ESSENTIAL FUNCTIONS:
Designs experimental protocols with minimal supervision.
Executes bench experiments; makes detailed and general observations and analyzes data.
Prepares technical reports, summaries and quantitative analyses.
Maintains complete and accurate records.
Normally receives general directions on routine work and detailed directions on new assignments.
Makes suggestions to improve work processes and laboratory environment.
Assists in identifying and reducing to practice patentable inventions.
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
May participate in cross functional technical teams such as a failure investigation team.
Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning.
Trains others in areas of expertise.
Troubleshoots problems and institutes corrective action.
Prepares and presents experimental procedures and results in group and project teams.
Monitors work to ensure quality, and continuously promote Quality First Time.
MINIMUM QUALIFICATIONS:
Requires Bachelor degree in Science.
Experience:
2 or more years relevant job experience.
Knows basic and a range of specialized laboratory techniques.
Capable with searching scientific literature to gain information about specific topics.
Source: Job Diva – Job Listing
Position Summary
The Manager of Drug Safety Quality is responsible for developing and managing the maintenance of Drug Safety processes and procedures to ensure compliance with global regulatory requirements. This role monitors adherence to Drug Safety processes and procedures, Pharmacovigilance agreements, and Safety Management Plans and oversees the staff responsible for performing quality monitoring and documentation activities. In addition, he Manager of Drug Safety Quality serves as the department point of contact and provides guidance and operational support for audits and inspections of Drug Safety processes and procedures.
Principal Responsibilities
Develop and maintain a Drug Safety Quality System and operationalize it across the Drug Safety Department.
Oversee Drug Safety global quality processes in conjunction with the QPPV and Research and Development Quality Assurance.
Manage the authoring, review/approval, and change management of Drug Safety process documents in partnership with cross-functional departments within and outside of Drug Safety.
Participate in cross-functional review of global regulations to determine if process changes are required.
Guides and supports the authoring, delivery and change management of all training on Drug Safety processes and procedures in partnership with Drug Safety and cross-functional stakeholders
Manage and maintain training matrices/role-based curriculum for Drug Safety staff
Serve as department liaison for audit/inspection activities in close partnership with Research and Development Quality Assurance
Manage the authoring and review/approval of audit/inspection responses in close partnership with Research and Development Quality Assurance; manages the development, review/approval, tracking and completion of Drug Safety staff actions required to fulfill audit/inspection response commitments
Partner with Drug Safety Project Manager to ensure alignment and compliance of PVAs and SMPs with Drug Safety processes
Continuously refine aggregate ICSR quality review processes based on trending of results and work with other Drug Safety functions to drive quality issues to resolution
Support vendor oversight by monitoring key performance indicator (KPI) metrics and quality/ timeliness of deliverables.
Monitor core compliance metrics and/or Drug Safety activities to ensure compliance with regulatory reporting timelines and Drug Safety processes
Identify and champion process improvements, and develop, track and complete action plans in partnership with Drug Safety staff and external stakeholders and update documentation and training as required
Manage Drug Safety process deviations and CAPAs in alignment with corporate processes
Oversight and management of Drug Safety Quality Specialists including goal setting and providing Manager Performance Evaluation Assessments
Perform other duties related to the position as required
Qualifications
Strong communication (verbal and written) skills a must
Demonstrated leadership responsibilities in previous role (s)
Experience managing staff and/or contract workers
Comparable experience in the pharmaceutical industry experience preferably in one or more of the following areas: Drug Safety, Clinical Operations, or Regulatory Affairs
Demonstrated experience working cross functional areas with strong negotiation skills
Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally.
Education
Bachelors degree
Competencies
Written Communications
Dealing with Ambiguity
Priority Setting
Managing and Measuring Work
Conflict Management
Problem Solving
Peer Relationships
Source: Job Diva – Job Listing
The agreed service concerns the input of stability programs (test articles, conditions, pull points, testing regime) as well as the input of specifications for the affected products into GLIMS based on given documents (e.g. stability protocols, analytical specifications).
Up to know, stability protocols have been issued as pdf documents that are stored in a document management system (Subway).
The stability protocol describes the program of the stability study: which batches have to be tested at which timepoints with which analytical methods.
The task of the contractor is to access these protocols and translate the program into the GLIMS system (LIMS system from Labware). To do that it is also required to create analytical specifications for the tested products. These specifications describe the analytical methods, that need to be performed for the product, in detail (in terms of number of results to be reported, number of reported digits). The source for this information is also available in Subway in so called Analytical Specifications. The approval of both, the stability programs and the specifications will be done by internal personnel. For these activities training on the GLIMS system is required to get access.
To current knowledge, this affects 19 stability studies from 9 different projects. Typically (but different for each study) a stability study consists of 2 batches (for each batch one program needs to be defined in GLIMS; sometimes there are up to 4 additional conditions that are treated as separate batches), three storage conditions (intended with 8-12 pull points, accelerated with 4 pull points and stressed with 2 pull points).
***Position is working remote and on-site
Junior level – 2 – 3 years of experience
Familiar with good documentation practice principles
Practical knowledge on data management and/or documentation, in regulated environment, beneficial
Experience on Labware LIMS beneficial if not more time for training required
Helpful to know something about stability studies and analytical background
English fluent
Source: Job Diva – Job Listing
Provide Clinical Quality support to the Clinical teams supporting the radioligand therapies. Ensure clinical is following the defined SOPs as well as GCP regulations. Work with the clinical teams to identify audit needs for clinical sites and vendors. Ensure inspection readiness and provide leadership and support in the event of a Health Authority Inspection
Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH and cGCP Guidelines
Excellent verbal and written communication skills, ability to work well in teams or independently
Ability to deal with ambiguity and provide a pragmatic approach to problem solving
Proven management skills, with the ability to prioritize multiple projects and act as an experienced advocate for Quality and Compliance
Knowledge of scientific, medical and statistical practice/techniques, tools and terminology
Exceptional critical reasoning skills who is detail oriented
Source: Job Diva – Job Listing
Senior Researcher (Discovery Sciences):
Qualification and Experience:
MS in biology or related field with 3 plus years of drug discovery experience in Biotech or Pharma setting. Experience with immunohistochemistry, immunofluoresence, microscopy, and image analysis is required. Experience in working with anti-sense oligonucleotide or RNAi field is required.
The candidate should demonstrate the following skills:
Experience with manual immunohistochemistry and immunofluorescence staining of tissue sections
Experience acquiring images of stained tissue sections using confocal microscopy and slide scanners and performing image analysis and quantification
Work in aseptic conditions and maintain cultures of various cell types related to CNS projects
Experience with human primary / iPSC neuronal cell cultures
Screening of ASO-based drug candidates in high-throughput cell-based assays
Experience with in vivo tissue handling, tissue homogenization and RNA isolation is required
Hands-on experience with various molecular/cell biology techniques are required; including nucleic acid isolation, qPCR methods, ELISA, Western blot
Ability to work in a cross functional environment
Source: Job Diva – Job Listing
Under the supervision of a Senior Technician or Chemist, the Technician will be expected to perform the following functions with a high level of initiative and independence: – Testing of coatings. – Evaluate, collect and record data. – Participates in organizing and performing experiments using established procedures while summarizing and reporting results in a laboratory notebook. – Uses a computer to enter data/information including charts and tables for communication of project results/details. – Involved in making cleaners/pretreatments/paints/coatings from chemical ingredients. – Tests performance characteristics of coated substrates using established procedures.
Quals–
– -year of demonstrated laboratory experience – Computer literate in Microsoft Office products – word, excel and powerpoint. – Ability to understand and follow experimental protocols for preservation of data. – Comfortable and able to work with toxic chemicals while following safe laboratory practices/protocols. – The ability to stand while working in the laboratory throughout most of the day. – Associates or Bachelor’s degree in a technical field
Source: Job Diva – Job Listing
Under the supervision of a Senior Technician or Chemist, the Technician will be expected to perform the following functions with a high level of initiative and independence: – Testing of coatings. – Evaluate, collect and record data. – Participates in organizing and performing experiments using established procedures while summarizing and reporting results in a laboratory notebook. – Uses a computer to enter data/information including charts and tables for communication of project results/details. – Involved in making cleaners/pretreatments/paints/coatings from chemical ingredients. – Tests performance characteristics of coated substrates using established procedures.
Quals–
– -year of demonstrated laboratory experience – Computer literate in Microsoft Office products – word, excel and powerpoint. – Ability to understand and follow experimental protocols for preservation of data. – Comfortable and able to work with toxic chemicals while following safe laboratory practices/protocols. – The ability to stand while working in the laboratory throughout most of the day. – Associates or Bachelor’s degree in a technical field
Source: Job Diva – Job Listing
Description
This job posting is for a temporary assignment in the Quality Control Biochemistry group.
Job Description:
The candidate will assist the department with testing related activities by strictly adhering to *** Pasteur policies and procedures and cGMP. The candidate filling this position will work to ensure assays are completed in a timely compliant manner, perform cleaning of work areas, equipment, and any other duties as assigned.
Key Accountabilities
Testing
1. Assists qualified analysts with current tests by strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules (when applicable), *** pasteur policies and procedures and safety procedures. This will including assisting the Biochemistry department in all aspects of testing with particular focus on Chromatography and Wet Chemistry based assays .
2. Performs required testing related activities as per testing schedule defined by laboratory management to meet demands of Production, Methods Development, Validation, Independent Demand and Stability program.
3. Completes required paperwork and documentation as required.
Laboratory:
1. Maintains laboratories in a safe and compliant state.
2. Archiving of raw data associated with testing
3. Performs cleaning of laboratories, equipment, and ancillary areas as required.
Training:
1. Attends/Contributes to scheduled team meetings, department meetings, and safety meetings.
2. Document review.
3. Safety and compliance training.
4. Module/Assay training as assigned.
Compliance:
1. Notifies laboratory manager of any deviations or laboratory related issues.
2. Support deviations, change controls and CAPA's.
*** Pasteur SA is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristic protected by applicable law.
Education/Requirements:
B.S. in Biological Sciences, Chemistry or Biochemistry
Qualifications:
Previous experience in a cGMP laboratory is preferred
Knowledge of chromatographic and wet chemistry method preferred
Annual Flu Vaccine required
Source: Job Diva – Job Listing
This job posting is for a temporary assignment in the Quality Control Analytical Chemistry group.
Job Description:
The candidate will assist the department with testing related activities by strictly adhering to *** policies and procedures and cGMP.
The candidate filling this position will work to ensure assays are completed in a timely compliant manner, perform cleaning of work areas, equipment, and any other duties as assigned.
Key Accountabilities
Testing
1. Assists qualified analysts with current tests by strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules (when applicable), *** policies and procedures and safety procedures.
This will including assisting the Analytical Chemistry department in all aspects of testing with focus on Raw Materials assays.
2. Performs required testing related activities as per testing schedule defined by laboratory management to meet demands of Production, Methods Development, Validation, Independent Demand and Stability program.
3. Completes required paperwork and documentation as required.
Laboratory:
1. Maintains laboratories in a safe and compliant state.
2. Archiving of raw data associated with testing
3. Performs cleaning of laboratories, equipment, and ancillary areas as required.
Training:
1. Attends/Contributes to scheduled team meetings, department meetings, and safety meetings.
2. Document review.
3. Safety and compliance training.
4. Module/Assay training as assigned.
Compliance:
1. Notifies laboratory manager of any deviations or laboratory related issues.
2. Support deviations, change controls and CAPA's.
*** Client is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristic protected by applicable law
Education/Requirements:
B.S. in Chemistry, Biochemistry, or Biological Sciences
Qualifications:
Previous experience in a cGMP laboratory is preferred
Knowledge of wet chemistry techniques/laboratory instrumentation
Annual Flu Vaccine required
Source: Job Diva – Job Listing
What You Can Expect in This Role:
Basic Qualifications:
Source: Job Diva – Job Listing
| EMS system engineer & tester | 10 years’ + experience | ||
| Knowledge | Windows server | ||
| Linux Red Hat 8 | |||
| Windows Office product | Excel | ||
| Visio | |||
| Word | |||
| PowerPoint | |||
| Oracle database query | |||
| Perl programming | |||
| SCADA | Required | ||
| Network Application | Ideal | ||
| Energy Management system | Required | ||
| E-terraPlatform product | Required | ||
| Any EMS vendor system | |||
| Client FGBuilder product | |||
| Generation application | Required | ||
| Market system | |||
| Skill | Critical thinking | Ideal | |
| Fast learner | |||
| Writing test cases | |||
| Leading test effort | |||
| Participate to testing | |||
Source: Job Diva – Job Listing
Performs polymer formulation, process and characterization in a research and development laboratory environment.
Demonstrates understanding in both, materials technology and lens production process, to insure compatibility between material and process. Identifies and optimizes Client materials for their use in lens, saline, and lens care product formulations.
Demonstrates understanding of structure-property-process relationship in polymers.
Documents experimental results details on all planned and completed experiments including raw materials, experimental plans and procedures, results, data analyses and conclusions in appropriate formats (laboratory notebook, memo and/or report) and communicate effectively to project teams. Files all new material concepts through invention disclosures and support patent filings as required to protect intellectual property.
Handles, uses, stores and disposes all lab used chemicals as outlined in MSDS, SOP and other company prescribed, state and federal guidelines. Also, complies with all company established Health, Safety and Environment operational requirements. Uses relevant statistical techniques and methods to plan and execute experiments and to analyze experimental data.
Actively monitors patent and scientific literature for significant technical developments relevant to CL and CLC products.
Rigorous application of the scientific method to strategic research targets
Timely achievement and effective communication of results and conclusions
Effective collaboration and leadership with team members
Compliance with all regulatory, quality, and safety requirements, including good documentation practices.
Source: Job Diva – Job Listing
Research Associate
We have an opportunity for a Chemist/Biochemist to join our core conjugation team in Research to help build our Client pipeline. We seek an individual who will enjoy working at the bench in a collaborative fashion alongside scientists with a variety of backgrounds and specialties. This position will allow an entry to mid-level research associate to contribute to new antibody-drug conjugate-based research programs.
Responsibilities:
Preparation and characterization of antibody-drug conjugates (ADCs) using established and experimental conjugation methodologies and analytical techniques, including HPLC and mass spectrometry analysis
Working collaboratively with other scientists and departments on Client-based research projects
Management and organization of reagent inventories, including the dispensing of critical reagents
Preparation of HPLC buffers and critical reagents
Regularly recording experiments in an electronic lab notebook
Required Skills
B.S. or M.S. degree in Biochemistry, Chemistry, or a related field with 1+ years of extensive laboratory experience in an academic or industrial setting
The ideal candidate will have a solid foundation in biochemistry with hands-on experience performing protein purification.
Prior experience performing bioconjugation is a plus
Previous experience using analytical HPLCs for protein analysis. Experience performing LC/MS is a plus
Experience working with cytotoxic compounds is a plus.
Good communication and organizational skills and the ability to interface constructively with other scientists
Desire to learn new techniques and be at the cutting edge of bioconjugation technologies
Source: Job Diva – Job Listing
Responsibilities:
Requirements:
Bachelor’s degree in Education, Adult Learning, Human Resources, Organizational Development, or related field preferred.
Minimum of 3 years GCP/GLP experience working with an LMS (ComplianceWire a plus).
Demonstrated experience with Learning Management Systems and Document Management Systems
Experience working in a regulated environment with strong knowledge of ICH/GxP and regulatory requirements.
Self-motivated, with the ability to work effectively in a dynamic and diverse environment.
Demonstrated ability to interface effectively with senior leadership and all levels of the organization.
Excellent problem-solving, written, and verbal communication skills.
Ability to effectively manage priorities under strict and dynamic deadlines.
Must be able to organize information in a consistent and readily retrievable manner
Strong attention to detail
Strong teamwork skills
Strong experience in Microsoft Suite
Competencies:
Is good at learning new industry, company, product, or technical knowledge – like internet technology
Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit, and/or the organization
Quickly zeros in on the critical few and puts the trivial many aside
Detailed oriented
Good at focused listening
Is action oriented and full of energy for the things he/she sees as challenging
Is able to write clearly and succinctly in a variety of communication settings and styles
Is an early knower, getting informal and incomplete information in time to do something about it
Understands that different situations and levels may call for different skills and approaches
Source: Job Diva – Job Listing
Description:
Position Summary
The Scientific Writer I will be in an immersive environment within the Research Department and engage with cross-functional teams to gain proficiency in the science behind the Seagen pipeline while producing high-impact scientific communication materials. The Writer will be responsible for authoring and revising scientific documents to support communication efforts, by working closely with the scientific lead of the program for which the scientific documents are being generated. The primary focus will be placed on authoring manuscripts for publication in peer-reviewed journals. The Writer will also aid in the development of abstracts and presentations for medical congress meetings. In addition, the writer will be responsible for authoring and revising scientific and regulatory documents for submission to the FDA and other agencies.
Principal Responsibilities
Includes but not limited to:
Under supervision, leads the development and authoring of abstracts, posters, manuscripts, slides of preclinical study data at medical congresses and the development of primary. manuscripts for publication in peer-reviewed journals.
Under supervision, leads the development and authoring of technical reports and investigator brochures in support of INDs, BLAs, and regulatory filings.
Under supervision, leads the development of the graphical representation of preclinical data that will be packaged into posters, manuscripts, technical reports, and other documents.
Performs macro-editing of documents for organization, content, structure, and tone, and to ensure documents are consistent, and micro-editing of documents for punctuation, grammar, sentences, paragraphs, and writing styles.
Develops/Maintains standards and processes.
Coordinates the submission, review, revision, quality control, quality assurance, electronic publishing, and approval of manuscripts, abstracts, and other documents.
Develops working knowledge of the preclinical science behind Seagen therapeutic assets, including the design, objectives, and results of studies, to enable accurate and effective communication to varied audiences.
Develops citation libraries of relevant publications corresponding to therapeutic programs.
Routinely engages with scientists and research associates, and attends relevant meetings, to gain understanding of therapeutic compounds.
Organizes, conducts, and leads cross-functional document development meetings.
Facilitates document review committee meetings and issues resolution.
Represents the Research Department from the perspective of scientific writing on study/project teams. Contributes to program strategy, through collaborative engagement with personnel from Medical Communications, Medical Writing, Clinical disciplines, Regulatory Affairs, and other departments.
Required Qualifications
Advanced degree(s) (PhD / doctorate degree) in life sciences
Academic research/transferable skills may be considered in lieu of industry experience
Must have published a first-author publication in a scientific journal
Experience as a research writer or scientific editing
Excellent written, verbal, and visual communication skills with the ability to interpret and present scientific data
Preferred Qualifications
1 or more years of experience in the biopharmaceutical industry
Ability to work cross-functionally
Skilled in Microsoft Word, PowerPoint; data analysis software (Excel, Prism); image analysis software (Image J); experience with Adobe Acrobat, Illustrator, or BioRender
Knowledge of cancer biology and the drug development process
Under supervision, able to coordinate and prioritize multiple projects
Competencies
Written communication
Oral communication
Visual communication
Drive for results
Learning on the fly
Dealing with ambiguity
Priority setting
Planning
Process management
Conflict management
Source: Job Diva – Job Listing
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