General
uniQure is dedicated to bringing therapies for unmet medical needs to patients. In doing so, each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life (i) by living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Under minimal supervision, the Facilities Technician- HVAC performs all responsible tasks necessary to operate, troubleshoot, service, adjust, repair and maintain facilities equipment and utilities supporting manufacturing processes. The incumbent must be able to perform a variety of tasks including, but not limited to, monitoring, adjustment, and implementation of corrective actions. He or she must be able to perform routine and non-routine maintenance with adherence to all safety, environmental, and quality policies and procedures, and must be able to communicate & coordinate with customers and stakeholders regarding schedule and impact of work being performed.

The Facilities Technician- HVAC must be proficient in the use of various types of instrumentation to service, maintain and troubleshoot issues for all types of heating, air conditioning equipment and refrigeration systems. He or she must possess working knowledge of DDC, pneumatic and electronic controls, VAV boxes, hot water heating systems, and large tonnage chillers, including related pumps. The Facilities Technician- HVAC must be capable to analyze, troubleshoot and repair HVAC equipment in both a team setting and independently. The incumbent will work with computerized building automation system to monitor, operate, and adjust environmental and process temperature and humidity controls to ensure efficient operations.

Main purpose of the job

• Performs scheduled and emergency maintenance on critical process equipment, utility systems, HVAC systems, and facilities. Ensures quality of work and thoroughly documents all maintenance activities.

• Responsible for HVAC and utility system operations, including creation of SOPs, Change Controls, CAPAs, and monitoring excursion investigations.

• Operation and administration of site wide Building Management System (BMS) including documented follow up to alarms in accordance with cGMP guidance.

• Supports the Facilities Manager, providing supervision of work performed by maintenance service providers and contractors, ensuring work adheres to / aligns with uniQure Procedures.

• Takes daily readings on critical equipment and systems, documenting findings and following up on issues in accordance with approved procedures.

• Coordinates maintenance and work activities with manufacturing, quality control, and process development groups.

Qualifications

• A High School diploma or its equivalent is required. A technical certification or relative trade experience is preferred.

• A minimum of 5-7 years of experience in a commercial environment is required. Experience in a regulated, automated industry (e.g. pharmaceutical, biopharmaceutical, or medical device) is preferred.

• Must be able to read and interpret drafts, diagrams, blue prints and repair manuals.

• Basic knowledge of Microsoft programs (Excel, Word, Outlook etc.) is required.

• Experience with building automation systems is preferred.

• Candidates must possess the ability to independently troubleshoot air distribution, pneumatic, electronic, and hydronic systems, in a safe, compliant, and effective fashion.

• Excellent verbal and written communication skills are required for this role as it includes interactions with government and company auditors / inspectors.

• Candidates must either possess or be willing to obtain Massachusetts Waste Water Treatment License.

• Candidates must be willing to be on call for off hours, holidays, and weekends, and able to respond to emergency calls.

• Must be Able to lift 40 pounds, access crawl spaces and use ladders to access equipment.

Core competencies

• Strong oral and written communication skills

• Ability to plan, coordinate, perform, and document work with minimal supervision

• Positive attitude, service oriented, and willingness / ability to perform maintenance on all equipment, systems, and facilities

• Demonstrated analytical and problem solving skills

• Must be able to perform under pressure, providing emergency troubleshooting and repair on critical process and utility systems.

PLEASE APPLY DIRECTLY VIA THE "CAREERS" TAB ON OUR WEBSITE AT WWW.UNIQURE.COM

Research Associate - Molecular Biology will join a group dedicated to the discovery of therapeutics for neurological diseases. 

For details visit:

http://www.cwsciences.com/Current-Openings/Research-Associate--Molecular-Biology

Email resume to: jobs@cwsciences.com

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


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

Applied DNA Sciences, Inc

Director Production Operations

JOB description

Applied DNA Sciences, Inc. is a provider of botanical-DNA based security and authentication that can help protect products, brands and intellectual property of companies, governments, and consumers from theft, counterfeiting, fraud and diversion. SigNature® DNA and smartDNA™, our principal anti-counterfeiting and product authentication solutions that essentially cannot be copied, provide a forensic chain of evidence that can be used to prosecute perpetrators.   

Position Summary:  

The Director Production/Operations is responsible for the overall operation of DNA and  biotechnology production.  He/she will directly manage 1 manager who in turn is directly responsible for directing and managing the activities of production.  This position will have the leadership responsibility for operations in a busy, labor intensive, biotech manufacturing space. This role has essential responsibility for ensuring operational effectiveness and stability and includes: overseeing several production functions, achieving volume and quality targets, managing of human and equipment resources and executing improvements in areas of responsibility. 

Essential Duties and Responsibilities:

• Raw materials are collected and/or received promptly and accurately. 
• Processing is performed promptly, accurately and proficiently.
• Metric-driven performance, quality, cost and throughput initiatives are implemented. 
• Oversight and leadership of all onsite production departments.
• Move production to cGMP certification.
• Management and improvement of operational systems, processes and policies in support of the organization’s vision and direction, specifically supporting: Management Reporting, Information Flow, Business Processes, Organizational Planning, Company Cohesion and Growth. 
• Maintaining production volumes and quality targets. 
• Ensuring production processes are according to Standard Operating Procedures (SOP’s).
  Assure that equipment and other resources are adequately maintained to support production functions. 
• Perform frequent production policy review and implement improvements. 
• Ensure adequate record keeping and accuracy in all functions.
  Maintain production to budget and contribute to financial control and cost reduction.
• Collaborate with HR executive to ensure effective training, coaching and growth of employees and maintain satisfactory work environment and conditions for all staff.
• Collaborate with the Finance Executive to ensure effective financial integration including reporting, budgeting and financial planning.
• Ensure that production procedures meet the company’s ISO 9001 & ISO 17025 quality standards.  
• Implementing initiatives geared toward furthering operational excellence, culture and values. 
• Coordinate the resolution of manufacturing and supply issues to ensure robust, reliable, compliant, and cost efficient process.   

Qualifications:

Education/Experience:

Bachelor degree in Scientific discipline, Biotechnology, Engineering or similar. BS with 8+ years relevant experience, or equivalent combination of education and experience. MS with 6+ years relevant experience, or equivalent combination of education and experience.

Several years of experience in production of (bio-) pharmaceutical products in international (bio-) pharmaceutical industry.

Knowledge of manufacturing process technology for (bio-) pharmaceutical products.

Knowledge of (bio-) pharmaceutical processes (Manufacturing /Logistics / Quality Management / Development / Regulatory).

Knowledge of global regulatory compliance (EMA, FDA, etc.) requirements. 

POSITION SUMMARY

We have an exciting newly created opportunity for an outstanding Senior Scientist in our Virology Group, who will be responsible for selecting and characterizing drug-resistance mutants, culturing and testing clinical isolates, and supporting in vitro and in vivo antiviral studies.

ABOUT ENANTA

Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs for viral infections and liver diseases.  Enanta has developed novel protease and NS5A inhibitors that are members of the direct-acting-antiviral (DAA) inhibitor classes designed for use against the hepatitis C virus (HCV). Enanta’s protease inhibitors partnered with AbbVie include paritaprevir, which is contained in AbbVie’s marketed DAA regimens for HCV. Enanta also has a program to develop a host-targeted antiviral (HTA) inhibitor class for HCV targeted against cyclophilin, as well as another DAA program to develop nucleotide polymerase inhibitors.  In addition, Enanta has a preclinical program in non-alcoholic steatohepatitis, or NASH, which is a condition that results in liver inflammation and liver damage caused by a buildup of fat in the liver.

Primary Responsibilities:

• Obtain clinical isolates and establish culturing and testing in house
• Perform resistance selection with novel antiviral drugs in vitro and characterize mechanism of resistance
• Build reverse genetics system in house to analyze drug-resistance mutants
• Support in vivo efficacy studies, analyze tissue samples for viral load reduction
• Perform time-of-addition study and investigate mechanism of action                                  

Key Competencies:

• Interpersonal Skills– Strong interpersonal and project management skills.  
• Communication Skills - Solid oral, written communication, and presentation skills.
• Productivity/Organizing/Planning – Must be proactive and self-disciplined and Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
• Collaboration & Teamwork– Advanced competence in collaboration & teamwork.

Education and Experience Requirements:

• Ph.D. in Virology with 5+ years of relevant experience. 

How to Apply:

Apply here - https://theapplicantmanager.com/jobs?pos=et134&fs=1.0em

Please include the following attachments with your application:

• Cover Letter
• CV

For more information on this position, or to see other current openings, log into our website at http://www.enanta.com/careers/.

Enanta offers employees a competitive total compensation package including a competitive base salary, bonus, stock options, and an excellent benefits package. 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or any other class protected by law.

Enanta Pharmaceuticals is an EO employer – M/F/Veteran/Disability

Sr. Research Associate - In Vivo will develop in vivo assays and perform microsurgical techniques.

For details visit:

http://www.cwsciences.com/Current-Openings/Sr-Research-Associate--In-Vivo

Email resume to: jobs@cwsciences.com

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


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

 

Scientist (PhD) – Electrophysiology

The Cystic Fibrosis Foundation, a highly regarded national voluntary health services agency, is seeking a Ph.D. level scientist for its growing R&D laboratory in Lexington, MA. The focus of the laboratory is on assay development, exploration of stem cell and gene editing approaches and early discovery of small molecules, which may lead to new treatments for Cystic Fibrosis (CF).

The work at the CFFT Lab includes state-of-the-art automation and encompasses screening of chemical libraries using multiple formats and readouts from biochemical, biophysical, and cell-based assays.  The potential candidate is expected to assume a leading role in the electrophysiological assay/screening group. 

Primary job duties include: Mammalian cell cultures including primary human bronchial epithelial cells, execution of low to medium throughput electrophysiological assays (Ussing chamber and similar) on semi-automated robotic platforms, data processing, QC and data analysis. The candidate will manage a team of highly motivated scientists. He or she will be responsible for timely execution of team projects, operational excellence, and data quality. The candidate is expected to present work and progress at internal meetings and select conferences.

Job Qualifications

• Ph.D. in life sciences and 3+ years of experience with (mammalian) cell cultures and electrophysiological techniques in academic or biotech/pharma laboratories
• Two or more, peer-reviewed, publications demonstrating a profound knowledge in membrane biophysics.
• Track record of generating data of high quality, proficiency in statistics, and excellent presentation skills.
• In depth and hands-on experience with automated liquid handlers will be considered a plus
• Detail-oriented and capable of multi-tasking in a small dynamic team.

For immediate consideration, please visit the employment section of our website www.cff.org under jobs located in Bedford, MA and submit your resume and cover letter. The following link will also direct you to the applicant page: https://chk.tbe.taleo.net/chk01/ats/careers/requisition.jsp?org=CFF&cws=1&rid=2661

Infinity Pharmaceuticals is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients first-in-class or best-in-class medicines for the treatment of cancer and related conditions.

Infinity is seeking a Patent Agent/Patent Counsel with 3-5 years of experience to join its dynamic legal team. This person will be a critical member of the organization and will work with a variety of cross-functional teams in a fast-paced environment to build and maintain a strong intellectual property portfolio in support of the company’s drug discovery and development efforts. The role will also involve exposure to a broad range of non-patent legal issues and require the development of independent partnerships with senior scientific and business management.

REQUIREMENTS

• Advanced degree in chemistry (organic chemistry preferred) with experience in the pharmaceutical field
• 3-5 years of law firm or corporate law department experience required
• Admitted to practice before the U.S. Patent and Trademark Office required
• Juris Doctorate from an accredited law school and member of at least one U.S. state bar (optional)

RESPONSIBILITIES

• Draft patent applications and responses to PTO correspondence
• Identify patentable inventions through frequent interactions with project teams
• Perform and analyze patentability and freedom to operate searches, identify any potential issues and advise project teams
• Assist with due diligence reviews
• Supervise outside counsel
• Educate other Citizen Owners about intellectual property issue

TECHNICAL COMPETENCIES

• Ability to independently draft patent applications and conduct patentability and FTO structures searches
• Excellent written and verbal communication skills
• Ability to work both independently and in a team environment with people at different levels within the company.
• This is an extremely interactive role that requires excellent listening skills, the ability to identify patent innovations, and succinctly identify and communicate decisions to a team.

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

Primary Duties :
The Head of Regulatory Operations will develop the vision and support for GRA while providing leadership for the Regulatory Submission and Lifecycle Management , Information Technology (IT), Compliance, training, and process improvement within GRA. In addition , the GRA Reg Ops Head will serve as the Lead Business owner of the Shire R&D Electronic Document Management System (EDMS) . This role will also ensure that all regulatory compliance activities and submission are completed on time and in the highest quality to meet agency standards . The GRA Reg Ops Head plays a leadership role in driving the GRA business forward and takes strategic ownership of critical aspects of GRA's contribution to the business overall.

Responsibilities:
60%:
Sets the strategic direction and leadership of GRA's Regulatory Operations function:
* Defines the glo bal and tactical strategy and governance of the Regulatory Operations team and manages updates accordingly.
* Ensures excellence in the global regulatory support to projects/products from inception through to end of lifecycle.
* Evaluates the global regulatory landscape and institutes changes that ensure Shire remains in compliance.
* Develops novel concepts and approaches to advance and/or challenge existing global regulatory paradigms.

10%:
Sets the strategic direction and leadership of Shire's R&D EDMS :
* Serve as the lead business owner of Shire's R&D EDMS; This is for all of Shire across all functions and geographies. Communicate key issues associated with
the process and technical environment to deliver R&D business objectives
* Serve as EDMS Governance board co-chair; responsible for setting overall strategy and direction

10%:
Sets the strategic direction and leadership of GRA systems .
* Supervises the Implementation of technology strategies to support R&D and Regulatory.
* Proactively leads Shire in formulating new technology and guidance .
* Provides leadership and advice on regulatory specifications for submissions, and the ability of publishing tools and systems to support them .
Provides leadership and advice on the approach for the application of expert knowledge of global regulatory requirements in developing systems or policies with all contributing functions that ensure submission compliance .

10%:
Sets the strategic direction and leadership of GRA Submission :
* Understands the submission related differences for small molecules, biologics, and devices .
* Provides leadership and direction to all individuals in submissions management to ensure the timely and
quality creation and lifecycle management of global submissions by developing appropriate processes, procedure and staff.
* Oversees the development of document research strategy and serves as Global Regulatory Affairs lifecycle and documentation expert for due diligence assessments , legal collections and divestments .

10%:
Other responsibilities:
* Mentoring employees/consultants .
* Interviewing, hiring and training employees/consultants .
* Aggregating resource forecasts for projects/programs .
* Planning, assigning and directing work .
* Setting objectives and appraising performance .
* Developing risk management plans and overseeing
implementation of risk mitigation activities.
* Managing performance assessments and career development activities.
* Establishing team objectives and developing team scorecard .

Education and Experience Requirements:
* Advanced degree in a science or technology or closely related field preferred.
* 15+ years of regulatory operations experience in the pharmaceutical/biotech industry.
* Generally has at least 10 years of management level experience
* Experience in global drug development regulations, regulatory submission, lifecycle management, compliance, business systems technology, process, training and labeling is preferred.

Other Job Requirements:
Domestic and international travel is required for this position.
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=amRpZXR6LjE4NzgzLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
Pfizer Centers for Therapeutic Innovation (CTI) is an entrepreneurial network of partnerships with leading academic medical centers that aligns leading academic scientific and clinical experts with Pfizer's world-class scientists, drug development capabilities, and breadth of resources to speed the translation of breakthrough science into innovative medicines for patients. Pfizer scientists work directly with academic scientists assigned to sponsored programs toward the common goal of clinical application of targeted therapies.

Responsibilities
The candidate will be an essential member of the CTI-San Francisco Protein Group. He/she will use strategic thinking and expertise in molecular biology, protein expression, purification, and characterization in the discovery and optimization of antibodies and protein therapeutics.

The applicant will function as a member of multidisciplinary project teams. He/she will present results and recommendations at project team meetings. The candidate will collaborate closely with other members of CTI-San Francisco, CTI and Pfizer scientists at other sites, and our academic partners to ensure the team meets aggressive project deliverables and timelines. The candidate is expected to embrace and embody the entrepreneurial spirit and biotech-like culture, values and goals of the CTI and contribute to creating an exciting, collaborative, results-driven, and scientifically rigorous working environment.

Qualifications
Degree in Molecular Biology, Biochemistry, Bioengineering, or related life science discipline
-1+ years post Ph.D. experience, or 6+ years with BS./M.S., in laboratory research, preferably in an industry setting
-Creative and nimble thinking, and aptitude for learning new technologies essential
-Technical expertise in molecular biology required
-Experience in protein expression, purification, biophysical and biological characterization required
-Experience in phage and yeast library display technologies preferred
-Excellent written and oral communication skills
-Comfortable working in a multidisciplinary collaborative environment
-Conscientious laboratory citizen

PHYSICAL/MENTAL REQUIREMENTS:
Lab based position requiring strong analytical skills and ability to learn new technologies.

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=QWxpc29uLlR1dGx5cy45ODcyMi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
We are seeking an experienced molecular biologist to join the Immune Protein Screening (IPS) group in the department of Global BioTx Technologies. The successful candidate will join a high-throughput protein production core group within the IPS group and will be responsible for semi-automated high-throughput antibody cloning from phage, hybridoma, and other sources. The candidate will also be responsible for development and use of new vector systems for high-throughput antibody cloning. The candidate should exhibit strong collaborative and communication skills working on cross-functional multi-disciplinary teams.

Responsibilities
The candidate will be responsible for:
1.Cloning of antibody panels for multiple projects simultaneously.
2.Optimizing efficiency and throughput of the cloning process.
3.Development of new antibody and antibody-like vector systems and adapting these to the high-throughput process.
4.Detailed clone tracking and archiving across projects and delivery of DNA to antibody expression scientists.
5.Documenting experimental data, conclusions and interpretations; presenting results at departmental and cross-functional team meetings.

Qualifications
BS or MS in molecular biology, biochemistry, or related discipline with 2-6 years for BS and 1-3 years for MS of research experience in academia and/or Biotech/Pharmaceutical environment.

Required:
* Technical proficiency with molecular cloning and plasmid construction.
* Technical skills should include extensive experience with most or all of the following: RNA/ DNA manipulation, restriction digestion, ligation-independent cloning, PCR, PCR primer design, laboratory automation, DNA sequencing, and standard microbiology techniques
* Proficiency with computational tools for molecular biology and database management, DNA editing software (VectorNTI/ DNASTAR etc.), and Microsoft Office
* Ability to work in a multidisciplinary, team-oriented environment

Preferred:
* Ability to work comfortably with automation and software
* Prior experience in antibody generation from phage and hybridoma sources
* Prior experience with: transient protein expression and purification, ELISA and other standard protein characterization techniques

PHYSICAL/MENTAL REQUIREMENTS:
* Ability to perform complex data analysis and mathematical calculations.

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=TWVnYW4uSGFycmlnYW4uNjcyMTguMzE2N0BwZml6ZXIuYXBsaXRyYWsuY29t

GENERAL SUMMARY OF POSITION:

Under the direction of the Principal Investigator or designee, the Research Associate I performs a variety of complex research experiments.

MAJOR RESPONSIBILITIES:

• Perform complex laboratory experiments
• Conduct in-depth analysis of research experiments
• Interpret data, form conclusions, and decide on and plan the next experiments to be done with a high degree of independence
• Write standard operating procedures, schedule work, analyze data, maintain accurate records, and write reports
• Compile and analyze data. Perform computations using image analysis software, spreadsheets, graphing, and curve fitting software
• May modify protocols and be responsible for a single, independent research project
• May assist with budget and/or operational aspects of grant and contract proposals
• Assist in writing the text of scientific publications and grants. Review literature
• Train new laboratory personnel, students, and collaborators
• Comply with all safety and infection control standards
• Perform other duties as required

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in the Biological Sciences, or equivalent experience
• 3 years of relevant research experience
• Knowledge of Microsoft Office products
• Strong ability to analyze complex visual data in a quantitative and objective manner
• Judgment and action skills required to solve commonly encountered problems

SUPERVISION RECEIVED:

Under the direction of the Principal Investigator, or designee

SUPERVISION EXERCISED:

May functionally supervise aides, technicians, and associates

ENVIRONMENTAL WORKING CONDITIONS:

Wet chemistry laboratory, and may require appropriate contact with biohazards, radionuclides, toxins, animals, and human specimens.

Apply Here

PI92484572

GENERAL SUMMARY OF POSITION:

Under the direction of the Principle Investigator or designee, the Clinical Research Coordinator is responsible for all aspects of collection and management of data for complex treatment, ancillary, and prevention protocols regulated by the FDA or DHHS, and sponsored by federal agencies, foundations, industrial sponsors or UMass Medical School in support of clinical trials.

MAJOR RESPONSIBILITIES:

• Participate in the development of protocol specific tools, (e.g., treatment data and/or therapeutic checklists) to aid with data submission
• Extract and transcribe treatment data from hospital and clinical records required to complete study patient’s record and sponsor’s case report forms. Monitors quality and timelines of data submissions
• Monitor status of all studies in database and ensures that all patient data (on-study and follow-up) are submitted, and respond to data queries from sponsoring organization, in a timely manner
• Track and maintain accurate data of studies, accrual, and patient status activity in database
• Maintain effective working relationships with research nurses and investigators participating in the study
• Monitor strict adherence to protocols. Assure that cases are being finalized and reviewed by appropriate clinician
• Review protocol requirements with physicians and research nurses. Identify and resolve issues with protocol compliance. Keep principal investigator and research nurse aware of any issues on compliance
• Ensure that protocol document has current amendments. Inform staff and updates database
• Provide data to study investigators as requested and submits data for analysis. Run quality control checks on data prior to transfer
• Serves as a resource to physician and nurses to locate information for special reports and treatment decisions
• Adheres to Good Clinical Practice (GCP) guidelines and all human subject protection practices
• Participate in all office staff meetings. Present current status of studies assigned
• Participate in regularly held Protocol Review Committee meetings
• Participate in the documenting work procedures specific to new studies
• Perform other duties as required.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in a scientific or health care field, or equivalent experience.
• 1-3 years experience in on-study data management and data collection in a research organization.
• Ability to read and understand complex protocols.
• Excellent computer skills including: proficiency in word processing; proficiency in relational databases.
• High degree or organizational and analytical ability to manage data collection and protocol adherence.
• Excellent interpersonal and oral communication skills
• Good writing skills with the ability to compose correspondence

SUPERVISION RECEIVED:

Under the direction of the Principle Investigator or designee

SUPERVISION EXERCISED:

None

ENVIRONMENTAL WORKING CONDITIONS:

Usual office environment, laboratory, medical, surgical, and off campus study sites

Apply Here

PI92484601

GENERAL SUMMARY OF POSITION:

Under the general direction of the Principal Investigator or designee, the Research Associate II performs a variety of complex research experiments and is responsible for overseeing laboratory operations within the Department.

MAJOR RESPONSIBILITIES:

• Perform complex laboratory experiments and conduct in-depth analysis of research experiments
• Write standard operating procedures, schedule work, analyze data, maintain accurate records, and write reports
• Report the status of projects and observations to the Department Chair
• Ensure departmental computer resources remain functional and provide on-site support to Investigators as requested
• Design and execute protocols and experiments, modify protocols as needed, and may be responsible for own research project
• Manage laboratory research staff
• Responsible for overall laboratory organization including oversight of safety protocols and the maintenance of related records
• May assist with budget and/or operational aspects of grant and contract proposals
• Long-range planning for laboratory and departmental equipment maintenance and replacement. Assist in procurement of departmental equipment. Responsible for physical inventory of all equipment, and maintaining records of all equipment acquired, moved off-site, or discarded
• Oversee and coordinate the use of centralized departmental facilities
• Work with Facilities Engineering, Environmental Health and Safety, and Radiation Safety to ensure department facilities and laboratories are in compliance with federal, state and institutional regulations
• Assist in writing the text of scientific publications and grants. Review literature
• Oversee and assist in the training of new laboratory personnel, students, and collaborators
• Comply with all safety and infection control standards
• Perform other duties as required

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in the Biological Sciences, or equivalent experience
• 5 years of relevant research experience
• Knowledge of Microsoft Office products
• Strong ability to analyze complex visual data in a quantitative and objective manner
• Judgment and action skills required to solve commonly encountered problems

SUPERVISION RECEIVED:

Under the direction of the Principal Investigator, or designee

SUPERVISION EXERCISED:

Supervise aides, technicians, and associates

ENVIRONMENTAL WORKING CONDITIONS:

Wet chemistry laboratory, and may require appropriate contact with biohazards, radionuclides, toxins, animals, and human specimens

Apply Here

PI92484638

GENERAL SUMMARY OF POSITION:

Under the direct supervision of a Principal Investigator or designee, the Research Lab Tech II performs and interprets routine and highly complex experiments.

MAJOR RESPONSIBILITIES:

• Performs a variety of laboratory experiments using both routine and special techniques and methods
• May assist in the training of others
• Provides input to improve current procedures, protocols, and/or methods
• Writes standard operating procedures, schedules work, orders supplies, and maintains an adequate inventory of supplies, reagents, etc.
• Prepares laboratory reagents, buffers, and media
• Records results, organizes data and performs computations
• Performs duties independently; requiring action and judgment to solve commonly encountered problems
• Complies with all safety and infection control standards appropriate to this position
• Perform other duties as required.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in a Biological Science or equivalent experience
• 1 year of related experience
• Knowledge of Microsoft Office products
• Ability to perform duties independently
• Judgment and action skills required to solve commonly encountered problems

SUPERVISION RECEIVED:

Under the direct supervision of a Principal Investigator or designee

SUPERVISION EXERCISED:

None

ENVIRONMENTAL WORKING CONDITIONS:

Wet chemistry laboratory, and may require appropriate contact with biohazards, radionuclides, toxins, animals, and human specimens.

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PI92484670

Vertex Pharmaceuticals, Inc. is looking for a highly motivated, versatile process development senior scientist or engineer to help develop microbial cell culture processes to support innovative biological pipeline project. The successful candidate will be responsible for the oversight of process development, characterization, and validation activities of upstream processes leading to commercial licensure. The candidate will be responsible for scale down laboratory experimentation, management of Contract Manufacturing Organization for clinical supplies. They should be capable of working independently and, within a multi-disciplinary team.Key responsibilities: Lead, design and execution of process development and technical support activities for upstream process from clinical process development to licensure and commercial manufacturing Troubleshoot and resolve challenges and issues of facility fit for GMP clinical and commercial manufacturing Familiar with GMP operations and able to review and revise master batch records and safety summaries with limited supervision.Independently design, plan and execute experiments supporting cell culture process development. Design and qualify upstream scale-down models and DOE design strategies to initiate process characterization and robustness studies. Design and execution of process development and characterization studies Perform process scale-up with pertinent engineering calculations relevant to scale. Develop process models that standardize and facilitate process scale-up. Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work. Serve as upstream development representative on cross-functional teams including CMC project teams, technology transfer teams, and external collaboration teams. Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and strategy. Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills. Evaluating novel and emerging manufacturing technologies for applicability and practicality in development and manufacturing processes. Keeping scientifically current through literature, courses, conferences and technical meetings.

Position Qualifications:

Ph.D in biochemistry, chemical engineering or biochemical engineering with a minimum of 6 years of biopharmaceutical experience or a MS with at least 10 years’ experience Ability to conceive and implement innovative process development strategies Understands how to build processes that are robust while mindful of bulk production requirements. Writes and executes project plans and coordinates team, sub team, or self to ensure deadlines are met. Strong project management skills and successful completion of projects. Ability to make a significant contribution to cross-functional project teams through technical expertise or scientific creativity. Consistent proficiency in problem solving and process optimization. In-depth understanding of cell culture and hand-on experience of bioreactor/PID operations, harvest and clarification processes. Demonstrated excellence in process technology transfer, scale translation, and statistical DOE (design of experiments). Excellent communication, technical report writing, and presentation skills and aptitude for problem solving. Experience with the preparation of regulatory filings for US and external markets. Understanding of GMP manufacturing.

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.

Job Description

The Clinical Scientist will provide scientific, pharmacologic and/or medical input into Curis publications, trial designs and protocols across all stages of clinical development and support regulatory submissions worldwide. This person will work with cross-functional teams and global collaborations to integrate broad medical and scientific input into assigned development programs. This individual will work with clinical research, translational, program management, regulatory  and operational staff (among others) to develop and implement protocols, publications, presentations and submissions that advance clinical development plans for assigned programs and molecules.

This role will work with cross-functional and global collaborations to integrate broad medical and scientific input into Curis’ development programs and clinical development plans for assigned programs and molecules.  Depending on corporate/programmatic needs and individual aptitudes, the role may primarily focus on Safety, Clinical or Scientific Research aspects of assigned programs.

Responsibilities in collaboration with the project physician will include, but are not limited to:

1. Project work and responsibilities as appropriate to skill set, including:
   • Prepare and/or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal and external presentations;
   • Prepare synopses and protocols (writing, reviewing, amending and cross-functional facilitation as appropriate);
   • Participate in clinical development plans for assigned compounds;
   • Review safety, primary efficacy variables, and laboratory data

2. Review scientific literature and prepare presentations, regulatory submission documents, etc.;
3. Collaborate with and support interactions with clinical sites as needed; and
4. Review clinical data including: safety, primary efficacy variables, and laboratory data.

Skills/Knowledge Required:

• Minimum of 2 years’ experience working in a technical capacity (eg, RN, PharmD, DO, MD) in biotech, pharmaceutical industry, clinical setting or equivalent;
• Minimum of 1 year working in a data-driven environment;
• Oncology experience required;
• Working knowledge of clinical trial design and execution;
• Experience in protocol development and regulatory submissions;
• Adherence to the highest standards for trial conduct, patient safety and data integrity;
• Medical/technical writing and basis statistics expertise preferred;
• Working knowledge of GCP, ICH Guidelines and standard medical terminology;
• Facility with Microsoft Office applications (eg, Excel, Powerpoint);
• Proficiency in literature searches and standard data mining, interpretation and presentation;
• Ability to assimilate technical and scientific information accurately and quickly;
• Able to work with cross-functional teams and meet deadlines in a fast-paced work environment;
• Outstanding written and verbal communication skills; and
• Meticulous and well-organized.
•  

Please send CV with job code (CS500) 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.

The Manager of Quality Operations and Validation will be responsible for developing and successfully executing New England Biolabs Quality Systems and Validation Programs that are compliant with ISO 9001, ISO 13485 Quality Standards and 21 CFR 820 GMP regulations.  The individual in this position will manage these functions at three localized Massachusetts based manufacturing facilities north of Boston.  Weekly travel is required to oversee each location.

Primary Responsibilities:

• Provide leadership and supervise all Quality Operations and Validation staff.
• Develop, manage and execute site validation programs, validation master plan(s) and ensure oversight of all third party validation contract resources.
• Serve as quality and validation advisor and core team member during an ongoing GMP plant start up, commissioning, and validation effort.
• Host and manage all external customer and third party audits, including Notified Bodies, to clearly and convincingly present quality data, reports, procedures or records.
• Serve as system owner and manager to ensure the successful execution of the following Quality Systems: compliant investigations, deviations. CAPA, supplier corrective actions, internal audits, batch record review and closure, and supplier qualification.
• Maintain timely and accurate records for all aforementioned quality system documentation.
• Provide routine metrics and system status summaries to senior management.
• Design and execute periodic quality or validation systems trainings for Production, Quality and Operations staff.

Qualifications and Experience: 

• B.S. / B.A. degree in Biology, Molecular Biology, Microbiology or related life science field.
• A minimum of 8 years’ experience in the biotech, pharmaceutical or medical device industry with at least 4 years’ direct experience in a professional quality role.
• Previous experience managing and developing staff required. 
• Previous experience in a GxP organization is required.
• Demonstrated knowledge and experience executing the quality and validation systems outlined above while working within an ISO 13485, ISO 9001 and/or cGMP structured environment.
• Experience leading and facilitating various site and system optimization projects via use of Operational Excellence concepts and techniques such as DMAIC, PDCA, FMEA, Kaizen, Lean Manufacturing, 5 Whys, Key Performance Indicators, Visual Management...etc.
• Strong interpersonal skills with the ability to collaborate closely with Production and Operations staff of varying levels to drive Quality System improvements and deliver necessary compliance requirements.
• A strong working knowledge of current Molecular Biology technique’s, applications and products is highly preferred.
• Current certifications from recognized Quality organizations (e.g. ASQ) for Quality Management, Quality Engineering, or similar preferred.
• Advanced level certification(s) in Operational Excellence technique’s (e.g. Six Sigma Black Belt certified or comparable) preferred.
• Possess strong written and verbal communication skills.
• Working knowledge of TrackWise eQMS software, MS Office applications, SharePoint and Lotus Notes.
• Up to 10% travel required.

New England Biolabs is an Equal Opportunity/ Affirmative Action Employer of Minorities, Females, Disabled and Protected Veterans

 Candidates may apply online at www.neb.com or by accessing the following link: Quality Operations and Validation Manager

Responsibilities:

The successful candidate will participate in working on a T cell program that aims to develop a novel T cell-based therapeutic approach that leverages neo-antigen biology in cancer immunotherapy. They will be responsible for setting up and conducting tests, assays, and other protocols under the direction of a scientist following Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLPs).

Additionally, they will be responsible for isolation and culturing of primary cells, expression, and purification of recombinant proteins, and performing antibody staining and flow cytometric analyses.

Qualifications:

• B.S., B.A., or M.S. degree in biology or relevant field
• Strong background in cell biology, molecular biology, virology, biotechnology, immunology, or stem cell biology.
• Primary cell culture, preferably with T cells.
• Experience with basic molecular biology and biochemistry techniques.
• 3+ years of relevant research experience; experience in oncology.
• Demonstrated mastery of flow cytometry assay development and cell sorting.
• Ability to organize and tabulate data.
• Excellent attention to detail.
• Ability to maintain inventories of equipment, supplies, and related research materials.
• Strong organizational and record-keeping skills.
• Excellent written and oral communication skills.
• Independent, flexible, self-motivated.

To be considered for this role, please submit your resume toCareers@Neontherapeutics.com with the job title in the subject line of your email.

We are an equal opportunity employer offering a competitive salary and benefits package.

All applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not responsible for any fees related to resumes that are unsolicited

Senior RA / Scientist, Cell Line Development/ Early Stage Process Development

About Acceleron:

Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair.  The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action.  These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.

Position Overview: 

We are seeking an experienced and talented individual who thrives in a dynamic, fast-paced, team-oriented and collaborative environment.  The successful candidate will work in the Cell Line Development area within the Process Development group and provide technical expertise across all stages of the protein therapeutic development life-cycle for multiple projects. This position will interact closely with the Research group but also the Manufacturing group where the cell lines and processed developed will be produced for clinical purposes.

Job Responsibilities:

• Create cell lines to produce recombinant proteins, monoclonal antibodies, and other novel molecules
• Perform transection, amplification, limited dilution cloning steps as well as screening tests to generate stable GMP cell lines
• Collaborate with external partners and vendors on projects relating to cell line development
• Design and perform DoEs to optimize media and feed components at small scale
• Perform early stage  process development in shake flasks, Wave bags, and small scale bioreactors to define basic cell culture process
• Support Process Development group in production of material at larger scale for Pilot needs (up to 250L scale)
• Actively pursue and implement new methods/technologies designed to improve and stream-line the activities of the cell line development area
• Author and review relevant CMC sections for regulatory filings (e.g. IND, IMPD, etc.) as well as provide technical oversight for responses to regulatory agency comments/recommendations
• Support MSAT group for tech transfer to a GMP setting as well as cell line testing post cell banking (ie cell line stability studies)
• Support internal investigations and process development activities
• Effectively interact and provide support to Research and Development groups internally as well as CMOs and vendors/collaborators/partners during technology transfer activities
• Effective communication of results through written documentation and oral presentations

Basic Qualifications:

• BSc. in biology or related field with 7+ years of industrial experience or MS 5+ years of experience
• Excellent knowledge of cell biology and cell culture techniques (aseptic processing, cell line development,  use of Wave bags etc)
• Excellent knowledge of tests for protein analysis (titer, Western blots, ELISAs, Octet etc) is required, knowledge of tests for protein quality is preferred
• Prior experience in cell line development
• Ability to manage multiple projects at various stages of
• Experience working with external collaborators or CMOs is preferred
• Experience drafting, reviewing and submitting required documentation relevant to Regulatory filings
• Technical expertise and creative problem-solving ability
• Ability to work independently, with minimal supervision, and to manage multiple projects at one time
• Enthusiastic with a high-level of integrity and attention to detail

*Recruiters - please do not send unsolicited resumes to this posting.

FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT:

www.acceleronpharma.com