Consultant 2 – Vision
Tasked with recommending product and configuration options to address security shortcomings. May leverage information gathered from Consultant 1 to shape recommendations. Assist with the formation and prioritization of security project work.
Source: Job Diva – Job Listing
Laboratory Services Associate
LOCATION: Cambridge MA
Cambridge, MA-based H3 Biomedicine (https://www.h3Biomedicine.com/) is a leading company in cancer genomics driven drug discovery, delivering on the promise of precision medicine. The company was launched in 2011 with an unprecedented *** million in initial funding from Client, plus a continued ongoing commitment to fund H3s robust discovery pipeline and clinical programs. Now with four clinical stage anti-cancer molecules in active development, H3 is able to uniquely leverage distinct insights from cancer genomics and real-life patient data to advance its projects to clinical proof of concept and beyond. H3 embraces a Client business model in which it collaborates with Client, a leading global pharmaceutical company, to create a prolific drug discovery engine and partnership platform.
The lab services position is responsible for laboratory support activities such as maintaining cleaning an inventory of research lab glassware, materials, and laboratory equipment. Follow Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLPs). Ensure all laboratory equipment and work areas are clean, sterile, and in proper working order. The Lab service person may be responsible for calibration of instruments involved in media / buffer prep. The service technician will be responsible for research laboratory related tasks such as collecting and distributing glassware, cleaning and sterilizing glassware and storing and inventorying glassware. These tasks require a working knowledge of research in order to determine what items will be needed. The position ensures that all regulatory requirements are adhered to.
Principal Duties and Responsibilities
Personal health and safety understanding and adherence is required.
Ensures adherance to SOPs, documentation to cGMP standards which may include procedures, training, and remedial activities and daily/weekly/monthly log review.
Equipment and laboratory glass and inventory control.
Collect, clean and sterilize and redistribute glass and laboratory equipment.
Operation of steam sterilizer and or perform other chemical cleaning and sterilization of equipment and materials.
Ensure laboratory equipment and inventory levels for laboratory supplies are maintained.
Media and Buffer preparation as needed.
Collection and removal of biohazardous waste in laboratory setting.
Other activities and function may be required in support of the laboratory environment as required by client contract.
Experience with resolving facilities requests
Customer service skills
Liaise with lab stakeholders to coordinate various projects (i.e. freezer management)
Regularly scheduled on-call weekends to address potential facility alarms
Support requests to assist team members with urgent issues
Special projects completion
Database/inventory monitoring and reconciliation
Manual re-stocking of lab supplies
Domestic and international shipping
Work Environment This job operates in a research lab. This role routinely uses standard lab equipment such as beakers, test tubes, flasks, thermometers and computers sterilizer and other lab equipment.. Position Type/Expected Hours of Work This is a full-time position, and hours of work and days are generally Monday through Friday (e.g. 7:00 a.m. to 3:30 p.m or 8 to 4:30 p.m.) Overtime may be required and scheduled shifts may vary based upon company need. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Qualifications
Excellent basic PM capabilities and skill sets
Ability to prioritize task importance
Excellent communication and interpersonal skills, coordination skills
Sense of urgency, responsive, proactive and multitasking
Demonstrated proficiency with Microsoft Office and Smartsheet
Collaborative team player
Ability to complete tasks independently
Ability to lift 20 lbs.
DOT/IATA, RCRA, HAZWOPER trainings a plus but not required
Commitment to Safety
Ability to work in a fast-paced, multi-tasking environment
Must be flexible, forward- thinking, motivated, and have the ability to act independently
Strong communication skills, in both verbal and written formats
Microsoft Office software proficiency, including Word, Excel and Outlook.
High school diploma or equivalent 0-3 years directly related experience
Client requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Client, and it applies regardless of whether the position is located at an Client site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
About H3 Biomedicine Inc.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.
Source: Job Diva – Job Listing
Job Summary
Sr Associate in Global Regulatory Systems & Process Management (GRSPM) will provide support, strategies and business solutions for the development and maintenance of regulatory systems. Establishing, managing and supporting regulatory systems according to system requirements. The development of regulatory requirements and business and system support processes. Ensuring the integrity of the data either managed within the system or migrated from legacy systems. Use of QC processes and training end users for key tasks within the managed systems.
Main Duties/Responsibilities Will include but will not be limited to the following activities:
o Maintain the data integrity of data within the regulatory systems
o Ensure that Regulatory Information Systems are supported and managed according to business need and regulatory compliance
o Capture and implement system enhancements to optimize their operational capabilities according to business need
o Develop user requirements specifications for future information systems and create business justification for new systems
o Initiate UAT Scripts, deployment of software, design and deliver training for systems accordingly
o Stay current with industry best practice and software regarding Regulatory Information Management, identifies opportunities to shorten approval timelines through enhanced knowledge sharing
o Engage with vendors and internal partners to drive future state of-the shelf software packages.
o Ensure completeness of content contained in information management systems specifically as it relates to compliance
Requirements
o BS/BA with minimum 3 years of experience with Document Management Systems.
o Experience in Regulatory Information Management systems supporting regulatory information or publishing tool is required.
o Degree in computer science or relevant field preferred
o Previous experience in pharmaceutical industry an advantage
o Experience of mapping User Requirements to Functional Specifications especially in respect of process management an advantage
Skills and Aptitude Required:
o Strong verbal, written and interpersonal communication skills, especially relationship management, with ability to give/receive feedback and build consensus
o Experience in handling multiple tasks
o Knowledge of MS Office (Word, Excel, PowerPoint, Project), Adobe acrobat as well as being familiar with the use of multiple regulatory system applications
Client requires all contractors providing services to Client to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date to their employer/supplier, to the extent permitted under applicable law. This requirement is a condition of providing services to Client, and it applies regardless of whether the contractor is located at an Client site, field based or is fully remote. If you are unable to receive the vaccine for qualified medical reasons (including pregnancy-related) or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation from your employer/supplier.
Source: Job Diva – Job Listing
As a member of the Registration Information Management (RIM) Team, responsible to support implementation of processes and procedures to ensure sustained compliance, at the global, regional and local level, with Health Authority regulations and internal *** expectations regarding the capture and management of the registration information for the global *** portfolio of products in current and upcoming systems.
Major Accountabilities (Describe the 5-7 main results of the role to be achieved )
With guidance, directs and monitors HQ and CO compliance with internal procedures governing registration information management activities at the global, regional and local level. Provides training as needed
Expert in RA Systems and related tools that support registration information management processes worldwide
Provides counsel and guidance to RA CO colleagues regarding their accountability in the registration information process
Supports the regulatory strategy and contributes to the implementation of NovaRIM in collaboration with business owner and IT through e.g. data cleaning supervision on legacy systems, authoring of project-related documents etc.
Key Performance Indicators (Indicate how performance for this role will be measured)
Supports the achievement of consistent and sustainable performance against worldwide HA expectations and internal *** procedures governing registration information management:
Demonstration of a strong Quality and Compliance mindset
Strong project management, teamwork and customer focus
Contribution to business and quality benefits
Ability to establish good working relationships within RA and with other key stakeholders
Superior communication, facilitation, negotiation, and problem resolution skills
Demonstrated ability to continuously improve operations
Ability to influence change
2-4 years experience mainly in a regulatory environment & closely related areas (eg; Clinical Development, GCP, QA)
Must have knowledge of global regulatory requirements
Understands and able to assist RA in understanding compliance and quality drivers from a global perspective,
Country regulatory/pharmaceutical experience from outside Europe or US
Use of IT systems
Experience and ability to work in matrix cross-functional environment
Excellent verbal and written communication skills.
Proven negotiation skills
Demonstrated ability as a creative thinker
Logical and methodical, with attention to details
Source: Job Diva – Job Listing
Performs necessary Quality Control (QC) tests following approved manufacturing procedures, GMP and
good laboratory practices. Additionally, maintains equipment and production documents and investigates
laboratory exception events and works independently with general guidance from supervisor/ senior team
members.
Formulates bulk solutions.
Performs incoming, in-process and final release QC testing.
Maintains complete and accurate records.
Conducts environmental monitoring of work areas.
Maintains work space and associated equipment with the lab.
Ensures equipment is in compliance with calibration standards.
Supports the execution of protocols and analyzes basic data.
Participates in production document improvements.
Investigates laboratory exception events.
Other duties as assigned by management
Knowledge of basic and some specialized laboratory techniques and QC testing.
Knowledge of manufacturing procedures and good laboratory practices.
Possesses team work, documentation, problem solving and troubleshooting, and quality
orientation skills.
Proficiency in oral and written communication skills in English.
Ability to utilize smart forms, mouse, keyboard, and other data entry devices. Ability to utilize electronic office suite of computer programs (i.e. Email, electronic calendar,
file download, save to network drive).
Ability to function with a respirator.
Source: Job Diva – Job Listing
Clinical Data Manager
Direct reports: None
Job Description:
Responsible for clinical data management activities for studies and ensuring FDA requirements for quality databases submissions are met. Perform and manage clinical Data Management (DM) activities for in-house and outsourced trials including protocol review, CRF (Case Report Form) development, database set up activities, data validation process (including manual data review of listings), and SAE (Serious Adverse Events) reconciliation, managing local laboratory and external labs and database lock. Represent DM on clinical teams, coordinate deliverables by other functions and/or CRO (Clinical Research Organization) as necessary to achieve DM deliverables. Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM (Study Data Tabulation Model). Coordinate CRO (Clinical Research Organization) data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution. Perform user acceptance testing of the database using Inform. Design electronic Case Report Forms (eCRFs) for study start-ups. Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed
Responsible for resolving data issues from clinical, SDTM, and Biostatistical groups.
Requirements
Bachelor degree or above in scientific or related field Minimum 3-5 years experience in Data Management with experience in managing projects, project teams. Experience with In-Form or other EDC software is desirable. Also, some experience in supporting Oncology studies is a plus. Must be able to work independently and be proficient on all related regulations, GCP, and Good Clinical DM Practice. Project management skills are required and must also have strong oral and written communication skills. – Leadership skills a must
Knowledge of the below systems and processes are a plus:
-Clinical Data Management Systems related to EDC studies: Inform, RAVE, COGNOS, and JReview,
-Clinical Data Management Processes; eCRFs design
-Knowledge of CDISC and CDASH is a plus
-Knowledge of Standard global medical coding system MedDRA and WHODRUG.
Source: Job Diva – Job Listing
Duties:
Job Description:
The Clinical Research Coordinator I assist in the daily activities of clinical research studies, obtains informed consent; collects, maintains and organizes study information.
Primary Duties and Responsibilities:
1. Collects and records study data. Inputs all information into database
2. Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.
3. Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
4. Maintains source documents and subject files in accordance with hospital procedures. Ensures accurate and complete compilation of subject data through chart reviews.
5. Secures, delivers and ships clinical specimens as required by the protocol.
6. Responsible for organizing and preparing for monitoring visits.
7. Coordination and management of clinical trials including communication with Sponsors
8. Performs other related duties.
Skills:
Excellent written and oral communication skills
Exceptional attention to detail and accuracy
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
QUALIFICATIONS AND COMPETENCIES
EDUCATION/ EXPERIENCE
Appropriate level will be determined based upon experience and knowledge.
TECHNICAL KNOWLEDGE, SKILLS, AND CAPABILITIES
The requirements listed below are representative of the knowledge, skills, and/or abilities required to perform each essential duty satisfactorily.
Technical Capabilities – Must also be proficient with the following:
Time Management – Ability to work within a fast-paced, deadline oriented environment with minimal supervision. Must be well organized with a high attention to detail and accuracy.
Computer Skills – Must have intermediate skills in Microsoft Word, Outlook, Excel and PowerPoint.
Project Management – Interest in developing, communicating and coordinating projects. Strong ability to multi-task and prioritize multiple projects.
Reasoning/Analytical Ability – Ability to define problems, collect & analyzes data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.
GENERAL CORE COMPETENCIES
Effective Communication – Ability to read and comprehend instructions, policies and procedures. Strong written and verbal communication skills; Interest in learning to present complex data to groups of internal and external customers in a clear and concise manner. Ability to articulate, in writing, detailed concepts. Ability to collaborate with other departments to complete projects on time.
Customer Service – Ability to provide excellent customer service to both internal and external clients.
Teamwork – Ability to collaborate in a team environment; seek regular feedback and contribute in team meetings. Provide back-up to other team members as necessary.
Results Orientation – Be accountable for producing an accurate, timely and quality work product.
Operational Excellence – Collaborate with others to identify efficiencies and process improvements. Embrace change and the focus on continuous improvement.
PHYSICAL DEMANDS
Source: Job Diva – Job Listing
Job Summary:
This role specifically:
• Helps maintain the health of the currently released BIOVIA Laboratory Execution System(LES)/Electronic Laboratory System (ELN) system in the production environment, ensuring the system performs its intended functions accurately and reliably.
• Provides end-to-end support for tickets requiring system change (requirements gathering, documentation updates, development, system configuration, validation protocol/script development to validation execution)
• Follows existing client support processes, procedures, and systems consistent to organizational compliance practices and relevant regulatory requirements (i.e., 21CFR Part 11) such that the system remains in a controlled, validated state
• Will take LES/ELN support calls from the user community through phone, email, and face-to-face to answer application usage questions, investigate application behavior, and determine if the issue is a:
1) System use, system behavior, or documentation issue requiring additional training to provide understanding of system functionality, and/or updates to documentation to resolve
2) System administration issue – user privileges, paths, product specification and analysis , directory maintenance , background/scheduler server, log files
3) System functionality enhancement change request – functionality not in system, system not behaving as desire, new functional addition requests
4) Technology, hardware, desktop, network issue or failure
5) Business concern requiring a management or technical decision which cannot be resolved by changing system
For the above issue types, the expectation will be to resolve or follow processes to resolve 1 through 4, and to notify the proper individuals to resolve 5.
• will enter support 'tickets' into Client support systems for tracking, prioritization , and management to closure
• Assists in the establishment and application of best practices in support management activities, both in the support systems used to track and manage support requests, and in making recommendations to improve the actual processes used to execute the Client support life-cycle, from user requests for change to deployment of that change.
• Assists in the establishment and application of best practices in change management, including how changes are approved and implemented, and how objects are tracked, managed and promoted.
• Communicates to Client leadership regarding system status, concerns, and ideas for continued improvement of the Lab Systems implementation.
• Follows Client configuration management and promotion processes between environments (dev, test, prod) to keep instances in sync as required.
Has good customer support and communication skills.
Source: Job Diva – Job Listing
Please note: Candidates with a recent Masters or PHD in Bio Engineering or Bio Medical Engineering have done VERY well in the past. Please focus your search on this type of degree!
Work with Cataract and Vitreoretinal R&D groups on development projects resulting in achieving R&Ds project goals. Tasks include supplier evaluation/qualification, component qualification, managing prototype builds, assuring assembly process is developed and documented, assure BOMs are entered and maintained correctly, assure product costs are accurate and rolled, conduct Production Readiness Review.
Support Product transfer projects either into or out of plant
Identify and qualify alternate materials and/or components for either risk mitigation or because of obsolescence.
Maintain adequate supply of purchased components through contact with Procurement and the Suppliers. Qualify tooling and equipment as required to assure capacity.
Address any component or product quality issue assigned, determining root cause and completing corrective action.
Address any requests from other departments related to BOMs and components.
Manage product labeling.
Identify and qualify Cost Improvements.
– Communicates clearly.
– Speaks/writes English.
– Works well with others.
– Has leadership capability and is self starter.
– Ability to learn and retain many complex processes quickly.
– Focuses on detail/quality.
– Experience writing technical protocols/reports.
– Ability to use MS Word/Excel/Powerpoint/Project.
– Root cause analysis experience to determinine cause of issues.
– Experience in Medical Device industry – Manufacturing / Design / Quality Engineering fields- preferred.
Source: Job Diva – Job Listing
Duties:
The primary responsibilities of the Labeling Compliance Specialist include supporting the implementation and operation of labeling systems including document management and milestone tracking, and performing quality/compliance processes including compliance tracking, reporting and proofreading of Company Core Data Sheets (CCDS), US labeling and artwork, and EU product information. The Labeling Compliance specialist will also perform a variety of other labeling tasks which may include, but are not limited to: maintenance of distribution lists, management of tracking spreadsheets, labeling systems management, management of drug listing and establishment information in SPL.
Skills:
Detail oriented
A high level of skill in written English, including spelling, grammar and punctuation
Experience with labeling systems and technologies
Experience with proofreading of pharmaceutical labeling and document comparison software
Familiarity with medical terminology
Ability to work independently and meet deadlines.
2-5 years of pharma industry related experience.
Source: Job Diva – Job Listing
Key responsibilities
The incumbent will join a dynamic multi-disciplinary multi-modality drug product development team, with responsibilities that span from formulation development to fill finish of clinical, commercial and life-cycle stage assets within the Biologics/GMU Drug Product Development and Manufacturing.
The successful candidate would be required to:
o Develop experimental plans and execute studies to assess physicochemical stability of non-viral, viral vectors- and cell-based therapeutics
o Assist in process development studies for manufacturing unit operations for injectable dosage forms (e.g. freeze-thaw, mixing, filtration, filling, lyophilization etc.).
Assist in developing new technologies in the areas of polymer-based drug delivery technologies
o Work closely and independently with counterparts from other functional areas to deliver on CMC milestones
o Generate, document and compile data for team and senior management discussions and draft development reports
o Mentor junior staff as required
Preferred Qualifications
Solid understanding and practical experience in drug product formulation and process development of non-viral gene therapeutics: formulation development of lipid nanoparticles, liposomes and polymer conjugates for nucleic acid delivery, container closure selection, stability studies, in-use studies and process development of liquid, frozen, and lyophilized drug product. Theoretical knowledge and hands-on experience in analytical techniques: Fluorescence based nucleic acid quantitation assays (e.g. Ribogreen assay), HPLC/UPLC, capillary electrophoresis, gel electrophoresis, DLS, zeta-potential, DSC, DSF, UV, CD, Cryo-TEM.
Experience in formulation and process development of viral vector-and cell-based therapeutics is a plus. Experience in cell culture, flow-cytometry, qPCR, ITA, plate-based potency assay is a plus.
Basic understanding of statistical data analysis. Good written and verbal communication skills.
Education:
BS in Chemical Engineering, Pharmaceutical Science, Analytical Chemistry, Biochemistry, Biology (or related discipline) with 6 plus years of relevant experience or MS in Chemical Engineering, Pharmaceutical Science, Analytical Chemistry, Biochemistry, Biology (or related discipline) with 2 plus years of relevant experience
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
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