Manager, External Manufacturing Operations
vor 3 Wochen
**Manager, External Manufacturing Operations**
Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.
Summary:
The Manager, External Manufacturing Operations is responsible for meeting Seagen’s supply demands, both clinical and commercial, at Contract Manufacturing Organizations (“CMOs”) they manage. The Manager, External Mfg Ops, is the CMO’s primary point of contact and focuses on achieving uninterrupted supply while ensuring excellence in quality and compliance. Results are obtained via direct collaboration with the CMO and internal stakeholders to coordinate and track production planning, execution, issue resolution, and on-time delivery.
Requirements or Responsibilities:
- Serve as the ”Supplier Relationship Manager” (SRM) for one or more CMOs.
- Lead cross-functional internal Virtual Management Teams (VMTs) consisting of representatives from Supply Operations, Quality, Manufacturing Sciences & Technology and Technical Development.
- Align CMO production scheduling with internal supply planning and drive resolution of operational issues such as investigations, deviations, corrective and preventive actions, production delays etc.
- Manage contract and work order negotiations, closely track the budget for contracted activities, navigate contractual disputes to resolution.
- Understand Seagen’s manufacturing processes; perform technical review of master and executed batch records, specifications, deviations, and change requests.
- Manage change planning and ensure timely implementation of changes in line with regulatory strategy and inventory management constraints.
- Maintain an in-depth understanding of the CMO’s systems, capabilities, capacities, requirements, and business practices, and be actively engaged in the CMO’s operations to ensure on-time, in-full delivery of clinical and commercial products.
- Monitor site performance according to Key Performance Indicators (KPIs); work to improve the CMO’s performance in-line with Seagen’s expectations.
- Lead periodic Operational Review Meetings and Executive Steering Committee meetings.
- Participate in cross-functional teams to drive projects related to manufacturing operations. Such projects may include technology transfers, process improvements, validation activities, regulatory submission reviews, associated change management and project management.
- Assist in efforts to evaluate and qualify new contract manufacturers.
- Work with Product Supply Leadership to assess risk and develop and execute Product Supply’s network manufacturing strategy.
- Contribute to recommendations for capacity expansion at contract manufacturers, as required.
Qualifications:
- Minimum of three years industrial experience in manufacturing operations, MSAT, supply chain, process development, project management, quality or similar functions in biopharmaceutical, pharmaceutical or chemical industry required.
- Hands-on experience in biologics or small molecule/API process development or manufacturing is required.
- Experience with highly potent (HiPo) manufacturing is a plus.
- Experience working at or with CMOs on a broad range of projects including support of commercial and/or clinical manufacturing in a cGMP environment
- Must have competent knowledge of cGMP’s for pharmaceutical manufacturing.
- Must have competent knowledge of quality systems, including investigations, corrective actions, and change management.
- Must possess excellent communication, project management, collaboration, and analytical skills.
- Ability to handle complex projects in fast-changing, challenging environment.
- Direct experience developing and negotiating contracts with external suppliers is a plus.
- Ability to travel within Europe and US occasionally, with occasional periods of frequent travel.
- Fluency in English required. Some proficiency in French, German, Italian, Portuguese or Spanish is a plus.
**Education**:
- Degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or other relevant Life Science discipline. PhD with -3-5 years of experience, Masters with 5-8 years of experience, or Bachelors with 8+ years of experience is desired.
-
Global External Manufacturing Director
vor 4 Wochen
Zug, Schweiz Galderma VollzeitWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
-
Global External Manufacturing Director
Vor 5 Tagen
Zug, Zug, Schweiz Galderma VollzeitWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
-
Manager, External Quality
vor 2 Monaten
Zug, Schweiz Pfizer VollzeitWhy Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...
-
Manager, External Quality
vor 3 Wochen
Zug, Schweiz Pfizer VollzeitWhy Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...
-
Manager, External Quality
Vor 6 Tagen
Zug, Zug, Schweiz Pfizer VollzeitWhy Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...
-
Manager, External Quality Operations
vor 2 Wochen
Zug, Schweiz Seagen VollzeitPosition Summary: Principal Responsibilities: - Serve as Quality Single Point of Contact on one or more internal Virtual Management Teams consisting of Technical Development, Quality, Planning, Logistics, and Manufacturing Sciences & Technology representatives - Develop, negotiate and maintain Quality Agreements with CMO and ensure compliance with...
-
Vp Partnership
vor 2 Monaten
Zug, Schweiz Johnson & Johnson VollzeitJohnson & Johnson Innovative Medicine is recruiting for the position of VP Partnership & External Supply - Large Molecule. Reporting to the VP Manufacturing and Technical Operations, the Vice President, Partnerships & External Supply Integration of Large Molecule will lead the management of Innovative Medicine’s global external supply base. In this role...
-
Director, Global External Operations
vor 4 Wochen
Zug, Schweiz Johnson & Johnson Vollzeit**_Caring for the worldone person at a time” _**inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo. Ethicon Supply Chain and Cilag GmbH are recruiting for a **Director, Global External Operations **(GEO) to be based in **Zug,...
-
QA Operations Manager
vor 2 Monaten
Zug, Schweiz Covis Pharma Vollzeit**THE JOB**: We are currently searching for a **QA Operations Manager **to work across all functions to ensure that Quality standards are maintained within the company. You will support the QA team with the maintenance of a functional and inspection ready internal Quality Management System. You will also ensure GMP compliance of pharmaceutical production of...
-
Rotkreuz, Zug, Schweiz F. Hoffmann-La Roche AG TeilzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Rotkreuz, Zug, Schweiz F. Hoffmann-La Roche AG TeilzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Director, Global External Operations
Vor 5 Tagen
Zug, Zug, Schweiz Johnson & Johnson Vollzeit_Caring for the worldone person at a time" _inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.Ethicon Supply Chain and Cilag GmbH are recruiting for a Director, Global External Operations (GEO) to be based in Zug, Switzerland.At...
-
Manager, External Quality, Contract Testing
vor 2 Monaten
Zug, Schweiz Pfizer VollzeitWhy Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...
-
Partnerships & External Supply Site Lead
vor 3 Wochen
Zug, Schweiz Johnson & Johnson Vollzeit**Caring for the world **, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day,...
-
Partnerships & External Supply Site Lead
vor 3 Wochen
Zug, Schweiz Johnson & Johnson Vollzeit**Caring for the world **, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day,...
-
Operations Innovation Manager
vor 2 Wochen
Zug, Schweiz SGS VollzeitResponsible for all strategic Ops projects across our Clients international regions (EMEA, APAC, & LAC). Within this structure, the position reports into the Equipment, Tech, & Format Design function. The type of projects will vary but tend to be of medium - to long-term focus, on one or more of these areas: franchisee profitability, restaurant efficiency,...
-
Manager, External Quality, Contract Testing
Vor 6 Tagen
Zug, Zug, Schweiz Pfizer VollzeitWhy Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...
-
Partnerships & External Supply Site Lead
Vor 5 Tagen
Zug, Zug, Schweiz Johnson & Johnson VollzeitCaring for the world , one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout...
-
Operations Innovation Manager
Vor 5 Tagen
Zug, Zug, Schweiz SGS VollzeitResponsible for all strategic Ops projects across our Clients international regions (EMEA, APAC, & LAC). Within this structure, the position reports into the Equipment, Tech, & Format Design function. The type of projects will vary but tend to be of medium- to long-term focus, on one or more of these areas: franchisee profitability, restaurant efficiency,...
-
Director Site Supply Operations
vor 2 Wochen
Zug, Schweiz Seagen VollzeitSeagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to...
