Headquartered in Lexington, Massachusetts, Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on becoming a leader in the discovery, development and commercialization of novel acute care therapies for use in hospitals and other acute care environments.Position Summary:

Cubist is seeking a Senior Manager, Medical Writing to be deeply involved in preparing for; leading and facilitating the medical writing effort for multiple regulatory submissions focusing on clinical documents, such as study reports and integrated summaries. The successful individual will be an experienced medical writer with extensive and broad prior role as a lead writer in a regulatory submission at a mid to large bio-pharmaceutical company. Previous experience preparing and integrating clinical documents prior to a new drug application (or equivalent) is required.

In addition, this person must be a skilled facilitator who can work closely with the clinical/development teams to drive document preparation, lead document review cycles roundtables and ensure that information is accurately shared, evaluated and presented.

Key Responsibilities:
* Research, author, edit, format and quality review clinical documents (i.e. clinical study reports, protocols, investigator brochures)
* Research, author, edit, format and quality review clinical portions of regulatory submissions (i.e. integrated summary of safety, integrated summary of efficacy, clinical overviews and summaries)
* Drive document preparation, lead document review cycles roundtables, and incorporate comments
* Establish metrics/timelines and hold functional groups accountable for delivery of essential documents crucial for the NDA submission
* Contribute to the development of standardized processes for the writing/submission organization (i.e. development of templates, shells, and standard operating procedures etc.)
* Supervise and ensure quality and consistency of work performed by the medical writing team and external vendors
* Mentor junior writers and manage external vendors as appropriate

Minimum Basic Qualifications:
* Master's degree in a life sciences discipline
* Minimum of 5 years experience as a medical writer working in the pharmaceutical/medical industry
* Experience in regulatory submissions, including functioning as a medical writing lead for a regulatory submission
* Knowledge of FDA and ICH guidelines
* Skilled in clinical data interpretation
* Attention to detail

Preferred Qualifications and Experience:
* Advanced scientific degree (MS, PhD, PharmD, MD)
* Project management experience
* Knowledge of the anti-infective therapeutic area

Competencies:
* Demonstrates the ability to communicate clearly, concisely, and effectively to express information in both written and oral context
* Aptitude to compile, analyze, and present data in a concise manner
* Proven capability to focus on delivering excellent results and continually improve performance
* Capability to work on multiple projects and meet deliverable timelines
* Proven ability to drive issues to closure and demonstrate an effectiveness to work co-operatively with others in a team environment

Work Environment:
* Office

Physical Demands:
* None

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

To apply for this position, please CLICK HERE

Primary Duties
Primary responsibility includes but is not limited to executing analytical testing to support clinical and commercial drug substance and drug product release, in process and stability sample testing. Leading technical investigations, CAPAs, and improvement initiatives related to method validation and method performance including data trending and lot release analysis. Author technical reports and investigation summaries. Planning, execution and authoring of analytical method validation studies in compliance with current regulatory requirements and industry guidelines. Maintain operational readiness and GMP compliance of the lab. Assist training of analysts in proper execution of GMP procedures.

Responsibilities:
• Testing
• Perform execution of sample testing and analysis for release, stability, non-routine and in process samples within established turnaround times including timely data review for QC Biochemistry test methods including Enzyme Activity (flu orometric, colorimetric), Protein Concentration (A280), tests for purity (SDS-Page Silver, DNA Analysis) and content (polysorbate 20 and free thiol). 35%
• Support and lead assay-related investigations, including data investigations (investigations, deviations, CAPAs) in support of routine testing and regulatory commitments.
• Assist with method related reviews and solving routine analytical issues and troubleshooting. 15%
• Perform statistical trending and analysis of assay controls and trending product results, including identification of assay related trends. Drive trend investigation and studies to completion – 15%
• Author and review technical protocols, reports or memos 10% Support Laboratory Operations & Compliance
• Support QC defined technical projects, including authoring of regulatory filings and responses, as needed. Identify compliance gaps and develop and drive remedial actions. Lead and/or support aberrant, OOS, OOT result investigations related to laboratory and process excursion – 15%
• Coordinate oversight of general QC laboratory activities in support of laboratory operations 10%

Education and Experience Requirements:
• MS with minimum 3-7 years relevant experience/phD with 0-2 years experience or BS degree with minimum of 6-9 plus years of related experience preferred.
• GMP experience strongly preferred. Experience with authoring technical reports, quality system investigations, method validation protocols, and SOPs highly desired.

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives

Shire is an Equal Opportunity and Affirmative Action Employer

To apply for this position, please CLICK HERE

Primary Role
As an expert in analytical development, contributes as part of a small team of scientists and development specialists to the design and implementation of HPLC and LC/MS solutions for the qualitative and quantitative analysis of proteins and glycoproteins in a compliance-based environment. Identifies, strategizes, prioritizes and manages own activities to bring agile resolution to a variety of problems of moderate scope and complexity to support company products in alignment with organizational objectives. Provides mentoring to junior team members and contributes to setting objectives and group priorities.

Responsibilities
- 55% Product development related work: design, prioritization and management of HPLC and LC/MS based activities leading to method development and qualification and associated protocol, report and procedure documentation. - Authorship of regulatory submission documents and internal and external presentations and publications.
- Possible involvement in Technology Transfer in alignment with Product Development Lifecycle.
- 30% Organizational support including talent development and successful partnership interactions.
- Possibility of mentoring direct reports. Project team participation.
- 15% Evaluation and implementation of new technologies relevant to own area

Education and Experience Requirements
- Ph.D. in Analytical Chemistry, Biochemistry and Pharmaceutical or biotechnology-related discipline with a minimum of 6 years relevant postdoctoral or industry experience in product and process development. Alternatively, MS in Analytical, Chemistry, Biochemistry and Pharmaceutical or related discipline with a minimum of 8 years of relevant industry experience in product and process development.
- Recognized expert in multiple analytical technologies related to HPLC and LC/MS with a proven track record of scientific contributions.
- Expertise of HPLC method development applied to primary and secondary structure of proteins and glycoproteins along with in-depth understanding of industry practices, techniques, and standards.
- Excellent communication, interpersonal and organizational skills. Proficient with standard computer applications.
- Proactive at keeping current with and leveraging literature and latest technologies.
- Ability to work well both independently and in a multi team environment.
- Ability to prioritize work and multitask.
- Conducts work in compliance with cGMPs, safety and regulatory requirements.

Key Skills and Competencies
Applies in-depth knowledge of HPLC, such as RP-HPLC, SEC, IEX, UPLC with UV, Fluorescence, and MALLS detection and mass spectrometry, and independently guide method development for elucidation and monitoring of primary and secondary structure of proteins and glycoproteins, peptide mapping and quantitation of process- and product-related impurities. Works with management to review progress and strategy in meeting team and project objectives. Complexity and Problem Solving Exercises independent judgment to determine most appropriate course of action including technique and method selection, protocol and study design and execution, in-depth data analysis, factor evaluation and use of established practices and procedures for a variety of problems of broad scope and complexity, in alignment with organizational objectives.

Provides expert input on product design and development, and project execution and acts as a consultant to management. Frequently presents challenging issues and results at department and cross-functional gatherings, and project team meetings. May act as organizational representative and present at external meetings or publishes in peer-reviewed journals. Internal and External Contacts Communicates effectively with line function and peers. Successfully conveys very complex information in both written and oral forms. Effectively interacts, communicates and influences decisions across multifunctional areas. Networks internally and externally outside immediate area of expertise. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives

Shire is an Equal Opportunity and Affirmative Action Employer

To apply for this position, please CLICK HERE

Clinical Programmer/ Analyst (Vertex Pharmaceuticals Incorporated; Cambridge, Massachusetts).

A senior opportunity, to provide advanced solutions to meet the needs of the Clinical Data Management department by applying experience with the SAS statistical programming language, relevant tools, and SQL, along with proven experience working with clinical trial data collection systems such as EDC for Phase I, II, and III, as well as CDISC standards and experience working with cGCP and compliance for relevant regulatory requirements (e.g., FDA 21 CFR Part 11 and ICH standards).  Must have solid skills in oral / written communication that are suitable for a multidisciplinary team environment.  Duties: write SAS programs to support cross-functional data review, external data reconciliations, and data review listings for clinical trial studies; provide technical support and consultation on complex, high priority projects for the Clinical department user community; interact with Data Management personnel to collect user requirements for required reporting elements; develop SOPs, work instructions, and other procedures for data collection and data management; ensure compliance and quality across multiple clinical studies; maintain timelines while assuring high-quality statistical programming output; may oversee vendor activities; and may supervise other staff, as required.

REQUIREMENTS:
Minimum requirements are: M.Sc. in Statistics, Biostatistics, MIS, Computer Science, or other relevant discipline plus 5 years of experience, either in the position offered or in a relevant clinical programming role. Must have:  proven programming experience working with the SAS statistical programming language and relevant tools (e.g., BASE SAS and Macros), along with SQL; proven experience working with clinical trial data collection systems for Phase I, II, and III such as EDC; proven experience working with the CDISC compliance standard for FDA submissions in terms of format, processing, and presentation; proven experience working with current Good Clinical Practices as well as compliance with the relevant regulatory requirements (e.g., FDA 21 CFR Part 11; and the International Conference on Harmonization); and solid skills in oral and written communication suitable for a multidisciplinary team environment.

An EOE/AAE.

HOW TO APPLY:
Send resume to: Lauren O’Hearn, Senior Human Resources Assistant, Vertex Pharmaceuticals Incorporated, 130 Waverly Street, Cambridge, Massachusetts 02139-4242.  No phone calls, please. Reference NRP-092012. 

Associate Clinical Pharmacologist (Vertex Pharmaceuticals Incorporated; Cambridge, Massachusetts).

Provide statistical support for the initiation of clinical studies by applying technical expertise in experimental design and the relevant statistical analysis methods (e.g., multivariate logical regression, survival analysis, clinical trial analysis), along with proven technical skills in the relevant programming languages and related toolkit, including the SAS suite of statistical programming tools.  Must have a demonstrable understanding of the theory of pharmacology and pharmacokinetics (PK) and its practical application in drug interactions and drug development.  Must have solid skills in oral / written communication suitable for a multidisciplinary team environment.  Duties: provide support to the lead Clinical Pharmacologist for study initiation; perform Non-Compartmental analysis using the WinNonLin statistical analysis tool; prepare specifications of PK data for clinical studies; perform QC for the PK portion of the Clinical Study Report; ensure that through-study data is included in the Pharsight Knowledgebase Server; maintain an up-to-date working knowledge of PK data, design and phases of clinical studies and relevant regulatory requirements; create SDTM (i.e., Study Data tabulation model) standard compliant data for regulatory submissions; create NONMEM data; provide programming support in SAS and S-Plus; prepare the relevant reports, review project documents, and assist with developing publication manuscripts;  and make presentations to internal scientific teams.

REQUIREMENTS:
Minimum requirements: MPH or M.Sc. in Biostatistics or related discipline and 1 year of experience, either in the position offered or in a relevant clinical or statistical programming role. Must have: proven technical expertise in experimental design and the relevant statistical analysis methods (e.g., multivariate logistical regression, survival analysis, clinical trial analysis); proven technical skills in the required programming languages and related toolkit, including the SAS suite of statistical programming tools; experience working with pharmacokinetic data; and proven skills in oral and written communication suitable for a multidisciplinary team environment.

An EOE/AAE.

HOW TO APPLY:
Send resume to: Lauren O’Hearn, Senior Human Resources Assistant, Vertex Pharmaceuticals Incorporated, 130 Waverly Street, Cambridge, Massachusetts 02139-4242. No phone calls, please. Reference VG-252012.

Research Scientist (Vertex Pharmaceuticals Incorporated; Cambridge, Massachusetts).

Work within a multidisciplinary drug discovery team, applying advanced technical expertise in heterocyclic synthesis and the related tools such as HPLC and the use and maintenance of relevant equipment such as 300 – 500 MHz NMR spectrometers, FT – IR spectrometer and polarimeter.  Apply expertise in organic synthesis to design experiments to synthesize novel molecules directed at the modulation of specified biological targets.  Must have proven team leadership experience.  Must have solid skills in oral / written communication that are suitable for a multidisciplinary team environment. Duties: collaborate with multidisciplinary scientists from biology, biochemistry, pharmacokinetics (PK), and pharmacology; aid in determining the overall direction of medicinal chemistry efforts within the target project(s); research and interpret scientific data, and draft patents as required; interpret results of scientific experiments and make related presentations to the internal and external scientific communities; and mentor other scientists in the proper use of relevant purification methods and media.

REQUIREMENTS:
Minimum requirements are: M.Sc. in Organic Chemistry and 5 years of experience, either in the position offered or in a relevant scientific research role. [In the alternative, will consider qualified candidate with relevant Ph.D. + 2 years of relevant experience.] Must have: advanced technical expertise in medicinal chemistry, particularly in heterocyclic synthesis and the related tools such as HPLC; proven experience working with modern synthesis techniques, such as organometallic chemistry, small molecule synthesis, enantio-controlled chiral molecule synthesis, and / or total synthesis of natural products, so as to design experiments to solve problems in organic synthesis or to overcome issues in medicinal chemistry; proven experience with state-of-the-art purification methodologies, such as chromatography, distillation, crystallization, and preparative HPLC, along with proficiency using and maintaining the relevant instrumentation such as HPLCs, 300 – 500 MHz NMR spectrometers, FT – IR spectrometer, and polarimeter, and in alternate separation media and techniques; proven ability to lead scientific teams and /or to mentor other scientists in the area of medicinal chemistry (e.g., purification methods and media); proven skills in oral and written communication suitable for a multidisciplinary team environment.

An EOE/AAE.

HOW TO APPLY:
Send resume to: Lauren O’Hearn, Senior Human Resources Assistant, Vertex Pharmaceuticals Incorporated, 130 Waverly Street, Cambridge, Massachusetts 02139-4242. No phone calls, please. Reference MB-262012. 

Interfacing regularly with the customer, the Product Planning Manager will be responsible for on-boarding and managing the operational aspects of product lifecycle of an array of multi-component customer-specified product reagent kits based on customer requirements and product-specific Bills of Materials (BOMs), including change management of these products through the engineering change order (ECO) process as triggered by customer-initiated BOM changes. The Product Planning Manager will perform tasks cross-functionally with internal departments (Operations, Quality Assurance, Quality Control, Supply Chain, etc.) and customer stakeholders to ensure internal and external deadlines are met on behalf of Enzymatics’ kitting services clients.

Responsibilities

• Maintaining high visibility presence as primary customer contact
• Project management for kitting products
• Ongoing BOM management and BOM change management through the Engineering Change Order (ECO) Process and ERP system
• Authoring and reviewing product-related documentation according to ISO 13485:2003 standard
• Collaborating with Supply Chain to ensure adequate inventory of raw materials to meet production demand based on customer forecasts and historical consumption
• Coordinating kit builds with the Production team
• Tracking non-recurring expenses incurred during production
• Scheduling and running regular Operations Management calls with the client(s)
• Ensuring that appropriate quality systems are established and executed
• Working with Production and Quality Assurance to define appropriate quality requirements with the client (process control plan)
• Coordination and collaboration with Operations to drive continuous improvement opportunities
• Responsible for initiating and facilitating customer complaint resolution with respect to kitting products
• Availability to travel (less than 10% of time) in support of projects which require scientific logistics support

Qualifications

• BS/MS in Life Science or Chemical Engineering discipline
• MBA, PMP or quality-related certifications a plus
• 5+ years life science industry experience
• 2-5 years in Product or Operations Management or similar experience, or equivalent combination of education and experience
• 2-5 years communicating with customers/outside stakeholders
• Proficient with an ERP system
• Background in ISO 13485:2003

Responsibilities:

• Provide engineering activities in support of research, development, verification, validation, manufacturing, and testing of new diagnostic tests
• Develop diagnostic product requirements, perform system design modeling and analyses, define and execute performance testing, develop/create/optimize diagnostic test processes, create documents needed for Design Control, create and/or execute Verification & Validation protocols, create and/or implement design transfer procedures, and document & present results to teams

Requirements:

BS/MS in Biomedical Engineering or related field with 2+ years experience testing and validating medical devices

Skills In vitro diagnostics (IVD) experience preferred. Familiarity with regulatory and compliance requirements for diagnostic tests desirable.

Candidates must live local and be a US Citizen or Green Card Holder

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.
www.cwsciences.com

The Quality Associate Manager is responsible for providing day to day quality oversight for one or more of MNTA’s clinical or commercial products.

Responsible for setting, maintaining and ensuring quality standards aligned with ICH, GMP, GLP regulations and guidance, along with MNTA’s policies and procedures.   Will represent quality in project teams and coordinates with the appropriate departments both internally and externally to ensure MNTA’s Quality objectives are met.

Responsibilities also include the review of GMP and GLP documentation for compliance and release of product.  Will actively participate in the resolution of investigations and compliance related issues.  May also support electronic system validations, deployment and management activities.

Requirements:

• BS in a scientific discipline with a minimum of 8+ years’ experience in the pharmaceutical or biotechnology industry or MS with 2-5 years’ experience.
• Experience with FDA inspections as well as strong understanding of disposition, investigations, computer, process and analytical qualification and validation, and change controls.
• Strong knowledge of FDA guidelines and regulations, quality systems and procedures regarding GLP and GMPs. GCP compliance is a plus.
• Outstanding written and verbal skills as well as problem solving skills.
• Demonstrated team player with experience contributing to multi-disciplinary project teams and ability to work with minimal supervision.
• Strong initiative and ability to assume significant project management skills.
• Must be flexible, and able to work in a fast-paced, dynamic, environment.

Veterinary Technician

Job Posting

This position provides pre-clinical veterinary support and technical expertise for small animals.

The Vivarium Technician will be responsible for supporting the basic operation of the vivarium including animal care, maintenance, cleaning and sanitization of equipment and facilities, and general record keeping.

Essential Functions:

• Providing daily animal care including feeding, watering, cage and bedding changes, and bladder expression
• Performing and documenting daily health status checks and environmental monitoring
• Maintaining vivarium supply inventory
• Maintaining compliance with SOP’s, protocols, and other guidelines
• Maintaining equipment and facilities by cleaning and sanitizing as required
• Assist research staff in performing technical procedures including injections, sample collection, animal behavior training and analysis
• Assistance with surgical procedures and post-operative care
• Coordination of waste disposal
• Help maintain safe & orderly lab environment
• Think creatively, problem solve,  develop innovative solutions based on strong theoretical and scientific arguments
• Document & maintain records using GLP notebook procedures: generate protocols, observe / record findings, and help generate test reports
• Coordinate activities with suppliers & contractors
• Other duties as required

Working Conditions

Emerging public life sciences company

Located in Kendall Square

State of the art facilities

Qualifications

• Bachelor’s degree in animal science, biology, or Associate’s degree plus 2+ years relevant experience, or equivalent required. AALAS certification preferred. 
• Excellent interpersonal skills, strong organizational skills, and animal handling experience.
• Ability to lift up to 50 lbs required.
• Must be able to work some weekends and holidays as required.
• Experience with animal handling, anesthesia administration and pre- and postoperative animal care.
• Authorization to work in the U.S. required.

Compensation

We offer a highly competitive salary commensurate with experience, options, medical, dental and vision coverage, matching 401K plan, flexible spending account, disability, and life insurance.

Contact Information

One Kendall Square

Building 1400 East, Floor 4

Cambridge, MA 02139

(617) 863-5500

hr@invivotherapeutics.com

The Commercial Supply Chain Planner is a key member of the Global Operations team and is responsible for planning and coordinating product supply activities for the company's commercial products. This role requires monitoring of commercial inventory level and coordination across functions to maintain supplies at target levels within Biogen IDEC and at external vendors.

Specific responsibilities include:
- Ensuring alignment of demand picture with commercial teams
- Developing production plans using Oracle MRP.
- Ensuring that inventory is maintained at target levels at all phases of production (bulk drug substance/API, filled drug product, finished goods)
- Develop inventory strategy & assess financial impact for new product launches, life cycle implementation strategies, major manufacturing or specification changes
- Serve as the inventory planning representative on product life cycle management, CMC or new product launch teams.

Biogen Idec (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers medicines to improve the lives of patients. As a company, Biogen Idec recognizes that cutting-edge science and medicines can address unmet patient needs to change the course of devastating diseases.

Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit every day from our industry-leading multiple sclerosis (MS) products. We have one of the strongest late-stage pipelines in the industry. In the coming years, we’re working hard to bring new therapies to market for patients with MS, amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s Disease), hemophilia, and others.

With more than 5,000 employees, Biogen Idec is a truly global organization – generating revenue of more than $5 billion worldwide in 2011. In addition to our headquarters in Weston, MA, and our research operations in Cambridge, MA, we have world-class manufacturing facilities in North Carolina and Hillerod, Denmark and offices in Canada, Australia, Japan and throughout Europe. We also have a direct commercial presence in 29 markets, including the US, EU, Brazil, China and India, and a network of distribution partners in more than 70 additional countries.

Requirements include:

Analytical/Problem Solving - Strong quantitative/problem solving skills are a core requirement of this job, including experience developing complex Excel spreadsheets. Must be able to convert detailed data into broad scenarios while clearly identifying assumptions and decision points.

Project management - Ability to set direction and create momentum on cross-functional teams and projects, including organizational skills to effectively balance a broad range of projects and tasks in parallel. Experience coordinating or leading teams strongly preferred.

Technical – Strong experience with MRP demand and supply planning is a must. Should be familiar with financial analysis related to inventory management and comfortable evaluating and communicating impacts based on underlying economic/accounting drivers. Implementation and execution experience with Sales and Operation planning process is desirable. Working experience in a cGMP environment is a plus.

Communication - Excellent written and verbal communicator with ability to articulate recommendations and key decision points to senior management; demonstrated experience reducing complex subjects to key points; ability to develop strong network across company.

Experience - Experience in BioPharma GxP; change management process highly preferred.

BA or BS, MBA preferred

Biogen Idec (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers medicines to improve the lives of patients. As a company, Biogen Idec recognizes that cutting-edge science and medicines can address unmet patient needs to change the course of devastating diseases.

Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit every day from our industry-leading multiple sclerosis (MS) products. We have one of the strongest late-stage pipelines in the industry. In the coming years, we’re working hard to bring new therapies to market for patients with MS, amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s Disease), hemophilia, and others.

With more than 5,000 employees, Biogen Idec is a truly global organization – generating revenue of more than $5 billion worldwide in 2011. In addition to our headquarters in Weston, MA, and our research operations in Cambridge, MA, we have world-class manufacturing facilities in North Carolina and Hillerod, Denmark and offices in Canada, Australia, Japan and throughout Europe. We also have a direct commercial presence in 29 markets, including the US, EU, Brazil, China and India, and a network of distribution partners in more than 70 additional countries.

The Sr Associate II, Quality Assurance will work closely with IT, IT Quality, site Facilities, Validation, Engineering, and Manufacturing to lead/support activities related to implementation and validation of GMP equipment and Enterprise systems.
This is a leadership role and will collaborate with teams from Cambridge and other Biogen Idec sites on behalf of Global Quality and QE. It will report to the Manager of site Quality Engineering in Cambridge. Summary of Key Responsibilities:
- Managing IT GMP Enterprise systems and activities in partnership with IT Quality. Provide technical expertise and high-level decision making authority with respect to this oversight area.
- Oversee the change-control aspects of these systems; ensuring validation impact assessment, procedural impact, regulatory impact, and prescribed testing is adequate and well justified.
- Collaborate with site Validation and Engineering and Facilities in continuous improvement projects related to these functional areas. Ensure quality is in integrated effectively while maintaining practical controls for both business and compliance needs
-Support regulatory inspections by acting as a Quality SME in given oversight areas.
- Routine operational activities include the quality oversight of:
> Engineering documentation and procedures associated with the maintenance and change control of GMP equipment/systems/utilities.
- Key contributor for validation studies, reports, and validation plans ensuring compliance, consistency, and adherence to industry standards and practices
- Development and management of performance metrics/KPIs related to Quality operational activities
- Mentoring and technical development of staff in areas of expertise and relevant experience
- Perform external/internal audits for critical engineering and Automation vendors and activities as required.

Requirements include:

- The candidate for this position must be confident in cGMPs and have a solid understanding of quality systems
- Confident in knowledge of validation principles, including GAMP, as related to the biopharmaceutical environment
- Strong understanding of Change Control Systems as related to equipment and software
- A minimum of 12 years of Quality experience in a biotech or pharmaceutical industry preferred
- Prior experience with Regulatory inspections preferred
- Experience with Microsoft Office, Visio, and basic statistics

-BS degree in Engineering or other technical discipline is required.

Reporting to the Associate Director of Information Technology for General and Administrative Systems, the Business Analyst will participate in the identification and implementation of fiscally sensible opportunities, ensure that technology products are properly deployed, maintained and operated according to documented procedures.  The position will be centered on applications that support organization-wide initiatives, such as:  Financial Business Intelligence, Learning Management, Travel and Expense, Enterprise Resource Planning, providing day to day application support to ensure maximization of existing technology investments.

Essential Functions

• Identify opportunities to apply new or existing technology to address the needs of the business.  Recommend and implement process improvements
• Act as a project lead for technology implementation/expansion projects including management of cost, resources, schedule and quality.
• Oversee the compliance and validation of technology projects
• Oversee the process for selecting software products and designing technology solutions
• Act as a business analyst; helping the end user to articulate business needs and user requirements
• Author, review and approve software implementation artifacts, i.e., user requirements specifications, functional specifications, process maps, data flow diagrams
• Author, review and approve standard operating procedures for the maintenance and operation of software applications
• Ensure that best practices for the service and support of technology products are established and followed
• Develop domain expertise in various areas throughout the general and administrative organization
• Manage the relationship between Dyax Corp. and our technology vendors
• Drives adoption of the solution with end users

Critical Success Factors:

Organized and detail oriented

Must be able to align business needs with technological capabilties

Strong written and verbal communication skills

Strong leadership skills

Strong skills in negotiation, facilitation, conflict resolution and coaching

Ability to foster a collaborative environment

Must be patient and manage change effectively

Education & Experience Requirements:

Bachelor's Degree in Business Administration, Management or Computer Information Systems or Project Management

Minimum 3 - 5 years designing, testing and leading the implementation of applications

Skilled in leading small to medium-sized projects

Experience with configurable commercial off-the-shelf (COTS) packages (especially within the general and administrative functions)

Knowledge of the drug development space

Some knowledge of regulated areas (including Sarbanes Oxley, 21 CFR Part 11, and cGXP)

Experience as a business or systems analyst desired

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

Please apply directly at:
http://hostedjobs.openhire.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=216434&company_id=15896&jobboardid=306

We are an Equal Opportunity Employer

Our client has an exciting opportunity for an experienced Quality Assurance Associate to join their team.  This is an exciting opportunity to participate in all quality assurance activities including oversight of the CAPA system, development of CAPA metrics, review /approval of non-conforming material reports and deviations.  You will play a key role in internal audits, supplier audits and support external audits.  You will also be responsible for the execution and improvement of Quality Management System and processes including reviewing and authoring all proposed documents (SOP’s, WI’s, forms, validations).  This position requires a BS in Biological Science with a minimum of eight years quality assurance experience in a medical device company.  Previous experience in conducting external and internal audits, prior experience with Word, Excel, Microsoft Project, and prior experience with ISO and FDA regulatory compliance is required.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

Our client is seeking an experienced GMP Chemist with experience in the preparation of small organic molecule API’s on a multi-kilogram scale to join their team.  This position requires prior experience with developing processes for small molecules for eventual GMP scale-up. Experience with writing/reviewing batch records and documentation/reconciliation of trackable events within a GMP setting would be a plus.  This position requires a BS in chemistry with a minimum of one year relevant industry experience.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

Reporting to the CIO and to join our Senior IT Leadership team to provide strategic direction and leadership in operational management and process improvement across all areas of IT. The Broad IT infrastructure comprises more than 2000 desktop systems, 1500 compute servers (both physical and virtual) , 50 database servers, and more than 10PB of network storage capacity. The infrastructure supports all aspects of the research and business of the Institute and it will be responsibility of this senior member of the IT team to provide day to day operational management of this infrastructure.

This position is responsible for providing desktop support, Windows and Mac administration, large-scale storage, database, data center and compute operations, continuous improvement of IT processes, system documentation, IT performance management, IT quality management and IT support planning. This position will have 3-5 direct reports and responsible for a total team of 15-20 persons, including contractors.

CHARACTERISTIC DUTIES
• Achieves IT operational objectives by:o Maintaining current systemso Evaluating, recommending, testing and installing new technologyo Contributing information and recommendations to strategic plans and reviewso Preparing and completing action planso Implementing production, productivity, quality, and customer-service standardso Resolving problemso Completing auditso Identifying trendso Determining system improvementso Implementing change
• Determines IT operations service requirements by analyzing needs of users/departments, prioritizing modifications to core system applications, resolves organizational conflict, developing, implementing and documenting requirements for problem resolution.
• Improves quality results by evaluating and upgrading IT processes
• Ensure alignment with strategic direction of IT department
• Provides information by collecting, analyzing, and summarizing data and trends in internal and external IT operations
• Updates job knowledge by participating in educational opportunities, reading professional publications, maintaining personal networks and participating in professional organizations.
• Works with IT and business stakeholders to define and implement service level agreement/contracts (SLA) and IT Operational Level Agreements (OLA) for managing IT performance.
• Serves as a member of the IT leadership team and works closely with peers in research computing, business systems, HRIS, administrative computing and network/security/data center operations
• Manages 3-5 individuals and mentors them in operational management and process improvement
- Bachelor’s degrees in Computer Science, MIS, or a Bachelors degree in Business Administration or equivalent experience required. Masters degree preferred.

- A minimum of 6-8 years of experience in a technical role as well as a minimum of ten years in a leadership role.
- Solid understanding of industry best practices and standards including ITIL.
- Advanced skills in operation management, leadership, communication, influence and conflict resolution.
- Demonstrated ability to work with a team and in a service-oriented manner
- Must be self-motivated, able to work independently, and have willingness to rapidly ramp-up in a variety of technologies.
- Strong analytical and creative problem solving capabilities and organizational and leadership abilities
- Understanding and experience (preferred) in process design and process improvement leveraging Six Sigma Methodology
- Ability to work effectively and collaboratively in a team environment and with employees at all levelsBroad will not offer visa sponsorship for this position.

To apply for this position, please CLICK HERE

The Clinical Safety Specialist is responsible for performing case processing activities, including narrative writing, event coding, and pursuit of follow-up information.  The Specialist applies technical proficiency and attention to detail in case processing as well as the ability to interpret and execute projects, with minimal guidance.  This individual ensures that all work performed is in accordance with relevant regulatory guidelines.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
- Sound ability to communicate effectively in a matrix environment
- Ability to multi-task
- Solid written and oral communication skills
- Sound attention to detail
- Strong sense of responsibility and an ability to work autonomously, as well as act as a strong team player
- Displays ability to understand established procedures and communicate those procedures to others
- Ability to prioritize workload
- Proficiency in Office environment computer applications
- Proficiency in safety database navigation including understanding of various medical coding applications

KEY RESPONSIBILITIES:  
- Reviews and interprets all new and follow-up adverse event reports to determine the appropriate information to enter into the Safety database
- Responsible for the management of all assigned cases from receipt to case closure, including follow-up requests
- Ensures that all FDA and international regulations are followed regarding pharmacovigilance processes and procedures.
- Interfaces with investigative sites to ensure complete and accurate event reporting
- Performs periodic safety database searches for data queries and assists in data reconciliation with clinical databases
- Assists in the creation of ad hoc safety reports for submission to relevant stakeholders
- May assist more senior department members with signal detection activities, as needed
- May conduct presentations of safety issues, initiatives and projects
- Reviews and may be responsible for authoring SOPs and Work Instructions, with minimal supervision
- Performs SAE Reconciliation activities and coding review as required
- Performs other duties as assigned

PREFERRED EDUCATION AND EXPERIENCE:
- B.S. in a scientific or allied health field and 3 – 5 years of relevant work experience

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

VERTEX is an Equal Employment Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, color, religion, age, disability, veteran status, genetic information or any other status protected by federal, state or local law.

To Apply for this position, please CLICK HERE

Working in a collaborative, exciting and fast-paced environment, the successful candidate will assist Microbial Genomics teams in  managing progress of genome sequencing and analysis projects for the Broad Institute Genome Sequencing and Analysis Program  (GSAP) as well as support microbial genomics projects within the Institute’s Genome Sequencing Center for Infectious Diseases.  This exceptional opportunity offers the chance to work at the forefront of genomics research and participate in creation of genomic  resources that will advance the development of disease diagnostics, therapeutics and vaccines.The successful candidate will  coordinate all aspects of microbial project tracking in close consultation with Project Scientists, team leaders and key internal and  external project staff.

Responsibilities will include helping to track grant deliverables, which includes managing real-time sample tracking from sample  shipment through data delivery, managing timelines for completion of genome sequencing, assembly and annotation, and managing  sample and data coordination between the production and analytic teams. The candidate serves as a contact point between external  investigators and platform staff and ensures that project aims are completed on time and within budget. The candidate will also work  with program Research Scientists to anticipate needs of investigators and platform teams, including regular reporting on project  status, delivery of results. Candidate will use organizational skills and knowledge of custom databases and reporting systems to  execute and monitor projects within multiple organizations within the Broad.

CHARACTERISTIC DUTIES
• Ensures that project needs have been clearly identified at initiation; develops project plans and translates project needs into
deliverables and timelines.
• Monitors sample inventory and reports status from receipt to data release
• Interacts with Program and Platform staff to ensure that projects are being conducted on time and on budget; works with project
lead scientists to manage changes in timelines, deliverables and budget as needed to meet scientific goals of project.
• Works closely with the program Research Scientists and Platform staff to establish quality criteria, monitor quality of projects, and
troubleshoot issues throughout production process.
• Assist with the submission of IRB documentation, material transfer agreements and data access agreements and other required
documentation for the Microbial Genomics project portfolio.
• Produces project-based progress reports and other relevant materials as needed.
• Other related tasks as required.
• Bachelor’s degree in biology or related field, with at least 2 years relevant professional experience; training in genome sciences
preferred.
• At least 1 year of experience coordinating or conducting projects in high throughput laboratory setting.
• Excellent oral, written, interpersonal and organizational skills required.
• Experience with Excel required. Experience working with databases preferred.
• Ability to thrive in a team setting with an interdisciplinary group including biologists, data analysts, computer scientists and
laboratory staff is essential. Experience working in a matrix organization is preferred.
• Demonstrated experience in communicating scientific information effectively required
• Ability to work both independently and as part of a multidisciplinary team
• Ability to work in a fast-paced environment and respond to shifting prioritiesBroad will not offer visa sponsorship for this position.

To apply for this position, please CLICK HERE

Vertex Pharmaceuticals is seeking a Lead QA Specialist to join our IS Quality Validation team in Cambridge, MA.

This position will be a senior contributor to the IS Quality/Validation function within the Quality Alliance group. This position will provide day-to-day support of the IS Quality/Validation function with a high degree of independence, and will play a key role on system implementation projects.   In addition this person will manage junior members of the IS Quality/Validation function. Emphasis is on quality oversight for IT Infrastructure systems such a network related qualifications and changes to the underpinning infrastructure services (e.g. data center, storage, databases, virtual services, etc.). 

Key Responsibilities:
The individual will serve as an IS Quality/Validation subject matter expert (SME) and provide guidance on validation and testing strategies for each implementation project based on system risk, complexity, and other relevant factors. 

This includes, but is not limited to:
- Represent IS Quality/Validation on projects – particularly infrastructure/network related projects; and management teams as appropriate
- Leadership on validation strategies for system implementations and changes to ensure solutions are demonstrated as fit for purpose
- Partner with the Vertex system implementation teams to ensure Part 11 compliance
- Provide consultation and support as required to meet project goals and objectives.
- Perform Quality review and sign-off of computer system control documents
- Review requirements packages and provide compliance & quality inputs to the requirements engineering process
- Manage multiple simultaneous validation, revalidation, and change control activities.
- Provide compliance / validation leadership to project teams and validation contractors
- Review and approve validation and test protocols for adequacy and completeness.
- Proactively identify opportunities for process improvement in the Systems Life Cycle
- Author and/or contribute to the development and implementation of Vertex Policies, SOPs, Work Instructions, Forms, and Templates surrounding the Vertex Systems Life Cycle for on-boarding and validating computer systems subject to 21 CFR Part 11.
- Independently solve Systems Life Cycle related problems and implements corrective actions as needed
- Work to maintain the validated state of Vertex computer systems by participating in the change control process
- Maintain validation related metrics and reports performance to management
- Participate in and/or support regulatory inspections as assigned
- Participate in and/or support software vendor audits as assigned
- May supervise other IS Quality/Validation staff
- Perform other duties as assigned

Minimal Requirements
-This position requires a Bachelor’s degree and 8+ years of IS or Quality Validation work experience
- At least 5 years of direct experience writing and executing validation documentation required

Preferred Qualifications
- At least 2 years of project management experience in the pharmaceutical/biopharmaceutical industry preferred
- Must be able to demonstrate excellent customer service skills
- Must have demonstrable flexible & out of the box thinking approach to problem solving and process improvement
- Experience with validating electronic records management, quality, and supply chain (ERP) systems preferred
- Must be able to demonstrate good communication skills both oral and written
- A practical working knowledge of validation, quality assurance, information systems, and risk management best practices.
- Knowledge of GCP, GLP, cGMP, HIPPA regulations is required with an emphasis on 21CFR Part 11.
- Experience with System Life Cycle models (Waterfall, Rapid Application Development, Spiral Model, etc.) is needed.
- Must be well organized and willing to work as part of a team
- Test automation experience a plus
- Knowledge of the application of ITIL good practices for IT Service Management preferred
- Excellent communication, interpersonal skills, and customer focus are also essential.

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

VERTEX is an Equal Employment Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, color, religion, age, disability, veteran status, genetic information or any other status protected by federal, state or local law.

To Apply for this position, please CLICK HERE

Headquartered in Lexington, Massachusetts, Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on becoming a leader in the discovery, development and commercialization of novel acute care therapies for use in hospitals and other acute care environments.Position Summary:

Cubist Pharmaceuticals is currently looking for multiple Research Associates in medicinal chemistry. The individuals will be key part of an interdisciplinary team of scientists and will be involved in the design, synthesis, purification, and characterization of novel drugs in the areas of antibacterials, pain, and other acute therapeutic research areas. In this dynamic team focused role, qualified candidates will contribute to the overall strategy and direction of projects.

Minimum Basic Qualifications:
* B.S. in organic chemistry
* At least 2 years of lab experience in organic chemistry
* Strong knowledge of first principals of organic chemistry – reactions and mechanisms
* Established track record of working well in a team setting

Preferred Qualifications and Experience:
* M.S. degree in organic chemistry preferred
* 3 years of lab experience in organic chemistry, including > 2 years in pharmaceutical industry
* Experience with small molecule and natural product chemistry, and a broad range of synthetic transformations
* Strong presentation and communication skills
* Proficiency in PC software and databases

Competencies:
* Demonstrates a sense of urgency in advancing research
* Flexibly adapts strategy and tactics
* Has a developed sense of their own strengths and weakness, and does not hesitate to speak up or ask for feedback.
* Demonstrates a respect for others and is highly effective in a team.

Work Environment:
* Standard organic chemistry lab; typical reaction scale: 20 mg – 20 g

Physical Demands:
* Minor lifting of intermediates, glassware and equipment
* Standing at hood for long periods of time

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions..

To apply for this position, please CLICK HERE