OVERVIEW

We are seeking a highly motivated individual to join our growing Medical Affairs team. This person will act as the right-hand to the VP, Medical Affairs in both a strategic and operational manner to ensure all aspects of our Medical Affairs program is executed on time and within budget.

MAJOR RESPONSIBILITIES

• In close alignment with VP Medical Affairs, oversee all aspects of Medical Affairs program
• Develop and execute against a strategically aligned and cross functional Medical Affairs strategy
• Lead development of all medical communications, slide decks and other medical communications needed to educate the medical community on our products
• Coordinate with Pharmacovigilance vendor to ensure compliant handling and communications around all adverse events
• Oversee Medical Science Liaison program both strategy and execution
• Develop and execute against a Medical Education strategy including compliant use of grant money and Continued Medical Education (CME) events. 
• Lead development of a speaker program engaging Key Opinion Leaders (KOLs) and other Health Care Professionals (HCPs) to speak on behalf of Chiasma in educational and other settings
• Partner with Marketing to develop and facilitate Physician, Nurse and Patient Advisory Boards
• Oversee Medical Affairs trials (e.g., registries, label expansion, IISs)
• Coordinate involvement of Medical Affairs personnel on Promotional Review Committee and Medical Review Committee
• Oversee creation of appropriate SOPs and policies across Medical Affairs program
• Develop and execute a publications strategy including white papers and abstracts for society meetings
• Lead efforts across Medical Affairs to keep abreast of latest scientific, disease state, emerging therapies and healthcare landscape information and use this information to provide value to both external and internal stakeholders
• Attend & participate in medical/scientific meetings and conferences

EDUCATION AND EXPERIENCE

• Bachelor’s Degree required.  Master’s Degree in a medical field preferred.  MD, PharmD, RN or PhD nice to have.
• Minimum of 10 years of experience in the Pharmaceutical industry in multiple different Medical, Clinical and/or Commercial roles of increasing responsibility
• Experience managing one or more Medical Affairs programs including Publications, Medical Information/Communication and/or Medical Education
• Minimum of 5 years of experience managing Medical Affairs professionals including both field-base and in-house/corporate office direct reports

SKILLS & COMPETENCIES

• Demonstrated ability to think strategically, see the “big picture”, be creative and generate innovative plans while tactically executing on initiatives
• Demonstrated ability to manage multiple high priority projects at the same time
• Track record of success working with key opinion leaders and scientific experts.
• Desire to help build a product brand from the ground up and contribute to the success of a new exciting company and therapy.
• Experience successfully working in a cross-functional team environment
• Strong interpersonal skills and communication skills, including superior oral, written and presentation skills.
• Strong work ethic with a ‘role up my sleeves and get it done’ mentality.
• Established ability to write scientific documents as well as medical affairs materials, including materials for promotions, presentations and medical information.
• Strong presentation skills – both in creating and delivering scientific presentations to high level audiences.

TRAVEL REQUIREMENTS

• Ability to travel approximately 20% of the time

OVERALL RESPONSIBILITY

Provide primary support for the Environmental Health & Safety programs at the Whitehead Institute. This person will be responsible for identifying and implementing EH&S strategies which apply to industrial hygiene, safety and chemical regulatory requirements, emissions-waste-water management, including all applicable permitting and reporting requirements. Engage directly with lab scientist to ensure compliance with Federal, State and local regulatory requirements for biomedical laboratory operations.

We are looking for a candidate who thrives in an interdisciplinary environment, is an excellent communicator and is self-motivated.

CHARACTERISTIC DUTIES

• Review appropriate government (Federal, State and City of Cambridge) regulations, determine the applicability to the Institute, and update or write policies and procedures in practical ways to be delivered to the different user groups.
• Audit policies and procedures to ensure understanding, compliance, and user comprehension. Procedures include, but are not limited to; Regulated Waste, New Chemical Review, Hazardous Communication, Incident Investigation, SPCC, RCRA and Tier II Reporting, MWRA, Industrial Hygiene, Ergonomics, IATA Shipping and Process Safety Management.
• Oversee the chemical hygiene program and the chemical waste program, the later primarily staffed by contracted vendors.
• Perform/oversee lab and satellite accumulation area inspections.
• Review chemical orders and manage chemical inventory system.
• Coordinate annual chemical fume hood certification and repair program, in conjunction with MIT’s IH group. Maintain records of certification.
• Provide guidance on the process for researchers seeking to use MA DPH or DEA Controlled Substances.
• Prepare environmental summaries, training reports, regulatory summaries, filings and reporting requirements.
• Regulatory Reports:
  • Chemical Hygiene Plan
  • Universal Waste Plan
  • DOT Security Plan
  • SARA Title III Tier 2 Report / LEPC filings
  • Air Monitoring and Emissions Reporting
  • MWRA yearly reporting
  • DHS Chemicals of Concern Oversight
• Coordinate Lab Decommissioning.
• Assist with the Radiation Safety Program, as needed.
• Identify, implement and manage third party service providers for EH&S services.
• Share emergency response responsibilities with other EH&S staff members (24 hour call, seven days a week).  This includes decisions on building closure, interface with municipal and contractor emergency responders via the Incident Command System.
• Attend training classes, as needed, to maintain certifications to perform job in compliance with regulatory requirements, e.g. Incident Command, Haz Mat, DOT, IATA etc.
• Serve in the 24 hour on-call service rotation. 
• Perform other special projects, as required.

QUALIFICATIONS

Education

• Bachelor’s degree or Environmental Health and Safety, Chemistry or Science.           

Experience

• Minimum of five to eight years related experience in a research laboratory environment. Background in Industrial Hygiene and current DOT and HMM certification preferred.
• Experience in emergency situations; 40 hour HAZWOPER training a plus.
• Certified Industrial Hygienist CIH preferred
• Previous security clearance a plus.
• Ability to prioritize and work well both independently and as a team member.
• Strong interpersonal, verbal and written communication skills.
• Proficient in the use of computers and applications.

Interested candidates should send resume to:

resumes@wi.mit.edu

Whitehead Institute for Biomedical Research

9 Cambridge Center

Cambridge, MA 02142

Novo Nordisk US Bio Production, Inc. is looking for a quality minded, detail oriented, team player to join the Cell Culture team as a Manufacturing Associate. This position has primary responsibility to support operations for the given area. The person in this role will assist in coordinating and executing process and equipment improvement programs, create technical reports, review completed quality records, generate quality comment and deviation responses, and train technicians on various equipment and processes.

ESSENTIAL FUNCTIONS:

• Liaison between Product Support and Manufacturing for the coordination of process/equipment improvements and data trending/analysis.
• Review/approval of completed process documentation.
• Ability to train others on the manufacturing equipment and processes.
• Revise and create documentation (SOP, batch records, reports, notebooks) associated with the manufacture of product, requiring minimal direction.
• Incorporate pre-planned process improvements and cost reduction projects into manufacturing.
• Ability to take on and manage multi-disciplined projects, with minimal supervision.
• Complete understanding/application of quality systems.
• Support of Health Authority inspections.
• Perform area equipment and process validations in accordance with validation procedures requiring minimal direction.
• Possesses technical and systems knowledge and is able to research information outside of knowledge base.
• Responsibilities also include hands-on manufacturing within the given area for production coverage. 
• Has ability to recognize problems and recommend solutions to problems based on technical understanding of the process and equipment.
• Support activities in other departments as instructed by manager.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.  Incorporates the Novo Nordisk Code of Conduct values in all activities and interactions with others.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• High School diploma or equivalent with a minimum of six (6) years relevant manufacturing experience or a Bachelor’s degree or equivalent in a science or engineering discipline with three (3) or more years of experience.
• Requires functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines.
• Ability to understand and execute established written instructions is essential.

Novo Nordisk US Bio Production, Inc. is located in Lebanon, NH, voted “Best Small Town in the US” by Livability. Along with being located in a wonderful place to live, Novo Nordisk offers excellent pay, benefits, 401K w/ company match, paid time off, and much more!

Apply today through our website at www.novonordisknewhampshirejobs.com to start your Life Changing Career!

Novo Nordisk US Bio Production, Inc. is looking for a quality minded, detail oriented, team player to join the Cell Culture team as a Manufacturing Associate. This position has primary responsibility to support operations for the given area. The person in this role will assist in coordinating and executing process and equipment improvement programs, create technical reports, review completed quality records, generate quality comment and deviation responses, and train technicians on various equipment and processes.

ESSENTIAL FUNCTIONS:

• Liaison between Product Support and Manufacturing for the coordination of process/equipment improvements and data trending/analysis.
• Review/approval of completed process documentation.
• Ability to train others on the manufacturing equipment and processes.
• Revise and create documentation (SOP, batch records, reports, notebooks) associated with the manufacture of product, requiring minimal direction.
• Incorporate pre-planned process improvements and cost reduction projects into manufacturing.
• Ability to take on and manage multi-disciplined projects, with minimal supervision.
• Complete understanding/application of quality systems.
• Support of Health Authority inspections.
• Perform area equipment and process validations in accordance with validation procedures requiring minimal direction.
• Possesses technical and systems knowledge and is able to research information outside of knowledge base.
• Responsibilities also include hands-on manufacturing within the given area for production coverage. 
• Has ability to recognize problems and recommend solutions to problems based on technical understanding of the process and equipment.
• Support activities in other departments as instructed by manager.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.  Incorporates the Novo Nordisk Code of Conduct values in all activities and interactions with others.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• High School diploma or equivalent with a minimum of six (6) years relevant manufacturing experience or a Bachelor’s degree or equivalent in a science or engineering discipline with three (3) or more years of experience.
• Requires functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines.
• Ability to understand and execute established written instructions is essential.

Novo Nordisk US Bio Production, Inc. is located in Lebanon, NH, voted “Best Small Town in the US” by Livability. Along with being located in a wonderful place to live, Novo Nordisk offers excellent pay, benefits, 401K w/ company match, paid time off, and much more!

Apply today through our website at www.novonordisknewhampshirejobs.com to start your Life Changing Career!

Novo Nordisk US Bio Production, Inc (NNUSBPI). is looking for a committed, team oriented individual to join the Cell Culture team as a Manufacturing Supervisor. This position is responsible for supervising personnel and day to day operations involved in applicable department. The person in this role will be the example for strict adherence to cGMPs, following established manufacturing practices and procedures, and compliance with Quality regulations and guidelines, and encourage discussion for improvement and simplification.

• Reports to Head of Manufacturing Area
• Oversees assigned manufacturing group
• This individual interacts with other manufacturing and manufacturing support groups including Quality, Materials, Engineering, MS&AT, as well as SMEs at other manufacturing and process development sites in Denmark.
• This individual has direct supervisory responsibilities with 2 or more technicians reporting to it.

ESSENTIAL FUNCTIONS:

• Oversees and supervises all manufacturing activities within the department.
• Reviews, trains and develops Manufacturing Technicians in applicable department.
• Prepares documentation associated with the job duties of applicable department.
• Assures operations and practices comply with established procedures and records.
• Assures in-process tests are performed in accordance with standard procedures.
• Provides input during Health Authority inspections.
• Acquires technical expertise on the function and control of applicable department equipment and techniques related to job function, and regulatory requirements for the operation of the area.
• Support evaluation, specification, installation, and validation of new manufacturing equipment as needed.  
• Maintains validated systems and re-validates existing systems in accordance validation procedures.
• Incorporates value improvement programs and new processes from Product Support, Engineering, EH&S, and OE as directed.
• Serves as project member or project leader on improvement programs as needed.
• Supports manufacturing activities in other departments as instructed by manager.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.
• Incorporates the Novo Nordisk Code of Conduct values in all activities and interactions with others.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• Bachelor’s Degree or equivalent experience.
• Three (3) years manufacturing or process development experience in the pharmaceutical or biotechnology industry.
• Knowledge of bioprocessing and GMPs is essential.
• Ability to lead people and projects is required.

Excellent communication skills and ability to work in teams also required.

Novo Nordisk US Bio Production, Inc. is located in Lebanon, NH, voted “Best Small Town in the US” by Livability. Along with being located in a wonderful place to live, Novo Nordisk offers excellent pay, benefits, 401K w/ company match, paid time off, and much more!

Apply today through www.novonordisknewhampshirejobs.com to start your Life Changing Career!

Novo Nordisk US Bio Production, Inc, (NNUSBPI) has an immediate opportunity for an experienced Process Utility Technician III in West Lebanon, NH. This position has primary responsibility for process utility systems and related equipment. The person in this role will assist in the coordination and execution of facility equipment improvement programs, SOP creation/modification, reviews quality records, supports all quality comment and deviation responses (process utility systems and equipment), and has the ability to train technicians on various equipment and methods. This position is also responsible for the Maintenance Management System data in-put and operation to ensure all scheduled maintenance task are completed on time and in compliance with SOP’s. The right candidate for this position will have functional understanding of cGMP’s, established manufacturing practices and procedures, and compliance with GMP, QS, and ISO regulations and guidelines.

Essential Duties & Responsibilities:

• Independently trouble shooting, repair and maintenance of facilities related systems, including:  Purified Water, Water For Injection, and Clean Steam. 
• Support as needed: Plant Steam Systems, HVAC Systems, Exhaust Systems, Hot Water Heating systems/ Hot Water Heat Circulating Pumps, Humidification Systems, Chillers / HVAC Chilled Water Systems/ Chilled Water Circulating Pumps, Compressed Air Systems, Building Waste Systems,Tempered Water Systems/ Tempered Water Circulating Pumps, Domestic Water Systems, waste water and neutralization systems
• Complete assigned PM work orders and Facilities Work Request
• Comprehensive understanding/application of quality systems
• Support coordination and manage the activities of outside contract vendors relative to Facilities projects and other projects within the West Lebanon campus as they pertain to Process Utilities
• Provide direction to Level 1 and 2 technicians in the trouble shooting, repair and maintenance of equipment and / or systems
• In cooperation with other departments, write, execute and summarize validation protocols for facilities related systems
• Perform and supervise in depth building, system and equipment repairs
• Understanding of and ability to perform basic electrical repair
• Lead Cross Training on Building Utility systems as directed by supervisor
• Responsible for daily checks on all process utility systems
• Provide departmental training as needed
• Responsible for the Maintenance Management System data in-put and operation to ensure all scheduled maintenance task are completed on time and in compliance with SOP’s
• Review approval of completed quality documentation
• Write, review and revise sophisticated standard operating procedures relative to facilities equipment and / or systems
• Available for “On-Call” as required
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates the Novo Way values in all activities and interactions with others
• Perform all other duties or task required by NNUSBPI

Physical Requirements:

• Ability to lift 40 lbs
• Ability to spend majority of work shift walking or in the field working on equipment

Education/Special training required:

• High school diploma or equivalent
• Minimum of five (5) years experience in facility equipment / system maintenance

Qualifications/work experience required

• Ability to read and understand detailed architectural and equipment/system blue prints.
• Knowledge of proper use of hand tools
• Must be familiar with computer programs pertaining to Process Utilities
• Demonstrated ability to use Microsoft Offices Suite
• Solid communication skills including verbal and written
• Possess basic electrical knowledge

Previous experience in clean room and GMP applications required.

Novo Nordisk US Bio Production, Inc. is located in Lebanon, NH, voted “Best Small Town in the US” by Livability. Along with being located in a wonderful place to live, Novo Nordisk offers excellent pay, benefits, 401K w/ company match, paid time off, and much more!

Apply today through our website at www.novonordisknewhampshirejobs.com to start your Life Changing Career!

Company Description

Curis is a biotechnology company seeking to develop and commercialize innovative drug candidates for the treatment of human cancers. Our most advanced drug candidate is CUDC-907, an oral, small molecule inhibitor of histone deacetylase (HDAC), and phosphatidylinositol-3-kinase (PI3K) enzymes, which has completed the dose escalation stage of a Phase 1 clinical study. Curis is also engaged in a broad collaboration with Aurigene in the areas of immune-oncology and precision oncology. As part of this collaboration, we expect to exercise options to exclusively license small molecule antagonists of programmed death ligand-1 (PD-L1) and interleukin-1 receptor association kinase-4 (IRAK4) and file IND applications for both molecules.

Our most advanced program, a Hedgehog pathway inhibitor program developed in collaboration with Genentech (Roche), led to the commercialization of Erivedge® (vismodegib), the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma.  Genentech/Roche are responsible for the development and worldwide commercialization of Erivedge. Roche and Genentech are also continuing Erivedge®’s clinical development in less severe forms of BCC as well as planned development in other non-oncology indications.

Our corporate culture is focused on learning and growing in a challenging environment with a committed group of peers working together as a team. For more information, visit Curis' website at www.curis.com.

Director, Data Management

The Director, Data Management, reporting to Curis’ Chief Medical Officer, will lead the Data Management (DM) Department & assume responsibility for all DM functions pertaining to clinical & translational activities.

Essential Functions

• Lead the design, implementation & execution of clinical DM & DM strategy.
• Ensure that Curis’ clinical DM processes, procedures & technologies are consistent with current industry practices & meet all regulatory requirements (domestic & international, as applicable).
• Assess & advise on the development, acquisition & use of tools to support & strengthen Curis’ clinical development capabilities and the achievement of registrational goals.
• Advise on the planning, execution & maintenance of DM projects.
• Coordinate & manage biostatics & programming activities.
• Manage & lead data review meetings.
• Develop department budgets & anticipate staffing requirements.
• Generate DM departmental SOPs, guidelines, & technical documents (as applicable).
• Supervise & manage DM staff, contractors/CROs (as applicable); monitor DM staff, CRO & vendor deliverables/activities.
• Maintain current professional knowledge in DM, computer science, quality assurance, & other fields as applicable.

Qualifications: 

• Bachelor’s degree required. Master’s degree preferred.
• 10+ years of increased responsibility within Data Management.
• 4+ years of Oncology experience.
• SAS knowledge and experience strongly preferred
• Must be highly skilled in MS Office (Word, Excel, PowerPoint, Outlook, Access)
• Attention to detail and the ability to prioritize/manage multiple tasks
• Strong organizational, communication, and decision-making skills.
• Ability to effectively interact with all levels of internal and external management, including CROs.
• Self-motivated with the ability to work in an unstructured environment

Please send CV with job code (DDM500) to:
Human Resources, Curis, Inc.
4 Maguire Rd.
Lexington, MA 02421

Email: jobs@curis.com or Fax: 617.503.6501.

No phone calls please.

Curis, Inc. is an Equal Opportunity Employer.

Novo Nordisk US Bio Production, Inc. (NNUSBPI) has an immediate opening for a QA Area Specialist to join our growing team in West Lebanon, New Hampshire. This position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. The QA Area Specialist will assist in the internal audit program and vendor assessment / vendor qualification program. If required, this position will also support, as assigned, GLP pre-clinical and clinical bioanalytical testing conducted in the Biology group.

ESSENTIAL FUNCTIONS:

• Performs walk through audits of NNUSBPI Manufacturing facilities.
• Releases product based on Quality Assurance record review and approval by Manager, Quality Assurance.
• Review and assess Corrective and Preventive Actions.
• Reviews and approves validations and technical reports.
• Reviews and assesses deviations; includes tracking, follow-up and reporting/trending.
• Reviews manufacturing and support records to certify compliance with specifications and procedures.
• Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of the facility, and deviation issues.
• Assists in performing and reporting internal and vendor audits as scheduled.
• Participate in Regulatory Inspections.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes. Incorporates the NNUSBPI Code of Conduct values in all activities and interactions with others.
• Other duties as assigned.

PHYSICAL REQUIREMENTS:

• Travel: 5-10%.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• Bachelor’s Degree (or equivalent) required, a scientific discipline preferred
• A minimum of three (3) years of GMP-related experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience.
• Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors.
• Excellent written and verbal communication and negotiating skills are required.
• Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken.
• Normally receives little to no instructions for routine work, and general instructions for new assignments.
• Strong planning and organization skills, with flexibility for changes in work priorities.

Novo Nordisk US Bio Production, Inc. is located in Lebanon, NH, voted “Best Small Town in the US” by Livability. Along with being located in a wonderful place to live, Novo Nordisk offers excellent pay, benefits, 401K w/ company match, paid time off, and much more!

Apply today through our website at www.novonordisknewhampshirejobs.com to start your Life Changing Career!

Position Summary
The Clinical Trial Manager will lead the planning and manage the implementation of clinical operational plans in alignment with the company’s strategic objectives, and in accordance with regulatory guidelines and Good Clinical Practice. Delivers the operational aspects of one or more clinical trials from protocol development to generation of clinical study reports. Supports effective trial reporting and closeout, submission activities and audits/inspections as appropriate. Responsible for effective global management of the study team and relationships with CROs, central labs, IRB’s, investigating sites and other external partners. Coordinates the activities of all trial conduct partners and team members and proactively identify and manage risks. The Clinical Trial Manager will liaise with cross-functional team members for technical system and process expertise and therapeutic area operational knowledge.

Key Responsibilities
Execute effective development operational plans aligned with the strategic development plan while ensuring compliance to current regulatory guidance and GCPs.
Review Project Specific Request for Proposal, vendor specifications and participate in vendor selection.
Develop and manage vendor scope of work as per contract and budget.
Function as primary liaison between clinical vendors and to assure understanding of expectations and scope of work.
Translate identified goals, key activities and associated timelines for assigned clinical operations programs and manage external resources toward successful achievement of the goals.
Lead the development of integrated study timelines through collaboration with internal and external stakeholders.
Develop the Project Plan and communicate content to all team members Manage aspects of trial operations, including vendor performance, internal metrics, quality assurance checks and communication of trial status within and outside the trial team.
Anticipate, recognize and resolve issues; recognize the need to seek assistance or inform senior management of specific issues.
Prepare and maintain assigned program files, study documentation and other regulatory documents.
Regularly meet with Manager to discuss overall clinical trial(s) plans, update forecasting, and potential issues or recommendations.
Manage and lead Clinical Sub-team Meetings collaborating with cross-functional team members regarding operational activities pertaining to the execution of one or more clinical trial(s).
Manage activities associated with routine and advanced trial start-up, conduct and closeout activities according to industry and corporate standards and goals.
Organize and lead necessary study team training efforts for all facets of trial-specific operations including consultation with other functional departments as needed.
Manage study timelines according to changing requirements. Build stakeholder commitment to deliverables and ensures progress toward the completion of trial(s) is in line with agreed study objectives.
Prepare and present trial specific updates to management. Review vendor invoices and help manage accruals and SOW changes.
Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, monitoring plans, trial reports and DSURs.
Provide trial support, performance management, and career development guidance to team members and direct reports.
Regularly provide feedback to team members on individual performance and contribution to the overall team effort.
Participate in performance review process for direct reports.
Participate in company sponsored training programs as required to ensure that skills are learned, maintained and focused accordingly.
Perform necessary administrative functions and additional duties as assigned

Requirements
Abilities Needed for Success
Proven ability to work with a high level of integrity, accuracy, and attention to detail
Strong technical/analytical skills to identify and solve problems.
Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making.
Proactively seeks out and recommends process improvements.
Entrepreneurial, enjoys working in a fast-paced, small-company environment.
Flexibility in handling work flow in a multi-tasking environment.
Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality. Job Requirements
Bachelor’s degree in life sciences or equivalent training required.
7-8 years of experience in clinical trial management in Phase 1 – 3 studies in a CRO or biopharma setting, with minimum of 3 years as a Clinical Trial/Project Manager.
At least 3 years of experience in managing clinical trial vendors (i.e. CRO, Central Laboratories).
Oncology experience is required.
Demonstrated experience in global clinical trial management and conduct(i.e. project and development plans, trial budgets, timelines, status reports, issue management, resource and personnel management).
Direct monitoring experience or equivalent in-house clinical management experience.
Demonstrated knowledge and understanding of FDA/EMA/GCP/ICH guidelines.
Experience with Quality Assurance activities preferred.
Demonstrated knowledge of the drug development and clinical trial processes, scientific research concepts data management and clinical operations. Willingness to work in a dynamic and changing corporate environment.
Accommodates a flexible work schedule according to clinical trial(s) priorities, as needed.
Must be willing to travel, both domestic and international.

Position Summary
The Clinical Trial Manager will lead the planning and manage the implementation of clinical operational plans in alignment with the company’s strategic objectives, and in accordance with regulatory guidelines and Good Clinical Practice. Delivers the operational aspects of one or more clinical trials from protocol development to generation of clinical study reports. Supports effective trial reporting and closeout, submission activities and audits/inspections as appropriate. Responsible for effective global management of the study team and relationships with CROs, central labs, IRB’s, investigating sites and other external partners. Coordinates the activities of all trial conduct partners and team members and proactively identify and manage risks. The Clinical Trial Manager will liaise with cross-functional team members for technical system and process expertise and therapeutic area operational knowledge.

Key Responsibilities
Execute effective development operational plans aligned with the strategic development plan while ensuring compliance to current regulatory guidance and GCPs.
Review Project Specific Request for Proposal, vendor specifications and participate in vendor selection.
Develop and manage vendor scope of work as per contract and budget.
Function as primary liaison between clinical vendors and to assure understanding of expectations and scope of work.
Translate identified goals, key activities and associated timelines for assigned clinical operations programs and manage external resources toward successful achievement of the goals.
Lead the development of integrated study timelines through collaboration with internal and external stakeholders.
Develop the Project Plan and communicate content to all team members Manage aspects of trial operations, including vendor performance, internal metrics, quality assurance checks and communication of trial status within and outside the trial team.
Anticipate, recognize and resolve issues; recognize the need to seek assistance or inform senior management of specific issues.
Prepare and maintain assigned program files, study documentation and other regulatory documents.
Regularly meet with Manager to discuss overall clinical trial(s) plans, update forecasting, and potential issues or recommendations.
Manage and lead Clinical Sub-team Meetings collaborating with cross-functional team members regarding operational activities pertaining to the execution of one or more clinical trial(s).
Manage activities associated with routine and advanced trial start-up, conduct and closeout activities according to industry and corporate standards and goals.
Organize and lead necessary study team training efforts for all facets of trial-specific operations including consultation with other functional departments as needed.
Manage study timelines according to changing requirements. Build stakeholder commitment to deliverables and ensures progress toward the completion of trial(s) is in line with agreed study objectives.
Prepare and present trial specific updates to management. Review vendor invoices and help manage accruals and SOW changes.
Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, monitoring plans, trial reports and DSURs.
Provide trial support, performance management, and career development guidance to team members and direct reports.
Regularly provide feedback to team members on individual performance and contribution to the overall team effort.
Participate in performance review process for direct reports.
Participate in company sponsored training programs as required to ensure that skills are learned, maintained and focused accordingly.
Perform necessary administrative functions and additional duties as assigned

Requirements
Abilities Needed for Success
Proven ability to work with a high level of integrity, accuracy, and attention to detail
Strong technical/analytical skills to identify and solve problems.
Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making.
Proactively seeks out and recommends process improvements.
Entrepreneurial, enjoys working in a fast-paced, small-company environment.
Flexibility in handling work flow in a multi-tasking environment.
Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality. Job Requirements
Bachelor’s degree in life sciences or equivalent training required.
7-8 years of experience in clinical trial management in Phase 1 – 3 studies in a CRO or biopharma setting, with minimum of 3 years as a Clinical Trial/Project Manager.
At least 3 years of experience in managing clinical trial vendors (i.e. CRO, Central Laboratories).
Oncology experience is required.
Demonstrated experience in global clinical trial management and conduct(i.e. project and development plans, trial budgets, timelines, status reports, issue management, resource and personnel management).
Direct monitoring experience or equivalent in-house clinical management experience.
Demonstrated knowledge and understanding of FDA/EMA/GCP/ICH guidelines.
Experience with Quality Assurance activities preferred.
Demonstrated knowledge of the drug development and clinical trial processes, scientific research concepts data management and clinical operations. Willingness to work in a dynamic and changing corporate environment.
Accommodates a flexible work schedule according to clinical trial(s) priorities, as needed.
Must be willing to travel, both domestic and international.

Novo Nordisk US Bio Production, Inc. (NNUSBPI)  has an immediate opening for a detail orientated Quality Control Analyst – Analytical to join our growing QC Team in West Lebanon, New Hampshire. This position works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.  The person in this role will exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions, while maintaining a high level of compliance with cGMP’s. 

ESSENTIAL FUNCTIONS:

• Supports routine release and stability testing using various analytical techniques such as ELISA, HPLC and SDS PAGE.
• Assists in writing assay validation protocols and writes summary reports, independently.
• Investigates and resolves issues related to assay failures, system deficiencies, deviations, equipment and assay troubleshooting independently or as part of a team.
• Maintains, calibrates, and troubleshoots equipment.  Performs routine laboratory activities, including peer data review, as needed.
• Conducts routine and specialized assays following SOP’s.
• Schedules laboratory work in conjunction with laboratory supervisor.
• Review and amend test method and instrumentation SOPs as needed.
• Works in conjunction with analytical scientists to provide support for method validation and method transfer.
• Updates and maintains trending files, and provides routine summaries of trending to support investigations.
• Assists with other routine laboratory investigations including analyst training.
• This person may participate in determining methods and procedures on new assignments as required.
• This person may participate in microbiology testing as needed.

• This person may also take part in warehouse duties revolving around in coming inspection and final packaging.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.  Incorporates the Novo Nordisk Way and Essentials in all activities and interactions with others.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• A Bachelor’s degree (or equivalent education/experience) in a scientific discipline with a minimum of three (3) years related experience or a Master’s with one (1) year of related experience. 
• Must be able to work independently in a team based setting and function in a rapidly changing environment while balancing multiple priorities simultaneously. 
• Excellent analytical and writing skills are also required.
• Demonstrated ability to work independently with minimal instructions.

Novo Nordisk US Bio Production, Inc. (NNUSBPI) is located in Lebanon, NH, voted “Best Small Town in the US” by Livability. Along with being located in a wonderful place to live, Novo Nordisk offers excellent pay, benefits, 401K w/ company match, paid time off, and much more!

Apply today through our website at www.novonordisknewhampshirejobs.com to start your Life Changing Career!

Novo Nordisk US BPI in West Lebanon, NH is looking for a QC Analytical Scientist to oversee, schedule and lead day-to-day Quality Control activities. The person in this role will be responsible for routine in-process and product testing ensuring compliance, accuracy and timeliness of testing processes in compliance current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). The QC Analytical Scientist will also provide QC Analytical training and guidance to Analysts and Technicians. Supply information to cross functional teams about testing timelines and related quality issues.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Mentor and lead Analytical team and manage overall workflow.
• Schedule and oversee all assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
• Follow and train analysts and technicians in all general and laboratory SOPs.
• Lead method transfer between Denmark facilities and internal departments.
• Review and amend test methods and instrumentation SOPs as needed.
• Lead laboratory investigations involving assay failures, system deficiencies, deviations, equipment and assay troubleshooting within Quality System.
• Oversee and participate in maintenance, calibration and troubleshooting of equipment.
• Conducts data review of results and reports data to Manager, QC.
• Communicate with manager and other colleagues re: daily lab activities.
• Manage preparation of protocols, final reports, investigations, and deviations.
• Update and maintain trending files, and provide routine summaries of trending to support investigations.
• Participate in personnel 3P and annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
• Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

PHYSICAL REQUIREMENTS:

• Ability to sit and stand for extended periods of time
• This position requires walking, holding, bending, stooping
• Ability to lift up to 25lbs
• 20/20 vision or ability to wear corrective eye wear to create 20/20 vision

Education/Special training required:

• BS in analytical chemistry, biochemistry or related field with a minimum of seven (7) years related experience or a Master’s/PhD with a minimum three (3) years of related experience. 

Qualifications/work experience required

• Must have a minimum two (2) years experience leading/mentoring scientific staff in a biotech/pharmaceutical analytical laboratory with demonstrated ability to develop scientific staff.
• Working knowledge of cGMPs and industry experience.
• Technical expertise in protein analysis using HPLC, SEC, ELISA, IEF.
• Experience with method qualification, validation and technology transfer.
• Experience with Quality Systems such as change control, document root cause analysis.
• Excellent analytical and writing skills are also required with the ability to author/review scientific and technical reports.

Novo Nordisk US Bio Production, Inc. (NNUSBPI) is located in Lebanon, NH, voted “Best Small Town in the US” by Livability. Along with being located in a wonderful place to live, Novo Nordisk offers excellent pay, benefits, 401K w/ company match, paid time off, and much more! 

Apply today through our website at www.novonordisknewhampshirejobs.com to start your Life Changing Career!

Novo Nordisk US Bio Production, Inc. (NNUSBPI) in West Lebanon, NH has an immediate opening for a Quality Control Microbiology Scientist. This position is the subject matter expert on industrial/pharmaceutical microbiology for the facility and will be responsible for ensuring facility program is in line with industry, regulatory and corporate practice.  The person in this role will need to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions, while maintaining a high level of compliance with cGMP’s.  It is expected that the QC Microbiology Scientist will be able to work with little to no instructions on routine work, and general instructions on new assignments.

Essential Duties & Responsibilities

• Key lead for microbial identification program.
• Responsible for introduction of new technology/equipment as needed.
• Technical subject matter expert on microbiological assays, techniques and industry practices.
• Conducts routine and specialized microbiological assays in standard techniques.
• Reviews microbiological trending data and writes reports summarizing the trends, independently.
• Investigates and resolves issues related assay failures, system deficiencies, deviations, and equipment / assay troubleshooting, with no assistance.
• Performs other routine laboratory activities and peer data review as needed.
• Conducts routine and specialized assays following SOP’s.
• Schedules laboratory work for self and others.
• Review and amend test method and instrumentation SOPs as needed.
• Updates and maintains trending files, and provides routine summaries of trending to support investigations.
• Assists with other routine laboratory investigations including analyst training.
• Determines methods and procedures on new assignments as required.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.
• Incorporates the Code of Conduct values in all activities and interactions with others.

Education/Special Training Required

• Bachelor’s degree in microbiology, biological sciences or related field with a minimum of six (6) years related experience or;
• Master’s/PhD with a minimum three (3) years of related experience.

Qualifications/Work Experience Required

• Must have a minimum three (3) years experience in a lead role within a biotech/pharmaceutical microbiology laboratory.
• Demonstrated ability to work independently in a team based setting and function in a rapidly changing environment while balancing multiple priorities simultaneously.
• Able to perform Sterility, Bacterial Endotoxin, Bioburden and Microbial Identification testing.
• Basic troubleshooting for laboratory equipment.
• Experience with environmental monitoring preferred.
• Excellent analytical and writing skills are also required with the ability to author/review scientific and technical reports.

Novo Nordisk US Bio Production, Inc. is located in Lebanon, NH, voted “Best Small Town in the US” by Livability. Along with being located in a wonderful place to live, Novo Nordisk offers excellent pay, benefits, 401K w/ company match, paid time off, and much more!

Apply today through our website at www.novonordisknewhampshirejobs.com to start your Life Changing Career!

Novo Nordisk US Bio Production, Inc. (NNUSBPI) has an immediate opening for a quality minded, detail oriented, Validation Engineer to join our team in West Lebanon, NH. This position will work on validation activities where in-depth analysis, authoring protocols, teamwork and flexibility are required.  Responsible for validation activities in several areas of pharmaceutical manufacturing such as: DQ, IQ, OQ, PQ, requalification, cleaning, sterilization and utilities.

ESSENTIAL FUNCTIONS:

• Primary responsibilities include validation protocol execution (IQ, OQ, PQ & PV), data analysis and final report preparation for utilities, equipment and instrumentation.
• Maintain effective communication and ensure alignment in coordination with appropriate teams.
• Support facility certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of such facilities.
• Ensures systems and processes are validated in a compliant manner in accordance with FDA, EU and NN requirements.
• Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
• Completes accurate and timely assessments associated with change control activities.
• Ensures change control activities for systems are completed in a manner in compliance with FDA, EU and NN regulations.
• Support validation of new and existing equipment, processes and instrumentation as needed.
• Write and review protocols, summary reports and other documentation associated with validations.
• Coordinate Validation activities within Novo Nordisk US Bio Production, Inc as well as with outside vendors as needed.
• Represent the Validation department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups).
• Assist in the training of and/or direct the efforts of less experienced Validation Engineers and Validation Technicians.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.
• Incorporates the Novo Nordisk Way in all activities and interactions with others.

PHYSICAL REQUIREMENTS:

• Ability to lift up to 40 lbs. with assistance.
• Ability to work in confined spaces and near operating equipment.
• Ability to be clean room certified.

• Ability to accommodate extensive international travel.
• Ability to work hours necessary to support project, 24/7 production and /or maintenance activities.

• Ability to work in loud noise environments.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• Bachelor’s degree or equivalent experience in life sciences or engineering.
• A strong work ethic (self-motivated) and demonstrated ability to work in teams.

• A minimum of three (3) years validation experience in the pharmaceutical or biotechnology industry.
• Experience preparing protocols, executing data analysis, and report writing.
• Ability to demonstrate broad understanding of:
  • Concepts of Validation.
  • Change control processes.
  • Root cause analysis techniques and cGMP documentation practices.
  • cGMP regulations, GMP and other industry standards pertaining to validation.
  • Technical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation.
• Excellent written and verbal communication skills a must.

Novo Nordisk US Bio Production, Inc. (NNUSBPI) is located in Lebanon, NH, voted “Best Small Town in the US” by Livability. Along with being located in a wonderful place to live, Novo Nordisk offers excellent pay, benefits, 401K w/ company match, paid time off, and much more!

Apply today through our website at www.novonordisknewhampshirejobs.com to start your Life Changing Career!

RESEARCH ASSOCIATE ­- BIOANALYTICAL CHEMIST

WaVe Life Sciences USA seeks an experienced and highly motivated research associate to join its team of scientists in Cambridge, Massachusetts. This is an ideal position for an individual with a strong background in analytical chemistry, organic chemistry, nucleic acid chemistry or related field who thrives in a team-oriented, fast-paced, and cross disciplinary biotech environment. The candidate will be an integral member of a small team of scientists aiming to rapidly and pragmatically realize the potential of an emerging technology.

POSITION RESPONSIBLITIES:

• Experience in small molecule compounds from a wide variety of therapeutic and chemical classes

• Responsible for analyzing and interpreting data from molecular pharmacology studies

• Involved in planning experimental design and execution of all aspects of bioanalysis, efficient assay development and creative problem solving

• Adept at preparation of clear and accurate reports for internal and external projects

• Capacity to be highly productive in a fluid and fast-paced work environment

• Committed and collaborative team player

  EDUCATION/EXPERIENCE:

• BS or MS degree in bioanalytical chemistry or related discipline with at least 3 years of bioanalysis of drugs in plasma, serum, and /or tissue samples

• Excellent verbal and written communication skills, and the ability to collaborate effectively with other scientists in a multidisciplinary environment

• Experience in the research and development of oligonucleotide therapeutics

• Experience within a start-up or small biotech environment

WaVe Life Sciences USA seeks an experienced and highly motivated individual to join our Early Development team in Cambridge, Massachusetts.  The ideal candidate will focus on developing and executing program requirements within a team-oriented, fast-paced and cross-disciplinary biotech environment.

POSITION RESPONSIBILITIES

• Responsible for planning and execution of product development projects 

• Plans and directs schedules and monitors budget/spending 

• Ensures consistent practices throughout all phases of the project life cycle 

• Drives the development and manages the execution of high quality, integrated cross-functional plans for projects

• Applies project management best practices in the development, initiation, planning, execution, control and closing of projects 

• Provides clear direction on product development requirements to meet expectations of external customers and business stakeholders 

• Interacts with research and development, manufacturing, and regulatory departments and with external stakeholders 

• Responsible for project performance, risk management, administration, financial management and issue resolution for functional group 

• Selects, develops and evaluates personnel to ensure the efficient operation of the function

• Develops and administers budgets, schedules and performance requirements 

REQUIREMENTS 

• BS/MS in life science and/or certification in Project Management plus 10+ years’ relevant experience in the development, initiation, planning, execution, control and closing of projects 

• Supervisory experience

• Excellent communication skills and ability to effectively manage projects cross functionally

WaVe Life Sciences USA seeks experienced and highly motivated individual to join its manufacturing team in Cambridge, Massachusetts.  The ideal candidate will focus on assuring quality requirements of products to be fulfilled within a team-oriented, fast-paced and cross-disciplinary biotech environment.

POSITION RESPONSIBILITIES:

• Oversees the development, implementation and maintenance of quality assurance systems and activities

• Oversees the generation and review of documents used in good manufacturing practices (GMP)

• Monitors audits of production and quality control areas 

• May audit raw material vendors and prepare manufacturing documentation for updated filing

• Wide ranging role to support manufacturing and chemistry, manufacturing and controls (CMC)

• May lead investigations and resolve potential product quality issues to improve efficiency 

• Selects, develops and evaluates personnel to ensure the efficient operation of the function

• Develops corporate and/or organizational policies and authorizes their implementation

• Identifies and evaluates fundamental issues for major functional areas

• Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies both internally and externally 

• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people

• Directs and controls the activities of one or more functional areas, divisions, product or service groups, etc. through managers with overall responsibility for the direction of those assigned areas 

• Has overall responsibility for planning and implementing budget

EDUCATION/EXPERIENCE:

• BS/MS in a scientific discipline with a minimum of 5-8 years of related experience

• Supervisory background

• Requires the ability to work effectively with a cross functional team

• Prior experience in a startup or small biotech environment is strongly preferred

Global cGMP Pharmaceutical company here in MA is looking to add a Sr. Automation Engineer – BMS to their team!  This role will support Manufacturing and Operations and help guide and direct major automation projects and as well as provide guidance to other automation engineers in technical know-how and best practices.   Engineer will also improve the efficiency and effectiveness of the Engineering Technical Services Group by contributing towards infrastructure and system improvements, policies, guidelines, procedures, standards and cross-functional business processes. The candidate should have a mindset of knowledge sharing, major contributor in design reviews across the portfolio of departmental projects, and contribute to best practice forums across Technical Operations.  Other responsibilities include but not limited to: 

• Providing tactical support and the ability to troubleshoot day to day issues will be expected, as well as providing well thought out solutions.
• Participate in all stages of engineering project lifecycle from conceptual design, detailed design, specification, implementation, commissioning, trouble-shooting, and continuous improvement of automation and instrumentation for biopharmaceutical production and supporting utility systems.
• Act as a liaise between Manufacturing and Facility clients and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of automation systems for cGMP production facilities. Candidate will manage continuous improvement projects and lead the automation portion of cross-functional capital projects. Make recommendations for expense and capital budgets to Automation leadership team.
• Lead the discipline and coordinate with functional peers to define issues, develop and document solutions, provide solutions to complex projects and communicate updates and performance back to peers and management.
• Assess and communicate risk associated with projects and tactical support solutions, which in many cases will be within a cGMP environment.

Requirements:

• Bachelor’s degree in Electrical Engineering, Engineering Sciences or Computer Sciences with appropriate industrial controls experience & 5+ years of BMS, PLC, SCADA, instrumentation configuration, programming, and design in a cGMP environment.  
• Experience with Allen Bradley PLC platforms as well as Schneider Electric and Johnson Controls BMS systems, SCADA systems, PI Historian, Siemens PLC S7, iFix, iHistorian, Industrial Ethernet networks, Profibus and AS-I networks.
• Experience with S88 and ASTM 2500 principals preferred.

We seek a highly motivated individual to join our team to support the functions of our laboratory operations.  We are looking for a team player willing to accept personal accountability for successful job performance and who has a willingness to learn new skills as well as to continually improve his/her existing skill set. 

 POSITION RESPONSIBILITIES: 

• Manages all glassware cleaning and sterilizing

• Manages laboratory reagent and consumables receiving and inventory

• Provides buffer preparation

• Troubleshoots operational issues as they arise in conjunction with operational personnel

• Assists with documentation of standard operating procedures

• Maintains logs and record books

• Supports shipping and receiving accepting and preparing shipments

REQUIREMENTS:

• BS or Associate degree in laboratory science or other science-related degree

• Minimum 2 years’ experience working in a laboratory setting

• Proficiency in MS Office and email, particularly Excel

• Ability to work both independently and in a team environment

• High attention to detail

• Excellent organizational and time-management skills

• Superior oral and written communication skills

• Ability to work in a fast-paced environment

If interested and qualified, please include Requisition # 2015-112 in the subject line when emailing resume to: careers@crisprtx.com.

Head of Human Resources

Position Summary

Reporting to the CEO, this person will provide strategic and operational Human Resources leadership in support of the organization’s growth at a critical phase of growth for the company. The successful candidate will facilitate leadership team discussion pertaining to HR strategy, culture, policy and programs.  This leader will have a broad and deep understanding of technical, strategic, and operational aspects of HR including: compensation, benefits, HRIS, strategic planning, organizational and leadership development, talent acquisition/management, employee relations, and training and development.

Responsibilities

• Lead the strategic planning as relates to growth of the company from an HR and personnel perspective
• Support the development of the organizational architecture to support long-term growth for the company
• Lead the design, development and implementation of a comprehensive performance management system
• Develop and launch an appropriate market competitive total reward (compensation and benefits) strategy that enables the Company attract, hire, develop, reward and retain top talent, and to deliver on mission critical business objectives. 
• Design and implement leadership and employee development programs (including succession planning)
• Engage with executives, management, staff and direct reports to establish an environment that is motivating and entrepreneurial in nature. Lead and coach the HR and executive teams to regularly reinforce a “best place to work” culture
• Develop and reinforce a strong collaborative culture (with and among) senior leaders, peers and other functions with the company
• Create, develop and promote a culture of innovation, teamwork, transparency, commitment, focus, excellence, and impact
• Assess/develop HR policies, processes, and systems. Build the HR infrastructure needed to support the Company’s growth and business strategies.
• Provide the appropriate day-to-day to help the business and support staff leaders run their respective areas effectively
• Provide strong leadership and business acumen, data and analytical skills and relationship-building capabilities to inspire employees and the organization around common goals, vision and values

Minimum Qualifications

• 10 years’ of successful HR or related experience in a dynamic, growing company
• Demonstrated success as part of the senior leadership team of their current/previous employer
• Experienced coach to CEO and senior management team
• Proven leadership experience and track record of success in leading an HR function; setting the vision, then building, leading and motivating the team
• Respected  HR leader with strong generalist/business partnership background and knowledge of emerging HR trends
• BS in Human Resources, Business, or related discipline

Preferred Qualifications (in addition to the Minimum Qualifications above)

• Masters/MBA or advanced degree in the Life Sciences
• 15+ years experience leading an innovative HR function for a growing Biotech/Pharma organization
• Prior success in the top HR role in an emerging, high growth life sciences company

Competencies

• Strategic Thinking– The ability to develop strategies and goals that recognize business issues, opportunities, and environment.
• Adaptability– Adjusts to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.  Shows initiative and demonstrates learning orientation and flexibility.
• Attracting and Developing Talent– The ability to assess gaps in the organization and recruit, assess and grow talent effectively to address those gaps.
• Integrity and Trust– Acts ethically and gains the trust and respect of others.
• Interpersonal Relations– The desire to understand others and their concerns and to initiate and develop relationships with others.  Builds and maintains productive working relationships across a diverse spectrum of people.
• Business Knowledge– Understands the overall industry and internal processes that produce business results.
• Results Orientation– Drives issues to closure and gets the job done.  Skilled at analyzing scope of work, as well as planning and executing a successful outcome. 

If interested and qualified, please include Requisition # 2015-112 in the subject line when emailing resume to: careers@crisprtx.com.

Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.