Primary Role:
Responsible for ensuring high quality of aggregate report production, Safety Review Team coordination, signal detection activities, and clinical development and product registration activities. Supports the PV Scientist Team Lead to ensure that their responsibilities as PV Scientist Lead are in accordance with global regulations and in collaboration with the Pharmacovigilance physicians and other key PVRM and R&D stakeholders.

Responsibilities:
30%:
Product Management/Oversight May act as a functional line manager to PV Scientists or a manager for a product or group of products. Oversight and assumes responsibility for assigned therapeutic products and PV activities. Supports an organizational structure that meets the evolving needs of Shire and the PVRM department. May be responsible to manage the development, objective setting and performance assessment of direct reports. Fosters a collaborative culture within the product team and to external stakeholders. Ensures therapeutic product governance and communication in support of the PV Scientist Team Lead, Therapeutic Area Head, Head of Shire Pharmacovigilance and Risk Management and the Qualified Persons for Pharmacovigilance, including the EU QPPV.

20%:
Development Aggregate Report Production. Responsible for the production of aggregate and ad-hoc safety reporting for therapeutic team products, where Shire is the Global Safety Database holder. Establishes project management responsibility for development aggregate reports (e.g. DSUR, topic reports) within the therapeutic team to ensure effective planning such that stakeholder input is requested/received for applicable sections of the report and regulatory timelines are met. Collaborates with the PV physicians to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the final document and utilizes Shire's EDMS system to provide quality control.

20%:
Safety Review Team Coordination and Signal Detection. Responsible for the technical and scientific support for safety surveillance and signal detection activities for assigned Shire products. Responsible for efficiently planning routine and ad-hoc Safety Review Team (SRT) meetings and ensuring that stakeholders provide input from their respective areas of responsibility. Ensures that regulatory commitments and risks described in the product Risk Tracking Document are efficiently tracked and presented as part of the SRT process. Works with SRT Co-chairs to facilitate communication and support for decisions resulting from the SRT. (e.g. update of RMPs, labeling, regulatory notifications).

20%:
Support for Investigational Products and Registration Activities Effectively collaborate with stakeholders outside of PVRM. Represent PVRM department in cross-functional clinical programs and registration activities and provide PVRM support for clinical developmental programs.

10%:
Alliance Management for Outsourced PV Work . Provide guidance and oversight for CROs performing activities related to clinical trial SAEs.

Education & Experience Requirements:
* Life Science Degree or Healthcare Professional.
* Experience in a pharmaceutical company preparing, writing, authoring and submitting periodic safety reports.
* Experience in project management and Safety Review Team Meeting management is preferred

Other Job Requirements:
Will be required to travel domestically and internationally to other Shire sites and CROs or to external meetings (~10%)

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=c3N6Y3plc255LjI2MjI0LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Role:
The Manager, Cold Chain role is responsible for providing the leadership and direction to Cold Chain Management and Lane Management for Clinical Supply group including driving improvements in the Cold Chain, ensuring adherence to GDP's, GMP's, harmonizing efforts globally, and identifying strategic solutions that will meet the business needs moving forward. In addition, this role is responsible for developing and supporting Supply Chain partners to oversee the management of cold chain responsibilities including training (3PL, CMO, Philanthropy partners). Furthermore, the Manager will oversee vendor management activities of our Cold Chain partners (day to day operations, QBR, metrics). The Manager, Cold Chain would be involved in further developing this technical capability at Shire and proposing what would be required to meet the future business needs.

Responsibilities:
100%:
* Responsible for identifying global and local solutions for controlling temperature sensitive products while in transit from the manufacturing sites through to final receipt by patient. The position will support Commercial, Clinical, and other functions as required.
* Maintain the ERP system with current approved shipping solutions.
* Create and implement Supply Chain SOP's ensuring compliance with GDP's, cGMP's, and country specific regulations
* Manage and Direct Cold Chain Suppliers/vendors, day to day operations, Supplier Relations and invoicing
* Conduct and support audits of Cold Chain service providers and their internal processes.
* Oversee training of SC partners on how to execute the shipment to include cold chain, TempTales and Shipping Systems.
* Provide direction, leadership, and management to Supply Chain projects. Deliver projects on time and within budget.
* Actively manage and/or participate in Quality Systems related to the Cold Chain including deviations, investigations, CAPA's, and Change Control.
* Evaluate current processes, identify, and implement improvement opportunities and implement business processes related to Cold Chain as required.
* Lane Management - ensure that lanes are appropriately established and maintained and adequately support/align with Cold Chain requirements.
* Lane Management- establishes new lanes that support/align with Cold Chain requirements for new market expansion.
* Responsible for assuring high value products reach their destination (our patients) in a safe, compliant, and cost efficient manner.
* Create and maintain metrics on Cold Chain operations

Education & Experience Requirements:
* 5+ years cGMP experience, preferably in cold chain distribution and finished goods management in both commercial and clinical environment
* 5+ years of experience executing cold chain validation and qualification activities
* Bachelor's degree in related field
* 3+ years experience with International Cold Chain Shipments.
* Demonstrated understanding of supply chain management and logistics in a complex distribution environment
* Effective analytical skills with demonstrated success in problem solving
* Strong communication, organizational, and customer service skills
* Some travel is required (Domestic and International)

Key Skills, Abilities, and Competencies:
* Strong communication, organizational and customer service skills
* Self-motivated and energized in approach to work
* Ability to work in a fast paced environment with multiple priorities at multiple locations.
* Ability to build trust and form effective relationships with a wide range of both internal/external stakeholders as well as to share/communicate best practice.
* Ability to interact with internal departments
* Effective analytical skills with demonstrated success in problem solving

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=c3N6Y3plc255LjgxNjY2LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Role:
Reporting to a Medical Writing Group Lead, will be responsible for designated medical writing activities within a project, including secondary/primary responsibility for direction, scope, and organization of specific documents in consultation with the Medical Writing Group Lead, project physician, statistician, and other team members as appropriate. Provide writing support for timely preparation of clinical regulatory documents such as investigators' brochures, study reports, and subject narratives, and assist senior level writers in the preparation of integrated responses and other IND/CTA or global regulatory submission documents, ensuring high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Must be able to work effectively in a team environment and must have strong scientific interpretive, organizational, and project management skills.

Responsibilities:
* With support from senior level writers and/or Medical Writing Group Lead, write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators' brochures, subject narratives, and other IND/CTA or global regulatory submission documents.
* Complete documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
* Manage writing, editing, QC and publishing activities for assigned projects under the guidance of Medical Writing Group Lead and/or senior level writers.
* Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.
* Contribute to statistical output plan concerning organization and table layout for a specific document.
* Work with Medical Writing Group Lead and/or senior level writers to ensure that medical writing activities are coordinated between the project team and the medical writing group.

Education & Experience Requirements:
* Advanced degree in a relevant scientific/clinical/regulatory field preferred
* At least 2 years of pharmaceutical industry or academic experience in the clinical/regulatory field preferred

Key Skills, Abilities, and Competencies:
* Excellent writing skills
* Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the clinical team
* Ability to interact effectively with team leaders/members and be able to proactively facilitate effective information exchange/communication (including problem solving and issue resolution)
* Ability to adhere to regulatory requirements and guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents
* Strong knowledge of MS Word, Excel, MS Project, PowerPoint, and Outlook
* Working knowledge of template use for document creation
* Ability to prioritize multiple projects

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=YXN0YW5pdHMuOTE1NjUuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description
The Piscataway Site Technical Operations group is seeking a highly motivated and experienced individual for a Manager, Technical Operations position. The ideal candidate will have extensive hands on experience in the tech transfer and scale up of sterile injectable (includes solutions, lyophilized products, suspensions and emulsions) and ophthalmic pharmaceutical dosage forms (includes solutions, suspensions) and be a subject matter expert in either upstream or downstream practices and operations while also having a fundamental understanding of other areas such as thorough understanding of cGMP, sterile operations etc.

Candidates should have experience in the area of large scale sterile injectable manufacturing. The individual will be expected to provide detailed technical, process understanding and expertise in support of complex technical investigations, process trouble shooting and other highly technical areas for the manufacturing, including technical transfer, scale up, engineering/ANDA/PV and/or commercial batch manufacturing. In such cases they would be responsible for gathering the needed process understanding and history from the appropriate sources and identify and collaborate with other relevant stake holders.

The candidate should be knowledgeable of process equipment and systems, manufacturing operations, and automation control (PLC, Delta V, etc) and will provide the support working with the contract manufacturing organization for coordinating manufacturing activities and troubleshoot complex or unusual problems arising from components, process, equipment and system failures. The candidate should have experience in the area of overall sterile process execution in support of cGMP clinical, engineering, ANDA, PV and /or commercial batch manufacturing.

Candidates should have a strong track record of leveraging collaboration across multiple groups and competing priorities. Proven track record of solving complex issues and leading the implement of robust solutions. Candidate must have extensive understanding and experience dealing with large technical group of engineers, scientist and technicians in large multi-product contract manufacturing facilities.

The individual would be expected to provide support for complex technical projects and in troubleshooting activities serving as the technical lead for the given project. Serve as the operations point of contact for technology transfer and manufacturing.

Potential candidates should have a working knowledge of GMP compliance expectations and conducts all activities that are in accordance with Company policies & SOPs, Pfizer Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc. Advise management of non-conformance issues and opportunities for continuous improvement.

Responsibilities
1.This position acts as Manager, Technical Operations position working in a team environment with Contract Manufacturing Organization to execute processing and operational activities in support of manufacturing of sterile injectable and ophthalmic pharmaceutical dosage forms.
2.Requires detailed knowledge of the technology transfer and scale up. Must be capable of assessing challenges and able to provide technical support to resolve the technical issues during the manufacturing. Able to trouble shoot/recommend the solutions to resolve the technical issues with manufacturing equipment. Able to handle multiple projects simultaneously at different CMOs.
3.Capable of detecting technical manufacturing process problems and assisting the CMOs for the resolution. Ability to collect and assemble applicable, vital information for presentation to assist in troubleshooting and decision making.
4.Able to travel globally, up to 30 % to CMOs for technical meetings, technology transfer, demo/ANDA, PV and/or commercial batches manufacturing.
5.Review and/or approve site technology documents such as tech transfer plans, validation protocols, reports, batch records, sampling protocols, CAPAs, change controls, requirement for the change parts, procedures, policy and instructions, etc.
6.Provide input for investigations, commitments, and change controls assuring changes provide robust manufacturing process - ensures changes are value added.
7.Responsible for working with R & D group in optimizing process parameters of commercial processes within the design space to evaluate/implement opportunities for process improvements. Collaborate with R & D colleagues for required process development and analytical support needed to address process issues and solutions.
8.Participate as needed in reviewing/authoring relevant regulatory and/or technical documents in support of implemented technologies or changes in the manufacturing process and evaluate the impact on the quality of the product
9.Proactively identify challenges and manage their resolution.
10.Guide formulators in developing commercially feasible and scalable sterile products
11.Responsibilities include interaction and collaborate with multiple groups both on site and off site to achieve goals and collaborating with them in review of data and drawing conclusions.
12.Participate in cross-functional teams in the evaluation and implementation of novel manufacturing technology and processes in commercial processes that increase process robustness.
13.The engineer/scientist drives continuous improvement efforts cross- functionally.
14.Drive changes that support right first time, efficiency and effectiveness.
15.Promote a culture of innovation and continuous improvement.
16.Able to work under extreme short time line
17.Improve and manage partner relationship with CMOs.

Qualifications
EDUCATION AND EXPERIENCE
MS or PhD in Science or Process Engineering with 8 + years of experience for an MS or 6 + years with PhD. Candidate must be self-motivating, be capable of driving multiple initiatives simultaneously and able to adapt to rapidly changing project priorities. Grade and title will be commensurate with level of experience
1.Must have at least 6 years of hands on industrial experience in injectable product development, scale-up and technology transfer.
2.The ideal candidate should possess extensive hands on experience in the tech transfer and scale up of injectables (includes solutions, lyophilized products, suspensions and emulsions) and ophthalmic pharmaceutical dosage forms (includes solutions, suspensions).
3.Strong communication skills and writing skills are required as well as the ability to effectively resolve the complex manufacturing process issues and provide the robust solutions.
4.A good team player who has excellent problem-solving and communication skill.
5.Working knowledge of cGMP and regulatory requirement of ANDA filing is preferred.
6.Strong technical and R&D background is desired.

TECHNICAL SKILLS REQUIREMENTS
The Manager, Technical Operations position uses technical knowledge to
* troubleshoot complex or unusual problems arising from components, process equipment and system failures
* lead tech transfer and scale-up activities
* provide investigations support
* analyze process data, and identify and implement process improvements
* Develops and present technical presentations

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Application URL: http://www.aplitrak.com/?adid=c3VzYW4ubS5kaXBhZ2xpYS45ODAxOS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

This is an incredibly exciting opportunity for anyone looking to make a meaningful contribution in science. Our client is a promising clinical stage therapeutic company dedicated to developing drugs that will make a critical difference in patients’ lives. This company is already seeing breakthrough results in the clinic, so if you have the drive to work on a team of intellectually gifted scientists, and in an environment where your thoughts are heard keep reading.

Your primary responsibilities include:

• Develop and perform SOP-driven assays for characterization of microorganisms
• Analyze data rigorously and critically, and report it out in a timely fashion
• Participate in developing core intellectual property.

REQUIREMENTS:

• BS degree in biochemistry, microbiology, or related field with 1-2 years in assay development and transfer
• Experience with biochemical assays (i.e. protein, DNA, ELISA or enzymatic)
• Experience with bacterial cultivation and execution of microbiological assays (i.e. CFU assays, MICs, phenotypic characterization)

About StratAcuity

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

 CHEMISTRY IS EVERYTHING™

About PixarBio

PixarBio’s intends to replace opiates and other addictive pain treatments in Q1 2018.  Our primary mission is to research and develop sustained drug, cell, and biologic delivery systems, for acute/chronic pain, epilepsy, spinal cord injury, and Parkinson’s disease.

We rely on the RSB R&D model to create our innovative engine, providing a creative work environment.  We have sought replacements for morphine for centuries so PixarBio combines a once in a life-time experience to join neuroscience most productive team. 

Robert Langer, ScD, Co-Founder of PixarBio is #1 in the history of US Life science patents, trailing only Thomas Edison for #1 in US history of patents.  Frank Reynolds, CEO and Co-founder of PixarBio invented the NeuroScaffold, won top 50 scientist in Ireland history, and he is co-inventor on 50+ pending and or issued biomaterials/life science patents.

About the Job

PixarBio is searching for a qualified, highly motivated Desktop Support Specialist to provide technical support of desktop computers, telephones, peripherals, applications, and related technology within established guidelines.

Primary Responsibilities

• Manage all desktop hardware and software in the office, lab, cGMP and GLP settings
• Manage helpdesk support queue and ensure all incidents and requests are resolved in a timely manner. Prioritize support tickets while maintaining a high level of customer service. Resolve PC hardware, software, and network connectivity/access problems reported by end users, including in-person, remote, or phone support.
• Manage user requirement definition and development, system configuration and testing, installation, implementation of ongoing support, system enhancements/upgrades and bug fixes.
• Ensure root cause of problems is understood and addressed. Verify fixes and obtain end user validation. Follow-up with documentation for Desktop Support team.
• Support Enterprise mobile devices including iPhone, iPad, cell, tablets and broadband devices.
• New workstation setup, assist with new hire training.
• Support Security Standards (anti-virus/anti-spam/firewall/patching).
• Evaluate and identify new technologies to advance end user experience.
• Drive initiatives that will empower a higher degree of efficiency and accuracy.
• Ensure standardization of configurations and provide hardware and software updates, including recommended operating system updates and security patches on all PC equipment.
• Build and maintain vendor relationships and purchase hardware and software products.
• Primary liaison for vendors as related to Desktop Support needs. Own and manage vendor relationship and escalate when appropriate. 
• Ensure that company assets are tracked and maintained responsibly.
• Develop, document, and maintain Desktop Support related Knowledge Articles.
• Utilization of CFR 11:20, FDA IT Validation, and  
• Support multiple locations in the Boston regions in the Medford, Cambridge Lexington region
• Support global travel for workforce and offsite office locations.
• Perform other related duties as assigned.

Qualifications

• Bachelor's degree in Computer Science or related discipline preferred. 
• 5+ years' experience in IT helpdesk support in a fast-paced environment.  Experience with configuration and troubleshooting of desktop PC/mobile device hardware and software (Windows and Mac OS).
• Knowledge of network administration, Microsoft operating systems, microsoft office suite, and corporate email systems.  
• Demonstrated operational familiarity with iOS and OSX.
• Experience with TCP/IP networking and related network services (i.e. DNS, SMTP, DHCP, etc.), installation, configuration and troubleshooting of audio/visual equipment including video/teleconferencing and projectors. 

Required Skills 

• Communicate professionally, concisely and consistently both verbally and in writing internally and externally.
• Ability to clearly communicate technical concepts to non-technical users.
• Deliver and demonstrate an expert level of customer service.
• Ability to organize and prioritize work effectively to meet timelines with quality deliverables.
• Ability to multi-task in a fast-paced environment.
• Demonstrate initiative, be a self-starter.
• Advanced ability to work independently, as well as collaboratively, within a team.
• Strong organization and problem solving skills required. 
• Must be able to maintain a high level of confidentiality.
• Experienced knowledge of the end-to-end business processes in the functional areas assigned.
• Learns and applies company policies and procedures when completing assigned tasks.

Notes

Authorization to work in the U.S. required.

Compensation

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

About PixarBio

PixarBio’s intends to replace opiates and other addictive pain treatments in Q1 2018.  Our primary mission is to research and develop sustained drug, cell, and biologic delivery systems, for acute/chronic pain, epilepsy, spinal cord injury, and Parkinson’s disease.

We rely on the RSB R&D model to create our innovative engine, providing a creative work environment.  We have sought replacements for morphine for centuries so PixarBio combines a once in a life-time experience to join neuroscience most productive team. 

Robert Langer, ScD, Co-Founder of PixarBio is #1 in the history of US Life science patents, trailing only Thomas Edison for #1 in US history of patents.  Frank Reynolds, CEO and Co-founder of PixarBio invented the NeuroScaffold, won top 50 scientist in Ireland history, and he is co-inventor on 50+ pending and or issued biomaterials/life science patents.

About the Job

PixarBio is searching for a qualified, highly motivated Desktop Support Specialist to provide technical support of desktop computers, telephones, peripherals, applications, and related technology within established guidelines.

Primary Responsibilities

• Manage all desktop hardware and software in the office, lab, cGMP and GLP settings
• Manage helpdesk support queue and ensure all incidents and requests are resolved in a timely manner. Prioritize support tickets while maintaining a high level of customer service. Resolve PC hardware, software, and network connectivity/access problems reported by end users, including in-person, remote, or phone support.
• Manage user requirement definition and development, system configuration and testing, installation, implementation of ongoing support, system enhancements/upgrades and bug fixes.
• Ensure root cause of problems is understood and addressed. Verify fixes and obtain end user validation. Follow-up with documentation for Desktop Support team.
• Support Enterprise mobile devices including iPhone, iPad, cell, tablets and broadband devices.
• New workstation setup, assist with new hire training.
• Support Security Standards (anti-virus/anti-spam/firewall/patching).
• Evaluate and identify new technologies to advance end user experience.
• Drive initiatives that will empower a higher degree of efficiency and accuracy.
• Ensure standardization of configurations and provide hardware and software updates, including recommended operating system updates and security patches on all PC equipment.
• Build and maintain vendor relationships and purchase hardware and software products.
• Primary liaison for vendors as related to Desktop Support needs. Own and manage vendor relationship and escalate when appropriate. 
• Ensure that company assets are tracked and maintained responsibly.
• Develop, document, and maintain Desktop Support related Knowledge Articles.
• Utilization of CFR 11:20, FDA IT Validation, and  
• Support multiple locations in the Boston regions in the Medford, Cambridge Lexington region
• Support global travel for workforce and offsite office locations.
• Perform other related duties as assigned.

Qualifications

• Bachelor's degree in Computer Science or related discipline preferred. 
• 5+ years' experience in IT helpdesk support in a fast-paced environment.  Experience with configuration and troubleshooting of desktop PC/mobile device hardware and software (Windows and Mac OS).
• Knowledge of network administration, Microsoft operating systems, Microsoft office suite, and corporate email systems.  
• Demonstrated operational familiarity with iOS and OSX.
• Experience with TCP/IP networking and related network services (i.e. DNS, SMTP, DHCP, etc.), installation, configuration and troubleshooting of audio/visual equipment including video/teleconferencing and projectors. 

Required Skills 

• Communicate professionally, concisely and consistently both verbally and in writing internally and externally.
• Ability to clearly communicate technical concepts to non-technical users.
• Deliver and demonstrate an expert level of customer service.
• Ability to organize and prioritize work effectively to meet timelines with quality deliverables.
• Ability to multi-task in a fast-paced environment.
• Demonstrate initiative, be a self-starter.
• Advanced ability to work independently, as well as collaboratively, within a team.
• Strong organization and problem solving skills required. 
• Must be able to maintain a high level of confidentiality.
• Experienced knowledge of the end-to-end business processes in the functional areas assigned.
• Learns and applies company policies and procedures when completing assigned tasks.

Notes

Authorization to work in the U.S. required.

Compensation

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

Responsibilities:

Under the supervision of Senior management:

• Write, review and assemble high quality regulatory submissions, such as Premarket Approval Application (PMA), Premarket notification (510k), De Novo submission and Investigational Device Exemptions (IDEs) 
• Ensure compliance of deliverables with US regulations and applicable guidelines
• Communicate clearly with clients as well as with US regulatory authorities for assigned projects
• Monitor, prioritize and supervise project strategy, timelines, and milestones and communicate them to the project team members

Complementary activities:

• Participate as requested and per directions from Senior management in pre-project tasks for US scope of works (incl. proposals for assistance drafting to prospects)
• Attend and present at conferences and/or write articles in your area of expertise.

Experience:

• 3+ years professional regulatory experience in Medical Device
• Solid knowledge of US Medical Device regulatory framework and associated FDA guidance
• Significant operational experience with Medical Device technical standards (ISO 14971, etc.

Personal attributes and skills:

• Ability to manage multiple projects and deadlines, monitor workload and prioritize
• Successful at time management and proven ability to meet deadlines
• Strong written and verbal communication, presentation, and facilitation skills
• Ability to apply problem solving skills and appetite for initiative
• Ability to work in a multicultural environment
• Ability to work remotely (position could be partially home-based envisaged).

Assists in the daily operation of the Animal Facility, in feeding of and caring for animals used in research experiments. Follows policies and procedures for fulfilling animals’ nutritional health, and environmental requirements as directed under supervision 

Primary responsibilities include:

• Handle, transfer, and distribute mice, supplies and waste as needed to and from work area(s).
• Clean cages and racks
• Monitor the daily health and welfare of the animals
• Coordinate with vendors and supervisors on operational, administrative and technical responsibilities 
• Responsible for overseeing procurement of animals and supplies, preventive maintenance of facility equipment
• Strong written and verbal English communication skills. Ability to follow written and verbal instructions
• Follows standard operating procedures and maintains recordkeeping pertaining to equipment operation, animal and supply inventories in accordance with federal and state guidelines and regulations
• Perform physical environment housekeeping duties and production operations according to Standard Operating Procedures (SOPs)
• Operate equipment and use supplies according to safety guidelines. Perform all job-related duties in accordance with company safety procedures.
• Perform all other related duties as assigned

Education and Skills Requirements: 

• Education: High school diploma ( A.S. or B.S preferred)
• Experience: 1 to 2 years related experience in and/or training in animal husbandry.

Gemini Staffing Consultants is seeking a Principal Regulatory Specialist for a Medical Device client in the MetroWest area of Massachusetts. The candidate will be a non-manager individual contributor. The company offers a highly-competetive compensation, benefit, and bonus package and significant opportunity for growth.

Requirements

• 510(K) and PMA authorship required
• Seven years' experience in an FDA-regulated industry preparing regulatory submissions for medical devices required
• BA or BS from a four-year college or university in an engineering or science discipline preferred
• US & global regulatory experience greatly preferred
• Certified Regulatory Affairs Professional highly desired

Biovest is currently recruiting for the position of Purification Manager, whose primary responsibility will be to monitor and guide daily activities related to the downstream work for projects in our BioServices Division.   This includes hiring, training, overseeing, and scheduling the work of direct reports, and performing hands on work to support recombinant protein/monoclonal antibody purification.  The manufacturing is performed to be GMP compliant meeting FDA and EMA guidances. 

Successful candidates will have a strong background in protein biochemistry and advanced laboratory skills, and have experience managing direct reports.  We look for this individual to become a versatile and valuable internal team member who is able to contribute to interdepartmental projects.  This position will work directly with our manufacturing, accounting, account services, and engineering teams to accomplish short and long-term goals.

Responsibilities:

• Arrange & participate in the organisation of Investigation Meetings & Study Team Meetings. Taking minutes & distributing.
• Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.
• Prepare protocols, Investigator Brochures and CRFs which includes keeping track and re-ordering supplies.
• Set up and maintenance of the Trial Master Files (TMF) or electronic filing systems / set up of the Investigator Site Files (ISF)
• Manage & maintain study documents & trial supplies e.g , Patient information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites
• Prepare essential clinical trial documentation, distributing, tracking and filing of documents on return.
• Ensure that any clinical trial databases / tracking tools are set up and maintained throughout the trial
• Create & maintain study contact lists for team / site / 3rd parties / set up mail merges
• Send out Study Newsletter / Study correspondence to all participating sites on an ongoing basis
• Set up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments
• Assist with collating, tracking & shipping CRFs & data queries to Data Management
• General study filing
• Coordinate & archive of study documentation

Other possible tasks may include :

• Processing SUSAR (Adverse Events) notifications in a timely manner
• Assisting with CRF Design
• Arranging translation of patient documents
• Assisting Clinical Research Associates on monitoring visits
• Re-ordering clinical drug supplies for sites

Experience :

• 18/24 months in a related position

Personal attributes & Skills :

• Understand clinical trial processes and needs
• Excellent organisational skills
• Good attention to detail
• Work under pressure and tight deadlines
• Pro- active, flexible and able to multi-task
• Work in a team and independently
• Excellent time management
• Excellent communication and influencing skills

Responsibilities:

• Arrange & participate in the organisation of Investigation Meetings & Study Team Meetings. Taking minutes & distributing.
• Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.
• Prepare protocols, Investigator Brochures and CRFs which includes keeping track and re-ordering supplies.
• Set up and maintenance of the Trial Master Files (TMF) or electronic filing systems / set up of the Investigator Site Files (ISF)
• Manage & maintain study documents & trial supplies e.g , Patient information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites
• Prepare essential clinical trial documentation, distributing, tracking and filing of documents on return.
• Ensure that any clinical trial databases / tracking tools are set up and maintained throughout the trial
• Create & maintain study contact lists for team / site / 3rd parties / set up mail merges
• Send out Study Newsletter / Study correspondence to all participating sites on an ongoing basis
• Set up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments
• Assist with collating, tracking & shipping CRFs & data queries to Data Management
• General study filing
• Coordinate & archive of study documentation

Other possible tasks may include :

• Processing SUSAR (Adverse Events) notifications in a timely manner
• Assisting with CRF Design
• Arranging translation of patient documents
• Assisting Clinical Research Associates on monitoring visits
• Re-ordering clinical drug supplies for sites

Experience :

• 18/24 months in a related position

Personal attributes & Skills :

• Understand clinical trial processes and needs
• Excellent organisational skills
• Good attention to detail
• Work under pressure and tight deadlines
• Pro- active, flexible and able to multi-task
• Work in a team and independently
• Excellent time management
• Excellent communication and influencing skills

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

RESPONSIBILITIES

• Key Clinical Project Management support role; ensures that delegated components of clinical trials are executed to expected and specified quality standards
• Builds knowledge of clinical trials operations and scientific principles and objectives of Infinity’s clinical trials under some direction and guidance but largely self-directed
• Learns best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations
• Work independently and know when to involve / collaborate with others
• Ensures understanding of clinical trial protocols and site specifications as well as scientific/medical objectives
• Ensures study conduct activities are within protocol guidelines including data verification, sample collection and analysis processes and monitoring report review
• Day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to Project Manager or senior Clinical Operations staff
• Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs
• Fully understands the need for and importance of inspection readiness; diligently follows Infinity Clinical Operations SOPs and processes; identifies and communicates gaps
• Accountable for meeting agendas and comprehensive and precise meeting minutes.
• Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking
• Actively participates in the development of department initiatives; contributes ideas on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations
• Communicates and coordinates with senior Clinical Operations staff/management to ensure accurate and comprehensive completion of documents needed by Regulatory Affairs
• Under the guidance and direction of the Project Manager and/or Clinical Operations management, interfaces with other Infinity functions to coordinate relevant and timely exchange of information / materials to support clinical trials delivery within the drug development process
• May assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations

REQUIREMENTS/QUALIFICATIONS:

• 2 years of relevant experience Clinical Operations experience and a BS in a relevant scientific discipline
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.

• Demonstrates ability to learn tools and processes that increase measured efficiencies of the project.
• Demonstrates ability to manage components of clinical trials with general guidance from senior staff.
• Demonstrates understanding of interdependencies of data, technology, vendor metrics and differences across vendor abilities and requirements.
• Strong verbal, written and presentation skills

This role will begin on a contract basis with the potential to transition into a permanent position.
To apply, please visit our website at http://www.infi.com

With our lentiviral-based gene therapy and gene editing capabilities, we have built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapy. Our clinical programs include Lenti-D™, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of childhood cerebral adrenoleukodystrophy, and LentiGlobin®, currently in three clinical studies: a global Phase 1/2 study, called the Northstar Study, for the treatment of beta-thalassemia major; a single-center Phase 1/2 study in France (HGB-205) for the treatment of beta-thalassemia major or severe sickle cell disease; and a separate U.S. Phase 1 study for the treatment of sickle cell disease (HGB-206). We also have ongoing preclinical CAR T immuno-oncology programs, as well as discovery research programs utilizing megaTAL/homing endonuclease gene editing technologies.

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  The focus of this position is to provide support for Manufacturing and Technical Operations for the cell procurement for gene therapy processes in Europe and South East Asia. We are looking for an innovative professional with the breadth of experience and drive to implement our vision for this function.

About the role:

• Working with supervisor, oversee the administrative and operational aspects of apheresis, bone marrow, and whole blood collections and product development.
• In a team setting, ensure that contracted facility collection functions are current as to equipment, training and technology according to internal procedures and recommendations.
• Oversee the development and maintenance of procedures related to standard cell procurement practices with supervisor. 
• Partner with clinical, quality, and development functions to help build a sustainable US, EU, and SEA collection network for clinical development and for commercial operations.
• Provide technical feedback and guidance on optimizing collection procedures, or impact of collection procedures on further manufacturing.
• Participate in clinical site qualification visits for training and method transfer. Travel throughout the United States, Europe and Southeast Asia is a must.
• Work closely with the Supply Chain department to ensure traceability of whole blood and apheresis product for clinical manufacturing. 
• Conduct periodic assessments of collection facilities as needed.

About you:

• BS/MS or RN degree with 5 – 7 years of experience in a relevant medical field.
• Knowledge of phlebotomy and apheresis techniques required.
• Willingness to travel, domestically and internationally
• Flexibility needed; some weekend work possible due to collection schedules
• Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals 
• Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
• Independently motivated, detail oriented and good problem solving ability

• Good understanding of applicable regulations and standards (AABB, FACT JACIE)
• Good understanding of GMPs and GCPs

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

HR Recruiter (Temp – Perm)- Needham, MA

The successful candidate will assist the staffing/employment/ recruiting programs and activities specifically in the biotech areas. This person will work alongside hiring managers and the Human Resources team.  The recruiter will schedule dedicated visits on a regular basis. Candidate must have worked in the Biotech/Pharma/Medical Sciences industry with an understanding of recruiting for positions in Marketing, Sales, Clinical, Medical Affairs and Drug Safety and other related positions.

Position Responsibilities:

• Works with hiring managers to document requirements of job openings as required.
• Assists with determining appropriate recruiting sources for posting positions.
• Surfaces candidates and develops networks of people and processes to support a strong pipeline of qualified candidates.
• Identifies and maintains contacts with recruiting sources.
• Assists with resume and candidate pre-screening.
• Works with internet website representatives in the course of conducting employment advertising campaigns.
• Support and maintain college recruiting, affirmative action and other recruiting events.
• Ensures that staffing needs are met in accordance with governmental requirements.
• Ensures consistent corporate image throughout recruiting campaigns.
• Submits reports concerning hiring trends, candidate feedback to HR.
• Works with HR Associate to coordinate scheduling and interviews.
• Assist with writing job descriptions and job postings.
• Assist with research on assigned projects
• May assist with Onboarding at all 4 sites
• Perform other position related duties.

Education:

• BA/BS required, Business or Human Resources preferred

Skills:

• Excellent written and verbal communications skills,
• Good listening skills.
• Detail oriented
• Proficient in Word, Excel and PowerPoint
• Some travel required
• HR staffing and recruiting experience 2-3 yrs.,
• Recruiting experience in Biotech/Pharma 3+ years
• HR related social media 1-2 yrs. in recruiting 
• Team Player
• Personable

Qualified candidates interested in applying for this position at Celldex are invited to submit a resume and cover letter: (please include job title on the subject line)

Human Resources

Celldex Therapeutics, Inc.

119 Fourth Avenue

Needham, MA 02494-2725

E-Mail: careers@celldex.com

Our biopharmaceutical client, aimed at developing therapies for nervous system disorders, is looking for a Clinical Trial Manager to join their talented team.   You will have the opportunity to manage both day-to-day operations as well as project work in a fast paced environment.  The clinical operations activities are growing rapidly so bring your skills and experience to this opportunity and hit the ground running.

REQUIREMENTS:

• A Bachelor’s degree in a scientific or health-related field is required, MS preferred, with a minimum of 4-6 years of general clinical research experience
• On-site monitoring experience preferred
• Must have a minimum of two years of experience in the management of clinical trials as a project manager at a pharmaceutical/biotech company or CRO.
• Advanced understanding of GCPs, FDA regulations and ICH guidelines is required.
• Therapeutic experience and knowledge in neurological and cardiovascular preferred, but not required. 

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

CHEMISTRY IS EVERYTHING™

Our client, a global leader striving to advance diagnostics to improve cancer patients’ lives, is looking for a Research Associate to join their growing team. If you are a self-motivated individual with extensive hands on experience with histology or pathology lab technique (preferable gained within an IVD or clinical biomarker development environment) this is a not to be missed opportunity.

You will be given the chance to join an innovative company and work in a goal oriented environment with other experts in IHC and IVD development. These key hires will prepare and conduct laboratory studies in support of the development of implementation of automated Immunohistochemistry (IHC) and FISH In Vitro Diagnostic assays. You will have  to be a team oriented and collaborative individual able to work under changing daily client demands. If you enjoy variety in your daily work life, this is a perfect role for you. 

Requirements:

• BS in histology or pathology related discipline
• Technical expertise in IHC and ISH assays preferably on automated staining platforms in academic, hospital, industry or pharmaceutical settings
• Ability to evaluate and concisely articulate complex scientific and business issues and contribute to the implementation of solutions
• Track record of success performing under time sensitive deadlines
• Upbeat personality with a “can-do” attitude

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

CHEMISTRY IS EVERYTHING™

Senior Director, DMPK

Company Description

Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB) is a clinical-stage company focused on the discovery, development and commercialization of novel therapeutics based on our proprietary Safely Metabolized And Rationally Targeted (SMART) linker technology platform. Our SMART linker technology platform aims to treat diseases by simultaneously modulating multiple targets in disease pathways. Our product candidates are designed for enhanced efficacy and improved safety and tolerability. Our focus is on treatments for rare diseases. We are also developing other product candidates for the treatment of serious lipid disorders. Our two clinical programs, CAT-1004 and CAT-2054, have the potential to disrupt treatment paradigms. CAT-1004 is an oral NF-kB modulator for Duchenne muscular dystrophy (DMD), with the potential to be a disease-modifying agent broadly applicable across age groups and mutations. CAT-1004 in DMD has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA. CAT-2054 is an oral Sterol Regulatory Element-Binding Protein (SREBP) modulator for hypercholesterolemia. Catabasis is building a team of highly motivated and experienced professionals who are committed to achieving its mission of bringing hope and life-changing therapies to patients. For more information please visitwww.catabasis.com.

Position Description

The Senior Director of DMPK will provide leadership and strategic oversight for investigating the pharmacokinetics, biodistribution, metabolism and PK/PD relationships of novel drug candidates in preclinical, toxicology and clinical studies required to advance candidates through drug discovery and clinical development. In addition, the successful candidate will build a capability in modeling and simulation to enhance human dose projections and exposures and pharmacodynamic responses.

Responsibilities

The Senior Director of DMPK will report to the Senior Vice President, Research and Non-Clinical Development and serve as a leader and key interface between all departments. Responsibilities include:

• Management and scientific leadership of all DMPK and PK/PD activities providing support to both discovery and development programs
• Build capabilities in PK/PD modeling and simulation
• Prepare and present documentation relating to regulatory submissions
• Ensure each activity is effectively prioritized and makes appropriate use of internal resources, CROs and academic / industrial collaborations to deliver optimal results
• Provide support to multiple programs from the early drug discovery phase through clinical development
• Develop the appropriate network of consultants and key opinion leaders to maximize odds of technical and commercial success of programs
• Increase the visibility and scientific reputation of Catabasis with external publications and presentations at scientific meetings and conferences

The successful candidate will embrace our culture to bring hope and life-changing therapies to patients and families through a patient-oriented focus on integrity, people, excellence and impact.

Qualifications and Experience    

The candidate will have a Ph.D. in Pharmacokinetics, Drug Metabolism or a related field, with at least 12 years of post-graduate experience working in industry. The successful candidate will also have:

• Extensive experience in designing and interpreting experiments to understand the absorption, distribution and metabolism of molecules, their pharmacokinetic profile and relationship to pharmacodynamic response in drug discovery and clinical development
• Experience in building and utilizing PK/PD models and running simulations to enhance human dose and exposure and pharmacodynamic response predictions
• Demonstrated knowledge of global regulatory requirements and expectations for nonclinical DMPK packages to support first-in-human and clinical development studies
• Excellent time management skills, with an ability to adapt to rapid changes in projects priorities and meet aggressive timelines
• Strong collaboration skills with a demonstrated ability to work effectively with project teams, management and CROs

Acorda Therapeutics is a major pharmaceutical company with a manufacturing facility in Chelsea, MA

Acorda is looking to hire a Manager – Clinical Supply to perform critical activities related to the supply of investigational drugs for clinical studies and returns reconciliation.  This Manager works with Clinical Operations and Medical Affairs to plan and manage supply for Investigator Initiated Studies (IIS) and with Acorda’s vendors to ensure critical information is communicated with respect to manufacturing, packaging and labeling of clinical drug supplies. 

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

 Supports the Head of Clinical Supply by performing critical activities necessary to ensure an uninterrupted supply of investigation supplies to all of Acorda sponsored clinical trials.

• Works with Technical Operations team to schedule manufacturing of bulk drug.
• Coordinates the Shipment and Storage of Clinical Trial Materials (CTM) with Technical Operations team.
• Supports CTM packaging activities within Acorda to fulfill clinical protocol requirements and to meet clinical timelines.
• Provides support for the distribution of all CTMs.
• Provides support for the returns and reconciliation of CTMs.
• Coordinates with label vendor to generate proofs and obtain required approvals to place order, in conjunction with other Acorda departments.
• Collaborates with clinical project manager to develop site drug accountability documentation procedures and forms.
• Reviews clinical trial protocols and develops and implements trial specific labeling/packaging/distribution (including re-supplies).
• Coordinates with Acorda QA to perform pre and post packaging batch documentation reviews. 
• Manages the inventory of clinical trial drugs and related supplies.
• Assists with the management of logistics between clinical supply vendors.

Education and/or Experience:

• Bachelor’s Degree in Chemistry, Mathematics, Pharmacy or related technical field required.
• Master’s Degree in Chemistry, Mathematics, Pharmacy or related technical field preferred.
• Minimum of three to five years of experience in the pharmaceutical industry working to provide investigational product supplies for both US/NA and Global studies.
• Basic understanding of GCP’s, GMP’s and ICH guidelines and applicable regulatory requirements.

 Supervisory Responsibilities: None

 Qualifications:

• Basic understanding of fundamental clinical trial designs and the application to packaging and labeling of clinical drug product.
• Basic understanding of clinical drug distribution and return/reconciliation activities.
• Basic understanding of IRT system setup to support clinical trials

 Computer Skills:

• Must be proficient in MS Office Suite.
• Basic Understanding of ERP systems required.

Other Skills and Abilities:

• Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate.
• Strong planning and coordination skills.
• Ability to work with individuals across a wide range of disciplines.
• Excellent written and verbal communication skills.
• Must demonstrate a keen attention to detail and timelines.
• Proven ability to work on multiple projects in a fast paced environment.

 hysical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• This position requires travel; average travel for this position is 40% with some variation based upon the demands of the business.

 Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

 No specific work demands.

 *To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please visit our website to learn more about acoda and this opportunity.    www.acorda .com

If you are interested and qualified, please submit your resume on line.  You may also email your resume to mricher@acorda.com