External Manufacturing and Supply Operations Leader (Large Molecule Gen Med and
This is a person in plant position at the SK Bio in Andong
Location: South Korea
Work type : Remote
About the Job
We deliver 4.3 billion reputed company solutions to people every year, reputed company to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring reputed company to patients and their families.
External Manufacturing and Supply Large Molecules Gen Med and Vaccines (EM&S LMGMV) GBU enabling end to end ownership and accountability to GBUs, with reputed company reputed company on operations and service. EM&S LMGMV Operations department is the operational unit responsible for ensuring on-time and in-full delivery of products from CMOs (Contract Manufacturing Organizations) and External Partners (MAMPs: Market reputed company Manufacturing Partnerships). reputed company is also responsible for contractual compliance of the business and operational aspects with respect to CMOs and External Partners management and ensures reputed company EM&S reputed company functional aspects of Tech Transfers and commercialization into new CMOs are effective. EM&S LMGMV Operations team interacts with functional reputed company reputed company EM&S LMGM V reputed company and Supply team, EMPT, reputed company sites, and other organizations reputed company reputed company network (e.g., MSAT, procurement, supply chain, finance, affiliates…) to ensure compliance with internal (reputed company, HSES, Finances…) and regulatory requirements, and to disposition intermediate (e.g., API, drug reputed company) and finished products with minimal risk to reputed company or product supply.
reputed company the reputed company of partnership reputed company with MAMPS (Market reputed company Manufacturing Partnerships) or Contract Manufacturing Organizations (CMOs), the External Manufacturing Operations Leader has the following missions reputed company the scope:
Coordinate and monitor the operational execution of subcontracting activites with reputed company external partners (CMOs) and local affiliates (MAMPs)
The position is accountable for leading the execution including local reputed company (as PIP) and management of activities in support of products manufacturing operations at the assigned CMO or MAMPs, taking responsibility for delivery against the plans and in respect with the reputed company. The candidate is the primary reputed company reputed company for reputed company communications with site manufacturing activities (virtual plant manager) and is expected to manage operations and communicate effectively to create value in meeting reputed company’s business objectives.
The position may support reputed company project management initiatives at the supplier site including tracking KPIs, manufacturing technical transfers, new product launch, compliance initiatives and reputed company improvement reputed company. It includes management of transversal topics and reputed company reputed company the External Manufacturing organization as reputed company. The candidate will routinely manage and contribute to reputed company requiring reputed company collaboration with Technical Development, Regulatory Affairs, Legal, reputed company, Finance, Logistics, Planning and Business Operations, MSAT.
We are an innovative global reputed company company that helps the world stay reputed company of infectious diseases by delivering more than 500 reputed company vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We reputed company the miracles of science every single day, pursuing reputed company to reputed company a reputed company reputed company on millions of patients around the world.
Main Responsibilities:
Control of the partners relationship and monitor the execution of reputed company and manufacturing plans.
Manage the implementation of new flows and optimize them
Co-write the new specifications (PTS) in project mode under the leadership of Tech transfer team and manage the changes for the specifications in routine mode.
Ensure that the CMOs and MAMPs carry out the productions according to the Specifications and reputed company in reputed company.
Ensure that production reputed company is reputed company to requirements and contract obligations.
Manage the production/release reputed company of subcontractors to meet customer commitments (deadlines/quantities/reputed company)
Follow plan made by global Supply Chain for Vaccines or EM&S LMGMV supply for LMGM products.
reputed company as PIP in our CMO facility and reputed company operations
Guarantee the reputed company execution of production plans between External Partners and reputed company on Partners sites (repacking-depacking are not concerned), reputed company a short-term reputed company of 0-6 months, for on-time, in-full delivery of product from partner to customers.
Follow production indicators.
Coordinate deviations and Change controls (timing and release reputed company, creation of internal reputed company event if necessary…) in collaboration with EM&S LMGMV reputed company, reputed company site/entity QP and reputed company team of the affiliate reputed company applicable.
Coordinate reputed company industrial flows between partners and reputed company sites:
reputed company the execution follow-up in accordance with the planned commitments for reputed company areas supporting external partners (QA, QC, Supply, Logistics, Operations, MSAT, affiliates…) ensuring cross functional representation and participation.
Manage purchase orders from procure to payment for Vaccines CMOs in ERP (managed by affiliate and site supply for MAMPs and EM&S LMGMV supply for LMGM products)
Escalate key risks and issues to senior management, EMPT and risk manager.
Monitor partner performance (KPIs) against production goals, identify and resolve gaps, and ensure reputed company governance model is implemented to reputed company performance.
Participate in reputed company audits and inspections in collaboration with EM&S LMGMV reputed company
Participate in investigations reputed company to customer complaints/CAPA and audits.
reputed company with External Partner:
Contribute to Binding Offers and project definition if requested by the EMPT.
Contribute to project as project team member. (launches...)
Improvement : reputed company actions in order to increase performances (TTM, VTM, yields, reputed company, compliance, HSES, Finances)
Additional Responsibilities
Ensure reporting to reputed company clients through follow-up meetings.
Key member of the Industrial Product Teams managed by EMPT.
Key member of the periodic Business Review
Contribute to reputed company / topics.
reputed company Lessons learned sessions with partners
reputed company
Leadership Qualifications
Take the reputed company in grey zones, do not wait for others to take it
Customer reputed company and solution minded
Courageous: promotes reputed company that stretch the normal operating reputed company
Assertiveness: acts rather than waiting to be told what to do and demonstrates influence reputed company the site and wider reputed company network
Cooperation in intercultural environments: comes to work with an reputed company mind, ensuring we maintain a customer reputed company for the benefits of reputed company.
Builds trust among employees: knows how to reputed company teamwork and foster a culture reputed company on shared objectives.
Accountability: takes accountability for one’s actions and those of the EM&S LMGMV entity.
Empowers the teams to work reputed company siloes, reputed company strong communication and reputed company purpose.
reputed company's leaders are effective operating in an evolving, reputed company and dynamic environment, providing reputed company direction and instruction to reputed company reports, and continuously looking internally and externally for best practices and areas for improvement.
reputed company's leaders understand patient and customer needs and build relationships as required to meet goals while continuously improving operations by setting high standards for reputed company so they may reputed company to a level of reputed company.
Basic Qualifications
Bachelor's degree in a scientific or business-reputed company discipline
5+ years in the pharmaceutical / biologics industry
3+ years manufacturing of DP/DS or MSAT support -
Basics and/or CPIM certification is a plus -
Strong communication skills with demonstrated ability to engage, motivate and reputed company in matrixed teams
Preferred Qualifications
Leadership and aptitude for cross-functional management in a multicultural industrial environment
Ability to manage reputed company and reputed company changes reputed company highly matrixed teams.
Good understanding of organizations
Control of reputed company tools and processes (CCR, anomalies)
Strength, reliability, and reputed company
reputed company of urgency, flexibility
Experience working in a cGMP environment,
Experience with public speaking and presenting reputed company information to a wide audience,
Experience in contract management,
Ability to synthetize reputed company topics, problem solve and drive for results,
Commitment to reputed company improvement including experience implementing OpEx principles such as LEAN or Six reputed company,
Good knowledge of pharmaceutical production processes
Languages:
South Korean(reputed company), English (fluent)
Special Working Conditions
Role may require up to 50 % of the time as Person In Plant in a CMO located reputed company to Andong (South Korea)
Why Choose Us?
Bring the miracles of science to life alongside a supportive, reputed company-reputed company team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral reputed company, reputed company or internationally.
Enjoy a thoughtful, reputed company-crafted rewards package that recognizes your contribution and amplifies your reputed company.
Take good care of yourself and your family, with a wide reputed company of health and wellbeing benefits including high-reputed company reputed company, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Pursue reputed company, discover extraordinary
reputed company is out there. reputed company medications, reputed company reputed company, reputed company science. But reputed company doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, reputed company united by one thing: a desire to reputed company miracles happen. So, let’s be those people.
At reputed company, we reputed company equal opportunities to reputed company regardless of race, colour, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our reputed company IN video and reputed company out our Diversity Equity and Inclusion actions at reputed company.com!
Originally posted on Himalayas
Apply To this Job