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Desktop Support Specialist

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Broad IT provides-and this role directly coordinates-end-user support of more than 2500 laptops, desktop systems (Windows and Mac) across Broad’s several buildings as well as telephony, printing, and conference room A/V, and a walk-up service desk. The desktop support organization comprises 8-10 Desktop Support Specialists and the Service Desk Coordinator under the supervision of the Manager for the Service Desk. The Desktop Support Specialist II role is responsible for second line support for the Broad community using remote tools or our walkup helpdesk though deskside service may also be needed. The position requires a strong focus on customer service and an ability to work efficiently and effectively in a fast paced environment. The work performed by a DTS II varies from day to day and as such the individual will need to be able to multi-task often to ensure the work gets processed and the incident closure rate remains high.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
-  Point of escalation for DTS I Specialist with a focus on a specific OS as needed (Windows, MacOS, Red Hat) with a strong familiarity with all the OS’s-  Second line of support for the entire lifecycle of our client hardware and is required to troubleshoot and answer basic questions regarding installation and configuration of computing resources
-  Imaging, deploying and reclaiming computing equipment to end users on a timely basis
-  Accurately record and update incidents on our Service Now instance in a timely manner
-  Assist in developing, documenting new procedures as well as suggest process improvements
-  Respond to and update incidents promptly
-  Other duties as assigned by the Service Desk Manager

MINIMUM QUALIFICATIONS:

-  Degree in Computer Science or other technical discipline with in-depth understanding of modern computing technology or equivalent training or experience 2-4 years’ experience
-  Strong problem solving ability
-  Be able to follow established procedures
-  Previous experience supporting Windows, MacOS, Dell and Apple hardware in a high paced real-time work environment

Preferred:
-  Microsoft Certified Professional, Apple Certified Macintosh Technician Certification, MacOS 10.9 Certification, Comptia A+, HDI Service Desk Analyst or HDI Desktop Support Technician
-  Previous customer service experience is strongly desired

WORKING CONDITIONS:

-  Normal office conditions
-  Ability to lift up to 50lb’s
-  Working hours are 9:00 am - 5:00 pm, may be asked to come in earlier or stay later as needed

The Broad Institute will not offer visa sponsorship for this opportunity.

EOE / Minorities / Females / Protected Veterans / Disabilities

To apply for this position, please CLICK HERE


Resource Tech-Flow Cytometry

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OVERALL RESPONSIBILITY:
The Resource Technologist is primarily responsible for the daily operation and associated quality control within the newly launched flow cytometry capability.

This individual works within a team of resource technologists, each relying on the expertise, guidance, and precision-orientation of the others. The Technologist I recommends and implements and maintains improvements in experiment design and assists in preparation and response to any regulatory inquiries.

This team member also regularly performs equipment, reagent and supply validation for any new and improved methods within the laboratory. Although this is an entry-level position, after a few months of training, this individual will take on the added responsibility to meet with clients and set up experiments/procedures from start to finish. Some experiments can take several days or longer.

Tasks are complex, and the user community is very broad, so this person must be capable of interacting well with a diverse group of individuals to establish experiment perimeters and variables. Then, he or she is charged with maintaining quality control throughout the duration of each experiment/procedure.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Perform specimen collection/analysis, and/or experiments/assays from start to finish.
- Optimize and design assay conditions for new projects; read literature to determine the best way to perform assays.
- Work closely with users to design and carry out sorting experiments, and to ensure that their cell sorting goals are achieved to the extent possible.
- Validate assay performance characteristics, write protocols, create excel worksheets that can do calculations based on the number of samples and volume used.
- Interpret results and generate reports; review with the supervisor; troubleshoot, if necessary, discussing the measures with the supervisor.
- Maintain equipment and assist with quality control procedures in the laboratory on a daily basis.
- Record time, track the workflow, maintain all experimental details and generate billing for each project.
- Attend training sessions apropos to the resource laboratory technology/instrumentation used within the laboratory.
- Perform additional duties as assigned.

MINIMUM QUALIFICATIONS:
- Requires a bachelor’s degree, preferably in science.
- Equivalent Biotechnical training at an accredited institution is also acceptable.
- Minimum of 1-2 years hands-on experience in an analogous laboratory situation.

The Broad Institute will not offer visa sponsorship for this opportunity.

EOE / Minorities / Females / Protected Veterans / Disabilities

To apply for this position, please CLICK HERE

Study Manager

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Make an impact at a dynamic and growing company! inviCRO currently seeks a Study Manager to handle compliance with workflows from pre-clinical imaging studies.  This individual should be motivated by the idea that together we can accomplish great things and make a positive contribution to society through the company’s mission and enjoys challenging and analytical work.  The ideal candidate for the Scientific Project Managerrole possesses a basic understanding of pre-clinical imaging techniques. 

Things to know about inviCRO:

  • We are a dynamic life sciences company that provides medical imaging services and software to the drug development community.
  • We come to work every day excited about the role we can play in developing life-changing therapies that cure disease.
  • We are fun and nerdy at the same time – a dynamic bunch trying to solve complex problems. 
  • We are growing – which means you have an opportunity to help build the company and the culture.

Position Overview

The Scientific Project Manager (Study Manager) is responsible for managing the organization and reporting of pre-clinical imaging studies within the Contract Research (CR) department.  The individual in this role is expected to manage compliance with workflows and timelines and support the organization of data and reporting of results from pre-clinical imaging studies across various therapeutic areas.  This individual is held accountable for all data in a study, qualitative and quantitative, scientific presentation of data in slide decks, and for managing study documentation and timelines/progress towards completion.

Key Duties

  • Organize and oversee data acquisition, reporting, and preparation of scientific presentations/interpretation of results for a given study
  • Work closely with the Analysis Manger to ensure that all desired deliverables are generated in a scientifically-relevant form, acceptable to send to the customer, and goals of a given study are clearly addressed
  • Take ultimate responsibility for quality control of all results and reports, as well as making sure all tasks get completed satisfactorily
  • Oversee the progress of a study from its opening to completion
  • Oversee and manage the accuracy of CRM entries for all projects and work closely with Operations and the Study Director to interface with customers and subcontractors on acquiring POs and invoices
  • Function as a representative of the CR department within inviCRO, and maintain a positive attitude in interactions with all involved in a study, while focusing on collaborative problem-solving

Minimum Qualifications and Skills:

  • BS in a relevant field (e.g. engineering, physics, chemistry or biology)
  • Ability to demonstrate past leadership experience in a team environment
  • Excellent communication skills
  • Superior time- and project-management skills
  • Ability to work quickly with strict attention to detail
  • Adaptable, able to professionally and confidently interact with teammates and subcontractors, as well as prepare and deliver written summaries of work

Preferred Qualifications:

  • MS (or BS plus 1 year experience) in a relevant field (e.g. engineering, physics, chemistry or biology)
  • Previous biomedical research experience.
  • Basic understanding of (or past exposure) to small molecule radiochemistry and/or radio- or fluorescent labeling of proteins and/or MRI, PET, SPECT, or CT

To apply: Go to www.invicro.com/about-us/careers/  to submit your resume and answer the two questions below in lieu of a cover letter.

Required Questions to submit with resume:

1)      Rank the following in order of importance: quality, speed, positivity.  Explain your answer.

2)      Do you consider yourself a more detail-oriented person, or a “big-picture” thinker?  Give an example from your life that portrays this.

Additional information about inviCRO

inviCRO, LLC, was founded in 2008 with a mission to apply imaging technology and tools to address biological questions in drug discovery and development .  inviCRO provides state of the art contract research, advanced data analysis services and software in the growing field of pre-clinical imaging research. In collaboration with partner imaging centers, inviCRO offers full-service contract research in vivo imaging services utilizing SPECT, PET, MR, CT and Optical imaging technologies, as well as ex vivo 2D and 3D autoradiography, fluorescence, and histology.

inviCRO has grown organically, building a multidisciplinary team of scientists to develop unique imaging and bioinformatics tools that inform the design and analysis of imaging trials across many species and therapeutic areas. Our team brings together specialized knowledge in a broad range of disciplines, including advanced degrees in physics, optics, software engineering, electrical engineering, chemical engineering, mathematics, neuroscience, biomedical engineering and statistics.

We currently manage or support more than 250 pre-clinical and clinical imaging studies per year, processing more than 30,000 medical images per quarter. Our software products are helping scientists at more than half of the top 25 pharmaceutical companies. Visit www.invicro.com

CRM Analyst

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Charles River Laboratories 

The drug research and development process is highly complex, lengthy and expensive, yet essential for delivering safe and effective therapies to patients.

To help our clients navigate this process, Charles River Laboratories offers a wide range of products and services that span the entire drug discovery and development continuum and can be tailored to specific research conditions.

Specialties: Research Models & Services, Preclinical Services, Discovery Research Services, Biologics Testing Solutions, Endotoxin Detection & Microbial Identification

WE ARE SEEKING TO ADD TO OUR TEAM:   CRM Analyst

Responsibilities 

BASIC SUMMARY:

Provide salesforce.com subject matter expertise to end-user in support of Sales, Marketing, and Customer Service global functions. Provide business support for planned system enhancements and implementations (i.e., mobile, field service, contracts, quoting, etc.) and data integration efforts to harmonize data.

 Please note:   This is NOT a CRM Administrative role, this is a cross between Business Analyst, Salesforce.com Admin AND User Trainer (Salesforce.com) to Charles River Lab employees. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide salesforce.com end-user support including documentation, reporting, data analysis, training, and troubleshooting end-user issues.

• Provide support for current and planned system changes (i.e., mobile, Field Service, Configure Price Quote, ERP integration, etc. by helping the business understand changes being made and preparing the business for the changes.

• Create and maintain documentation on processes, policies, and partner with Charles River’s training team to create related training materials (individual and team) as the salesforce.com application evolves.

• Partner with the Enterprise and Commercial I.T. team to lead and manage end-user testing of new system enhancements and assists in gathering requirements for enhancements and functional changes as needed.

• Provides business support to sales and marketing leadership for reporting (ad-hoc and quarterly) in a timely and professional manner.

• Train users to create, modify and enhance personal custom reports and dashboards.

• Accountable for data governance to ensure data quality standards are adhered to and the management of processes to ensure data integrity is maintained.

• Perform routine opportunity pipeline management to ensure key performance business metrics and overall pipeline health is achieved.

• Exercise creative thinking and apply experience to improve processes as needed.

• Proactively share knowledge and disseminate information to team members on a local and global basis.

• Perform all other related duties as assigned.

 Qualifications 

• EducationBachelor’s degree (B.A./B.S.) or equivalent in computer science, engineering, business administration or related discipline. 

• Experience: Three to five years related experience in Salesforce.com with direct experience working on large (500+) Global SFDC instances. Advanced reporting and dashboard (salesforce.com) design skills. Experience conducting both individual and team training on processes and systems required.

• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. 

• Certification/Licensure: Salesforce.com administrator certification preferred. 

• Other: Excellent analytical skill. Ability to independently and effectively multi-task in a fast paced environment, with appropriate level of prioritization and escalation skills. 

Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

 

Account Manager II - Microbial Solutions (Mid-Atlantic Territory - DC, MD, OH, VA & WV

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Charles River Laboratories 

The drug research and development process is highly complex, lengthy and expensive, yet essential for delivering safe and effective therapies to patients.

To help our clients navigate this process, Charles River Laboratories offers a wide range of products and services that span the entire drug discovery and development continuum and can be tailored to specific research conditions.

Specialties: Research Models & Services, Preclinical Services, Discovery Research Services, Biologics Testing Solutions, Endotoxin Detection & Microbial Identification

WE ARE SEEKING TO ADD TO OUR TEAM:   Account Manager (Sales) Microbial Solutions (Mid-Atlantic Territory - DC, MD, OH, VA & WV) -

* Highly desired to reside in one of these states*

BASIC SUMMARY:   Responsible for achieving quarterly and annual sales targets for assigned region for all Charles River products and services into commercial mid-tier accounts in a designated geographical region.  

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•Work with both the specialist sales staff and management teams to increase market share of both in-house and outsourced revenue spend at assigned accounts.

•Generate account-specific sales strategies to sell all company products and services.

•Prepare and provide accurate account forecasts for assigned accounts/territories throughout the year to track achievements versus goals.

•Develop and qualify account leads through frequent customer contact and prospecting.

•Gather data on potential customers in the designated geographic region.

•Build relationships with customers to influence the acceptance and use of company products and services.

•Communicate available products and services and inform customers of new products and services in a timely manner.

•Handle initial inquires and qualify all prospective opportunities. Identify the drug development business model at these accounts and effectively communicate the value proposition of the company’s products and services.

•Work collaboratively with the specialist sales staff to ensure that the customer has a cohesive and responsive team throughout the sales process

•Prepare and implement a comprehensive territory management plan to indicate target opportunities, potential new accounts, expansion of existing accounts and an analysis of competitor accounts.

•Gather data on marketing trends and competitive products and pricing.

•Utilize CRM to capture customer information.

•Complete all required sales documentation in a timely manner.

•Participate in sales meetings and trade shows as required.

•Share customer problems/concerns with all appropriate departments for quality resolution.

•Perform all other related duties as assigned.

Qualifications

Education: Bachelor’s degree (B.A. /B.S.) or equivalent in life sciences, sales or related discipline.

•Experience: Minimum 5 years experience, preferably in life science industry.

•An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

•Certification/Licensure: Valid driver’s license required.

•Other: Excellent communication and presentation skills. Proficient in the use of standard office computer applications (word processing, spreadsheets, presentations, e-mail).

Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

 

Account Manager II Microbial Solutions (Southeast Territory - AL, GA, NC & SC)

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Charles River Laboratories 

The drug research and development process is highly complex, lengthy and expensive, yet essential for delivering safe and effective therapies to patients.

To help our clients navigate this process, Charles River Laboratories offers a wide range of products and services that span the entire drug discovery and development continuum and can be tailored to specific research conditions.

Specialties: Research Models & Services, Preclinical Services, Discovery Research Services, Biologics Testing Solutions, Endotoxin Detection & Microbial Identification

WE ARE SEEKING TO ADD TO OUR TEAM:   Account (Sales) Manager II Microbial Solutions (Southeast Territory - AL, GA, SC & NC)

*Highly desired to reside in NC - Triangle Park area is our largest client base) or close to that location*

BASIC SUMMARY:   Responsible for achieving quarterly and annual sales targets for assigned region for all Charles River products and services into commercial mid-tier accounts in a designated geographical region.  

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•Work with both the specialist sales staff and management teams to increase market share of both in-house and outsourced revenue spend at assigned accounts.

•Generate account-specific sales strategies to sell all company products and services.

•Prepare and provide accurate account forecasts for assigned accounts/territories throughout the year to track achievements versus goals.

•Develop and qualify account leads through frequent customer contact and prospecting.

•Gather data on potential customers in the designated geographic region.

•Build relationships with customers to influence the acceptance and use of company products and services.

•Communicate available products and services and inform customers of new products and services in a timely manner.

•Handle initial inquires and qualify all prospective opportunities. Identify the drug development business model at these accounts and effectively communicate the value proposition of the company’s products and services.

•Work collaboratively with the specialist sales staff to ensure that the customer has a cohesive and responsive team throughout the sales process

•Prepare and implement a comprehensive territory management plan to indicate target opportunities, potential new accounts, expansion of existing accounts and an analysis of competitor accounts.

•Gather data on marketing trends and competitive products and pricing.

•Utilize CRM to capture customer information.

•Complete all required sales documentation in a timely manner.

•Participate in sales meetings and trade shows as required. •Share customer problems/concerns with all appropriate departments for quality resolution.

•Perform all other related duties as assigned.

Qualifications

Education: Bachelor’s degree (B.A. /B.S.) or equivalent in life sciences, sales or related discipline.

•Experience: Minimum 5 years experience, preferably in life science industry.

•An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

•Certification/Licensure: Valid driver’s license required.

•Other: Excellent communication and presentation skills. Proficient in the use of standard office computer applications (word processing, spreadsheets, presentations, e-mail).

Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

Research & Development Associate I

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GENERAL SUMMARY OF POSITION:

 

The Research & Development Associate I is responsible for carrying out downstream process development activities, supporting the development and optimization of downstream processes and product formulation as well as performing scale up and scale down studies. The incumbent will also perform basic protein characterization assays to support purification efforts.

 

For more information please visit our website:

 

www.MassBiologics.org

MAJOR RESPONSIBILITIES:

  • Operates and maintains standard laboratory and department-specific equipment.
  • Prepares buffers, packs chromatography columns, carries out purification experiments, and makes detailed observations.
  • Performs analytical biochemistry assays and other laboratory testing as required.
  • Keeps timely and accurate documentation per cGMP, GLP, and MBL SOPs in notebooks and in electronic documents.
  • Coordinates with other group members to maintain and organize assay request and data entry on common projects.
  • Analyzes experimental data and provides accurate, concise and pertinent summaries and reports.
  • Provides support for protocol writing, project summaries and technical reports.
  • Prepares written and oral reports for presentation to the supervisor(s) and development group.
  • Maintains reagent and equipment inventories, orders supplies and cleans laboratory areas, hoods and common equipment.
  • Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies within defined parameters.
  • Perform additional job related duties as required.



REQUIRED QUALIFICATIONS:

  • Requires a bachelor's degree in Chemistry, Biology, or related field with a minimum 0-2 years of relevant experience
  • Ability to follow instructions precisely, recognize deviations, and recommend corrective action within scope of training
  • Ability to troubleshoot within scope of training
  • Computer literate and proficient in MS Word, Excel and other relevant electronic systems
  • Strong critical thinking, time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
  • Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills
  • Excellent written and verbal communication skills. Ability to communicate effectively with others
  • Ability to work effectively both independently and as a member of a team
  • Occasionally projects require flexibility in work schedule to meet business needs
  • Working knowledge on protein purification and hands-on experience on chromatography workstations preferred

Must be able to carry out the essential functions of this position, with reasonable accommodation if disabled

 

 

SUPERVISION RECEIVED:

Reports to R&D Scientist I or designee

 

SUPERVISION EXERCISED:

None.

 

ENVIRONMENTAL WORKING CONDITIONS:

Job may involve working with or near toxic, radioactive or infectious materials. Employee will be required to follow MBL SOPs and procedures.

Available to work a flexible schedule to meet business needs.

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Apply Here

PI92741186

Operating Specialist

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Company Overview

OpGen, Inc. is an early commercial-stage company using molecular testing and bioinformatics to assist healthcare providers in combating multi-drug resistant bacterial infections.  The company’s products and services are designed to enable the rapid identification and treatment of hospital patients who are colonized or infected with life-threatening MDROs. The company’s products include the Acuitas® MDRO Gene Test, the Resistome Test, microbial whole genome sequencing, and the Acuitas Lighthouse™ MDRO Management System. OpGen’s July 2015 acquisition of AdvanDx, Inc. brought a suite of diagnostics for rapid molecular testing of positive blood cultures designed to assure appropriate antibiotic therapy for patients with bloodstream infections. AdvanDx is a world leading provider of fast, accurate and easy-to-use in vitro molecular diagnostic products (QuickFISH™) that advance the prevention, diagnosis and treatment of infectious pathogens.

 

Position

Manufacturing/Operations Specialist in Woburn, MA, USA

 

Position Description

This position is responsible for operations activities including shipping and receiving of product, incoming inspection (quality control), manufacturing, assembly, and certain laboratory QC testing of incoming materials and/or finished goods.   The role includes assisting with inventory management.  Additional activities may include coordinating the maintenance and calibration of equipment in manufacturing areas and document support for quality documents related to product orders, delivery and inbound/outbound product inspection.

 

Essential Duties and Responsibilities

  • Receive incoming materials
  • Inspection and disposition of inventory products received by AdvanDx
  • Manufacture/Assembly of finished product, including printing and application of labels
  • Completion of all documentation related to manufacturing and release of product
  • Fill customer orders
    • Picking and packing of product
    • Generation of shipping labels and related documentation
    • Processing and filing of related documentation
  • Maintenance and organization of calibration records and scheduling calibration cycles for manufacturing equipment.

Other duties may be assigned by the Operations Manager

 

Qualifications and Skills

  • B.S. Degree in life sciences or biotechnology related major
  • Two – Three (2-3) years experienced in the manufacture/assembly of finished product, monitoring final manufacture and delivery of manufactured products to customers according to GMP/SOP requirements
  • Fluent in using Microsoft Word, Excel, and PowerPoint
  • Strong written, oral, interpersonal, and communication skills
  • Effective organization and planning skills
  • Follow established policies and procedures and comply with GMP requirements
  • Perform detail oriented work with a high degree of accuracy and recall
  • Communicate, in English, both verbally and in written materials 
  • Recognize problems, recommend and implement solutions
  • A logical and organized thought pattern is required
  • Requires a motivated individual that is able to work with minimal supervision
  • Strong attention to detail and ability to produce consistent high quality work
  • Experience with Food and Drug Administration’s Quality System Regulations (QSRs) and/or GMP is a plus

 

How to apply

Send resumes to Human Resources job@advandx.com

 


Document Control

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Company Overview

OpGen, Inc. is an early commercial-stage company using molecular testing and bioinformatics to assist healthcare providers in combating multi-drug resistant bacterial infections.  The company’s products and services are designed to enable the rapid identification and treatment of hospital patients who are colonized or infected with life-threatening MDROs. The company’s products include the Acuitas® MDRO Gene Test, the Resistome Test, microbial whole genome sequencing, and the Acuitas Lighthouse™ MDRO Management System.  OpGen’s July 2015 acquisition of AdvanDx, Inc. brought a suite of diagnostics for rapid molecular testing of positive blood cultures designed to assure appropriate antibiotic therapy for patients with bloodstream infections.  AdvanDx is a world leading provider of fast, accurate and easy-to-use in vitro molecular diagnostic products (QuickFISH™) that advance the prevention, diagnosis and treatment of infectious pathogens.

Position

Document Control Specialist, reporting to Quality Assurance Manager, Woburn, MA, USA

Position Description

The Document Control Specialist will coordinate, implement, and maintain the company’s Document Control and Training System. 

Essential Duties and Responsibilities
  • Responsible for overall coordination of controlled documentation within the company.
  • Arranging and filing the DHF, DMR, DHR and all quality records.
  • Maintain current regulatory and Standards requirements under FDA QSr, ISO 13485, ISO 14971, and others as needed.
  • Assist in complaint handling and maintaining the tracking systems for complaints, NCMR, and CAPA, and other QA administrative responsibilities.
  • Maintain employee training files; review and audit employee training files as needed.
  • Manage the change control (DCN) procedure and activities throughout the approval and release process.
  • Provide support to manufacturing inspection activities as required and participate in the Material Review Board (MRB), internal auditing, training, and generating work instructions.
  • Maintain Supplier files and current Approved Supplier List (ASL).
  • Maintain calibration, inspections, maintenance procedure to ensure that the system is in compliance.
  • Review Device History Records (DHR) and data forms for completeness and accuracy.
  • Performs self-audits and ensures that the current revision is available in a timely manner.
  • Investigates and responds to corrective actions related to Document Control, Training and External Standards.
  • Other duties may be assigned as deemed necessary by the supervisor.

Qualifications and Skills

  • Education: B.S. Degree or a bachelor’s degree with equivalent work experience.
  • Minimum of 2 to 5 years document control experience in Medical Device industry
  • Experience with electronic document control and training system preferred.
  • Experience conducting and hosting quality system audits.
  • Knowledge of medical device quality systems including but not limited to FDA QSr and ISO 13485.
  • Experience in the IVD field preferred and experience in process validation is a plus.
  • Unique Device Identification (“UDI”) implementation is a plus.
  • Demonstrated ability to operate independently, with initiative, and good business judgment.
  • Strong organizational and time management skills.
  • Strong ability to communicate verbally and in writing.

How to apply

Send resumes to Human Resources epv@advandx.com

 

Process Engineer

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Company Overview

OpGen, Inc. is an early commercial-stage company using molecular testing and bioinformatics to assist healthcare providers in combating multi-drug resistant bacterial infections.  The company’s products and services are designed to enable the rapid identification and treatment of hospital patients who are colonized or infected with life-threatening MDROs. The company’s products include the Acuitas® MDRO Gene Test, the Resistome Test, microbial whole genome sequencing, and the Acuitas Lighthouse™ MDRO Management System. OpGen’s July 2015 acquisition of AdvanDx, Inc. brought a suite of diagnostics for rapid molecular testing of positive blood cultures designed to assure appropriate antibiotic therapy for patients with bloodstream infections. AdvanDx is a world leading provider of fast, accurate and easy-to-use in vitro molecular diagnostic products (QuickFISH™) that advance the prevention, diagnosis and treatment of infectious pathogens.

 

Position

Process Engineer in Woburn, MA, USA

Position Description

The Process Engineer will be responsible for translating R&D methods and equipment into a robust manufacturing process.  This individual will manage and perform all functions associated with process development, process transfer, and scale up at external manufacturing partners; and to ensure the timely availability of validated processes and product to support the development and commercialization of a molecular diagnostic disposable and chemistry for the detection of diseases in the regulated in vitro diagnostic market.  In addition, the Process Engineer will be a technical resource to Product Development and work closely with that team to establish a pilot manufacturing environment to support R&D future product development, ensuring that equipment, processes and facilities are designed and operating to represent production processes.

The Process Engineer will be part of an internal team that works cross-functionally with Product Development, R&D, Contract Manufacturers, Marketing, Quality, and Regulatory to define and manage project goals, specifications, schedule and resources to complete projects on schedule and within budget.

Essential Duties and Responsibilities

  • Convert R&D prototype methods and instruments into robust manufacturing processes at Contract Manufacturer sites.
  • Identify key Controls for each process step.
  • Manufacturing lead in Design Transfer activities and development of Design Transfer Plans, Facilities Integration Plans, and Validation Master Plans based on process transfer documents with external manufacturing partners.
  • Leads the Process Risk Management activities.
  • Represents company in the process transfer, scale up and validation of manufacturing at external manufacturing partner.
  • In collaboration with area managers: identifies areas, systems, methods, processes and/or equipment that require validation
  • Scopes projects, designs strategies, and writes Process Validation Protocols.  Negotiates with all stakeholders to agree on acceptance criteria, and gain required approvals
  • Oversees execution of protocols.  Gathers and records all required data during validation. Documents all work according to cGMP.
  • Maintains calibration of equipment and systems
  • Coordinates sampling plans with QC; coordinates testing at external test labs if required
  • Organizes and presents data in validation reports.  Analyzes data, draws conclusions, writes deviations, and assesses product/validation impact of nonconforming data
  • Defends work in internal and external audits
  • Provides regular program management project team updates.

Qualifications and Skills

  • BS Engineering or equivalent.  Mechanical Engineer is a plus.
    • Min. 5-7 years industry experience in process development and process transfer and scale up / manufacturing validation in a GMP or ISO regulated in vitro diagnostic (“IVD”) environment.
    • Strong knowledge of validation principles.  Knowledge of software validations highly beneficial
      • Experienced in program management.
      • Familiar with regulatory requirements of FDA/QSR, ISO 13485 and ISO 9001 a plus.
      • Demonstrated ability to operate independently, with initiative, and good business judgment
      • Strong organizational and time management skills.
      • Strong ability to communicate verbally and in writing.
      • Design experience in R&D prototype methods and equipment is highly desired.
  • Demonstrated computer skills.  Familiarity with Windows/Macintosh operating systems required. Familiarity with Microsoft Office is essential.

How to apply

Send resumes to Human Resources job@advandx.com

 

Manager, Field Sales Training (618-419)

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ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

 

Job Summary:
The purpose of this position is to support the Director of Training in areas of field sales training initiatives, including new hire training, ongoing product and disease state training, and other projects that support the ongoing education of the sales team.

 

 

Responsibilities:

  • Effectively execute projects within timelines and budgets, working with both internal resources and external vendors/consultants
  • Support and aid in the development and execution of home study and live training curricula for onboarding RAMs
  • Maintain up-to-date EXPO (medical/legal/regulatory) approved learning modules that reflect the most current label and treatment guidelines
  • Maintain an up-to-date learning portal, ensuring all materials are current versions and compliant with legal and regulatory guidance
  • Support and facilitate key projects such as meeting workshops, training pull-through on marketing pieces, and the development of supportive training material, such as Objection Handlers, Competitive Overviews, Backgrounders, etc.
  • Represent/navigate training initiatives through the EXPO approval process
  • Work cross-functionally with marketing, medical affairs, and the commercial team to better understand market factors and develop updated or new training materials
  • Collaborate with US and/or EU marketing and training colleagues, as appropriate, on initiatives including POAs, Cycle Meetings, and training resources
  • Work in the field with new and tenured RAMs to remain current with the marketplace and HCP trends, and to provide coaching and training as appropriate
  • Measure outcomes of training initiatives and create plans for continuous improvement

 

Qualifications:

  • Minimum of a Bachelor's degree (or equivalent) and 5 years of industry experience
  • Minimum of 3 years sales experience in the biopharmaceutical industry
  • Proven track record of sales results during experience as a sales rep
  • Some sales training experience in the biopharmaceutical industry preferred
  • Experience in specialty markets, with hematology/oncology or orphan drug experienced preferred
  • Ability to develop strong relationships, with internal colleagues as well as providers
  • Ability to work effectively in a cross-functional environment as well as independently
  • Ability to develop strong, professional relationships with both internal stakeholders and HCPs
  • A. or B.S in business or scientific field preferred
  • Approximately 40% US travel

 

ARIAD Pharmaceuticals, Inc. provides equal employment and affirmative action opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

 

Submitting a resume online at a job site could cause valuable screening information to be missed.

Click here to apply:
http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=618&company_id=16419&jobboardid=306

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

Research Associate, Bioanalytical Development

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Research Associate, Bioanalytical Development

About Acceleron:

Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair.  The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action.  These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases. 

Position Overview:

We are searching for an enthusiastic individual with experience in protein assay development to join our Bioanalytical Development group.  The successful candidate will design and execute assays for our clinical and preclinical platforms, with assays supporting pharmacokinetic/toxicokinetic determination, biomarker evaluation, immunogenicity analysis, and identification of neutralizing antibodies.  This individual will be responsible for assay development, optimization and transfer to external contract organizations as well as periodic preclinical sample analysis.  He/she will be required to write and review protocols and reports and to assimilate and evaluate data.  The ideal candidate will have experience with various assay formats such as ELISA and ECL.  Knowledge of pharmacokinetics and Phoenix/WinNonlin software is a plus. 

Basic Qualifications:

  • The successful candidate should have a B.S. or M.S. degree with 2 to 5 years of relevant industry experience in Biochemistry, Immunology, or related discipline with 2+ years of Biotechnology industry experience preferred.
  • Experience with assay development/validation for large biomolecules and a working understanding of immunoassay technologies such as ELISA and electrochemiluminescence
  • Experience in biological sample handling including primary blood
  • Experience with data analysis software (e.g. Excel, SoftMax, Sigma Plot)
  • Strong problem solving skills
  • Working knowledge of GLPs and SOPs preferred
  • Ability to communicate effectively with management as well as laboratory personnel

*Recruiters - please do not send unsolicited resumes to this posting.

FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT:

www.acceleronpharma.com

Associate Director, Competitive Intelligence for CF Marketing

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Position Responsibilities:

Vertex is seeking a talented individual to join our Cystic Fibrosis Global Marketing group. The individual will have key responsibility for generating competitive strategy insights, providing business development support and collaborating with key stakeholders on  an annual update of CF epidemiology. This energetic individual will possess a desire for team success in a highly innovative company that aims to discover, develop and commercialize innovative new medicines so people with serious diseases can lead better lives. The position reports to the Vice President of Global Marketing, CF  

Key Responsibilities:

§  Lead the Competitive Intelligence (CI) initiative for the CF franchise working with CI agencies and internal partners

§  Provide strategic and objective CI insights aligned with business objectives to the Executive Committee, Investor Relations, Business Development, Corporate Communications, Commercial Leadership and the cross functional Franchise Leadership Team (DAT)

§  Coordinate with cross functional stakeholders  as well as external agencies to provide in depth coverage at scientific and industry conferences

§  Responsible for providing insights regarding trials and launch timelines of competitors, and their impact to the internal development program

§  Manage relationships with external CI vendors, securing timely insights, validating initial reports and developing CI  insights from multiple sources

§  Liaise closely with CI team in San Diego

§  Maintain a portal with CI content including secondary sources, monthly reports, conference presentations

§  Collaborate, on an annual basis, with several cross functional stakeholders to update CF epidemiology

§  Provide CI and epidemiology support to the brand planning and Long Range Planning work streams

§  Work in close partnership with Medical Affairs, Marketing , Investor Relations, Business Development, and Corporate Communication

§  Manage budget for specifically assigned projects

§  Active participation in other Global Marketing initiatives

Position Qualifications:

§  Bachelor's degree, preferably in life sciences

§  3-5 years of pharmaceutical or biotechnology competitive intelligence experience

Preferred Qualifications:

§  An advance degree (Ph.D., MD) and/ or MBA and/or significant industry experience with a BS required

§  Ability to understand and analyze primary information and secondary reports in a timely manner

§  Understanding of the CI compliance and SCIP guidelines, familiarity with reviewing registry reports for global epidemiology data

§  Effective communication skills, both verbal and written, with senior executives and across several functions

§  Demonstrated progression of responsibility and confidence working in a matrix environment

Sr. Director, Clinical Operations Immuno-Oncology

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Our client launched their first commercial product in the fall, is expanding the development of their lead anticancer product, and advancing their robust portfolio of immuno-oncology agents into the clinic in 2016.  This person will be charged with setting and implementing the global strategy for the immuno-oncology clinical trials.

The Sr. Director, Clinical Operations will be tasked with not only performing on a strategic level but will need to operate tactically in this fast-paced biotech culture. 

Job Responsibilities

•             Provide input to study design, protocol synopsis and protocol to ensure operational success and clarity for CROs/clinical sites.

•             Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, monitoring plans, study reports and annual reports

•             Provide strategic input to clinical development programs including various clinical trial scenarios and associated risks and costs. Work closely with Core Program Team and Clinical Operations VP to define operational strategies aligned to corporate goals.

•             Develop internal and external resource strategy to support corporate and program goals for development compounds. Hire, mentor and retain clinical team members and vendors to achieve goals. Maintain a positive culture and strong working relationships across organizations and internal functions

•             Provide oversight and guidance to clinical operations teams, documents and processes to ensure patient risk-benefit is optimized.

•             Develop and manage vendor performance and quality metrics through contracts and periodic review meetings adjusting scope of services as needed.

•             Oversee development of operational plans by clinical operations team to ensure compliance to current regulatory guidance and GCPs.

•             Develop and maintain productive partnerships with internal and external stakeholders (CROs, consortia, investigators) including communication plans and setting of program milestones.

•             Review and update integrated program timelines and budgets through collaboration with internal and external stakeholders as required to support operational plan.

•             Report status of program milestones and escalate issues to Program Core Team and Clinical Operations VP on agreed schedule. Identify program risks and develop and manage mitigation plans.

•             Regularly meet with manager to discuss overall clinical trial(s) plans, update forecasting, and potential issues/risks or recommendations

•             Lead process development through lessons learned, organizational development and functional excellence initiatives

Education and Experience

•             Bachelor’s degree in life sciences or business administration required. Advanced degree/ clinical research certification/project management certification desirable.

•             At least 12 years of experience in clinical operations leadership in Phase 1 – 3 global studies in a CRO or bio-pharma setting, At least 8 years of experience managing clinical staff including study managers, CRAs, monitors and coordinators

•             At least 8 years of experience in managing CROs and other vendors

•             Demonstrated knowledge of the drug development process with clinical operations management experience and skills. Oncology experience strongly preferred.

•             Demonstrated knowledge of FDA/EMA/GCP/ICH guidelines and global regulatory standards

•             Experience with Clinical Quality Assurance, data management and statistical analysis in Phase 2/3 clinical trials

•             Willingness to work in a dynamic and changing corporate environment

•             Works in office setting in Waltham, MA and accommodates a flexible work schedule according to clinical trial(s) priorities, as needed.

•             Must be willing to travel, both domestic and international

Study Coordinator I

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BASIC SUMMARY:  Assist in the coordination, organization, and prioritize study tables as well as assist in the review of in-life data.  This is an entry level position with the expectations of supervised and/or semi-independent functionality, demonstrating a comfortable level of project coordinating and writing skills in the Medical Writers  Department.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Assists in the quality control (QC) of in-life data in accordance with SOP, GLPs, and protocol standards.  Also assists to ensure that the appropriate person(s) receive and make corrections to data before returning to Study Director and/or QA.  Assists in meeting data submittal timelines through the coordination of data review.
  • Participates in the general data overview during procedures as appropriate (ie, assisting in the in-life QC process of study records on a daily basis for compliance with SOPs and/or protocols)
  • Assist in the assembly of in-life tables for reporting purposes as well as the final preparation of the study binder.
  • Assist in the administrative tasks (ie, back-up assistance in Test/Control Article log in and study shipment process, scanning items for Study Directors, and/or Medical Writers)
  • Assist/coordinates Sponsor requests to aid Study Directors
  • Assists in interdepartmental collaboration; ensure effective communication, process improvement, and data flow/transitions.
  • Sorts/distributes the CBSET and outside vendor paperwork
  • Assists in the coordination and responds to in-life QAIRs to ensure that the QAIRs are addressed in a timely manner.
  • Assists in updating data timelines on portal/Excel spreadsheet.
  • Assists in the transfer of study books to DSU (Data Storage Unit) when initial QC is complete and track data update data schedule.
  • Performs other duties as assigned.

 

 

QUALIFICATIONS:

  • The ability to multi-task, coordinates, prioritize, and implement change in combination with flexibility as well as excellent communication and writing skills is a must.
  • Experience with Microsoft Office, Word Processing spreadsheets (Excel, etc.), and Adobe software.

 

  • Industry related pre-clinical data management skills experience preferred.
  • Undergraduate degree in a related life sciences field preferred.
  • Experience with Electronic Data Management System software in a lab setting preferred.
  • Must be computer literate with a willingness to learn and adapt to various computer skills.
  • Must pay attention to detail and constantly question the validity of data.

Oncology Global Forecasting and Analytics Manager

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The Manager, Oncology Global Forecasting and Analytics (OGFA) for managing all aspects of forecasting in support of the Takeda Oncology Business Unit including 3 marketed products and 10-12 pipeline products as well as BD forecast assessment. The individual is expected to deliver accurate patient based and/or analog level forecasts and associated analytics. This role reports to the head of OGFA and supports the global marketing brand leads, the New product Planning team, and the Oncology BU countries and regional groups.

Key areas of responsibility:
• Patient forecasting: Design, enhance, develop, maintain and analyze monthly patient-level forecasts platforms with forward-looking market share views, ensure appropriate training of stake holders and for multiple internal customers.
• Ensure continuity of forecast drivers and assumptions across short- and long-term horizons.
• Collaboration: This individual will also collaborate with Global Finance, Global Brand Teams, and Global Makret research, NPP, BD to leverage analytics and forecasting tools and insights to address critical strategic questions (e.g. impact of brand strategies, ROI, montecarlo simulations, etc).
• Assist in developing a world-class forecasting methodology and excellence, supporting SOPs, knowledge management processes and capabilities, forecasting tools and methodologies.
• Identify, maintain, recommend and generate data references/databases for oncology epidemiology
• Promote harmonization between short and long-range planning approaches

Requirements
• BA/BS degree in finance, mathematics, statistics, Engineering, or business. MBA a plus. 
• 4+ years of forecasting, analytics or commercial finance experience, preferably within Biopharma 
• Minimum of 4+ years of pharmaceutical and/or healthcare experience 
• Highly analytical critical thinker with exceptional MS Excel skills, attention to detail and focus on accuracy 
• Proven knowledge and proficiency in forecast modeling platforms and tools
• Highly collaborative - must be able to navigate, manage the needs and take guidance/direction from multiple stakeholders, as well as driving effective partnerships with individuals and teams globally to promote a shared view of the oncology market drivers and trends 
• Experience in Pharma / Biotech markets and understanding of US, international and local market dynamics, data sources, etc. 
• Knowledge of Oncology market, rare diseases and/or product launches is a plus 
• Driven, bright and high-energy individual invested in the success of the team and Takeda Oncology.
Other
Position Location: Cambridge, MA, USA
Requires excellent written and verbal communication skills
Approximately 20% of domestic/international travel may be required to attend important meetings. Travel may be outside of normal working hours and over weekends

Data Analyst I

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BASIC SUMMARY:  Initiate, direct and execute projects of diverse scope in a GLP environment, working independently (with peer guidance as needed) or as part of a multi-disciplinary team. Develop strategies, applying broad scientific principles and concepts for the preclinical assessment of treatment modalities including pharmaceuticals and medical devices.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Responsible for creating and maintaining various data arrays, including pathology and in-life data.
  • Assist in the development of study specific spreadsheets in consultation with pathologists and study directors.
  • Demonstrate an understanding and proficiency in analyzing, restructuring and sorting data arrays for reporting purposes.
  • Demonstrate strong analytical and problem solving abilities, including but not limited to: basic algebraic mathematics, statistical analyses and various methods of graphically presenting data.
  • Review and conduct preliminary quality control evaluations of completed data, sorting, tabulating and/or graphical summations.
  • Assist in identifying data collection fields are relevant to study specific parameters.
  • Assist in morphometric measurements and analysis.
  • Design, oversee and execute projects and aspects thereof.
  • Locate and define opportunities in process initiation and improvement.
  • Perform other related duties as required.

 

Other requisites:

  • Excellent verbal and written communication skills.
  • Excellent client relationship skills including planning, client interaction, and fulfilling administrative responsibilities.
  • Proficiency with computers and standard application software (e.g., Excel, Photoshop, etc.).
  • Knowledge of GLP regulations.
  • Excellent organization skills and the ability to meet deadlines.
  • Ability to interact appropriately with all levels of employees.
  • Proven leadership skills and the ability to work effectively with, and direct the efforts of, team members.

 QUALIFICATIONS:  Advanced degree in related scientific discipline or equivalent experience.

 

Education/Experience: 5+ years experience with a Bachelor’s Degree, preferably in a pharmaceutical or contract laboratory environment.

 

Certification/Licensure: Driver’s license

Global Quality Systems Support (Manager)

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OBJECTIVES: 

  • Support documentation and training activities for global quality system implementations. 
  • Design training content and deliver training programs for global quality.
  • Provide support for deployment of documentation and training for Global Quality Organization
  • Provide support for SharePoint (intranet) page development and maintenance

ACCOUNTABILITIES: 

Training

  • Design and deliver training and educational programs globally on quality topics including GMP topics, quality system rollouts (i.e. DMS/LMS, Catsweb, et al.)
  • Perform training needs assessments and gap assessments to determine need/size/complexity of training programs.
  • Collaborate with training and/or system vendors to design global quality systems training content.
  • Support Global Quality to drive collaboration and sharing of training content within sites/regions/business units.

Documentation

  • Manage process for communication to key stakeholders regarding global quality documentation and training programs
  • Communicate new document/training changes to quality system network
  • Process documents in documentation system as needed.
  • Assist Quality System project teams with creation of system documentation (SOPs) as needed.

Global Quality Systems Support

  • Provide change management and communication support for quality systems projects including developing slide decks, written communications and multi-media presentations.
  • Manage logistics and facilitation of Quality Systems forums where information and best practices are shared around Quality System topics
  • Manage Global Quality Systems Documentation and Training SharePoint site
  • Support Global Quality Systems staff with additional tasks as needed.

 

 EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

  • Bachelors degree with experience in pharmaceutical/ biotechnology industry, or equivalent (5-10 years)
  • Strong working knowledge of the operation of pharmaceutical quality systems and applicable global regulations
  • Strong knowledge in training design and delivery, preferably in quality or quality systems.
  • Experience with Documentation and Training activities in a pharmaceutical/biotechnology company.
  • SharePoint 2013 experience.
  • Ability to network and interact effectively with colleagues across functions and cultures.
  • Strong written communication skills.
  • Experience in project management activities including communication, change management, and document development.
  • Prior experience working in a global role or with global project teams is preferred.

 LICENSES/CERTIFICATIONS:

  •    Training instructional design certificates preferred.

Planning Analyst

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Overview:

The Planning Analyst role will support business and financial planning capabilities, as well as the management of Alnylam’s research and development programs. The key areas in which this role will facilitate planning activities include managing Alnylam’s employee time reporting system, supporting Investment Plan management, and/or managing reporting to alliance partners. The Planning Analyst will also conduct a variety of business analyses, including maintaining and updating expense tracking files, R&D efficiency metrics and long range program cost analyses. This position will support the operations of the program management function with responsibilities for processes that extend across a variety of R&D programs (timeline updates, purchase request support, presentation preparation, data management, and overall management of intranet Program sites). This position may also contribute to ad hoc analyses required for business development and strategic planning across the organization.

Excellent communication is critical to the success of this position, as the analyst will regularly collaborate cross-functionally with Program Managers, Finance, Human Resources and other R&D employees. Strong analytical skills and attention to detail are required to ensure the accuracy of data. Will also conduct a wide variety of reports and analyses, and recommend courses of action based on a thorough review and understanding of available information.

Enthusiasm for life sciences and biotechnology is essential for success in this role.  The ideal candidate is somebody with a passion for science, and a pragmatic drive to transform science into life-saving therapies to benefit society.  The Planning Analyst reports into the Director, BPPM.

Summary of Key Responsibilities:

  • Support the operational and information management of the Business Planning & Program Management team
    • Coordinate with Program Managers to update program timelines
    • Maintain BPPM’s intranet sites, and serve as point of contact between IT and BPPM functions
    • Assist Program Management, Alliance Management, and  Business Planning functions with preparation of presentation materials
    • Support the review and approval process for purchase commitment requests, and collaborate with Finance to acquire monthly cost estimates from vendors
  • Manage Alnylam’s time entry system and support Full Time Employee (FTE) planning and reporting processes
    • Ensure timely completion of hours worked and time-off hours for each employee, including daily tracking of compliance and individual follow-up for non-compliant employees
    • Provide general support for and maintenance of the R&D Time system
    • Communicate cross-functionally among Human Resources and Finance/Payroll to ensure accuracy of headcount and other applicable information across systems
    • Facilitate mid-month and month-end reviews of time allocation, including generation of reports from the time reporting system, data analysis, and clear presentation of information in PowerPoint on a monthly basis
    • Update Investment Plan with FTE actuals on a monthly basis, and provide insights and analyses to support forecasts of FTEs across various programs
  • Support the management of the Investment Plan (budget) and monthly close
    • Input actuals into the Investment Plan on a monthly basis, and collaborate with Finance to ensure accuracy of invoice processing
    • Coordinate timing of monthly close process between BPPM and Finance and support close process with timelines, deck preparation, etc.
    • Assist in preparation of monthly financial review presentation materials
    • Support the maintenance and continuous improvement of Investment Plan
  • Engage in business analytics to supportoperational, financial and strategic management
    • Update cost tracking reports on a quarterly basis
    • Apply cost tracking to projection of long range program costs
    • Participate in special projects to improve business planning processes and analytics
    • Prepare regular reports on FTEs and expenses for alliance partners
    • Provide business insights through ad-hoc reports and analyses as needed
  • Manage cross-functional projects to tight timelines and high quality output
    • Work with project leads to develop appropriate project structure, plans, and timelines
    • Manage regular project communication regarding progress and milestones, including updates to senior management
    • Orchestrate development of interim and final deliverables

Qualifications:

  • Strong interpersonal skills; demonstrated ability to work well in a collaborative and dynamic team environment
  • 2-5 years industry experience in finance, planning, business operations, management consulting or similar role
  • Strong analytical and problem-solving skills; ability to combine attention to detail with big picture perspective
  • Excellent written and oral communication, including presentation and facilitation skills
  • BS/BA required. Dual educational concentrations (e.g. BS/BA/MS major or minor) in Life Sciences or other relevant discipline and Business/Management/Economics preferred
  • Familiarity with MS Office (particularly Excel and PowerPoint) required.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

Program Manager-Clinical Compound Support

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Responsible for collaborating with PDD Global Compound Support Quality Assurance function to develop and implement a strategic audit plan for the development of all assigned TDC US compounds. Ensure that activities are conducted and reports written according to applicable regulations and Takeda SOPs.
Audits conducted will require advanced auditing skills and will include the most technically complex assignments, including audits of potentially high risk to TDC. Assess impact of audit findings on subject safety, data integrity, and business operations. 
Obtain audit responses from TDC functional areas and/or vendors, and evaluate proposed corrections, corrective actions, and/or preventive actions for compliance with applicable regulations, guidelines, and Takeda policies. Facilitate risk remediation. 
As assigned, review and approve audit reports submitted by Clinical Compound Support Compliance Specialists for content, format, regulatory risks, and compliance with SOPs. 
Identify potential systemic compliance risks, through audit activities and data analysis, and elevate to immediate manager for immediate and long-term resolution across TRGD. 
Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of TDC research for timely product applications to worldwide regulatory authorities.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 
Bachelor's degree required.
Five (5) years of quality assurance auditing experience preferred with a minimum of 3 years required 
Knowledge and Skills:
In-depth knowledge of the interpretation and application of FDA and international clinical trials regulations and guidance, and ICH Good Clinical Practice guidelines.
Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject safety and data integrity.
Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.
Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality assurance oversight for clinical trials and to assure the ethical treatment of subjects. Understands medical terminology, standards of care, and disease states.

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