Job Summary (Primary function):
The job is based in Wilmington Delaware, US.
Essential Functions of the Job (Key responsibilities):
• Design and develop phase appropriate process/manufacturing to support preclinical and clinical studies.
• Lead in RFP writing, technical transfer, process and method development, optimization, qualification, validation, and activities related to all manufacturing operations.
• Evaluate third-party manufacturers by working with Quality Assurance and Regulatory Affairs, negotiate effective supply/technical agreements.
• Work closely with contract manufacturers (CMOs), Supply Chain leads, Quality and operations partners to ensure supply continuity with optimal cost and quality.
• Manage Interactive Response Technology (IRT) systems from specification, user acceptance testing and release to support randomization and management of CTM.
• Manage investigation, reporting and communication of outcomes from temperature excursions, product complaints, etc.
• Design and oversee execution of drug product activities in preparation for registration and validation, and commercial activities.
• Manage and execute Primary/Registration batch manufacturing aligned with regulatory filings.
• Participate in cross functional project teams for product development as CMC functional area representative.
• Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator’s Brochure and Pharmacy Manual.
• Ensures that key project milestones and schedules are met.
• Manage consultants, vendors, and CDMOs to meet agreed upon program timelines/budgets.
• Travel to various CDMO sites (20%).
• Other projects as assigned.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- PhD/MS/BS in Biochemistry, Chemical Engineering, or related field with a minimum of 10 years of experience in biopharmaceutical industry.
- Hands-on experience working in a cleanroom environment and in drug product manufacturing of biologics.
- Experience and knowledge in the entire drug product manufacturing process, from drug substance thawing and compounding, sterile filtration, filling, stoppering, lyophilization, capping, to visual inspection and labeling.
- Familiar with filtration systems, filling lines, filling isolators, and environmental monitoring.
- Experience in CDMO management and working closely with the Quality Assurance and Clinical Supply Chain Management functions.
- Experience in risk management, deviation and root-cause investigations and CAPAs.
- Experience in writing CMC sections of IND and BLA.
- Experience in formulation development, lyophilization cycle development, drug product process characterization and validation, equipment validation, and cleaning validation are highly desired.
- Must be proactive, detail-oriented, collaborative, and able to work effectively in a fast-paced environment with minimal supervision.
- Excellent communication, organization, and collaborative skills are essential.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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