Sr. Specialist Drug Substance Lead External Manufacturing
vor 4 Wochen
Job Description
Our Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open position to support Drug Substance tech transfer and commercial manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in biologics or vaccines manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the large molecule line of business at our company.
Our Engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
Responsibilities include:
- Work with external partners to achieve business goals and to establish a common culture that benefits both our company, external partners, and patients.
- Lead and act as the primary interface on technical issues between technical operations and external partner drug substance manufacturers.
- Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
- Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
- Develop solutions to complex technical issues that require a high degree of ingenuity, creativity, and innovation. Requires understanding and application of principles, concepts, practices, and standards that govern the manufacturing of sterile products.
- Provide on-site coverage at external partner in support of commercial and/or tech transfer person in plant activities.
- Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners.
- Ensure that external partners are inspection ready for all routine inspections and/or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory.
- Responsible for participation in creating, sharing, and adopting best practices and business process strategies.
Education Minimum Requirement:
- Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Required Experience and Skills:
- Minimum of 5 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, or Engineering.
- Ability to work independently as well as excellent organizational skills.
- Strong professional and interpersonal communication skills.
- Must be able to multi-task and work within tight deadlines.
- Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation.
- Proven team building skills.
- Excellent command of English (both written and oral).
- Travel will be a requirement of this position at approximately 25%.
Preferred Experience and Skills:
- Experience in biologics manufacturing.
- Experience with the manufacturing of ADCs.
- Project management experience.
- Experience in deviation management and/or change control and/or equipment support, and/or project management.
- Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.
-
Luzern, Schweiz Merck Gruppe - MSD Sharp & Dohme VollzeitJob DescriptionOur Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open position to support Drug Substance tech transfer and commercial manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in biologics or...
-
Luzern, Schweiz MSD VollzeitOur Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open position to support Drug Substance tech transfer and commercial manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in biologics or vaccines...
-
Manufacturing Operations Specialist
vor 2 Wochen
Luzern, Luzern, Schweiz nemensis ag VollzeitJob DescriptionAt nemensis ag, we are seeking a highly motivated Manufacturing Operations Specialist to support the transfer and commercial manufacture of large molecule drugs. This role offers an exciting opportunity to collaborate with external partners, gain technical expertise in biologics or vaccine manufacturing, and contribute to high-visibility...
-
Process Engineer
vor 2 Wochen
Luzern, Luzern, Schweiz nemensis ag VollzeitAbout the Role:We are seeking an experienced Process Engineer - Large Molecule Drug Substance to join our team at nemensis ag.As a Process Engineer, you will be responsible for collaborating with external partners to achieve shared goals and fostering a cooperative culture.Key Responsibilities:Collaborate with external partners to achieve shared goals and...
-
Technical Expert for Large Molecule Manufacturing
vor 2 Wochen
Luzern, Luzern, Schweiz nemensis ag VollzeitJob Summary: We are seeking a highly motivated Engineer to support the transfer and commercial manufacture of drug substances in collaboration with external partners.Key Responsibilities:Collaborate with external partners to achieve shared goals and foster a cooperative culture.Develop innovative solutions to complex technical issues, applying principles and...
-
Process Engineer III
vor 1 Monat
Luzern, Schweiz https:www.energyjobline.comsitemap.xml VollzeitProcess Engineer III - External Manufacturing Large Molecule DS Tech Ops, Lucerne Fulltime. Duration: 1 year duration with option of an extension. Home office: 100% remote with 20% travel requirements. This is an exciting opportunity to work with key strategic external partners, grow technical experience in biologics or vaccines manufacturing, and work on...
-
Process Engineer
vor 2 Wochen
Luzern, Schweiz Randstad (Schweiz) AG VollzeitFor our client company in Luzern, we are currently looking for a Process Engineer, a highly motivated individual to fill an open position to support drug substance tech transfer and commercial manufacture within their External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in...
-
Luzern, Schweiz Merck Gruppe - MSD Sharp & Dohme VollzeitJob DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact on our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...
-
Process Engineer
vor 1 Monat
Luzern, Schweiz Michael Page International (Switzerland) SA VollzeitPrestigious pharmaceutical company12 months project with extension possibility About Our Client For our client, a leading international pharmaceutical company with modern offices in the canton of Lucerne, we are currently looking for a Process Engineer (m/f/d) within the Large Molecule Technical Operations department to support drug substance tech transfer...
-
Eqa Vaccines Platform Lead
vor 5 Monaten
Luzern, Schweiz Merck Sharp & Dohme VollzeitOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an...
-
Quality Assurance Specialist
vor 4 Wochen
Luzern, Luzern, Schweiz CBRE GWS GmbH VollzeitJob Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at CBRE GWS GmbH. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our facility management services.Main Responsibilities:* Lead investigations and technical follow-ups to identify and resolve quality...
-
Executive Director, Drug Safety
vor 1 Monat
Luzern, Luzern, Schweiz Organon VollzeitJob DescriptionJob SummaryOrganon is seeking a highly experienced and skilled Executive Director, Drug Safety to lead our global safety strategy and ensure the safe use of our medicinal products and medical devices. As a key member of our Pharmacovigilance and Safety Science (GPSS) Department, you will be responsible for setting and implementing the overall...
-
Process Engineer
vor 1 Monat
Luzern, Schweiz https:www.energyjobline.comsitemap.xml VollzeitThe Process Engineer (m/f/d) will help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate. Our client offers an extensive range of facilities and environments, whereas the selected candidate will have opportunities to work across many diverse areas including Biological, Chemical, Automation,...
-
Executive Director, Drug Safety
vor 1 Monat
Luzern, Schweiz Organon VollzeitThe Position Strategic leadership role accountable for setting and implementing the overall safety strategy and procedures for an assigned therapeutic area product portfolio (medicinal products and/or medical devices), for post-marketing pharmacovigilance (PV) activities (including interventional and non-interventional studies) from a scientific...
-
Executive Director, Drug Safety
vor 1 Monat
Luzern, Schweiz bioM?rieux BV VollzeitJob DescriptionThe PositionStrategic leadership role accountable for setting and implementing the overall safety strategy and procedures for an assigned therapeutic area product portfolio (medicinal products and/or medical devices), for post-marketing pharmacovigilance (PV) activities (including interventional and non-interventional studies) from a...
-
Quality Assurance Specialist
vor 3 Wochen
Luzern, Schweiz Randstad (Schweiz) AG VollzeitFor our client, a pharmaceutical company based in Lucerne, we arelooking for aQuality Assurance Specialist.In this role the QA Specialist will review batch record of clinical supplies which are packaged locally and at CMO. This position offers a thrilling cross functional work environment with multiple stakeholders in multiple countries.This job requires a...
-
Executive Director, Drug Safety
vor 3 Monaten
Luzern, Schweiz Organon VollzeitJob DescriptionThe Position Strategic leadership role accountable for setting and implementing the overall safety strategy and procedures for an assigned therapeutic area product portfolio (medicinal products and/or medical devices), for post-marketing pharmacovigilance (PV) activities (including interventional and non-interventional studies) from a...
-
Quality Assurance Specialist
vor 3 Wochen
Luzern, Luzern, Schweiz Randstad VollzeitJob DescriptionWe are seeking a Quality Assurance Specialist to join our team at a pharmaceutical company based in Lucerne. In this role, you will review batch records of clinical supplies, ensuring timely supply of drugs to patients. This position offers a cross-functional work environment with multiple stakeholders in multiple countries.The ideal candidate...
-
Global Supply Planning Specialist
vor 1 Monat
Luzern, Schweiz bioM?rieux BV VollzeitJob DescriptionOrganon is in looking for a Global Supply Planning Specialist based in Switzerland close to Lucerne.The Global Supply Planner - Specialist reports to the Global Supply Planning Franchise lead or Global Supply Manager and he/she is a primary contact in Integrated Supply Planningfor the assigned portfolio that consists of product families and/or...
-
Executive Director, Drug Safety
vor 3 Monaten
Kanton Luzern, Schweiz Organon Vollzeit**The Position** - Strategic leadership role accountable for setting and implementing the overall safety strategy and procedures for an assigned therapeutic area product portfolio (medicinal products and/or medical devices), for post-marketing pharmacovigilance (PV) activities (including interventional and non-interventional studies) from a scientific...
