USA-Accountant III (Professional) (20-00499) – PA – Swiftwater

Accountable for monthly balance sheet reconciliations. Responsible for clearings. Perform analytic assessments (aging, etc). Work cross-functionally and liaison with Controlling, Procurement, Procurement Operations Shared Service, Accounts Payable and Business Owners surrounding GR/IR clearing requirements or issues (invoice remediation, quantity/price variances). Establish best practices surrounding controls, roles and responsibilities and process flow. Create and update policies and procedures as required. Develop and perform relevant training for Finance, Purchasing, Procurement Operations shared services, and Business. Act as a liaison and single point of contact for internal and external auditors. Performs all related compliance controls. Obtain all required documentation. Generate various reports and status updates as needed..Controller Experience Years of Experience: 6 – 9 Years
Source: Job Diva – Job Listing

Senior Researcher (20-00498) – MA – Cambridge

Description:
We are seeking an experienced and highly motivated research scientist who will work to assist scientists in the group with the development of in vitro and in vivo based assays focused on cell signaling, cell function and biochemistry.
The successful candidate will be proficient in utilizing his/her experience in molecular and cellular biology techniques to support project objectives. Specifically, this person will be responsible for:
– Isolation and maintenance of murine cells from the brain and other organs.
– Mammalian tissue culture.
– Using high-content imaging and flow cytometry plate-based assays to determine effect of lead compounds on cellular function.
– Examination of protein expression, modification, and secretion using flow cytometry, ELISA and western blotting, qPCR.
– An organized approach to stringent data analysis and the maintenance of an Electronic Laboratory Notebook.
 
Required:
• MS in biological sciences or BS in biological sciences with 2-3 years relevant experience in academia or industry.
• Experience in mammalian cell culture and familiarity with processing cell samples for downstream assays is required.
• Flow cytometry experience is required.
• Experience in RNA isolation from cell culture and qPCR is required.
• Experience with ELISA, western blotting and imaging are preferred.
• Understanding of basic neurobiology of neurodegenerative diseases and mechanisms of neurodegeneration is preferred.
• Experience with in vivo disease models is a plus.
• The ideal candidate should be well organized, possess excellent technical and communication skills, as well as the ability to work collaboratively in a team environment.
• Flexibility and willingness to learn and master new techniques are highly valued.
• We seek a creative and diligent person who brings care and attention to detail to the job.
The candidate should be experienced in primary cell culture and be familiar with processing cell samples for downstream assays.
They should have strong flow cytometry experience and experience with techniques such as ELISA and western blotting.
An understanding of CNS cell-based assay development is a benefit.
Significant understanding of basic neurobiology of neurodegenerative diseases and mechanisms of neurodegeneration is preferred.
BS/MS in biological sciences with 2-3 years relevant experience in academia or industry.
Source: Job Diva – Job Listing

Project Clinical Manager (20-00496) – AZ – Tucson

ESSENTIAL FUNCTIONS:
Assists in the planning, execution and reconciliation of clinical projects, while adhering to budget, scope and schedule requirements. Coordinates clinical budget and related pricing strategy services for the purpose of executing a clinical trial or ancillary services agreements, including medical education and communication programs. Utilizes and implements cost models to support pricing, and helps to develop and maintain resource modeling within research and development.

Responsible for the planning and execution (process planning) across different medical affairs activities, that can include educational and training programs, clinical study planning, and internal and external medical and scientific communication campaigns. Coordinates the activities of functional groups that comprise the larger collaborative medical affairs project teams including, but not limited to the pathology office, clinical operations and biometrics, lifecycle commercial teams, affiliate medical and commercial teams, regulatory, compliance, contracting and legal, and various launch and on-market support teams . Applies best practices in the development, initiation, planning, execution, control and closing of projects. May also interact with finance, research and development, marketing, manufacturing and other departments as appropriate.
The Project (Clinical) Manger may also support database management, in collaboration with the Senior Medical Information Specialist in support of corporate IVDR directives and management and in support of regulatory and notified body submissions.

Skills:
– Expert knowledge and application of scientific principles and concepts.
– Demonstrated proficiency in typing, use of Adobe Acrobat 9 Pro, Microsoft Office products including Microsoft WORD, Outlook, and Power Point and the Google suite of products. 
Experience with EndNote and Microsoft Visio 2010 preferred.

– Excellent and proven leadership skills, team skills, written and oral communication skills.
– Strong ability to handle multiple projects simultaneously.
– Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
– Advanced technical or clinical writing skills.
– Ability to produce reports and documents independently and evaluate those of others.
– Demonstrated creativity and ingenuity through the development of novel, multi-disciplinary approaches to projects and strategic issues.
– Skill and ability in implementing strategic projects, acting as a catalyst to remove organizational barriers, reduce cycle times and direct process improvements.
– Ability to rapidly develop expertise in FDA guidelines for in vitro diagnostic devices and the statistical basis for sensitivity, specificity and reproducibility testing required for validation and FDA clearance and approval.
– Ability to rapidly develop expertise in the company’s internal document management system.  
 
Manager's Must Haves: 1) Sound logic and reasoning. 2) Solid understanding of the scientific method and be able to critically think through unforeseen opportunities.  3) Ability to communicate and write clearly and concisely. 4) Proficient Keyboarding.  5) Interacts well with others. 6) Capable of working independently.  

Education:


– Bachelor of Science, with a strong science background preferred.  

 
Desired Experience:
– Two years of experience in project management, critical data analysis, and report generation in a clinical or regulated environment
– Experience in study design and data analysis.
– Experience in regulatory, academic or clinical writing is preferred.
– Experience in design control processes is preferred.
– Experience with approval of in vitro diagnostic devices is preferred.
– Oncology experience is preferred.
 
 
Source: Job Diva – Job Listing

USA-Compliance Specialist III (Manufacturing/Quality) (20-00494) – PA – Swiftwater

Vaccines Industrial Affairs (VIA) is preparing its future through an ambitious program named Evolutive Vaccine Facility (EVF). The EVF Project is at the cornerstone of client's strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges.
The EVF validation strategy will be essential to help EVF reach its ambition. A validation lifecycle approach, based on Quality risk management and a holistic control strategy will be key elements of the validation Strategy. In that context we are looking for a Quality Validation Expert.
Under the directives of the EVF validation strategy leader and the EVF quality team, the Quality validation expert will, during the basic design phase of the project:
– Assist in the definition the initial control and validation strategies, planning the associated activities and ensuring the integration of digital tools and quality oversight.
– Work with sub-teams involved in validation activities (Quality, Engineering, Manufacturing technology, Data Science, Operation).
– Facilitate risk analysis sessions for the Validation and Control strategies which will be based on Quality risk management and Quality by design principles.
– Draft the associated documentation. Interpret complex, explicit documentation to ensure quality standards and compliance.
-Support the Senior Quality Project Team in case of Health Authorities communication.
Critical thinking and innovation thinking are key in the context of the EVF project.
May provide training to project team members. Work under only very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
Key competencies
– Process validation (biologics / vaccines)
– Quality by Design, Control strategy
– Quality risk management, FMEA
– Project management and Communication
– Continuous Quality Improvement and Quality Culture
Key deliverables
– Validation risk assessement
– Control Strategy document
– Validation Strategy document

Education and experience
– Advances degree or PhD, with 10+ years in quality validation.
– Risk-based approach / ICHQ9 mindset
– Vaccines & Biotech Processes understanding/knowledge
– Methodology ability
– High level of autonomy
– Excellent communication skills, able to manage cross functional communications
– Leadership during workshops / Experience in understanding customer's voice and quality requirements is a must
Source: Job Diva – Job Listing

Sr. Pharmacovigilance Quality Assurance Specialist (20-00492) – WA – Bothell

Position Summary:
We are seeking a highly motivated Good Vigilance Practices (GVP) Compliance contractor to support our drug development programs and European expansion. This position will report to the Director, Research & Development Quality (RDQ) – GCP/GVP Compliance.
The successful candidate will be responsible for supporting GVP compliance by:
• Overseeing and assisting with a GVP gap assessment,
• Developing and maintaining GVP SOPs, training programs, inspection readiness support, deviation/CAPA management, and metrics reporting.
• Ensure a high level of quality and consistency across the entire program
• Contribute to the GVP audit strategy and conduct audits
• Lead a GVP gap assessment of Drug Safety and associated processes/departments versus EU GVP and FDA Pharmacovigilance guidance
• Oversee the remediation of an assessment findings such as:
• Develop and review GVP SOPs
• Develop and coordinate GVP Training
• Support regulatory inspection readiness activities
• Support the management of regulatory inspections
• Oversee and manage the GVP Deviation and CAPA management process using Veeva
• Develop and periodically report Quality Metrics/KQIs
• Ensure existing GVP regulatory intelligence information gathering process is fit for purpose (i.e. regulations, guidance documents, countries)
• Define GVP audit program strategy
• Prepare GVP audit plans and conduct GVP audits
• Prepare, review, and approve internal and external reports and other documentation required by regulatory agencies, or customers, to support the quality assurance function
• Partner with colleagues in Development, Regulatory, and Medical departments to increase the overall effectiveness of the PV Quality role, and instill a Quality Improvement approach in all activities
 
Requirements:
• Minimum Bachelor’s degree in Chemistry or related life sciences is required
• A minimum of 5 years' experience supporting EU and FDA GVP functions
• Full understanding of FDA GCP and Part 11 regulations, EMA and MHRA regulations, ICH Guidelines and European Clinical Trials Directive, EU GVP Modules and an understanding of their application in the field.
• Understanding of good documentation practices, ability to organize and utilize electronic systems to track and manage information
• Knowledge of clinical development process and Phase I-IV trial operations and the related regulations/guidelines
• Experience with effectively managing pharmacovigilance regulatory inspections, working with regulators and partner audits
• Experience developing SOPs, reviewing internal drug safety, clinical operations, regulatory and medical processes to ensure they are accurately represented in current SOPs
• Experience with Veeva is desired
• Must have excellent communication skills (verbal and written)
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Source: Job Diva – Job Listing

USA-Application Support Specialist I (IT) (20-00491) – NJ – Bridgewater

JOB MISSION
The ITS Expert Quality GBUs is a key member of the ITS Quality Operations team providing mission-critical Quality and Compliance expertise to the ITS Global Business units and will be reporting to the Head, ITS Quality Operations for GBUS.
The incumbent will provide Quality & Compliance expertise and services to Global Solution centers and ITS Service managers within ITS GBUs , notably on Project & Application Quality Support, Audit & Inspection Support and Even and CAPA Management.

This position covers a diverse Commercial operations and digital scope, with a variety of critical ITS solutions built on both established and emerging technologies.

Additionally, it provides an opportunity to work in a dynamic, international Quality Operations team, while at the same time gaining experience with and contributing to a variety of projects and system lifecycle activities in support of the discovery and development of life-saving new medicines.

Based on prior experience of the selected applicant, upskilling opportunities will be provided.

.MAIN EXPECTATIONS AND RESPONSIBILITIES:
Computerized System (CS) Validation and Application Lifecycle Management:
o Advise and guide project and application teams on and oversee validation activities in collaboration with Business Quality
o Advise on and support the effective quality management of third parties, including SaaS / cloud suppliers
o Ensure compliance of projects and applications with applicable regulatory and internal requirements by leading risk assessment, validation and testing strategy definition and overseeing their execution in collaboration with external service providers
Quality Risk Management:
o Work with ITS Risk Managers and Service Lines to proactively address and mitigate Quality and Compliance risks
o Contribute to operational excellence in application management and support through management of Corrective and Preventive Actions
Audit and Inspection Readiness and Support:
o Collaborate with Business System Owners, Business Quality and ITS Service Line representatives to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective/preventive action plans to improve compliance and effectiveness of the Quality Management system
Quality Management System and System Lifecycle Methodology:
o Contribute to the continuous improvement of the ITS Quality Management System and System Lifecycle methodology and its continuous evolution to adapt to new technologies and ways of working
o Contribute to the education and upskilling of the ITS community on Quality and Compliance topics
o
Formal Education, Experience and Skills Required:
Bachelors degree in a scientific, engineering or IT discipline
3+ years of experience in Quality Management and compliance (GxP, SOX, Data Privacy) or Information Technology contributing to regulated projects or system lifecycle activities
Strong problem-solving skills
Excellent written and oral communication in English
Strong interpersonal skills to build effective relationships with a variety of stakeholders
Ability to work effectively and collaboratively in an international, multi-cultural and multidisciplinary environment
Ability to adapt to a changing and highly dynamic work environment
Curiosity with respect to new technology and its application in a regulated pharmaceutical Commercial operations environment

Preferred Qualifications: ITS will provide necessary upskilling for final candidate
Experience in the validation of Computerized Systems in a GxP environment
Experience in the application of Agile System Lifecycle methodologies
Experience implementing digital technologies such as Mobile apps, websites and chatbots .
Source: Job Diva – Job Listing

USA-Drug Safety Associate II (Clinical) (20-00490) – NJ – Bridgewater

Description:
Reporting to the Director, Global Regulatory CMC, this position will provide Regulatory CMC support
Main responsibility will include monitoring and tracking regulatory information and assuring accurate communication of the current status of post-approval change control assessments and submissions; ensures all databases are up-to-date and accurately reflects registered information.
May support global regulatory submissions such as annual reports, PAS, CBE supplements, variations, registration renewals, response dossiers, etc.
Interacts with RA colleagues world-wide;
May provide project team representation while working closely with site Manufacturing, Quality, Technical Support/service groups to compile required information in accordance with established timelines;
May coordinate and work with sites to prepare regulatory document packages to support post-market changes
May provide project team representation, consults on regulatory project needs and is responsible for developing required regulatory documentation/submissions.
May review technical documentation (i.e., Change Controls); Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals;
 
Qualifications:
• Bachelors or Master’s degree in the Life Sciences and at least 2-5 years of experience in regulatory, manufacturing, technical development or QA/QC
• In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing. 
• BS, MS or PhD in Biology, Chemistry or related field.
• Excellent written and verbal communication skills.
• Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to drug and/or biologic regulations.
• Strong understanding of manufacturing processes
• Excellent organizational skills demonstrated ability to prioritize multiple projects.
• Ability to work in a team environment, possessing interpersonal skills to effectively work with other departments at various levels. Excellent communication skills and ability to influence across the broadest of constituencies.
• Have direct hands-on experience with post-marketing regulatory activities (i.e. AR, CBE-30, PAS, Variations) for biologic and/or drug products
• Ability to effectively interpret guidance and provide recommendation to key stakeholders.
• Regulatory, Manufacturing, QA/QC experience
• Proficient in MS Word, Excel, PowerPoint, MS Project
• Ability to set ambitious and realistic targets, drive for results and build accountability.
• Ability to effectively manage the balance between delegation/empowerment and a hands-on approach
Source: Job Diva – Job Listing

USA-Buyer II (Professional) (20-00489) – MA – Northborough

Source and process orders in support of assigned organizations and/or commodities while ensuring the proper review, authorization, pricing, specifications and delivery dates have been achieved. Maintain compliance with regulatory as well as company and department policies and procedures. Analyse supplier data to determine strategic approach to supplier consolidation, higher buying leverage, compliance with contract pricing, and identify opportunities for process improvements and/or cost efficiencies to meet the procurement needs of the internal customers. Procure supplies, services, equipment and commodity products for delivery at specified time and location. Place and expedite orders. Source and negotiate for goods and services (to specified value) subject to management approval. Manage assigned suppliers. Actively involved in supplier/quality management. Meet cost savings targets. Begin to work more independently with internal clients, suppliers, and cross functional groups. Create relationships with lower dollar/low risk suppliers. Begin to develop project management skills. Work under general supervision. Work is reviewed regularly for soundness of judgment and overall adequacy and accuracy. Contribute to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify. Frequent internal company and external contacts. Represent organization on specific projects. Years of Experience: 3 – 6 Years
Source: Job Diva – Job Listing

USA-Research Associate III (Scientific) (20-00488) – MA – Framingham

Support a Biopharmaceutical Drug Product Development project (Biologics, Gene Therapy, Protein therapeutics or applied research) using biophysical characterization techniques (liquid and solid state/lyophilized). Coordinate lab activities and maintenance of lab systems. Responsible for the execution and analysis of experiments and analytical procedures for stability testing, formulation or process screening and container closure selection. Display an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigate basic technical problems and performs routine scientific procedures and experiments independently. Plan and prioritize concurrent experimental procedures. Integrate, compile, and tabulate data and assist supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Work independently but with active supervision and team interaction. Follow established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy. Contribute to the completion of milestones associated with specific projects. Failure to achieve results or erroneous execution may cause delays in program schedules, and may result in the allocation of additional resources. Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters. Good communication skills (oral and written), a strong work ethic, and good documentation practices including laboratory notebook maintenance, and compilation and presentation of data. Works well with others and has the flexibility and adaptability needed in a fast paced team environment. Years of Experience: 6 – 9 Years
Source: Job Diva – Job Listing

USA-Validation Engineer III (Engineering) (20-00487) – PA – Swiftwater

BS/MS in Science or Engineering with previous experience in CQV field. Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment. Areas of experience : cleaning validation, CIP, COP, laboratory studies, filling lines, formulation. Well-developed communication skills, both verbal and written.. Years of Experience: 6 – 9 Years

Duties
1. Authoring, reviewing, executing and approving validation documents
2. Interfacing with Quality organization and defending rationale in validation documents
3. Reviewing and analyzing data
4. Determining sampling procedures, plans and sample size
5. Rinse and Swab sampling
6. Bracketing and worse case rating
7. Establishing Dirty hold times and clean hold times
Skills
• Design and execution of cleaning validation studies
Proficiency in utilizing documentation management systems to author protocols and reports
• Experience participating in teams and collaborative work environments.
• Good communication skills (verbal and written), math skills, general computer skills
• Strong root cause analysis with cGMP experience.
Source: Job Diva – Job Listing

Sr. Tester- Ethics & compliance (20-00485) – NJ – East hanover

 

Tech Experience: Pharma background with experience in system testing in the ethics and compliance space – speaker engagements and MDM   

JD brief desc: Project will entail building test cases for UAT for the IQVIA Centris system.  With the anticipated changes as a result of the CIA, this will drive additional changes to the system.  Strong skills in systems testing, writing test scripts, managing meetings, requirements input.  Candidate should be able to drive decisions and get responses from the team.  Good documentation and communication skills are critical.

Source: Job Diva – Job Listing

Associate Scientist I (20-00484) – TX – Fort Worth

Position is for a microbiology associate scientist responsible for completing routine microbiology activities including endotoxin, environmental monitoring, preservative effectiveness testing, and other laboratory support tasks that enable completion of testing required for Vision Care, and Surgical projects.
Major Accountabilities: With direct supervision, carries out microbiological assignments, including execution of established microbiological assays and the development/validation of new assays
Routine endotoxin testing; Processes microbiological environmental monitoring samples
Responsible for accurately recording experimental methods, materials and results in laboratory notebooks, analyzing data and evaluating results, communicating effectively and presenting findings at group and departmental meetings; Ensures compliance with internal and external standards; Responsible for collaboration with other Microbiology team members to accomplish necessary testing and meet project milestones

Experience:
Previous laboratory experience in microbiology or genetics laboratory; Endotoxin experience preferred
>1 yr of applicable experience with Bachelors degree; Good analytical skills and documentation practices
Demonstrated ability to follow scientific procedures
Strong interpersonal and communication skills
Source: Job Diva – Job Listing

Clinical Supply Planning Manager (20-00482) – WA – Bothell

 Summary
Responsible for planning and management of global clinical supply plans. Includes tracking
CMO scheduling (international & domestic production/packaging), working closely with each
Clinical Supply Project Manager to ensure accurate forecasts from Clinical Development,
analysis of clinical supply/demand trends, and creation and implementation of clinical supply
plans to support clinical trials. Expected to have extensive knowledge across many
functional areas and resources related to global clinical supply operations. Works closely
with all internal resources to optimize clinical supply availability and inventory investment.

Responsibilities
Create Work in Progress trackers, create supply forecasts based on study forecast
provided by Clinical Development Operations (CDO)
Assist with the lot information and tracking of inventory by study by country.
Monitor the inventories of clinical product, including comparator drug at the
distribution points
Prepare and distribute status reports on clinical drug product inventories, and
planned production
Provides timely and accurate clinical inventory information to the required systems
Assist in the maintenance of the IWRS/IRT inventory database
Provide liaison between SGEN teams and the Clinical Operations group
Manage the development of packaging plans/schedules and track/report against
actual performance
Requirements
Minimum of 5+ years planning experience within a manufacturing environment or 3
years of being in a pharmaceutical or process industry setting.
Experience in an FDA regulated atmosphere.
Excellent verbal and technical written communication skills, excellent interpersonal
skills and negotiation skills are essential.
Experience working with an integrated enterprise-level planning system. (SAP,
Oracle etc.)
APICS certification desired

Source: Job Diva – Job Listing

Clinical Packaging Associate (20-00481) – WA – Bothell

Summary
Responsible for execution of standard/non-complex US and/or EU open label clinical
packaging and labeling projects. Supports business coordinators in the management of third
party clinical packaging CMOs as needed. May work independently with the SGEN clinical
teams and internal and external resources to achieve clinical packaging project deliverables.
Supports other team members with the implementation of Clinical Supply Operations
projects and initiatives. Knowledgeable of functional areas and resources related to clinical
packaging operations and/or project management.

Responsibilities
Executes project plans for the packaging and labeling of standard/ non-complex
open label US and/or EU clinical trial supplies.
Coordinates the project plan with the CMO to ensure clinical supply timelines are
achieved.
Develops and communicates accurate lead time requirements to our
packaging/distribution vendors
Contributes to the preparation and distribution of periodic status reports on planned
packaging
Assist and provides timely and accurate information in the maintenance of the
Electronic Data Capture inventory database (Great Plains)
May become a liaison between SGEN clinical teams and the Clinical Supply
Operations group
May act as point of contact for third party packaging vendors
Requirements
College degree in a business field and/or 2 years of relevant industry experience.
Good verbal and written communication skills
Interpersonal and negotiation skills are essential.
Project management skills
Experience in a FDA regulated atmosphere helpful.
Knowledge of clinical trial supplies desired.
Experience working with an integrated enterprise level planning system an
advantage (SAP, Oracle etc.)

Source: Job Diva – Job Listing

Contracts Administrator (20-00480) – WA – Bothell

Summary: *** is seeking a Contracts Administrator to assist lawyers by investigating facts, or preparing legal documents. Job Responsibilities: Attend legal meetings, such as client interviews, hearings, or depositions, and take notes. Prepare all contract documentation proposed by the Company. Manage change order process and follow up with relevant parties. Prepares change orders and proposed change order documentation for acceptance and legal signatory execution. Maintain change order log, timely billing and collection. Eliminate any possible dispute over any change order administration. Continuously compares contract documents to the dollar amounts entered in the accounting system and resolves any deviation. Drive the timely collection and accurate completion of all departmental documents required of staff within the department. Ensure that job dollar values are neither over nor undervalued or reported. Assists in preparing and maintaining any documentation needed for collection purposes. Coordinates with production and field personnel to ensure all material and supplies reach the job site as scheduled and required. Manage Work on Hand Schedule.Skills: Verbal and written communication skills, attention to detail, customer service and interpersonal skills. Basic ability to work independently and manage ones time. Basic knowledge of laws, legal codes, court procedures, precedents, government regulations, and the democratic political process. Previous experience with computer applications, such as Microsoft Word, PowerPoint and Excel. Education/Experience: Associate’s degree in paralegal studies or equivalent training required. 2-4 years of experience required.
Source: Job Diva – Job Listing