Manufacturing Director
2 weeks ago
Responsibilities
Production Delivery and Operational Leadership:
- Oversee the day-to-day operations of the mAb intermediate and bioconjugation drug substance facility, leveraging Daily Management approaches, ensuring production schedules are met while maintaining compliance with cGMP, FDA, EMA, and other regulatory requirements.
- Manage and optimize manufacturing processes, including upstream (cell culture), downstream (mAb purification) and bioconjugation processes operations, to ensure high yield, quality, and efficiency.
- Ensure timely delivery of bulk drug substances to meet clinical and commercial demands.
Team Management:
- Recruit, lead, mentor, and develop a high-performing team of manufacturing professionals, including managers and engineers.
- Foster a culture of PROUND, WBS, quality, and continuous improvement within the team.
- Conduct performance evaluations, provide coaching, and ensure training to enhance team capabilities and be comply with GMP requirement.
Safety, Compliance, and Quality:
- Ensure all personnel behaviors are comply with company EHS policies and local safety regulatory guidelines.
- Ensure all manufacturing activities comply with cGMP, and regulatory guidelines.
- Collaborate with MSAT, QA and QC teams to resolve deviations, investigations, change control and CAPAs, etc. in a timely manner.
- Participate in regulatory inspections and audits, ensuring readiness and addressing findings effectively.
- Organize and collaborate with relevant functions (QA, QC, WH, etc.) on initiating and keep updating all levels of quality risk assessment.
Process Improvement:
- Identify and implement process optimization initiatives leveraging WBS methodologies to improve yield, reduce costs, and enhance operational efficiency.
- Stay abreast of industry trends and technological advancements in antibody and bio-conjugates manufacturing, and evaluate their potential application within the facility.
- Lead or support technology transfer, process design and implementation activities for new products or processes.
Budget and Resource Management:
- Develop and manage the team budget (including HC and expense), ensuring cost-effective utilization of resources.
- Oversee the procurement, utilization, and maintenance of equipment, ensuring operational readiness and compliance with regulatory standards and company policies.
Cross-Function/Department Collaboration:
- Work closely with PD, CMC, BD, PM, MSAT, QA, QC, WH, SCM, SAS, IT, etc. to ensure alignment on manufacturingoperations, production goals and timelines.
- Support new product introductions and scale-up activities by providing manufacturing expertise and resources.
Other assignment from leadership:
- Execute and support other assigned task or taskforce from leadership, to meet the evolving needs of the organization
Requirement
- Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field. Advanced degree (MS, PhD, or MBA) preferred.
- Minimum of 10 years of practical experience in pharmaceutical manufacturing, with at least 8 years in a leadership role overseeing antibody or bioconjugate drug substance production
- Familiar with FDA/China/EU and ICH GMP requirements.
- Master of cell culture, downstream purification, and bio-conjugation processes. Be familiar with technology transfer and process fit analysis.
- Be familiar with new facility (drug substance) design and construction. With good understanding on DQ, FAT, SAT, IQ, OQ, PQ (commissioning and qualification).
- Experienced in interaction with regulatory agencies (e.g. FDA, EMA and NMPA), and have solid understanding of quality system in terms of deviation investigation, CAPA and change control, etc.
- Excellent Leadership and team management skills, with the ability to motivate and develop staff
MES
Biochemistry
CAPA
FDA
Bioconjugation
Technology Transfer
Quality System
WBS
Cell Culture
Purification
Manufacturing Operations
Biology
Change Control
Process Optimization
Manufacturing
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