Source: Job Diva – Job Listing
The Research Associate II (RA-II) will be the lead contributor to a Biopharmaceutical Drug Product development project (including Gene Therapy, Protein therapeutics, etc) and will be responsible for stability testing, formulation screening and container closure selection. Successful candidate is expected to work with internal and external partners to timely and comprehensively address stability and compatibility aspects using established assays, across a variety of technological platforms and disciplines (biochemical, molecular biology, biophysical, and analytical). Prior experience in developing molecular biology, analytical and biophysical methods for accelerated (high throughput) protein characterization, formulation screening and candidate selection is a plus.
Key expectation and training include execution of stability studies under various formulation conditions comprising of gene therapy capsids or protein/enzyme sample preparation, testing, data analysis and interpretation of results. Planning, prioritization and initiation of concurrent experimental procedures for multiple programs to ensure their timely completion is essential. The RA-II should have good communication skills (oral and written), a strong work ethic, and good documentation practices including laboratory notebook maintenance, and compilation and presentation of data. The RA-II is also expected to work well with others and have the flexibility and adaptability needed in a fast-paced team environment.
Basic Qualifications:
A M.S. degree or equivalent in pharmaceutical science, biochemistry, chemical engineering or any related discipline and 3-6 years of relevant laboratory experience or a B.S. degree or equivalent in pharmaceutical science, biochemistry, chemical engineering or a related discipline and 5-8 years of relevant laboratory experience in the pharmaceutical industry.
Preferred Qualifications:
Source: Job Diva – Job Listing
This position supports North America Scientific Purchasing with contract coordinating for new contracts and change orders including contract planning, preparation, and follow-up for services pertaining to clinical studies Phase I through Phase IV The position receives contract requests and works to understand customer requirements, processes request forms with Legal, maintains follow-up on contracts and works to resolve issues. The position will monitor the quality of data and the compliance of the purchasing project files following Scientific Purchasing procedures. Experience: 3 to 6 years.
– Candidate must have experience with drafting contracts
Source: Job Diva – Job Listing
This position supports North America Scientific Purchasing with contract coordinating for new contracts and change orders including contract planning, preparation, and follow-up for services pertaining to clinical studies Phase I through Phase IV The position receives contract requests and works to understand customer requirements, processes request forms with Legal, maintains follow-up on contracts and works to resolve issues. The position will monitor the quality of data and the compliance of the purchasing project files following Scientific Purchasing procedures. Experience: 3 to 6 years.
– Candidate must have experience with drafting contracts
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
Summary:
Represent Analytical Outsourcing (AOS) as the LabVantage SME and responsible for:
Being a liaison between AOS and IT
Training LabVantage Stability Module
Entering and managing stability protocols
Generating reports and tech memos for stability extensional use for product batches and standards
Entering and tracking data for stability of product batches.
Writing stability related sections in dossiers
Managing shipment of stability samples as needed
Technical writing including preparation/formatting of documents of regulatory submissions, technical memos, etc.
Management of budgets and shipping requests for analytical studies
Coordination of document review and approval processes and archiving
Required:
• Two plus years professional experience in LabVantage LIMS, LabWare LIMS, Quality Systems, IT Strategy, and BusinessObjects
• Past roles include as a LIMS lead, LIMS analyst, process analyst, master data builder, trainer, or developer
• Experience as a Technical Writer in the Pharmaceutical arena
• BS in chemistry, biology or a related scientific discipline
• 1-3 years scientific background
• Excellent oral communication and technical writing skills
• Excellent interpersonal skills
• Demonstrated attention to detail
• Experience in GMP or GLP and/or a regulated industry (preferred)
• Knowledge/experience with proteins and biotechnology (preferred)
• Strong background in Microsoft applications such as Word, Excel & OneNote a must
• Quick learner & attention to detail
Source: Job Diva – Job Listing
Job Summary
Position independently performs a variety of mechanical repairs, installations and maintenance on facility equipment, building and utility systems such as R.O Water Systems, Air Compressors, Vacuum Systems and HVAC Systems. This individual works independently on the majority of assignments. Provides proactive support by inspecting equipment for proper lubrication and performing other preventative maintenance duties. Performs regular maintenance checks on problem areas, making repairs and adjustments using the maintenance work order system. Assists in preparing maintenance Clean Room Reports. Performs repairs and maintenance of Manufacturing production equipment such as Labeling and Packaging machines.
Essential Functions
1. Performs daily maintenance checks and/or repairs on facility and equipment and will provide guidance to other less experienced Facilities Technicians. This ensures that the facility is well maintained and is operating in an optimum manner to support the business demands.
2. Performs maintenance task such as mechanical repairs to R.O. Water Systems, Air Compressors, Vacuum Systems and HVAC Systems. Responsible for the appearance of mechanical areas as well as equipment operations. Will work with contractors during scheduled and emergency repair maintenance mechanical systems.
3. Coordinates closely with outside contractors, and interacts with other organizations to insure that the Company objectives are being met. This includes, but not limited to communicating closely with Gliadel Operations, Quality, Calibration Contractors, Finance/Accounting, Purchasing, and other organizations. This ensures that all organizations maintain a focus on optimizing the Companys assets.
4. Responsible for working with the other Facilities Technicians and/or other staff to assist them with repairs requiring more than one person. Also assists with special projects as needed.
Requirements
Working understanding of cGMPs preferred but not required.
Ability to work independently and proactively
Demonstrated ability to successfully manage multiple priorities and tasks
Prior responsibility for maintenance (i.e., physical condition) of building (inside and outside)
Knowledgeable of appropriate construction codes.
Ability to quickly determine and solve equipment malfunctions.
Good oral and written communications skills.
Attention to detail
Excellent Organizational Skills
Excellent Customer Service Skills
Ability to lift/carry heavy items (50+ pounds)
Walking/standing for extended periods of time
Rotating on call and call in availability (nights and weekends)
Valid Maryland drivers license
Working Conditions include
o Heat, cold and heights
o Dust, fumes and odors
o Electrical wires or machinery
Education:
High School Diploma or GED required
Coursework in HVAC, plumbing, or general maintenance preferred
Technical:
5+ years of experience as a Facilities Maintenance Technician (or comparable role); in the pharmaceutical manufacturing/packaging industry preferred but not required.
Basic computer skills (including keyboarding and Internet Explorer)
Working knowledge of Microsoft Word and Excel
Lotus Notes or other e-mail program
Knowledge of internet based supply ordering
Source: Job Diva – Job Listing
The Laboratory Technician I position is part of Process Science in Global Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Boston, MA. The Global MSAT team is within the Industrial Affairs (IA) unit of ***Clients Specialty Care organization. The Team is responsible for providing laboratory-based technical support to *** biologics. The Team recently designed a state-of-the-art laboratory with capabilities to support small-scale models of the commercial cell culture and purification operations, as well as analytical testing.
The Process Science team member will:
Learn and execute protein stability studies on liquid, frozen, and/or lyophilized formulations
Participate in design and execution of experiments using small-scale models, analyze and interpret results, and recommend additional experiments. Utilize this knowledge to expand process understanding and drive improvements in the commercial manufacturing operations including improving process robustness/reliability.
Apply design space knowledge to support effective investigations and root cause analysis
Use scientific principles and professional practices to solve a range of complex problems in creative and practical ways
Effective communication & presentation skills
Experience in biologics stability studies is beneficial
Experience with aseptic technique is beneficial
Understanding of protein stability, characterization, and/or analytical theory preferred, but not required
Source: Job Diva – Job Listing
Job Description: Administrative Assistant
Duties
Provide general administrative site support. Maintain inventory oversight and ordering of all general office supplies. Primary point of contact and management of all external office service and facility maintenance providers. Plans site events including all-hands meetings and holiday special events. Manages incoming and outgoing mail including distribution to employees. Confirms internal and external appointments for individuals and greets external visitors.
Skills
Must be proficient with Microsoft Office suite. Ability to use Excel. Must be well organized and able to manage multiple projects at one time
Education
High school diploma or equivalent required. Associate degree preferred or equivalent work experience
Source: Job Diva – Job Listing
Summary: *** is seeking a Senior Cost Accountant that will support the Technical Operations & Process Sciences Finance group. This position has a strong focus in manufacturing, cost accounting, cost variance reporting, and inventory control.
Principal Responsibilities:
Support the accounting month-end close process:
Review daily transactions in the Oracle Process Manufacturing (OPM) module
Review clinical Contract Manufacturing Organization (CMO) contracts, Purchase Orders, and invoice payments
Support the lot costing process for internal manufacturing campaigns at the North Creek facility
Prepare month-end journal entries and related reconciliations related to clinical CMO accruals
Prepare month-end journal entries and related reconciliations for clinical and commercial inventory (Raw Materials, Inventory-in-transit, WIP, and Finished Goods)
Review cost of goods sold to ensure proper cut-off and allocation to the appropriate program
Support the Forecasting and Budgeting process for TOPS:
Monitor the plant costs factors including labor, overhead, and freight
Monitor the plant waste of scrap, raw materials, WIP, finished goods inventory, and raw material variances by program
Track and monitor Commercial production capacity
Track and monitor daily movements of Commercial and Clinical inventory between CMOs, 3PLs, and storage facilities
Analyze and review bills of material to ensure accurate product costing.
Prepare actual versus budget analysis; review costing of manufactured lots
Prepares month end manufacturing variance reports
The ideal candidate would have a minimum of 3 years of cost accounting experience and/or 3 years experience in a manufacturing environment, plus experience in Oracle.
Source: Job Diva – Job Listing
The Biospecimen Coordinator will be responsible for management of the physical human biospecimens such that utilization of samples is monitored and in alignment with business/project priorities.
Responsibilities
Maintains Tissue Bank inventory, including filing incoming shipments of tissue blocks, pulling them for requests, and returning them to their proper location after their use.
Organizes Tissue Bank sample cabinets and ensures accurate and consistent labeling of tissues slides.
Maintains TSM data in either spreadsheet or database format, evaluates and enters clinical data provided by sample suppliers to properly categorize the tissue samples, and incorporates sample clinical data from pathologists reports such as pathological diagnosis of Hematoxylin & Eosin (H&Es), assay results from further characterization of samples, etc., to aid in future searches.
Processes internal Histology requests; finds appropriate samples within the inventory, works with the scientists to clarify needs, and prioritizes requests. Serves as liaison between histotechnicians and pathologists; labels slides and ensures all necessary paperwork is completed.
Retrieves and ships incoming and outgoing requests and orders internally and to affiliate locations.
Communicates directly with sample vendors suppliers to acquire samples and resolve discrepancies.
Assists in ordering reagents for Research & Development (R&D) histology group.
Knowledge of and skill in inventory management.
Knowledge of and skill in utilizing word processing, spreadsheet, database and email software.
Strong written and verbal communication skills.
Skill in data evaluation.
Ability to work cross-functionally and effectively build relationships to drive group and corporate objectives.
Knowledge of histology and tissue staining laboratory techniques preferred.
Source: Job Diva – Job Listing
The Associate Scientist is responsible for research and development of new contact lens materials, packaging salines, and contact lens care products
Performs polymer formulation, characterization and process in a research 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 and property relationship in polymers, specifically the relationship between molecular architecture and morphology and bulk properties. Identifies and executes appropriate testing methodologies to evaluate potential new contact lenses, lens surfaces, package saline and lens care products
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.
Background in Chemistry, Chemical engineering, process engineering
Formulation and process experience with hydrogel and contact lens care are desired
Must be able to write reports and communicate well to internal customers.
Source: Job Diva – Job Listing
Summary:
We are seeking a Research Associate, with skills as a protein chemist, to participate in the development of our antibody drug conjugate technology.
We seek an individual who will enjoy working at the bench in a collaborative fashion alongside scientists with a variety of backgrounds and specialties.
Duties:
Preparation and characterization of antibody-drug conjugates (ADCs) using established and experimental conjugation methodologies and analytical techniques, including HPLC and mass spectrometry analysis. Preparing reports from analytical results.
Working collaboratively with other scientists and departments on ADC-based research projects.
Preparation of critical reagents.
Required:
B.S. or M.S. degree in Biochemistry, Chemistry, or a related field with 2+ years of extensive laboratory experience in an academic or industrial setting.
The ideal candidate will have hands-on experience and a good understanding of protein chemistry, bio-conjugation, protein purification, and characterization including chromatography, analytical HPLC, and mass spectrometry.
Experience working with cytotoxic compounds is a plus.
Good communication and organizational skills and the ability to interface constructively with other scientists.
Source: Job Diva – Job Listing
As a Software Developer and Technical Lead you will:
Solutions may involve design, implementation, testing, debugging, performance tuning, documentation, validation, and support.
Implementation may involve development of operating procedures and/or training of service personnel and end users
Translate business requirements into maintainable software components.
Understand business drivers and processes.
Identify risks and dependencies and work on mitigation plans
Work with limited supervision with some guidance.
Work with little instruction on day-to-day work and general instructions on new projects or assignments.
Interface with Senior Software Developers, Architects, Operations leads, Project managers/scrum masters etc.
Oversee and lead the work of other contractor software developers.
Experience implementing authentication with SAML, Single Sign On, etc.
Experience with system and data integration from several systems
Knowledge of Windows/Linux commands is a plus
Knowledge of F5 LoadBalancer, Network concepts DNS, firewall is a plus
Web development with HTML, CSS, JavaScript, Angular JS, REACT, Apache (web server)
Programming with Java, XML, Python, PHP
Good understanding of database concepts Knowledge of SQL, MySQL, Oracle is a plus
Biotech or Healthcare work experience is preferred
Source: Job Diva – Job Listing
Maintaining and coordinating the Record Retention process of GMP documents. This responsibility includes onsite and offsite record retention.
Creation and control of Production logbooks pre, post and during use.
Maintaining document control through Production Floor Support, including but not limited to exchanging inactive official copies of documents for active official copies of documents in real time.
Supporting production needs by being responsible for performing administrative tasks such as gathering and preparing documentation to support investigations, operational optimization and/or change controls/CAPAs
Ensure cGMP regulations regarding documents, logbooks and forms are adhered at all times.
Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
Experience: 0-3 years
Attention to details
Able to gown aseptically multiple times throughout the course of a day.
Working knowledge of cGMP is required
Good Communication skills both written and verbal
Proficiency in WORD, and EXCEL, and have a working knowledge of other MICROSOFT OFFICE programs.
Excellent organizational skills.
Sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.
Work quickly with a high degree of accuracy.
Technical Writing experience preferred
Previous experience working within a production department of a pharmaceutical company preferred
Candidate must be able to work extended and flexible hours (including weekends) when needed.
Source: Job Diva – Job Listing
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