with CROs and CDMOs for the manufacture, packaging, labeling, and blinding of clinical supplies, manage CTS shipping and returns; maintain CTS inventory system; unblind clinical trials
Manage CMC-related SOPs, plans, policies, and other documents and support QC oversight
Reviews and may be responsible for approving all specifications and master production instructions, approving all procedures impacting the quality of intermediates, DS/DP, and CTS
Work with QA expert to conduct product quality reviews, manage quality incident investigations, deviations, corrective and preventive action (CAPA) plans
Ensure CMC risks are identified proactively, and mitigation plans are executed as required.
Complete CMC sections for regulatory submission.
Core Qualifications and Experience A Bachelor's degree in life science or a related field with at least 10 years of experience in pharmaceutical, biotechnology, or a related industry
OR a Master's degree in life science or a related field with at least 8 years of experience in pharmaceutical, biotechnology, or a related industry
OR a Ph.D. with at least 6 years of experience in pharmaceutical, biotechnology, or a related industry is required.
Large Molecule CMC experience is required.
Prior hands-on experience in one or more of the following IND enabling activities: upstream/downstream CMC process, bioanalytical and QC/QA process, formulation, or DS/DP interface experience.
Well-rounded knowledge inflows/sequence and contents of CMC activities and regulatory requirements along with product development and life cycle management
Solid track record of CMC Biologics project delivery.
Minimum 3 years project management experience
Familiarity with FDA-regulated CMO environment, including manufacturing of DS/DP, labeling, CTS etc.
Demonstrated ability to set and lead priorities, resources, performance targets, and project initiatives in a global and regional environment.
Strength in building collaborative working relationships with colleagues and stakeholders.
English-Mandarin bilingual and effective communication skills (oral and written).
Desired Additional Experience Familiarity with FDA submissions or experience with CMC submissions is a good plus.
CMC regulatory writing skill is a good plus.
Having CDMO experience is a good plus.
