Contract Manufacturing Manager, APAC
Location Wanchai, Hong Kong SAR
Contract ManufacturingManager, APAC
Reports to (Job Title):
Associate Director, CMO Packaging
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Contract Manufacturing Operations (CMO) Manager, APACwill work as an integral member of the Global CMO Packaging team who have responsibility for running clinical and commercial Packaging operations, supporting BioMarinclinical and commercial programs. This role is primarily responsible for co-ordinating contract packaging activities in the APAC region to ensure commercial product supply needs are defined and met and will also work closely with the Global Supply Chain group as required for the APAC region.
Primary Responsibilities Include:
- Provides routine production support in the form of on-site visits and responding remotely to any technical challenges or issues.
- Oversee production on site and coordinates activities at the external CMO to meet BioMarin supply needs
- Lead technical transfer projects for the introduction of new products to the APAC CMO
- Work with other departments to co-ordinate product launch requirements for the APAC region
- As single point of contact for BioMarin, is responsible for managing the relationship with external organisations for resolving problems and issues as they arise. Works closely with other internal groups and coordinates across those groups as challenges arise (Supply Chain, Quality, Product Launch, and Commercial).
- Analyses inventory levels at the CMO to ensure accurate and timely reporting, optimise cost and actively maintains financial targets and budget for each external manufacturer.
- Responsible for scheduling and maintaining routine business operations meetings with each CMO. As part of these meetings the effective use of metrics and business targets are coordinated to support internal requirements.
- Identifies areas of risk and acts appropriately to mitigate or remove the risk.
- Is acutely aware of the standards by which BioMarin operates and is able to ensure that the external organisations consistently deliver product which meets that requirement
- Builds strong relationships with CMO partners and internal cross functional groups; sharing information and best practices
- Provides regulatory filing support in connection with new site introduction or new product launch.
- Collaborate with APAC partners to ensure successful delivery of APAC business goals (eg. Commercial, Quality, Marketing, Regulatory)
- Work with APAC commercial demand team and Global Supply Chain Planning group to facilitate product supply for APAC markets
- Support Global Logistics team as an in-region resource to resolve issues as required
EDUCATION / SKILLS
- A relevant third level qualification in science, engineering, business administration, or related disciplines.
- Masters or higher degree preferred.
- Fluent English & Japanese speaker required
- Proficiency in other APAC languages preferred
- A minimum of 5 years experience working in a highly regulated manufacturing environment (pharmaceutical, medical devices, etc) is required.
- Experience in CMO technical oversight will be a distinct advantage.
- Proficiency with Trackwise and with Oracle or other materials management systems is desired. Excellent general computer application skills are required.
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is an advantage.
- Working knowledge of GMP/GDP regulations is desired.
- Must have excellent written and verbal skills coupled with excellent interpersonal skills. Experience in Technical Writing is a distinct advantage.
- Must be quality oriented and possess a rigorous attention to detail, coupled with a demonstrated track record of delivering on goals and on initiative to institute change.
- Packaging experience beneficial.
- Technical knowledge of Biologics CMC, GQP, GMP and pharmaceutical-related laws and regulations in Japan
- Overall knowledge for SCM related activities, especially cold chainproducts
- Previous experience working with or liaising with the pharmaceutical and medical device agencies(PMDA) and other administrative agencies preferred
- Strong written and verbal English language skills
- Demonstrated conversational English language skills
Computer work, utilizing common software programs
Quality, Pharmacovigilance, Commercial, Legal, Distribution (GXP)Compliance, Regulatory Affairs
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