Analytical Development and Quality Control Manager
vor 20 Stunden
Analytical Development and Quality Control Manager – 6255 URA
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed to delivering products on the market over the next 5 years, is looking for an AD/QC Manager for a 12-month contract based in Basel.
Analytical Development / Quality Control (AD/QC) is responsible for the analytical development of Drug Substance (DS) and Drug Product (DP). AD/QC must ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines. An ideal candidate is someone who has a background in Biology or Chemical Engineering with a proven track record in a managerial role as a Senior Scientist within a pharmaceutical company.
Main Responsibilities:
- Manages a team of up to 3 direct reports.
- Responsible for a project portfolio of up to 4 small projects (typically up to phase 2) or 1-2 highly complex or late-stage projects (typically phase 3 and commercial).
- Organization of laboratory activities. Follow the processes defined in Guidelines and SOPs.
- Development, optimization, and implementation of analytical methods, e.g., for purity, stability, cleaning verification/validation, excipients, content, and potentially genotoxic impurity determinations as well as documentation for implementation.
- Representation of AD/QC in technical project team and CMC team meetings.
- Conduct release, retest, stability studies, transfer, and validation analyses.
- Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
- Review, interpretation, and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
- Write and review analytical protocols and reports and establish specifications.
- Assure adequate maintenance and operation of analytical equipment according to GMP.
- Draft and review CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs, and FRMs.
- Organization of GMP (re)qualification and validation of analytical equipment with external companies.
- Elaboration of qualification plans and review of qualification documents.
- Ensure initial and continuing training of AD/QC personnel and adaptation according to business needs.
- Ensure cleanliness of laboratory and workspace.
- Independently design and execute projects or experiments with hands-on involvement.
- Independently review scientific work in project-related activities.
- Ensure availability of adequate lab materials and justify acquisition of new materials or equipment.
- Contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks.
- Independent evaluation and development of novel analytical techniques and instrumentation.
- Leverage workload of respective project members to assure timelines and budget are met.
- Establish source documents for IND, IMPD, and NDA/MA submissions as well as respond to agency questions and interact with Health Authorities.
- Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints, and other analytical tasks independently.
- Set and accomplish product development timelines working closely with formulation scientists.
- Responsible for the management of the GMP laboratory and employees.
- Responsible for the analytical expertise for defined drug substances and/or drug products.
- Summarize, defend, and communicate results and product quality issues to management.
Qualifications and Experience:
- Relevant Swiss working/residency permit and/or Swiss/EU Citizenship required;
- Biology or Chemical Engineering with 12+ years BS, 9+ years MS, or 2+ years PhD experience in the pharmaceutical industry with demonstrated previous success in a managerial function.
- In addition to knowledge of GMP/regulatory requirements, a strong background in analytical chemistry is required.
- Personality and disposition to manage professionals effectively in a matrix system. Diligent attention to detail. Willingness to limited travel. Mature, stable person with a positive and dynamic demeanor.
- High flexibility, superior communication, time-management, and team-working skills. Ability to work independently and take initiative.
- Proficient in English. Life-long learning mindset and a strong sense of accountability. Should actively seek technical and scientific solutions to improve quality and productivity.
- Ability to complete assignments, meeting quality- and time-oriented objectives.
- Strong skills in timeline development and management.
- Excellent problem-solving skills, excellent team player, including the ability to work with diverse teams of people with multiple perspectives and talents, capable of functioning as an individual contributor or team leader.
- Broad knowledge in analytical chemistry. Basic knowledge in synthetic chemistry, drug substance processing, and/or formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug substance or product development.
- Experience in the development and performance of analytical tests for a variety of drug substances and products.
-
Manager Analytical Development and Quality Control
vor 2 Wochen
Basel, Schweiz CTC Resourcing Solutions Vollzeit**The Life Science Career Network** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a: **Analytical Development and Quality Control **Manager for Solid Formulations** for a contract of 12...
-
Analytical Development
vor 2 Wochen
Basel, Schweiz Hobson Prior VollzeitHobson Prior are seeking for an Analytical Development & Quality Control Manager Drug Substance to join a fantastic biotech corporation on a contract basis located in Basel. Our client is focused on finding, producing and marketing novelty solutions to help more patients. Please note that to be considered for this role you must have the right to work in...
-
Basel, Schweiz CV-Library VollzeitHobson Prior is seeking a Manager in Analytical Development/Quality Control to join a dedicated team in Basel, Switzerland. This role will focus on ensuring that drug substances and products meet quality standards and comply with regulations. The successful candidate will lead a team, manage projects, and oversee laboratory activities. Please note that to...
-
Manager in Analytical Development/Quality Control
vor 4 Wochen
Basel, Schweiz Hobson Prior International Ltd VollzeitHobson Prior is seeking a Manager in Analytical Development/Quality Control to join a dedicated team in Basel, Switzerland. This role will focus on ensuring that drug substances and products meet quality standards and comply with regulations. The successful candidate will lead a team, manage projects, and oversee laboratory activities.Please note that to be...
-
Analytical Development
vor 1 Tag
Basel, Schweiz ALTOGEN AG VollzeitALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...
-
Analytical Development
vor 2 Wochen
Basel, Schweiz ALTOGEN AG VollzeitALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...
-
Analytical Development Scientist
vor 2 Wochen
Basel, Schweiz ALTOGEN AG VollzeitALTOGEN is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...
-
Basel, Schweiz F. Hoffmann-La Roche Gruppe VollzeitRoche 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,...
-
Manager, External Quality Control
vor 7 Monaten
Basel, Schweiz Moderna Therapeutics Vollzeit**To be considered for this role, you must supply a CV / resume in English (as English is our internal business language) Additionally, this role will be working closely with our CMO partners who have locations in Europe (Italy) - therefore, trips to the sites are expected to be frequent (as we have a face-to-face / on-site ethos)** **The Role**: Reporting...
-
Analytical Quality Assurance Manager
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitAbout the RoleWe are seeking a highly skilled Analytical Quality Assurance Manager to join our team at Gi Group SA. As a key member of our organization, you will be responsible for ensuring the highest standards of quality in our analytical-pharmaceutical environment.Key Responsibilities:Review and approve SOPs, protocols, reports, Certificate of Analysis,...
-
Associate Analytical Development Biochemistry
vor 2 Wochen
Basel, Schweiz We make it GmbH VollzeitWe make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest...
-
Associate Analytical Development Biochemistry
vor 2 Wochen
Basel, Schweiz We make it GmbH VollzeitWe make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest...
-
Analytical Development Specialist
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit**Company Overview:**Gi Group SA is a leading staffing agency with extensive experience in the pharmaceutical industry.**Salary:** The estimated annual salary for this position ranges from $80,000 to $110,000, depending on qualifications and experience.**Job Description:**We are seeking an analytical development specialist to join our team in Basel. As a key...
-
Head of Quality Control Operations
vor 7 Monaten
Basel, Schweiz Takeda Pharmaceutical Vollzeit**Job Title**:Head of Quality Control Operations **Location**: Neuchâtel **About** the **role**: Directs the Quality Control Laboratories (Microbiology, Biochemistry, Lab Support and Quality Sterility Assurance) in a large size plant and directs a large department to support Facility, Division and Corporate wide initiatives. Responsible for performances...
-
Quality Assurance Manager
vor 1 Tag
Basel, Schweiz ITech Consult Vollzeit**Quality Assurance Manager (M/F/d) - cGMP / Quality requirements / analytical working / CAPA/ OOS / deviation management / English/ German** **Project**: For our customer a big pharmaceutical company in Basel we are looking Quality Assurance Manager (M/F/d). **Background**: As within Quality Assurance for Quality Control Basel/Kaiseraugst you are ensuring...
-
Senior Manager, External Quality Control
vor 20 Stunden
Basel, Schweiz Moderna Therapeutics VollzeitSenior Manager, External Quality ControlThe RoleJoining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health...
-
Quality Manager Combination Products
vor 7 Monaten
Basel, Schweiz Skillhubs VollzeitOur client is looking for a **Quality Manager**. **The role** In this pivotal role, you will be responsible for providing compliance oversight associated with **medical devices** and **combination product **development and manufacturing processes internally or at contract manufacturing organizations (CMOs). Performs quality assurance responsibilities for...
-
Associate Analytical Development Biochemistry
Vor 3 Tagen
Basel, Schweiz Work Selection Vollzeit**Beschreibung**: Für unseren Kunden, ein weltweit führendes Schweizer Pharmaunternehmen in Basel, suchen wir per sofort einen **Associate Analytical Development Biochemistry** für einen befristeten Einsatz von einem Jahr mit Option auf Verlängerung. Die Abteilung 'Analytical Development and Quality Control Biotech Europe' ist für die analytische...
-
Analytical Project Leader
vor 2 Wochen
Basel, Schweiz Healthcare Businesswomen’s Association VollzeitJob Description Summary Location: Basel, Switzerland Role Purpose: Defines, leads and manages the analytical project strategy including the overall analytical control strategy for Drug Substance(s) and Drug Product(s) in line with the overall CMC project development plan; ensures project specific high quality analytical submission documents and ready for...
-
Quality Assurance Manager
Vor 2 Tagen
Basel, Schweiz ITech Consult AG VollzeitQuality Assurance Manager (m/f/d) - cGMP / Quality requirements / analytical working / CAPA/ OOS / deviation management / English/ GermanProject: For our customer a big pharmaceutical company in Basel we are looking Quality Assurance Manager (m/f/d).Background:As within Quality Assurance for Quality Control Basel/Kaiseraugst you are ensuring that all process...
