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Manufacturing Director
$ 10,000 - $ 15,000 / month
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Responsibilities
Construction and manufacturing activities
- Coordinate and manage the resources of the manufacturing team, and collaborate with the validation, engineering, and QA teams to facilitate the smooth GMP release of XDP4.
- To meet customer needs, make full use of resources, coordinate and organize production in the region.
- Ensure the production process in accordance with GMP requirements in domestic and foreign, according to the standard operating procedures, so that the quality of products can be effectively guaranteed
- Manage the daily equipment use, cleaning, self-maintenance and mold change to keep the equipment in effective operation and management.
- Constantly improve and perfect the process, equipment, methods and other to further improve the production efficiency and stabilize the quality of products and meet the continuous development needs.
- Supervise the area personnel to operate strictly according to the procedures and processes.
- To ensure the safety of production, ensure the cleanliness of the production site, formulate the corresponding management measures, guide and supervise the staff to comply with the implementation.
GMP quality management activities.
- Be responsible for the preparing and approving of cGMP documents, such as technical report, SOPs, BPRs and risk assessment report in XDP4.
- Be responsible for the audit, internal audit, complaints, product recall and deviation, change control, CAPA approval, etc. in XDP4.
- To ensure the necessary qualifications or validations are done appropriately, and to review and approve validation protocols and reports.
Operation management activities
- Ability to build a team according to the technical requirements of the responsible area.
- In order to ensure proper training for employees before starting work, develop training procedures and plans, ensure effective training for employees through appropriate procedures, develop staff skills, and make staff reserves in the area.
- To ensure the smooth implementation of new products, new equipment and new process, organize relevant employees to participate in the new process. Investigate, install and debug new equipment, coordinate to develop related operating procedures, and effectively train staff to make it go on smoothly.
- In order to maintain a good production order, ensure the normal operation of production, implement the relevant employee rules, conduct performance assessment and other effective management of employees.
- Be responsible for the WBS initiatives in XDP4, such as DM, PSP Kaizen, etc.
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
Responsibilities
Construction and manufacturing activities
- Coordinate and manage the resources of the manufacturing team, and collaborate with the validation, engineering, and QA teams to facilitate the smooth GMP release of XDP4.
- To meet customer needs, make full use of resources, coordinate and organize production in the region.
- Ensure the production process in accordance with GMP requirements in domestic and foreign, according to the standard operating procedures, so that the quality of products can be effectively guaranteed
- Manage the daily equipment use, cleaning, self-maintenance and mold change to keep the equipment in effective operation and management.
- Constantly improve and perfect the process, equipment, methods and other to further improve the production efficiency and stabilize the quality of products and meet the continuous development needs.
- Supervise the area personnel to operate strictly according to the procedures and processes.
- To ensure the safety of production, ensure the cleanliness of the production site, formulate the corresponding management measures, guide and supervise the staff to comply with the implementation.
GMP quality management activities.
- Be responsible for the preparing and approving of cGMP documents, such as technical report, SOPs, BPRs and risk assessment report in XDP4.
- Be responsible for the audit, internal audit, complaints, product recall and deviation, change control, CAPA approval, etc. in XDP4.
- To ensure the necessary qualifications or validations are done appropriately, and to review and approve validation protocols and reports.
Operation management activities
- Ability to build a team according to the technical requirements of the responsible area.
- In order to ensure proper training for employees before starting work, develop training procedures and plans, ensure effective training for employees through appropriate procedures, develop staff skills, and make staff reserves in the area.
- To ensure the smooth implementation of new products, new equipment and new process, organize relevant employees to participate in the new process. Investigate, install and debug new equipment, coordinate to develop related operating procedures, and effectively train staff to make it go on smoothly.
- In order to maintain a good production order, ensure the normal operation of production, implement the relevant employee rules, conduct performance assessment and other effective management of employees.
- Be responsible for the WBS initiatives in XDP4, such as DM, PSP Kaizen, etc.
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