Manufacturing Director
1 week ago
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
MES
Biochemistry
CAPA
FDA
Bioconjugation
Technology Transfer
Quality System
WBS
Cell Culture
Purification
Manufacturing Operations
Biology
Change Control
Process Optimization
Manufacturing
-
Manufacturing Director
3 weeks ago
Singapore Fortitude Partnership Full timeManufacturing Director Petrochemical IndustryKey Responsibilities:In this role, you will be responsible for the Jurong Island Singapore production site provide day-today leadership and management of the manufacturing plant to ensure compliance with company objectives, quality systems, and customer expectations. (Must have prior Jurong Island Experience)The...
-
Manufacturing Director
2 weeks ago
Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full timeRoles & ResponsibilitiesResponsibilitiesProduction 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. ...
-
Senior Regional Director
3 weeks ago
Singapore PANASONIC ASIA PACIFIC PTE. LTD. Full timeRoles & ResponsibilitiesRoles & ResponsibilitiesOverall responsibility and accountability for formulating and executing the business strategies across the company's operations in Singapore and Indonesia. Actively contributes to business decisions as a Board of Directors member, offering insights into key organizational changes to drive growth and...
-
Operations Director
5 days ago
Singapore GALA FOOD PTE. LTD. Full timeRoles & ResponsibilitiesJob Summary: As the Director of Food Manufacturing and Restaurant Operations, you will play a pivotal role in overseeing the seamless integration of food manufacturing processes and restaurant operations. This multifaceted position involves strategic planning, production management, quality control, and coordination with restaurant...
-
managing director
3 weeks ago
Singapore JIAJIAJIA MANAGEMENT PTE. LTD. Full timeRoles & ResponsibilitiesKey responsibilities:Lead the strategic direction of the company's operations in Singapore, aligning with the global vision and goals from HQ Develop and execute long-term business plans that support growth, market expansion, and profitability. Identify new business opportunities, markets, and potential partnerships in Singapore and...
-
MANAGING DIRECTOR
3 weeks ago
Singapore JIAJIAJIA MANAGEMENT PTE. LTD. Full timeRoles & ResponsibilitiesKey responsibilities: Lead the strategic direction of the company’s operations in Singapore, aligning with the global vision and goals from HQ Develop and execute long-term business plans that support growth, market expansion, and profitability. Identify new business opportunities, markets, and potential partnerships in Singapore...
-
director
5 days ago
Singapore HANG YICK ITRADING PTE. LTD. Full timeRoles & ResponsibilitiesJob Description:The Director mainly needs to organize and oversee all daily operations of Hang Yick iTrading. He/She will be the one to ensure the company business is well-coordinated, productive, efficient and profitable by using his/her knowledge as well as experience to facilitate accelerating development and long-term success....
-
Singapore DHL SUPPLY CHAIN SINGAPORE PTE. LTD. Full timeRoles & ResponsibilitiesResponsibilitiesLead, develop and leverage constructive relationships within target accounts to gain access to key decision makers and establish coach network Support and coach local sales/ account teams in the pursuit of local opportunities. Lend SME knowledge as needed Lead & develop sub sector strategies for key focus areas. Tie...
-
Business Development
3 weeks ago
Singapore GENIC (SINGAPORE) PTE. LTD. Full timeRoles & ResponsibilitiesDuties and ResponsibilitiesAs a business development, you will be reporting to the Director. Your principal duties include but are not limited to the following:· Maintain organized sales records and report month-end goal-setting to the senior management team.· Support management by completing orders and keeping customers informed of...
-
Technical Director
5 days ago
Singapore RONNIE & KOH CONSULTANTS PTE. LTD. Full timeRoles & Responsibilities1) Civil & Structural Consulting Engineering firm looking for the right candidate to fill the post of Technical Director.2) Minimum Master and/or Degree in Civil / Structural Engineering, 3) Registered Professional Engineer in Singapore or a qualification registrable with the PE Board of Singapore 4) Candidate is expected to manage...
-
R&D Director
2 weeks ago
Singapore ASMPT SINGAPORE PTE. LTD. Full timeRoles & ResponsibilitiesASMPT is a global leader in semiconductor and electronics assembly solutions, driving cutting-edge innovation in Advanced Packaging technologies. Our Singapore R&D center plays a critical role in pioneering next-generation solutions for high-performance semiconductor applications.R&D DirectorWe are seeking an experienced R&D Director...
-
Finance Director
5 days ago
Singapore MICHAEL PAGE INTERNATIONAL PTE LTD Full timeRoles & ResponsibilitiesExposure to global operations with the chance to lead cross-border teams Involvement in strategic decision-making for their global operationsAbout Our ClientOur client is a well-established leader in precision engineering with over 50 years of experience. With significant investment in R&D, our client provides exposure to...
-
Director of Quality Assurance
2 days ago
Singapore GenScript Full timeProBio OverviewProBio is a state-of-the-art Contract Development and Manufacturing Organization (CDMO) providing end-to-end services from drug discovery to commercialization. We leverage our expertise in cell and gene therapy, vaccine, biologics discovery and antibody protein drug development to accelerate customer success.Quality Management at ProBioThe...
-
Human Resources Director
3 weeks ago
Singapore WORLD METAL RECOVERY PTE. LTD. Full timeRoles & ResponsibilitiesHuman Resources DirectorReporting directly to higher management, you will lead a team of Human Resource Business Partners to identify, develop, and drive key initiatives which include talent acquisition, talent/performance management, workforce and succession planning, manpower review, industrial relations as well as rewards and...
-
Singapore ROBERT HALF INTERNATIONAL PTE. LTD. Full timeRoles & ResponsibilitiesThe CompanyOur client is a leading US multinational in the manufacturing industry seeking an experienced Regional Financial Controller to oversee their finance and accounting operations across Southeast Asia.The RoleReporting to the Global Finance Director at HQ, you will lead a regional team and play a key role in financial planning,...
-
Regional Sales Director
3 weeks ago
Singapore RANDSTAD PTE. LIMITED Full timeRoles & ResponsibilitiesAbout the companyOur client is a global leader in delivering advanced technology solutions to industries such as telecommunications, aerospace, automotive, and manufacturing.As part of their succession planning, they are seeking an experienced and dynamic Regional Sales Director to drive their sales strategy at an organizational...
-
Business Development Director
3 weeks ago
Singapore STAFFKING PTE. LTD. Full timeRoles & ResponsibilitiesIndustry: Precision Engineering (Medtec)Target Sector: MedtechLocation: East Overview:This is a director position of Business development/Sales that required to lead efforts in expanding company's precision engineering solutions tailored to the Medtech sector (Supporting the company's business development mainly for the growth within...
-
Senior Director Operations
5 days ago
Singapore VANTIVE PTE. LTD. Full timeRoles & ResponsibilitiesYour Role at Vantive:The Senior Director - Quality Solutions for Kidney Care segment is accountable for implementing the mid-long term strategy, leading and directing all of the quality resources to support the new product development projects, commercialized products and to maintain and improve the compliance profile of the...
-
Regional Finance Manager
3 weeks ago
Singapore PEOPLE PROFILERS PTE. LTD. Full timeRoles & ResponsibilitiesSummary :We are seeking a highly skilled and experienced Regional Finance Manager to oversee the financial operations of our company's regional offices.A strong background in finance and accounting, excellent leadership skills, and a strategic mindset to drive the company's financial performance.Responsibilities:- Develop and...
-
Marketing Director
5 days ago
Singapore SHOPSENSE PTE. LTD. Full timeRoles & ResponsibilitiesJob Description:We are looking for an experienced and dynamic E-Commerce Marketing Director to lead our online business growth. The ideal candidate will have strong resources in both China and Singapore and a proven track record in driving e-commerce sales, brand visibility, and strategic marketing initiatives.Key...