QC Documentation Specialist will perform quality control reviews of clinical documentation and review/edit documentation for technical accuracy.

For details visit:

http://www.cwsciences.com/Current-Openings/QC-Documentation-Specialist

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

Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device and Biotech industries. 

Job Summary

Toxikon is seeking an experienced Health and Safety Officer.  The successful candidate will possess excellent communication skills and have the ability to organize and maintain accurate records, and interpret regulatory statutes.  Requires current and maintained training for, but not limited to, DOT, RCRA, HAZWPR, CPR and IATA.  Additional job responsibilities include assisting technical and support personnel in area inspections, job safety analysis and OSHA training.  This position will work closely with management development, implementation, and administration of an expanding and complex health and safety program. 

Essential Duties/Job Functions

• Oversight and management of the laboratory OSHA standard, including the management of the hazardous waste and radiation program.
• Handling emergency situations and developing written materials and safety training modules. 
• Update all health and safety plans and SOP's as required, including the contingency plan and all related permits and licenses.
• Conduct training in all related laboratory safety standards. 
• Facility related duties and maintenance of fire extinguishers, emergency eye wash stations, spill response and spill control kits, respirator fit testing, medical surveillance, and compliance with general safety and maintenance standards. 
• Assisting and managing site visits related to safety assessment and working closely with hiring managers and HR on all related training and safety assessments/reviews of laboratory staff risks, and providing safety strategies.

Minimum Requirements

• Bachelor's or Masters Degree in Occupation Health and Safety or Chemical Hygiene.
• At least 3 year's of experience in managing a Health & Safety program.
• Waste water treatment operator license required.
• Strong laboratory OSHA knowledge.
• Highly motivated individual with strong communication skills, computer skills and ability to analyze and solve problems. 
• Independent thinking who can work well in a fast-paced, team oriented, laboratory environment. 
• Knowledge of biological, chemical and radioactive materials and all associated risks and mitigation. 
• Proficient in computer programs, databases and training software. 

To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=12922&lang=en_US&source=CC2 

For additional information about Toxikon go to www.toxikon.com. 

Toxikon offers a comprehensive benefits program including: paid vacation, sick and personal time, 401(k) plan with company match, medical, dental, vision, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave (FMLA) entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 

Research Associate will execute bacterial sub-cloning, mammalian cell culture, and aseptic technique.

For details visit: http://www.cwsciences.com/Current-Openings/Research-Associate-I

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

Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device and Biotech industries. 

Job Summary

Toxikon is seeking an IT Associate dedicated to the analytical laboratory.  The IT Associate will be responsible for providing support to the chemistry department for data management and automation initiatives.  The successful candidate will work to develop automation and data management procedures with Department Head and senior laboratory personnel.  The individual will provide interface to the IT group for implementation.  Responsibilities include but not limited to the following tasks: staying current with system information, changes and updates, responding to requests for technical assistance, advising employees on appropriate procedures, training staff on the use of automated procedures, managing ongoing support requests and administrative needs of users.  

Job Duties and Responsibilities 

• Database management. 
• Macro writing with Visual Basic and within Word and Excel environment.
• Instrument networking. 
• Provide support for automation initiatives including data reduction and report automation.
• Providing basic training to new users. 
• Maintain documentation.

Requested Experience/Skills

• Knowledge of Windows Desktop OS and Sharepoint. 
• Basic knowledge of Visual Basic for Applications (VBA) programming.
• Basic knowledge of networking and SQL.
• Knowledge of Active Directory account maintenance is a plus. 
• Knowledge of chemometrics preferred.
• Experience with CFR compliant computer/instrument system.
• Experience with Agilent Openlab and Chem Station preferred. 

Minimum Qualifications

• Associate's Degree or equivalent with relevant prior experience in Desktop or Systems support. 
• Customer service attitude and focus. 
• Have strong organizational skills and work ethic.
• Communicate clearly and cautiously, both written and oral. 
• Be able to focus on problem solving and prioritization. 
• Be available for occasional on-call support in off-hours as needed. 

To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13242&lang=en_US&source=CC2 

For additional information about Toxikon go to www.toxikon.com. 

Toxikon offers a comprehensive benefits program including: paid vacation, sick time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 

Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device, and Biotech industries. 

Job Summary

Toxikon is seeking a data entry professional to assist with record keeping and inventory control of regulated medical device and pharmaceutical samples.  The ideal candidate will have familiarity with software systems designed for supporting laboratory operations or more generic enterprise resource planning tools, sample tracking, sample usage, sample reconciliation and material storage conditions.  Experience working in a laboratory environment is a plus, as well as, knowledge of GLP compliance criteria.  

Essential Duties

• Assist with incoming sample receipt and entry into the laboratory management system (LIMS), as well as, sample reconciliation and customer returns. 
• Work with laboratory staff to locate samples in inventory and track samples that are signed out of inventory in efforts to maintain inventory organization.
• Ensure full quality control of all samples and project-initiation documents prior to release to the laboratories. 
• Maintain electronic records for documentation of all samples as submitted by sales staff, laboratory staff and customers. 

Minimum Requirements

• High School Diploma or equivalent.
• 1-3 Years of data entry experience, preferably in a lab setting. 
• Previous use of LIMS software is preferred. 
• Must be skilled at performing filing, scanning, copying, faxing, and other office related tasks. 
• Attention to detail is crucial.
• Must be capable of lifting at least 30 pounds. 

To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13000&lang=en_US&source=CC2 

For additional information about Toxikon go to www.toxikon.com. 

Toxikon offers a comprehensive benefits program including: paid vacation sick time, 401(k) plan with company match, medical, dental, vision, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state, and local laws. 

Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device and Biotech industries. 

Job Summary

Toxikon is looking for a self-motivated and quality focused individual to join our medical device extraction team.  The successful candidate will work hand in hand with our study directors, quality assurance and sponsors/clients to ensure all medical device preparation aspects are performed per scientific and regulatory standards.  Highly motivated individuals will have an advancement track through the departments it supports.  This position is an integral component of a fast paced environment.  You will be joining a rapidly growing team and will be selected based on both experience, aptitude and a dynamic personality. 

Prior to being tested in clinical trials, medical devices are required by the FDA, EU, Japan, China, etc. to perform pre-clinical safety testing referred to as biocompatibility.  As most medical devices cannot be directly dosed or applied to the test system, they are extracted using common vehicles and solvents which mimic the conditions found in the human body (blood, muscle, lipids, etc).  It is these "extracts" which pull compounds out of the devices, which the body would naturally, and these solutions are dosed as equivalent alternative to the original, whole device.  This Medical Device Extraction Research Associate position is responsible for the preparation of the medical devices and creating the required dose solutions (extracts). 

Requested Experience

• Medical devices are prepared for testing using geometrical calculations an therefore skill in routine mathematics principals is required. 
• Review the nature and composition of medical devices and determine sample requirements for testing. 
• Must have strong communication skills as frequent conversations about testing plans and requirements occur with Sponsors, study directors, sales/customer service and the research associate staff. 
• Inherent curiosity of how things work since the position will offer an exposure to a wide variety of medical devices and learning how they operate allows for a greater adeptness in appropriately preparing them for testing. 
• Daily calibration and maintenance of laboratory equipment and instruments.
• Ability to independently solve both technical and theoretical problems and deal with a variety of variables related to the lab and the scientific conduct of studies the lab supports. 
• Ability to comprehend and conform to SOPs and with GLP, ISO and FDA standards. 
• Good interpersonal skills, proficiency with computers, organization and time management skills are required. 
• Motivated worker with willingness to learn additional skills and complete tasks independently is a plus. 

Minimum Qualifications

• Bachelor's degree in a scientific area (Biology, Chemistry, etc.)
• Associates degree may be considered based on prior knowledge/work experience. 

To apply for this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13364&lang=en_US&source=CC2 

For additional information about Toxikon go to www.toxikon.com. 

Toxikon offers a comprehensive benefits program including: paid vacation, sick time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 

Analytical Scientist will develop analytical methods as well as be responsible for formulation development. 

For details visit:

http://www.cwsciences.com/Current-Openings/Analytical-Scientist-

*This is not a PhD role

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

Primary Duties:
The Director, R&D Program Management - Devices (Dir. R&D PM - Devices) is responsible for managing the operational, planning, and decision-making processes within Shire’s Device Strategy Teams (DSTs). They work closely with DST Leaders to provide management and oversight of cross-functional team(s) encompassing all aspects of medical device development from concept through post-commercialization review. In addition, they ensure robust and balanced cross-functional planning, decision-making, implementation, monitoring, and reporting of the DST’s programs as well as ensuring strong alignment between Global Development Team strategy and operational execution by the DDT(s). The R&D Program Manager - Devices also works to ensure the cross-functional teams operate effectively with positive team dynamics.

The Dir. R&D PM - Devices will be responsible for one or more complex device programs with significant complex cross-functional and cross-program strategic issues.

The Dir. R&D PM will:
* Work independently to provide best in class program management expertise and capabilities to drive DST(s) towards robust strategies and excellence in execution.
* Oversee all aspects of device development activities from the earliest definition of the product concept through commercialization and further life-cycle management in the defined global markets.
* Work closely with the Device Strategy Team (DST) Leaders to facilitate the creation, approval and execution of the device development strategy, as well as to facilitate decision-making and risk identification/mitigation processes for assigned program(s)
* In close collaboration with PSTL’s, PSPM’s and Tech. Ops PM’s, ensure that R&D strategies and activities are operationally aligned with PST endorsed strategies, goals, and priorities (where applicable).
* Working with appropriate Team members, establish key decision points, process for Team decisions, and criteria for development decisions (e.g. go/no go criteria and stage-gated spends).

Effectively manage DST operations:
* Drive team meetings/agendas/minutes (including driving and tracking action items)

Responsibilities:
80%
DST/DDT Operations / Program Management

10-20%
R&D Program Management Processes and R&D Ops

0-10%
Supervision of Junior R&D PM Staff (if applicable)

Education and Experience Requirements:
BS Mechanical Engineering, Biomedical Engineering, or Life Sciences degree required. MS or PhD preferred.
* Minimum ten years’ experience in medical device product development in the surgical, disposable, in-vitro diagnostic, or other related industries with particular experience in products involving complex clinical and global regulatory considerations.
o For candidates who have less than 10 years of medical device development experience, relevant drug development experience in the pharma/biopharma industry may also be considered.
* Minimum of 6 years of cross-functional program management experience, or related experience
* Strong business acumen
* Demonstrated experience managing device development programs in different stages of development from concept through commercialization
* Proven Leader with ability to manage multiple complex cross-functional teams and processes
* Project Management Professional (PMP) certification or equivalent proficiency a plus
* Strong knowledge and understanding of global device development.
* Strong understanding and competency in planning processes and decision making
* Demonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring.
* Proven verbal and written communication skills at the functional team levels.
* Proven interpersonal leadership skills at the functional team levels.
* Knowledge of US and international GMP’s, current FDA Medical Devices legislation and global medical devices regulations.

Other Job Requirements:
International and domestic travel as required
* Domestic and international business travel of ~5%, however this may vary based upon assigned project demands.

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 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 applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjM0MTAzLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Role
The individual will be a key leader within a group responsible for performing purification process development, including timely completion of small-scale experiments, scale-up, technology transfer and GMP support for programs that bring new biopharmaceutical products to pre-clinical, clinical and commercial manufacturing phases. The successful candidate will be a leading contributor during execution of engineering activities for the department, including troubleshooting problems, analyzing data and issuing reports/memos.

The candidate will design, execute and lead experiments for optimization and process robustness studies for therapeutic protein purification. The scope includes IND- and BLA-enabling studies and preparation of regulatory submissions. The experimental studies involve both lab scale and pilot plant runs, including, but not limited to toxicology, clinical and validation batches. The individual will seamlessly collaborate and communicate within the framework of cross-functional, multi-disciplinary process development and CMC teams. In addition this person will interact extensively with other departments such as research, internal manufacturing, external contract manufacturing, facilities/engineering, supply chain, project management, procurement and quality.

The individual will work with a significant degree of independence, thus should have excellent problem solving abilities. The successful candidate will be involved in a wide range of complex problems, requiring the regular use of ingenuity and creativity. Applies scientific and engineering knowledge to discover and implement highly innovative solutions and designs strategy in alignment with company objectives. Leads the pursuit of new technical areas, including new processes that provide Shire with competitive advantage. Constantly benchmarks with the goal of attaining systems improvement. Exercises judgment to leverage established practices and lessons learned from difficult experiences, leading to best practices and procedures that can be applied to problems of diverse scope and complexity.

Responsibilities
* 25 Leads experimentation and manufacturing support related work including laboratory and pilot scale studies (chromatography and filtration unit operations) to support new process development and optimization. Evaluates new generic platform technologies that can be applied across multiple programs. Leads tech transfer of multiple programs spanning all phases of biopharmaceutical lifecycle, including discussions of scale, equipment design and oversight of GMP, engineering and pre-clinical batches. Interacts with manufacturing operations staff, troubleshoots problems and supports their operations.
* 25 Writing, reviewing and approving of data summaries, technical reports, technology transfer packages, regulatory submissions and presentations.
* 25 Organizational support and cross-functional project team leadership and participation. Advises senior management on goals and project direction.
* 25 Effectively leads, trains and mentors group of direct reports. Provides guidance on design of experiments, data analysis and derivation of appropriate conclusions. Creates opportunities for the development of direct reports. Recognizes achievements, inspires the team and provides constructive feedback.

Education & Experience Requirements
PhD (8+ years), MS (10+ years) or BS (12+ years) in Chemical/Biochemical Engineering or related discipline with relevant product and process development experience in the biotechnology/pharmaceutical industry. PhD engineering degree with expertise in protein separations is the preferred qualification.

Recognized industry expert in the field of separations, including small-scale process development and optimization, scale-up, tech transfer and manufacturing support to large scale GMP operations. Thorough knowledge of advanced scientific theories, concepts, principles, experimental techniques and industry practices and standards. Keeps current with latest literature and technologies, including advanced computer applications. Proven record of technical leadership, including the ability to motivate and influence technical rigor.

Proven ability to work in a fast paced environment with demonstrated capacity to juggle multiple competing tasks and prioritize accordingly to meet program timelines. Uses extensive project leadership experience to drive the planning and management of risks, priorities and contingencies.

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 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 applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Application URL:http://www.aplitrak.com/?adid=amVucy44NzE2OS4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ

Primary Role:
Architects Shire’s global network. The global network supports Shire’s voice, data, video and Internet communications and spans over 20 countries. Primary responsibilities include the development of voice, data, video and Internet communication strategies based on a combination of business, technical and operational needs taking into account industry trends and direction. Work with business and external business partners in developing and implementing communications to our business partners and customers.

Provide technical guidance in the diagnosis and resolution of complex network issues.

Provide ongoing technical and business leadership in shaping and evolving Shire’s global network.

Responsibilities:
40%:

Develop high-level network designs to meet business and technical requirements:
* Determine business and technical requirements.
* Define and analyze design options to meet requirements.
* Work in collaboration with application design teams and Network Engineer to determine optimal placement of technology, selection of protocols and use of performance enhancement network capabilities such as caching to optimize application performance and end-user experience.
* Work in collaboration with IT security to ensure architecture supports communications of sensitive and confidential data that is adequately protected while in transit.

25%:
Develop network strategies including:
* Assess technical and business requirements.
* Identify gaps in capabilities to meet current and future needs.
* Evaluate communication/network marketplace for strategic technology solutions.
* Develop roadmap to transition Shire network from current to future state (milestone targets, financials, resource requirements)
* Develop and manage approach to engage stakeholders for feedback on strategy in order to refine it.
* Communicate strategy to stakeholders and promote implementation based on roadmap.

15%:
Assist IT operations in the diagnosis and resolution of complex network issues (24/7 availability)

10%:
Evaluate new technologies to improve the overall performance, agility, security, efficiency and resiliency of the global network

10%:
Work with Head of Network and, as appropriate, Enterprise Architecture to establish network standards and policies for the design, implementation, configuration and management of the global network.

Education & Experience Requirements:
* Education: BS degree or equivalent experience. (Required) Preference for degree in computer science, mathematics.
* 12+ years of IT Experience with 7+ years of global network architecting experience. (Required)
* Work experience spans multiple companies with complex network structures supporting voice, data and video communications. (Required)
* Experience in communicating with various stakeholders from business executives to technicians and the ability to communicating technology strategic direction issues in business terms. (Required)
* Strong consultative skills with the ability to lead business in making good technology investment decisions and clearly articulating IT risks and options to enable the business to make good technology risk based decisions. (Required)
* Experience with a wide range of IT infrastructure (Data, Voice, Video, MAN/WAN/LAN, Domain Name Services, Network Protocals) as detailed in key skills (Required)
* Development of capital and operating budgets (Required).
* Proven experience working globally and adapting to different cultures and working practices (Required)

Key Skills, Abilities, and Competencies:
* Strong communication and consultative skills
* Strong technical knowledge of a wide range of technologies including:
oVoice, Video and Data networking (LAN & WAN) and performance enhancing technologies (packet shapers and accelerators)
oActive Directory and Domain Name Services
oExperience with Cisco technologies
* Network strategy development.

Other Job Requirements:
The location of this position is in Shire’s Lexington, MA with occasional travel to Shire and service provider offices in other North American, EU and International locations. All travel will be agreed in good time whenever possible.

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 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 applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Application URL: http://www.aplitrak.com/?adid=anN0Z2VvcmdlLjQ2Njk5LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Overall responsibility:

Assist two key senior executives with a broad range of tasks that support the smooth operation of the company.  Professionalism and good judgement, coupled with the ability to anticipate, and the desire to jump in, is key for this position, and our entrepreneurial environment.

Key tasks and responsibilities:

• Function as an important interface with our Board of Directors and external parties
• Manage calendars for several  active key executives
• Coordinate meetings & travel plans, both domestic and international
• Prepare and edit corporate presentations
• Meet and greet visitors
• Manage catering when required
• Handle and share a variety of general office management & operational duties

Skills and attributes:

• Proficient with MS Office applications
• Excellent communication and organization skills
• Team player able to multi-task in a fast paced environment
• Be a proactive ambassador for our great culture
• Consistency with our core values

Education and Experience:

College degree with at least 5 years in a similar position, preferably a small biotechnology company.

If interested, we would welcome a cover letter and CV sent to careers@pronutriabio.com   No phone calls please, and only those we will be following up with, will receive a reply.

Visit our website and learn more about us www.Pronutriabio.com    

We are working closely with an innovative and successful commercial drug development company located in Cambridge MA who is seeking a motivated, goal-oriented individual to join their Program Management team. This company exhibits a unique sense of culture, and this opportunity will give the right applicant the chance to part of an amazing, collaborative team working towards creating medicines.

The right fit for this position will play a crucial part in supporting the drug development teams quest to bring inventive new life changing human medicines to the market. This key hire will provide leadership, coordination & cross-functional communication to help all teams meet and exceed their goals.

The perfect fit for this position will be an excellent communicator, possessing strong conflict resolution skills, a scientific background and a strong knowledge and experience in clinical stage drug development, including hands on oversight of programs from an IND submittal into phases 1-3.  A PMP certification is preferred, but not required. 

Requirements:

• A 4-year degree and a minimum of 3-5 years of relevant work experience
• Strong communication, presentation and cross-functional management experience a need
• Strong experience in project planning tools, content management systems, and Microsoft Office Suite.
• Budget development and tracking experience

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

The Sr. Clinical Trial Manager provides strategic and operational leadership of for several aspects of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development program, timelines and budget.  Job responsibilities include, but are not limited to, preparation of study related materials, relationship management between study sites and vendors (in particular CROs), supervision of study related activities, identification of project risks and contingency planning.

Responsibilities will include:

• Primary operational contact for the study and lead the cross-functional global team for execution of the study in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions
• Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
• Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and cost
• Strong understanding of the cost drivers and are able to proactively manage the study budget
• Operational and strategic input into study documents such as synopsis, protocol, Informed Consent, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
• Development of the subject recruitment/retention strategies and related initiatives
• Participation in clinical service provider (vendor) selection, specification development, and management/oversight
• Development/coordination of study training for study team, investigational sites, and vendors in collaboration with Clinical Scientists
• Proactive management of issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms.
• Lead both an internal and external/CRO trial management team, to ensure the successful conduct in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
• Contribute to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team
• Supports the development and application of standardized operational processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness
• Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF)

Who You Are

• Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study
• Minimum of 8 years of progressively increasing clinical trial management experience within the Pharma, Biotech or CRO; Oncology/Hematology experience preferred
• Good understanding of global regulatory and compliance requirements for clinical research
• Solid teamwork, organizational, interpersonal, and problem solving skills; exercises good judgment with respect to confidential information and strategies
• Critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes, budgets and timelines.
• Extensive knowledge of clinical research to provide leadership, direction and guidance to others, has a broader perspective to deal effectively with ambiguity, can effectively communicate and work through others
• Ability to influence and collaborate successfully with colleagues and partners; ability to work effectively in a fast paced environment
• Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of ImmunoGen are carried out with the "best" industry practices and the highest ethical standards
• Experience managing junior staff who are eager to develop into a Clinical Trial Manager role

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

The Complaint Specialist is a hands-on position that will be responsible for maintaining the Company’s Complaint program. The individual is responsible for full cycle complaint handling from initial response to investigation, assessment, resolution, and complaint closure. The position will make recommendations and file governmental reporting as directed. This position will also support the preparation, and filing of documentation as required for domestic and international regulatory submissions.

Required Qualifications:

• Bachelors’ degree in the life sciences or related field or previous relevant experience
• 5 years’ experience in the medical device, biologic, or pharmaceutical industry
• Knowledge and understanding of GMP/ISO regulations, including but not limited to 21 CFR Part 820 and 211, ISO 13485, EU Council Directive 93/42/EEC
• Must have excellent communication and organizational skills
• Minimum 2 years pre/ post-market regulatory experience

Desired Experience, Knowledge, and Skills:

• Advanced knowledge and experience with global post-market surveillance activities and reporting requirements.
• Experience preparing regulatory submissions (domestic and international) for medical devices or pharmaceuticals
• Ability to interact positively and professionally with customer
• The ability to communicate effectively across disciplines, gather information and perform analysis
• Ability to evaluate and interpret the data and write conscious reports
• Proficiency in word processing, spreadsheets and databases
• Good presentation, organization and communication skills
• Ability to work autonomously, effectively manage time and deliver results on time

Click Company Link Below to Apply!

http://www.anikatherapeutics.com/careers/explore-jobs/posting/sr-product-complaint-specialist/ 

Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device and Biotech industries.

Job Summary

Toxikon Corporation is seeking a Research Associate for the Analytical Chemistry department.  Candidates will be responsible for providing technical expertise in supporting preclinical studies conducted under GLP, ISO 17025 and various other regulatory agencies.  Excellent communication skills needed as this position works closely with other research associates and scientists.  Individual must be highly organized to handle multiple projects on an ongoing basis.

Essential Functions

• Assist in managing inventory for all laboratory supplies.
• Ability to independently solve both technical and theoretical problems and deal with a variety of variable related to the lab and the scientific conduct of studies.
• Operate, calibrate and maintain laboratory equipment.
• Perform chemical analysis using required methods under SOPs, as well as FDA, GLP and other regulatory guidelines.
• Responsible for documentation, labeling and quality control related to assigned analysis.
• Meet project deadlines including the completion of technical work to appropriate standards.
• Work in conjunction with other research associates, study directors, quality assurance and to ensure all study aspects are conducted per scientific and regulatory requirements.

Minimum Qualifications

• Associates Degree in Chemistry, or related science field.
• Must have some knowledge of GMP/GLP regulations in an analytical laboratory setting.
• Exceptional oral and written communication skills.
• Good interpersonal skills, proficiency with computers, organization and time management skills are required.
• Ability to work in a high volume, fast paced environment.
• Must have experience with solution and reagent preparation.
• Experience with methods of sample preparation of solid and liquid samples.
• Experience with liquid/liquid extraction and sample digestion preferred.

To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13280&lang=en_US&source=CC2

For additional information about Toxikon go to www.toxikon.com.

Toxikon offers a comprehensive benefits program including: paid vacation, sick time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance programs, employee referral bonus, discount programs and more.

Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 

Toxikon Corporation, originally founded in 1977, is a Contract Research and testing company with laboratories in Bedford, MA and Belgium.  Our mission continues to focus on providing quality pre-clinical services, competitively priced, with on-time delivery for the Pharmaceutical, Medical Device and Biotech industries. 

Job Summary

Toxikon is looking for a self-motivated and quality focused individual to join our In-Vivo team.  The successful candidate will work hand in hand with our study directors, veterinarians, quality assurance and sponsors/clients to ensure all study aspects are conducted per scientific and regulatory standards.  This position offers great possibilities for growth with exposure to all aspects of studies including sample preparation, dose techniques and surgery in many different animal models.  Highly motivated individuals will have an advancement track through the department.  This position is an integral component of a fast-paced environment.  You will be joining a rapidly growing team and will be selected based on both experience/aptitude and a dynamic personality. 

Requested Experience

• Ability to create and interpret scientific documents including study protocols, SOP's and regulatory guidelines. 
• Generate, record and report raw data.
• Coordinate specific study activities with laboratory management. 
• Dose different animal models via various techniques including intramuscular, intravenous and intradermal routes. 
• Perform daily health assessments of study animals. 
• Collect blood and tissues for analysis and interface with the histology and clinical pathology labs. 
• Daily calibration and maintenance of laboratory equipment and instruments. 

Minimum Qualifications

• Bachelor of Science in a scientific area (i.e. biology, veterinary sciences) required
• ALAT certification or greater is preferred but not required.

To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13061&lang=en_US&source=CC2 

For additional information about Toxikon go to www.toxikon.com.

Toxikon offers a comprehensive benefits program including: paid vacation, sick time, 401(k) plan with company match, medical, dental, vision, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

Toxikon is an equal opportunity employer.  As an equal opportunity employer, we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 

Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device and Biotech industries. 

Job Summary

As a Research Associate in the Analytical Chemistry Department, candidate will be responsible for providing technical expertise in supporting pre-clinical studies conducted under GLP, ISO 17025, and various other regulatory agencies.  Research Associates must work closely with study directors, analytical services staff and quality assurance to ensure all study aspects are conducted per scientific and regulatory requirements.  Excellent communication skills are needed as this position works closely with other research associates and scientists.  Individual must be highly organized to handle multiple projects on an ongoing basis.  

Job Duties and Responsibilities

• Performing routine analysis and troubleshooting utilizing various analytical instruments, specifically HPLC, LC/MS (single quad, orbitrap, etc.), etc. 
• Experience with LC instrument maintenance. 
• Experience with methods of sample preparation of solid and liquid samples in a variety of matrix types for LC and GC analysis. 
• Review data and prepare summary results for reporting. 
• Assist in managing inventory for all laboratory supplies. 
• Review and assist Study Director and Quality Assurance in closing out any protocol amendments, or deviations and work to ensure compliance with all applicable regulatory guidelines. 
• Meet project deadlines including the completion of technical work to applicable protocols and standards. 
• Experience with other analytical instrumentation including GC/FID, GC/MS and TOC preferred. 

Minimum Qualifications

• Bachelor's degree in Chemistry, with preferably 3-5 years of equivalent laboratory experience.  However, we are willing to train the right candidate.
• Must have some knowledge of GMP/GLP regulations in an analytical laboratory setting. 
• Experience with analytical method validation is a plus. 
• Exceptional oral and written communication skills. 
• Ability to work in a high volume, fast paced environment. 

To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13361&lang=en_US&source=CC2  

For additional information about Toxikon go to www.toxikon.com. 

Toxikon offers a comprehensive benefits program including: paid vacation, sick time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

The Analytical & Pharmaceutical Sciences Scientist will play an important role in advancing ImmunoGen’s key development programs as well as, oversee the commercialization of our Antibody Drug Conjugates (ADCs) as the final goal.  The Analytical Scientist will play a key role in the department developing and implementing analytical methods to be used in the release and characterization testing of our ADC products.  The Analytical Scientist will also be responsible for leading the development of novel formulations for our ADC products by developing stability indicating methods, testing stability samples and supporting drug product development. An important role of an Analytical Scientist involves helping to support the development of antibody and ADC manufacturing processes by providing the needed technical support and expertise in analytical and characterization development, writing and reviewing reports in support of IND filings.

Responsibilities include, but are not limited to, the following:

• Develop and qualify analytical methods for the release and characterization of ADCs

• Troubleshoot analytical methods and instrumentation

• Transfer methods as appropriate to CMO, CRO and QC groups

• Support ADC formulation development by setting up appropriate development and forced degradation studies

• Provide analytical support to drug product development teams working with partners and CMOs

• Plan experiments, summarize results, write and review technical reports

• Represent the department as needed at interdisciplinary meetings either internally or with external partners and CMOs

Who You Are

Degree in Chemistry, Biochemistry or Pharmaceutical Sciences or related field. PhD with 0-5 years of related experience performing analytical and formulation development in the biopharmaceutical industry.

• Expertise in the development and performance evaluation of chromatographic analytical methods (e.g. RP, SEC and IEX HPLC/UPLC)

• Experience using UV and fluorescence spectroscopy to analyze proteins

• Team player with excellent oral and written communication skills

• Self-motivated, independent contributor with minimal supervisory guidance

• Demonstrated ability to function and lead in a collaborative team

•  Multitasking, ability to prioritize tasks, manage risks, and solve challenging technical problems

Desired skills:

• Experience performing capillary electrophoresis (e.g. CIEF, CZE and CE-SDS)

•  Thorough knowledge of protein chemistry and common techniques for protein characterization (e.g. N-glycan mapping, peptide mapping)

•  Experience formulating or assisting with formulation of proteins, especially monoclonal antibodies (e.g. formulation stability studies, forced degradation studies, freeze/thaw studies etc.)

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Exciting opportunity to be an integral part of a dynamic, successful and driven team in the heart of Kendall Square!

Cambridge BioLabs is a rapidly growing shared lab services company in Cambridge, Massachusetts seeking an experienced Accounting Manager/Bookkeeper for our team.  This is a hands-on position with high management exposure responsible for the completion and oversight of day to day finance and accounting operations. This role will focus heavily on the day-to-day accounting tasks and will also assist with payroll and human resources administration as well as administrative duties.

You should be a highly capable, self-directed individual who employ a high level of autonomy in their work. If you are the kind of person who not only thinks critically about problems, but also likes to take the initiative to pursue new ideas, you would probably enjoy working here.  This is a job for a balanced, self-confident individual.

Requirements & Responsibilities:

• Manage and perform daily transactional accounting tasks including accounts payable and vendor management, accounts receivable, bank reconciliations, billing and collections
• Timely month-end closings including preparation and review balance sheet reconciliations, monthly journal entries and financial statement preparation.
• Develop and implement finance and administrative policies and procedures.  Monitoring and improvement of internal controls.
• Implementation and oversight of centralized purchasing system.
• Oversee treasury functions and cash flow management.  
• Potential overflow handling of Human Resources requirements as they arise including new hire paperwork, benefits renewals, PTO tracking.

Qualifications:

• Bachelors Degree in Accounting, Finance or related degree is required.   
• Solid 3 to 5 years of accounting/bookkeeping experience required.
• Must be professional, proactive, collaborative, conscientious and results-oriented individual.  Must have an optimistic and positive demeanor, excellent oral and written communication skills, good intuition and ability to adapt to changing priorities.
• Superb organizational and analytical skills required.  Must be creative and proactive yet disciplined with the ability to prioritize multiple tasks.  Outstanding project management, problem-solving and communication skills.
• Proficiency with Quickbooks and Excel is required.
• Must be a self-starter and able to work independently.
• Willingness to identify and assist with a variety of activities within a fast paced organization.

Compensation/Benefits

Salary commensurate with experience and qualifications, 401(k) package, plus 50% of the cost of a premium healthcare and dental package.

Please submit resumes to:

Johannes Fruehauf
CEO
office@cambridgebiolabs.com

Please use Subject line: Accounting Manager/Bookkeeper job application

Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device and Biotech industries. 

Job Summary

Toxikon is seeking a Study Director for its Analytical Chemistry department.  The Study Director has overall responsibility for the technical conduct of studies according to compendia, ISO or other applicable guideline and GLP/GMP regulations.  The individual represents the principal point of study control for activities related to compliance for studies.  

Responsibilities include but are not limited to: protocol preparation and approval, supervision of the study, documentation of protocol deviations and amendments, reviewing data, collecting and/or approving data analysis from a variety of analytical instrumentation, ensuring accurate incorporation of results and conclusions into the study report, working with the Sponsors to address study changes, and ensuring archiving of all study reports.  

Job Duties and Responsibilities

• Meeting study timelines and quality standards.
• Training/mentoring scientific laboratory research associates and/or other junior study directors to department or study specific SOPs and procedures.  
• Reviewing protocols and data generated by the lab.
• Lab work. 
• Assist in the preparation and review of SOPs and ensuring compliance with quality system requirements. 
• Support sales staff by assisting in study design and interacting with clients. 
• Maintain accurate schedule and follow-up efficiently.

Minimum Qualifications

• BS in Chemistry is required. MS or Doctorate in Chemistry is preferred. 
• At least 5 years of experience in a regulated chemistry laboratory or appropriate education experience. 
• Experience with USP and/or ISO testing guidelines is required. 
• Extensive experience with a wide variety of analytical instrumentation, including, but not limited to HPLC, ICP, GC/MS & LC/MS.
• Strong organizational skills and work ethic. 
• Materials knowledge related to polymer, rubbers, and/or plastics, particularly as related to medical devices and pharmaceutical packaging. 
• Possess excellent written and oral communication skills. 
• Attain a strong knowledge of GLP regulation and work closely with regulatory affairs on interpretation issues. 
• Ability to be a team player. 

To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13261&lang=en_US&source=CC2 

For additional information about Toxikon go to www.toxikon.com. 

Toxikon offers a comprehensive benefits program including: paid vacation, sick time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs, and more.  

Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws.