We seek an experienced Associate Director/Director, Regulatory Affairs who will be responsible for developing regulatory strategies for our innovative gene therapy oncology programs.  This position will be responsible for the preparation, submission and approval of INDs and CTAs, pediatric investigation plans, orphan drug designations, and managing corresponding interactions with regulatory authorities.Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.

About the role:

• Proactively participate in design of regulatory strategies for the development of gene therapy products for oncology in the US and the EU. 
• Manage preparation and submission of high-quality regulatory dossiers in the US and the EU according to set timelines; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.
• Manage transparent and proactive regulatory agencies interactions for oncology projects
• Collaborate with regulatory-CMC function to ensure seamless integration of CMC components to all submissions
• Drive adherence to regulatory guidelines for development of gene therapy products.
• Participate in regulatory intelligence activities; monitor regulatory guidelines and trends.

About you:

• BA/BS degree in life sciences, MS/PhD preferred
• At least 5-10 years of pharmaceutical product development, preferably oncology biologics
• Well-versed in regulatory strategy, and regulatory science writing
• Experience as primary regulatory author for IND and CTA documents
• Knowledgeable in ICH, FDA and EMA guidelines
• Understanding of advanced therapy products development
• Ability to work independently and thrive in a fast-paced environment.
• Excellent people leadership skills
• Excellent communication skills and ability to influence across multiple functions
• Experience in the development of biomarker in oncology and immuno-oncology, and translation of these biomarkers into use in clinical trials, including development of laboratory developed tests (LDTs) and in vitro diagnostics (IVDs)
• Experience in the field of gene or cell therapy and orphan diseases
• BLA/MAA experience

• Ability to execute and follow-through to completion and documentation.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Independently motivated, detail oriented and good problem solving ability.
• Excellent communication skills and ability to influence across multiple functions.
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

We seek an experienced Associate Director/Director, Regulatory Affairs who will be responsible for leading the development of the regulatory strategy in partnership with Vice President, Regulatory Science and senior team members for a key pivotal program at bluebird bio. This position will be responsible for the preparation, submission and approval of IND and CTA amendments, pediatric investigation plans, original marketing applications (BLA/MAA) and supplements/extension of indications globally.

About the role:

• Proactively participate in design of regulatory strategy for the development of one of bluebird’s key pivotal program, a gene therapy product for the treatment of a rare disease in the US and the EU.

• Manage preparation and submission of high-quality regulatory dossiers in the US and the EU according to set timelines; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.

• Collaborate with regulatory-CMC function to ensure seamless integration of CMC components to all submissions.

• Participate in negotiations with regulatory agencies to resolve issues, and in proactive interactions with regulators; prepare and submit responses to questions.

• Lead preparation of meetings with regulatory agencies and lead or participate in regulatory meetings.

• Drive adherence to regulatory guidelines and internal standard processes for development of gene therapy product.

• Oversee, prepare and review sections of regulatory submissions; for INDs/CTAs, pediatric investigation plans, and BLAs/MAAs.

• Partner with Quality, Research, Manufacturing, Nonclinical and Clinical teams, as well as other regulatory team members to assure achievement of submission deadlines.

• Assist team during regulatory agencies inspections.

• Participate in regulatory intelligence activities; monitor regulatory guidelines and trends.

• Monitor and effectively manage project budgets.

  About You:

• BA/BS degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields including bio-chemical engineering minimum, MS/PhD preferred

• At least 6-10 years of pharmaceutical product development, preferably biologics

• Well-versed in regulatory strategy, and regulatory science writing

• Experience in major filings in the US and the EU, including as primary regulatory author for IND, CTA and MAA/BLA documents

• Travel required up to 20%

• Knowledgeable in ICH, FDA and EMA guidelines

• Understanding of advanced therapy products development

• Ability to work independently and thrive in a fast-paced environment

• Attention to details

• Excellent people leadership skills

• Experience in the development of orphan drugs

• Experience in the field of gene or cell therapy

• Expanded Access Programs experience

• Excellent communication skills and ability to influence across multiple functions

• Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

Chromatography Technician will be responsible for maintaining a fleet of analytical instruments.

For details visit:

http://www.cwsciences.com/Current-Openings/Chromatography-Technician

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com
 


 

Analytical Chemist will characterize and purify proteins in support of drug development activities.

For details visit:

http://www.cwsciences.com/Current-Openings/Analytical-Chemist--Protein

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com
 

 

The Position:

The Sarepta Therapeutics Quality Unit is seeking to fill a full-time position of Quality Assurance Sr. Associate eQMS to assume responsibilities associated with eQMS Application Support and/or Design supporting the Quality Operations providing technical oversight to Sarepta Therapeutics Operations in support of GMP systems operations.

Primary responsibilities include:

• Configure modules and develop workflows within EtQ Reliance by consulting with process owners
• Perform system administration tasks such as user access and maintaining security in conjunction with IT.
• Authoring and reviewing IQ, OQ, and PQ documents including ISD (Installation support document), IQSW (Installation Qualification of software and hardware components) and various change control documentation for validated systems
• Develop and execute Installation & Configuration of Document Content Servers, or Document Webtop clients, or Document system Admin
• Perform Requirement Analysis, Functional Studies and Quality Reviews
• Project management of system deployment
• Validate configured modules within EtQ Reliance prior to implementation
• Enhance and troubleshoot existing modules within the eQMS platform
• Partner with IT department as well as external vendor technical support to ensure continued positive performance of system.

Education and Skills Requirements: 

• Bachelor’s Degree required in a scientific discipline required
• Minimum 5 years in the Pharmaceutical or Medical Device industry
• Knowledgeable in quality systems and quality processes
• Experience with enterprise application software used within life science companies
• Experience with eQMS applications such as, EtQ Reliance
• Experience using development and support tools
• Project management skills, team collaboration, detail-oriented
• Other requirements include: Excellent organizational skills; ability to work independently and in team environments; understanding of FDA GMP Quality Requirements; familiarity with FDA current Good Manufacturing Practices and Good Documentation Practices and experience training personnel on Quality Management and Quality Assurance concepts

The Position:

The Sarepta Quality Assurance Unit is seeking to fill a Full-Time position for a Quality Engineer for QA Compliance to assume responsibilities associated with providing general Quality and Compliance oversight to Sarepta Therapeutics Operations in support of GMP both internal and external operations.

• Provide QA support and guidance to internal and external customers and support teams related to current regulations and industry best practices for maintaining quality compliance.
• Investigation activities (Deviations, Laboratory Investigations, Corrective and Preventive Action activities, Change Control and product complaint activities
• Work with cross functional teams during development and pilot scale batch production, scale-up/transfer trial at new or existing CMOs.
• Generation and reporting of Quality Metrics (APRs), drafting, review and approval of Controlled Documents,
• May assist with compliance audits as and interface with regulatory agencies as required.
• Support the improvement and maintenance of quality systems
• Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Participates in developing Standard Operating Procedures to ensure quality objectives are met.
• Interfaces with contract manufacturers as well as internal departments to address compliance issues.
• Demonstrates strong proficiency in application of QA Systems principles, concepts, industry practices and standards.  

The successful candidate will have experience with general Quality Management Systems in a regulated environment, ability to collaborate with small teams to meet program deliverables, job history with a focus on Quality Assurance Compliance, and will be expected to interact with many groups of different levels across Sarepta. Knowledge of risk assessment processes, root cause analysis and change control is also preferred.

This appointee will be responsible for working closely with the Sr. Manager of QA Compliance and Departmental staff in support of the ongoing maintenance and continuing improvement of Sarepta’s QMS.  

This position reports to the Sr. Manager QA Compliance.

 Education and Skills Requirements: 

• Bachelor’s Degree required; Bachelor’s Degree or higher in a scientific discipline preferred
• Minimum 6 years’ experience in a regulated industry required; in a Quality Assurance Compliance role preferred
• Other requirements include:  Excellent organizational skills; ability to work independently and in team environments; understanding of FDA/EU GMP Quality Requirements; familiarity with FDA current Good Manufacturing Practices
• Must have technical knowledge of API, finished Pharmaceuticals/Biologics manufacturing and laboratory operations.
• Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is required
• Travel required

Overview:

The Assistant Controller is responsible for accounting matters, including the closing and consolidation process, compliance with Sarbanes-Oxley (SOX) and accounting policies for the organization. This responsibility includes the ongoing development of reporting and control policies and processes, review of key transactions and contracts, and assistance with development of global accounting and accounting systems.

Working in a fast growing company, this position gives the individual the opportunity to staff and grow the finance department.

Reporting to the Controller, the position will require extensive and effective collaboration with multiple accounting functions, cross-functional teams and with senior financial management, including the Vice President of Finance and Treasurer.

  Summary of Key Responsibilities:

• Lead monthly close and internal reporting process, including performing a detailed review of R&D accruals, investments, review of monthly binder and journal entries
• Own the consolidation process including assistance in the development of the company’s global expansion
• Develop and maintain effective internal control process in compliance with SOX requirements
• Manage external audits and quarterly reviews conducted by independent accountants
• Improve and build appropriate systems and processes to facilitate timely and accurate closing of monthly financial statements
• Assist with special projects, such as assistance with implementation of finance systems (e.g. ERP)
• Own financial responsibilities for ERP and accounting systems

Qualifications:

• Bachelor’s degree in Accounting and C.P.A. certification required

• Minimum of 8+ years’ experience in public accounting and/or private industry is required
• Expertise in accounting in accordance with GAAP
• SAP experience a plus
• International experience a plus

Competencies:

• Excellent verbal and written communication skills
• Ability to successfully manage multiple projects with competing priorities and tight deadlines
• Detail-oriented with both the ambition and willingness to dive into the details
• Strong financial systems skills and knowledge of reporting tools
• Ability to work with cross-functional teams (Program Management, Manufacturing, etc.) and senior finance management

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

https://career012.successfactors.eu/sfcareer/jobreqcareer?jobId=130261&company=merckgroup&username=

Overview:

Alnylam Pharmaceuticals, Inc. is seeking an experienced corporate/life sciences paralegal to join the legal department in Cambridge, MA.

Summary of Key Responsibilities:

Opportunity to join a dynamic legal department in a growing biotechnology company, responsible for public company and state licensing related matters and supporting corporate governance, as well as the growth of our European operations as Alnylam moves towards commercial launch of its first product.  This position reports directly to the Vice President, Associate General Counsel.

Responsibilities include: Manage and maintain board and committee related materials from the legal department, including meeting materials and minute books.  Lead formation of domestic and international subsidiaries, and maintain associated corporate books and records.  Support preparation and filing of all SEC filings, including periodic and current reports, proxy statements, Section 16 reports and confidential treatment requests.  Assist in development and maintenance of corporate governance policies and guidelines. Prepare, file and maintain all state qualifications to do business, annual reports and business licenses, including manufacturing and distribution licenses, as applicable.  Occasional support of litigation efforts, due diligence and responses to third party inquiries. Partner with Corporate Communications department to ensure company's public website is current and compliant with legal requirements for public companies.  Maintain legal department's intranet site; and assist in development and maintenance of templates, training and communications materials.

The following skills and experience are essential for a strong candidate:

• Experience with SEC reporting and NASDAQ compliance requirements.
• Experience with Delaware corporate governance requirements
• Excellent drafting and proofreading skills, with the highest attention to detail.
• Excellent organizational and time-management capabilities demonstrated through ability to coordinate multiple projects and priorities simultaneously, as well as a strong sense of project ownership.
• Ability to maintain confidential information.
• Strong oral and written communication skills.
• Strong interpersonal skills and the ability to communicate effectively throughout all levels of the organization as well as with external parties.
• Ability to work independently.

Qualifications:

The ideal candidate will have 5-7 years of legal experience, including independent work in relevant areas including: public company reporting, corporate governance matters, subsidiary formation and maintenance, and evaluation, application and maintenance of state licenses for a life science company.  Life science industry experience and experience interacting with international subsidiaries preferred.

Educational background: Bachelor's degree and/or formal paralegal training and certification combined with significant work-related experience in a law department or law firm.

Alnylam Pharmaceuticals is an Equal Employment Opportunity (EEO) employer committed to an exciting, diverse, and enriching work environment.

https://career012.successfactors.eu/sfcareer/jobreqcareer?jobId=130281&company=merckgroup&username=

Primary Responsibilities Include:

• Review of batch records, testing data, and packaging/labeling from Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories
• Track/maintain metric logs related to lot release and deviations/investigation
• Attend CMOs meetings as applicable to ensure resolution of batch record review comments or questions
• Represent QA on project teams as required
• Assisting in Investigation and deviation activities, and CAPAs, and providing general quality assurance support for the overall Quality System at Sarepta
• Scans approved documents to the QA files and, provide applicable approval documentation to CMOs.
• Assist with SOP writing and other QA activities as required

Education and Skills Requirement:

• The candidate must be a self-starter
• 8-10 years’ experience with general Quality Systems in a regulated environment, with a focus on Lot Release, Product Disposition, Investigation/Deviation writing and reviewing
• Demonstrated proficiency and knowledge of cGMP (FDA and EU) and ICH requirements
• Experience in implementation and maintenance of quality systems
• Candidate will be expected to interact CMOs and other groups across Sarepta.

Alnylam is a midsized and rapidly growing biotechnology company in Cambridge, MA focused on the discovery and development of RNAi therapeutics.  The Bioanalytical Sciences department at Alnylam is seeking an experienced scientist to join our fast-paced team to advance our RNAi therapeutic programs from discovery to the clinic.  The successful candidate will have a strong scientific knowledge and hands on experience in ELISA, MSD, protein-binding, Western blot based analytical assay development, validation, and sample analysis to assess anti-drug Ab (ADA), PD biomarker, drug-protein binding and interaction, and drug MoA.    

• Develop ligand binding based method such as ELISA, MSD, etc. to assess ADA and PD biomarkers in biological matrices.
• Develop drug protein binding assays, gel electrophoresis, and Western blot methods to understand drug-protein interactions and MoA.
• Transfer assays to CROs and serve as technical expert on assay trouble shooting.
• Generate and characterize assay reagents such as 
  • rabbit anti-drug antibodies.
  • Write method protocols and sample analysis procedures.
  • Perform sample testing, data analysis, and data QC.
  • Improve lab efficiency via development of high throughput methods and automation.
  • Collaborate with research and development teams on method development and data analysis/reporting.
  • Prepare clearly articulated experimental reports and data presentations.
    Qualifications:

  Requirements include a PhD in biochemistry, biology, immunology or related fields with 5+ years including post-doctoral and/or industrial work experience or (a MS with 7+ years of industry experience).  In-depth knowledge and hands on experience with ELISA and other ligand binding method (such as MSD, luminex, etc.) is required.  Experience in a compliant lab environment such as GLP and GMP is preferred.   Knowledge on regulatory expectations on analytical method development and validation and immunogenicity assessment is also preferred.  Hands on experience on biomarker assessment using ELISA, MSD, and Luminex methods are preferred.  Experience on reagent characterization and drug-protein interaction analysis (such as Biacore and protein binding assay) is also preferred.  Familiar with LIMS and automation is a plus.  Excellent communication skills (both written and oral) and interpersonal skills are expected.  Attention to details and ability to multi-task is also preferred. 

Alnylam is a midsized and rapidly growing biotechnology company in Cambridge, MA focused on the discovery and development of RNAi therapeutics.  The Bioanalytical Sciences department at Alnylam is recruiting an Associate Director or Director, reporting to the Senior Director, to join our fast-paced team to advance our RNAi therapeutic programs from discovery to the clinic.  The successful candidate must have good interpersonal skills and strong scientific and technical experience across multiple bioanalytical platforms, specifically, HPLC, LC-MS, LC-MS/MS, qPCR, and ligand binding assays (ELISA, MSD, Luminex). Prior experience with assay development, validation, and sample analysis to support both pre-clinical and clinical programs is required.  In-depth knowledge on regulatory expectations and industry best practice on analytical method development and validation is required.  

• Lead Bioanalytical Sciences group responsible for assay development, qualification/validation and sample analysis for in house non-GLP pre-clinical studies.
• Collaborate with outsourcing manager and transfer assays to CRO to support GLP pre-clinical and clinical studies.
• Oversee assay design and implementation of Atto probe or PNA probe hybridization-HPLC, Mass Spec, and qPCR based method to quantify siRNA in biological matrices such as plasma, urine, and tissue samples to support PK and TK analysis according to regulatory expectations and industry’s best practices.
• Design and implement novel assays or improve current 
  • assays for assessment of anti-drug Ab and PD biomarkers for different programs. Implement these methods for internal and CRO sample analysis.
  • Manage lab operation for lab safety, quality, and compliance. Responsible for data QC and QC reports.
  • Responsible for in house project timeline and deliverables (data and reports).
  • Improve lab efficiency via development of high throughput methods and automation.
  • Collaborate with Alnylam R&D and DMPK scientists on assay needs and study support.
  • Prepare clearly articulated experimental reports and data presentations. Prepare and oversee all preparation of BA regulatory document sections.
  • Manage staff for performance, career development, and project timeline and deliverables.
    Qualifications:
  • Requirements include a PhD in analytical chemistry, biochemistry, organic chemistry or related fields with ~15+ years of industry experience.  
  • Strong background and experience in a compliant laboratory environment in biotech/pharmaceutical companies and/or CROs (GLP, CLIA, etc.) is needed. 
  • In-depth scientific and hands-on technical experience with HPLC, LC-MS.
  • LC-MS/MS, qPCR, nucleotide sequencing, immunoassays, Western blot, etc. is required. 
  • Familiar with regulatory guidance documents and industry’s white papers on analytical and immunogenicity method development, validation, and sample analysis is necessary. 
  • Previous skills on RNAi analysis are preferred.  
  • Experienced with use of  LIMS system and automation 
  • • Collaborate with Alnylam R&D and DMPK scientists on assay needs and study support.
    • Prepare clearly articulated experimental reports and data presentations. Prepare and oversee all preparation of BA regulatory document sections.
    • Manage staff for performance, career development, and project timeline and deliverables.
      Qualifications:
    • Requirements include a PhD in analytical chemistry, biochemistry, organic chemistry or related fields with ~15+ years of industry experience.  
    • Strong background and experience in a compliant laboratory environment in biotech/pharmaceutical companies and/or CROs (GLP, CLIA, etc.) is needed. 
    • In-depth scientific and hands-on technical experience with HPLC, LC-MS.
    • LC-MS/MS, qPCR, nucleotide sequencing, immunoassays, Western blot, etc. is required. 
    • Familiar with regulatory guidance documents and industry’s white papers on analytical and immunogenicity method development, validation, and sample analysis is necessary. 
    • Previous skills on RNAi analysis are preferred.  
    • Experienced with use of  LIMS system and automation is a plus. 
    • Experience in project management and people management (with direct reports) is required. 
    • Excellent communication skills (both written and oral) and interpersonal skills are expected. 
    • Attention to details and ability to multi-task is also preferred.

     

    Alnylam Pharmaceuticals is an AA/EEO employer 

Alnylam is a midsized and rapidly growing biotechnology company in Cambridge, MA focused on the discovery and development of RNAi therapeutics. The Bioanalytical Sciences department at Alnylam is seeking an experienced scientist to join our fast-paced team to advance our RNAi therapeutic programs from discovery to the clinic. The successful candidate will have a strong scientific knowledge and hands on experience in real-time qPCR, ELISA, MSD, Luminex, protein-binding, Western blot based analytical assay development, validation, and sample analysis to assess drug concentration, anti-drug Ab (ADA), PD biomarker, drug-protein binding and interaction to understand drug MoA. The candidate will perform bench work as well as manage a small group of scientists and research associates for their projects. 

• Manage a group to support assay development, qualification/validation, and sample analysis using qPCR, ligand binding, immunoprecipitation, and Western blot assays.
• Develop qPCR based method for drug (siRNA) quantification in blood and tissue samples and support sample analysis for non-GLP studies pre-clinical studies.
• Develop ligand binding based method such as ELISA and MSD (direct or bridging), etc. to assess anti-drug Ab (ADA). Responsible for in house non-GLP pre-clinical sample analysis.
• Develop drug protein binding assays, gel electrophoresis, and Western blot methods to understand drug-protein interactions and drug MoA and 
  • support sample analysis for non-GLP studies.
  • Transfer assays to CROs to support GLP pre-clinical and clinical studies, serve as technical expert on assay trouble shooting, and assist in review of assay qualification/validation reports and sample analysis reports from CROs.
  • Generate and characterize assay reagents such as rabbit anti-drug antibodies.
  • Write bioanalysis method protocols, sample analysis procedures, and reports
  • Be responsible for data QC and QC report.
  • Prepare clearly articulated experimental reports and data presentations.
  • Improve lab efficiency via development of high throughput methods and automation.
  • Collaborate with research and development teams on method development and data analysis/reporting.
  • Manage staff for performance, career development, and project timeline and deliverables.
    Qualifications:

  Requirements include a PhD in biochemistry, biology, immunology or related fields with ~10+ years of bioanalytical experience. Hands on experience on qPCR and nucleotide sequencing, biomarker and ADA assessment using ELISA, MSD, and Luminex methods are preferred. Strong technical skills on protein binding, immunoprecipitation, Western blot is required. Ability to develop and trouble-shoot biomarker and ADA assays. Experience in a compliant lab environment such as GLP, GMP, and/or CLIA is preferred. Knowledge on regulatory expectations on analytical method development/validation for analytical methods for PK is required. Knowledge on regulatory expectations and industry’s best practice on biomarker and immunogenicity assessment is also required. Experience on reagent characterization and drug-protein interaction analysis is also preferred. Familiar with LIMS and automation is a plus. Experience in managing direct reports is required. Excellent communication skills (both written and oral) and interpersonal skills are expected. Attention to detail and ability to multi-task is preferred.

Our client is a dynamic biotechnology company in Cambridge, MA with a passion for developing new drugs in areas of high unmet need. They were nominated by Fierce Biotech in 2014 as a “Fierce 15” company “that could change how physicians approach infectious disease”

Do you consider yourself organized, meticulous, and enthusiastic?   Then you might just be the type of Quality Assurance Specialist we're looking for to join the team. This position will assist the QA Department in quality system compliance and product quality.  You will also be maintaining systems and standards to ensure compliance with Gxp and International regulations.

REQUIREMENTS:

• BA/BS and 3-5 years’ experience as a QA specialist
• GMP experience
• Coordinate the creation, revision and distribution of controlled documents
• Assist in creating, implementing and executing the training program

About StratAcuity
Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways.

This position is responsible for the implementation, support and continuous improvement of the Infinity commercial systems and data environment. The individual is expected to have a thorough understanding of the commercial oncology data environment and be comfortable working with commercial leadership as well as vendors and technical colleagues. Responsibilities range from relationship manager to project manager to system administrator for our Veeva CRM.system. We are looking for a passionate, energetic individual that knows the business as well as the technology and is looking for their next challenge!

• Responsible for the successful implementation of our commercial systems and data infrastructure in support of our first product launch.

• Responsible for the technology and data portfolio for the commercial business functions including field force automation, aggregate spend data collection and reporting, promotional and medical materials review, commercial information management, warehousing and reporting.

• Ensures the technology portfolio supports and enhances the commercial strategy through successful, consistent, and predictable delivery of programs, projects and applications.

• Translates commercial business strategy into an aligned commercial technology strategy and portfolio of programs, projects and applications.

• Manages vendor contracts and performance from implementation and Project Management to ongoing operational support.

• System administrator for Veeva CRM.

• Bachelors degree in computer science, business administration or another discipline relevant for the life science industry or equivalent experience.

• A minimum of 6 years IT experience in small or mid-size oncology focused biotech / pharmaceutical organization.

• At least 3 years’ project management experience.

• At least 3 years’ experience in Relationship Management for a Commercial organization.

• Experience as Veeva CRM System Administrator.

• Experience leading teams - both indirect reports and vendor project teams.

• Experience in setting technology strategy and commercial business technology alignment.

• Experience with managing commercial data management capabilities / environments.

• Experience with vendor and contract management.

• Broad knowledge of all technologies used or to be used by the commercial environment, their external customers and internal partners.

• Strong influence and negotiating skills.

To apply, please visit our website at http://www.infi.com

Research Associate Job Description

TissueVision is seeking a research associate to be a contributing member of our research organization. The qualified research associate will work under the general supervision of senior colleagues on sponsored research projects utilizing serial two photon tomography instrumentation developed by TissueVision. This position will provide an opportunity for growth in regards to scope and capabilities. A qualified applicant is enthusiastic about biomedical research, able and willing to rapidly learn new skills and begin applying them immediately.            

Major Responsibilities:

• Assist with the execution of externally initiated research projects as part of our contract research services and aid with internal projects focused on novel application development.
• Assist with in vivo procedures in common research species including, but not limited to
  • Handling and dosing
  • Transcardial perfusion
  • Tissue dissection
  • Maintain accurate and timely record of test results
  • Operate, calibrate and perform routine maintenance on specialized equipment
  • Maintain supply inventory
  • Organize and centralize files and records
  • Prepare solutions, reagents, media or stains for prescribed tests
  • Participate in weekly meetings with the senior researchers and other TissueVision colleagues to present and discuss lab results

Qualifications:

• Bachelor’s of Science degree in Biology, Biochemistry, Microbiology, Molecular Biology or related field with 0-3 years of laboratory experience
  • Strong organizational skills with ability to manage complex experimental designs
  • Proficient in Microsoft Office applications
  • Strong written and oral communication skills
  • Must be willing to work flexible hours as necessary

Reporting to Senior Manager, Strategic Sourcing this position is responsible for supporting Infinity project teams in business oversight of CROs, laboratories and all other vendor types in support of Infinity’s clinical programs. The position provides support and assures that strategic sourcing and relationship management best practices are employed throughout the project life cycle to assure best-in-class services are maintained.

Duties and Responsibilities:

• Support supplier relationships (inclusive of surveys, KPIs, and other metrics), and support evaluation and reporting on supplier performance against established goals and benchmarks
• Establish and maintain analytical tools to drive business decisions
• Gather and analyze data frequently to produce metrics essential for outsourcing excellence
• Own outsourcing management business systems and act as the subject matter expert of these systems
• Support proposal review including cost and qualitative criteria
• Coordinate and attend supplier presentations
• Manage the design, collection of information/data and maintenance of supplier presentation library
• Perform due diligence on new providers, including review of financial statements, corporate stability and conduct reference checks
• Work in close collaboration with other functional areas and groups within Infinity
• Stay current with the industry marketplace and implement outsourcing industry best practices
• Contribute to organizational initiatives related to achieving outsourcing excellence
• Participate in and represent Strategic Sourcing team on assigned cross functional projects

Qualifications:

• 5-8 years of experience in Clinical Outsourcing with a minimum or 5 years in a Sponsor organization
• Bachelor’s degree or relevant experience with sourcing and/or vendor interactions.
• Thorough understanding of FDA, ICH and GCP guidelines as well as a thorough understanding of cross-functional clinical processes including clinical operations, data management, biostatistics, medical writing, drug safety, pharmaceutical development, manufacturing, legal and regulatory affairs
• Top computer skills including, but not limited to, advanced knowledge of Excel, Powerpoint, Word, Visio, and SharePoint, with the ability to quickly master new systems and technologies
• Ability to operate in a cross-functional matrix team environment
• Proven problem solving and organisational skills
• Excellent planning, analytical and project management skills
• Title will be commensurate with experience

To apply, please visit our website at http://www.infi.com

Phase III trials looking for a leader in the Bay Area. 

Our client, a clinical development focused biopharmaceutical company in the Bay area is looking for an experienced Medical Director to join their team. This is an extremely progressive & innovative company working on a very exciting science that will create an exponential increase in the quality of life for patients. For this high profile position, the selected individual will join a dynamic team in a cohesive, collaborative environment and have the opportunity to lead Phase III trials with their eyes on a quick path to NDA. This individual should be comfortable facilitating recruitment efforts for the clinical operations group, engaging & relationship building with foundations and partners, and making sure protocols are followed as written.

REQUIREMENTS:

• MD degree
• Industry experience
• Gastroenterology experience or Generalist
• Willingness to collaborate and share innovative ideas throughout the company
• Exhibit strong leadership qualities & handle day to day medical functions
• Possess ability to build positive collaborative relationships and handle outreach to relevant foundations & partners

About StratAcuity
Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

Overview:

ERT is the leading cloud platform solutions provider that captures quality efficacy and safety endpoints, harmonizes data from any clinical source system, and delivers real-time insights for optimum trial performance – innovating better health for over 40 years and tomorrow. ERT’s combination of technology, services, and consulting increases the accuracy and reliability of patient data and improves the efficiency of the clinical development process throughout the product lifecycle.  ERT provides sponsors and CROs with the most widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments (COAs including patient, clinician, and observer reported outcomes).  ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.

ERT is looking for a Senior Quality Assurance Auditor to perform quality audits and assessments of ERT’s procedures and data at an advanced level to assure compliance and quality of the services and systems developed and implemented by ERT.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Performs internal/vendor audits, quality reviews and gap analyses of ERT’s operational and technical departments, processes and systems to ensure:

• Compliance with ERT SOPs, Good Clinical Practices, and EN ISO 9001/ISO 13485 and applicable regulatory requirements. Includes all processes related to ERT’s System Development Life Cycle, Operations, and Quality Management System.
• Effectiveness of vendor Quality Management Systems, and their ability to meet ERT contractual agreements, ERT quality standards, and applicable regulations.
• Identification of potential/realized risks and determination of systemic approaches to effectively correct and prevent issues from recurring through utilization of risk based and control concepts.
• Data, processes and systems implemented by ERT are compliant with applicable regulations, guidelines, and internal procedures through quality reviews of primary study documentation and software applications.

Manages multiple QA tasks in parallel and effectively prioritizes tasks to align with corporate quality objectives. Coordinates intra/interdisciplinarypersonnel through scheduled meeting and written communications, effective time management, tracking deliverables and when necessary, escalations to supervisor.

Acts in leadership role for joint department/vendor auditing efforts with other QA Auditors  and oversees activities including:

• Develops auditing plans and compiles reports for assigned audits at a level that requires minimal feedback from Quality Assurance Management.
• Reviews audit plans and reports developed by other QA Auditors and provides mentoring and feedback for development of their writing skills.

• Assigns and manages tasks to ensure that the audit is conducted efficiently and effectively.
• Oversees the mitigation and closure of observations by conducting proactive follow-up with the applicable departments to ensure timelines for corrective/preventive actions are met.
• Performs tracking/trending analysis of audit findings.
• Executes audits in compliance with the Annual Audit Schedule and completes reports within the timelines defined by ERT SOPs.

 Acts in hosting role for management of client audits.  Ability to demonstrate:

• Knowledge of ERT’s quality management system, regulatory requirements, business line products/services, and organizational structure.
• Acting as the liaison between ERT and the client, and coordinating with applicable department representatives when their participation is required.
• Effective distribution of audit requests and communications with auditors to address concerns.
• Successful client audit outcomes; Tracking/trending analysis of audit findings within the quality management tool.
• Analysis of observations identified; ability to oversee and work collaboratively with applicable departments to generate effective corrective and preventive action responses.
• Oversight of mitigation and closure of observations. Conduct follow-up with the applicable department to ensure timelines for corrective/preventive actions are met. Effectively communicates mitigation to clients.

 Supports Continuous Improvement Program through:

• Effective investigation of issues and complaints including collaboration with applicable department head(s).
• Facilitation of root cause analysis to determine appropriate corrective and preventive actions.
• Management of Issues and Actions in quality management tool.
• Development of the Continuous Improvement Committee agenda.

Ability to oversee department initiatives effectively to support improved Quality Management functions such as document management, process development/management and QA tool administration.

OTHER DUTIES AND RESPONSIBILITIES:

Authors Quality Assurance/Regulatory Affairs standard operating procedures as required.

Trains QA personnel on advanced concepts on auditing, quality management, or regulatory principles.

Provides Annual Quality Assurance/Regulatory Affairs Training Courses to ERT staff, as necessary.

Provides consulting services to contracted external sources as required.

Assists in the development or execution of system testing as required.  Participation in this task may only occur if the Quality Assurance Auditor is not assigned to the project in an audit role.

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.

QUALIFICATIONS AND SKILLS NEEDED:

1. College Degree in Health/Life Sciences.
2. 5-7years experience in a Quality Assurance capacity with a focus on GCPs and previous auditing experience.  GMPs experience with medical devices is a plus.
3. Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities.
4. Excellent leadership, analytical, organizational and communication skills.
5. Detail oriented.
6. Ability to write concise and accurate audit reports.
7. Competent in Microsoft Office, especially spreadsheets, database and reporting tools. Experience with CAPA Management systems desired.
8. Ability and willingness to travel at least 10-15% of the time (international and domestic).
9. Ability to exercise good judgment, tact and confidentiality in all matters.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.