Job Summary:

This position will be responsible for clinical product development including drug substance, drug product and formulation development, and the development of manufacturing processes and analytical methods toward the establishment of Chemistry, Manufacturing & Controls (CMC).  Product development for clinical studies includes protein-based therapeutic vaccines, protein-peptide complexes, and small molecules.   The individual will participate in process development studies aimed at improving manufacturing process yield and product quality using analytical tools including protein chemistry-based, immunochemistry-based assays, HPLC and chromatographic methods to evaluate raw materials, process intermediates, drug substance and drug product.  Responsibilities of this individual also include development of purification processes which may involve processing of microbial fermentation harvest, cell culture harvest or human and animal tissue, using column chromatography, membrane diafiltration and analytical tools including SDS-PAGE, Western blotting, ELISA, FRET and microtiter plate-based protein quantitation.  The individual will design and perform the studies independently, document experimental methods and results in well-maintained laboratory notebooks and technical reports, participate in interaction with R&D, Immunology, QC and Manufacturing and presentation of data in group settings.

Hierarchal Position:  The person in this role reports directly to the Associate Director of Process & Analytical Technology.

Spectrum of Tasks

• Design and perform experiments independently for product/ process/ analytical development;
• Develop drug substance and drug product formulation for clinical studies;

• Develop, improve and validate as needed manufacturing processes (mainly purification and formulation processes) to enhance manufacturing efficiency and product quality.
• Execute developmental scale production work, which may involve the processing of tissue/cell harvest, purification and chromatography.
• Implement processes and assays in PAT, Manufacturing and QC groups under cGMP.
• Provide training to QC and Manufacturing personnel on assays and processes as needed.

• Develop assays using tools including HPLC, LC-MS, SDS-PAGE, Western blotting , FRET, ELISA to evaluate raw materials, process intermediates, drug substances and drug products.

• Quality – Responsible to perform job function in accordance with the Agenus Quality Policy and Quality Manual as appropriate.

• Specific skills relevant to the job
  • Experience in qualitative and quantitative analysis of protein and peptide in complex matrix; analytical development in a GMP environment;
  • Experience in tissue/ cell lysate/ cell harvest processing and protein purification, knowledge of process development and GMP compliance.
  • Experience in protein formulation development.

Education and Experience

• Requires a PhD with a minimum of 3 years of product/ process/ analytical development in a cGMP setting, or BS/MS degree in a scientific discipline plus 5 to 10 years of drug/vaccine development experience.

The Massachusetts Institute of Technology invites applications for our entry-level Technology Licensing Associate – Biotechnology position.

Job Summary

The Technology Licensing Office (TLO) of the Massachusetts Institute of Technology has an entry level position available in technology transfer.  Under the direction of the appropriate Technology Licensing Officers in the biotechnology section of the TLO, the Technology Licensing Associate will administer and maintain license and other contractual agreements and monitor patent filing and prosecution.  This individual will record invention disclosure, patent and licensing data into a database system and keep updated files.  In addition, the Technology Licensing Associate will investigate and identify commercialization opportunities for MIT technologies, and assist in managing a patent portfolio and negotiating agreements.  This individual will communicate with industry counterparts, faculty, patent attorneys and accountants on invention disclosures, license activities and patent matters.

Qualifications:

B.A. or B.S. degree in the life sciences required; some research and/or business experience is a plus.  Facility with computer applications, preferably involving database systems is necessary.  Must be detail and deadline oriented.  Excellent verbal and written communication skills are essential, including the ability to quickly communicate complex issues clearly and succinctly.  Excellent organizational and priority setting skills, good judgment, and an ability to manage multiple projects simultaneously are also required.  The ideal candidate demonstrates strong intellectual curiosity, is a self-starter who thrives in an environment that encourages strategic thinking, and enjoys working independently in a collaborative setting.  This is a full-time position. Candidates must be a US citizen or be able to work in the United States without needing any current or future employer sponsorship.  Interested candidates may apply on-line at http://web.mit.edu/jobs.  Please reference job number is mit-00009250 and indicate where you saw this posting.  MIT is an equal opportunity/affirmative action employer.  Applications from women, minorities, veterans, older workers, and individuals with disabilities are strongly encouraged.

Third Rock Ventures is launching an exciting new company focused on developing novel immunotherapies for the treatment of cancer.  This new biotech start-up will be based in Cambridge, MA.  The company will be developing protein-based therapeutics aimed at achieving durable anti-tumor immune responses for multiple cancer indications. Leadership includes an experienced management team provided by Third Rock, in concert with world-class advisors in the field of cancer immunotherapy.  As a company at the forefront of cancer immunotherapy, we are seeking highly motivated, hard-working, creative, and collaborative individuals.

Job Description:

The successful candidate will be responsible for evaluation of novel cancer immunotherapeutic candidates in vivo. Responsibilities include designing and conducting syngeneic and/or genetic tumor models to assess activity, define PK-PD parameters, and elucidate immune mechanisms of action of novel candidates.  Key experiments will also involve ex vivo analyses including isolation of immune infiltrating cells, preparation and analysis of specimens for histology, mRNA and flow cytometry.  In addition, the candidate will help train and work closely with research associates, and will be responsible for analyzing data and presenting results in a group setting.  Additional responsibilities include keeping abreast of new developments in the scientific literature and proposing creative solutions to experimental problems. 

Qualifications:

The applicant must have a PhD or MD in Cancer biology or a related field with 2+ years of postdoctoral experience in an academic or industrial setting.  Special consideration will be given to those individuals with experience in immunology and/or cancer immunotherapy. The ideal candidate will have extensive experience with one or more of the following: syngeneic and/or genetic mouse models of cancer, PK-PD modeling, ex vivo analysis of tumor infiltrating lymphocytes, adoptive transfer studies.  Some knowledge of tox is desired.  Experience with in vitro immunological assays is a plus.  The candidate must be detail-oriented, reliable and conscientious, with excellent organizational skills and oral and written communication skills. He or she must be capable of contributing independently and able to thrive in a highly collaborative, fast-paced, team-oriented environment with colleagues from diverse disciplines.

To be considered for this role, please submit your resume to Careers@thirdrockventures.comwith Cancer Immunotherapy 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

Computer Systems Compliance/Validation Specialist

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

Job Duties and Responsibilities

• Oversight and documentation compliance of electronic systems including archiving processes, including training for appropriate user groups.
• Complete SOP for clinical instrumentation qualification procedures, validation and work with Metrology and Validations Services (MVS) department on implementation.
• Audit all required SOPs for compliance to FDA and other computerized system guidance documents.
• Interface with quality assurance and laboratory operations as part of the Information Technology Group (IT) in structuring and implementing automated reporting templates to ISO and other standards.
• Complete review of standalone computer systems, process controls, passwords (per 21 CFR Part 11 requirements)  and keep information current for all departments.
• and assist with the implementation and validation of automation with vendors
• Create post validation help desk documentation-CAPA system-work with IT /QA to close out all open tickets
• Create training program for 21 CFR Part 11 methodology  and perform the training
• Assist QA and IT in all vendor and FDA/other audits related to computerized systems
• Participate in software system evaluations for regulatory compliance.
• Perform gap analysis on applications to address regulatory requirements such as Part 11.
• identify and document risk assessments.
• Take leadership role in all computerized system validations.
• Maintain compliance with master validation plan and keep MVP and other documentation current.
• Perform code review for any custom code applications.
• Assess and manage regulated from non-regulated business processes together with QA and IT

 Qualifications and Experience

• Associate’s or Bachelor’s degree in a technical or science field.
• 2-4  years’ experience working in regulated software systems.
• Attention to detail critical
• Strong interpersonal, writing, and communication skills.
• Proficiency in commonly used business applications.
• Working knowledge of SQL databases is a plus.
• Familiarity with statistical software is a plus.
• Knowledge of FDA 21 CFR Part 11 is a plus.

This is not a software QA position.

For additional information please visit our website at www.Toxikon.com.

Submit resumes to:

Human Resources

Toxikon Corporation

15 Wiggins Avenue

Bedford, MA  01730

Email:  hr@toxikon.com

 Toxikon employs 160 people and offers a generous benefit program including health, dental, fsa, std, ltd, life insurance and matching 401K plan. Toxikon is an EOE.

Analytical Chemist

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

 As an Analytical Chemist, candidates will be responsible for providing technical expertise in supporting preclinical studies conducted under GLP, ISO 17025, and various other regulatory agencies.  Other responsibilities include, but are not limited to:

 Performing analysis and troubleshooting utilizing various analytical instruments such as; HPLC, GC, LC/MS/MS, ICPMS, etc.

• Write, review, and update SOP’s, Protocols, and final reports.
• Assist in managing inventory for all laboratory supplies
• Review and assist Quality Assurance Unit in closing out any protocol amendments, or deviations and work to ensure compliance with all applicable regulatory guidelines.
• Meet project deadlines including the completion of technical work to standards.

Candidates must have a Bachelors or Masters degree in Chemistry, with preferably 3-5 years of equivalent laboratory experience. However we may be willing to train the right candidate.  Must have some knowledge of GMP/GLP regulations in an analytical laboratory setting, exceptional oral and written communication skills, and ability to work in a high volume, fast paced environment. 

For additional information visit our website at www.toxikon.com

Submit resumes to:

Human Resources

Toxikon Corporation

15 Wiggins Avenue

Bedford, MA  01730

Email:              hr@toxikon.com

 Toxikon employs 160 people and offers a generous benefit program including health, dental, fsa, std, ltd, life insurance and matching 401K plan. Toxikon is an AA/EOE.

Our client is one of the top biopharma companies in the country with several approved products on the market and a reputation for being a great place to work. They currently have an opening for an experienced QC Stability professional to step into a lead role, reporting directly to the Sr. Manager. This position will be based in Cambridge and join an established group of dedicated GMP professionals to support critical programs.

This role is focused on protein therapeutics being developed and qualified candidates must have experience in designing stability studies, analysis of data, and report generation. The GMP stability program encompasses clinical drug substance, drug product, reference standard, and placebo.

The Hiring Manager can be flexible on education level and will consider BS through PhD candidates with the relevant experience listed above. Unfortunately, no relocation assistance is available. Must be commutable to Cambridge or able to self-relocate with minimal assistance. Interested parties should send resumes directly to nuno@hireminds.com. Your information will be kept strictly confidential until you choose to pursue a specific role with one of our clients.  

Primary Role:
Principal function is to plan and manage the efforts of interdepartmental teams in the accomplishment of projects supporting manufacturing and facility operations. The successful candidate identifies project risks and develops mitigation strategies to protect against loss and business interruption.

The Sr. Project Manager is accountable for:
• Planning and delivering the project scope by managing a team of internal and external resources
• Project performance against established targets (cost and schedule)
• Monitoring, controlling and reporting on project status including risks and issues
• Ensuring the successful return of the facility, equipment and/or system(s) to routine operations The successful candidate leverages his/her experience planning and executing complex projects in operating facilities to ensure that project objectives are achieved without compromising compliance, safety or performance

Responsibilities:
* Project implem entation - oversees all design, procurement, development, fabrication installation and testing of all systems and equipment as specified and in accordance with all project requirements. * Oversees the preparation and hand-over to end users to enable successful operation of newly installed or modified systems and equipment. (50%)
* Project planning - works with functional area representatives to develop plans to successfully implement project scope while optimizing resource investment and risk tolerance. Develops cost and manpower estimates as well as implementation timelines. Presents plans to sponsor and governance bodies for authorization. (30%)
* Project initiation - Works with project sponsors and solution providers to identify business drivers, project objectives and project requirements. (10%)
* Contributes to other Facilities and Engineering programs and initiatives as required. (10%)

Education and Experience Requirements:
• Strong knowledge of biotech processing manufacturing, facility design, process and control systems is required.
• Expert knowledge of Project Management methodologies and life cycle including ISPE good practice is required.
• Must have experience working in a regulated industry including experience with commissioning, validation, and start-up of manufacturing facilities.
• Requires a minimum of eight years of project management experience in engineering, construction or owner organization and a minimum of twelve years related experience in Biopharmaceutical, Pharmaceutical or High Technology facility design and construction.
• A BS degree in engineering or related discipline is required.

Other Job Requirements:
• Ability to work at all Shire MA locations
• Travel to accommodate vendor visits or other Shire owned facilities may be required and may include international travel Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives

Shire is an Equal Opportunity and Affirmative Action Employer

To apply for this position, pleaseCLICK HERE

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.

Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Genzyme is seeking an Associate Director of Biostatistics. The Associate Director of Biostatistics will be responsible for providing statistical leadership for clinical studies within selected therapeutic areas. Primary responsibilities include collaborating with clinical trial teams on the design and analysis of clinical trials and providing strategic input to and innovative solutions for clinical development programs.
This is an exciting opportunity to join a team of talented and experienced biostatisticians working on complex and impactful clinical studies.

Qualifications
- Ph.D in biostatistics or statistics
- 5 or more years of experience working in a clinical trial setting (biotech, pharma, CRO, academic institution)
- Excellent communication and writing skills including the ability to clearly describe advanced statistical techniques and interpret results
- The ability to produce statistical documents such as publications or technical reports
- Experience providing statistical perspectives in regulatory interactions
- Knowledge of advanced clinical trial design concepts, such as non-inferiority, adaptive methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings
- Thorough and up-to-date knowledge of advanced clinical trial statistical methodology, including time-to-event and recurrent event analysis, sequential methods, longitudinal data analysis (e.g. LME, GEE), techniques for handling missing data, nonparametric methods, Bayesian methods
- Thorough and up-to-date working knowledge of SAS
- Understanding of clinical / regulatory concepts for at least one therapeutic area

To apply for this position, please CLICK HERE

Provide high level input on clinical development strategies across the assigned therapeutic areas, in conjunction with other relevant functional area leaders in Medical Affairs, Regulatory, Global Patient Safety, Clinical Operations, Exploratory Development, Commercial, Pharmaceutical Development, Research, Business Development, and Marketing.

- Participate in business development and strategic planning activities to ensure a productive and viable product portfolio
- Serve as high level clinical development strategy lead for both internally and externally facing stakeholders
- Provide specific therapeutic area expertise to enhance innovation and efficiency in clinical development
- Interface with international regulatory authorities, as appropriate, in support of the development objectives for the compound or program
- Ensure compliance with Vertex SOPs, ICH, GCP and other national and international regulatory requirements
- Assist with department activities such as physician training/development, SOP/business process development, and alignment with cross-functional stakeholders.
- Monitor and/or oversee medical monitoring of clinical studies.

REQUIREMENTS:

- MD, DO or international equivalent medical degree.
- Minimum of 5-7 (Sr Dir) 3-4 yrs (Dir) years pharmaceutical industry experience, including time leading clinical trials executions and formulating and implementing clinical development program(s)
- Experience in the therapeutic areas (e.g. immunology/inflammatory diseases)

Preferred Requirements:
- Sub-specialty training in a relevant clinical discipline is desirable (e.g. immunology, rheumatology)
- Ability to work collaboratively in a challenging cross-functional team matrix environment
- Ability to work independently to resolve challenges and conflicts
- Possess a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process
- Possess experience in clinical aspects of INDs, NDAs, CTAs, MAA and other international regulatory filings
- Proven leadership, strong interpersonal skills and the ability to communicate effectively to scientific and non-scientific groups is necessary
- Pre-clinical research experience is desirable.

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

Vertex is 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. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

• Review and approve supplemental logs,charts and other documents in support of cGMP operations
• Review batch records and certificates of analysis for accuracy and completion prior to final release of product
• Maintain the Approved Supplier List including updating and reviewing performance of vendors
• Perform line clearance and checks on the production floor; troubleshoot and investigate quality issues
• Perform internal and external audits as assigned
• Particpate in regulatory and customer audits as assigned
• Assist in the maintenance and implementation of the Quality System
• Participate in project teams and perform other related duties as assigned

• Bachelors Degree required, preferably in the life sciences
• 2-4 years industry experience and knowledge of GMP/ISO requirements
• Experience auditing in a GMP/ISO environment
• Requires proficiency in word processing, spreadsheets and databases
• Ability to interact positively and professionally with customers
• Good presentation and organization skills
• Excellent written and verbal communication skills

Quality Engineer

Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet  requirements. Serve as a Quality System Compliance representative to improve awareness, visibility, and communication on quality initiatives. Provide Compliance guidance and support for technical development concepts, regulatory, operational, or system/services. Provides focused quality analysis leadership within the Quality System Compliance team. Functions as the compliance data liaison and the resource for analysis related to external audits, inspections and industry trends.

Responsibilities

• Analyze Quality data related to external audits / inspections and industry trends
• Develop, implement and maintain effective communication mechanisms
• Apply Quality and Compliance principles to assigned projects, products or sites and guides them into implementation.

Education & Experience:

• 5-8 years medical device experience with BS in Basic Sciences/Engineering or related discipline.
• Demonstrated use of Quality tools/methodologies and comprehensive working knowledge of FDA, ISO, MDD, CMDR, JPAL.
• Superior written/verbal and interpersonal communication skills with ability to work either independently or within a team environment.
• Expert in all Microsoft Office programs, specifically PowerPoint, Excel and Visio as well as in depth knowledge of Share Point.

Local Candidates Only (MA/RI/NH)

• Help implement new solutions to address the robotic and automation needs
• Responsible for establishing, monitoring and maintaining a stable and productive environment through QC, preventative maintenance and standard operating procedures
• Collaborate with scientists to bring new assays or troubleshoot existing assays on automation platforms
• Responsible for the maintenance of lab automation systems in the screening and compound management groups
• Provide and/or coordinate vendor training to new users of equipment

Requirements:

• BS in biological sciences or engineering field with 3+ years of experience using and implementing automated systems
• Experience with automation scheduling software (e.g. VWorks, Cellario, Overlord, Momentum) and programming language (e.g. Visual Basic)
• Experience with the maintenance of liquid dispensers, plate readers, and other integrated equipment
• Experience with Tecan liquid handling instrumentation
• Familiarity with high-throughput screening, compound management and/or chemical purification methods

The Compound Technician will operate and maintain high throughput screening production equipment.   The technician must have basic skills in compound preparation including concentration calculation, weigh-out and dissolution. They will be expected to monitor and record production run progress, errors and corrective action in accordance with regulatory requirements.  The technician will be customer oriented and familiar with current good manufacturing practices (cGMP) and current good laboratory practices (cGLP).  The technician must have the ability to troubleshoot scientific production equipment so that program timelines remain on-track for anticipated data-delivery.

Requirements

• Associates or Bachelor's degree in a scientific discipline, Bachelor's preferred
• 2+ years’ experience working with compound handling
• Experience with operating and troubleshooting production equipment (robotic-based equipment preferred)
• Demonstrated ability to work in a highly regulated environment
• Experience in fast paced environment with aggressive timelines

A career with Randstad at Millennium Pharmaceuticals, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time.

Manager, Regulatory Affairs

POSITION
The Submission Manager will be an integral member of the Global Regulatory Dossier Management Group. On a daily basis, the Submission Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, and utilizing a wide array of document management, authoring, and publishing tools. The Submission Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.

DUTIES
Working closely with the Regulatory Leads, the Submission Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management.
Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines.

Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management.

Identify issues that may delay product or project and recommend appropriate action.

Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology.

Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity.

Prepare and maintain templates that meet Regulatory electronic submission standards.

Assist in development and maintenance of our electronic submission capability at Millennium, representing the Regulatory business function on technology teams.

Basic qualifications:
Minimum of 4 years of experience within the pharmaceutical industry and strong submission management and/or project management experience is required. Skill in using desktop applications and proficiency in computer systems and procedures is required.

Preferred qualifications:
Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired. Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired

A career with Randstad at Millennium Pharmaceuticals, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time.

Position Summary: This individual is expected to contribute to the development and implementation of CMC regulatory strategy for products in development with minimal supervision as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs. This person will serve as the regulatory CMC representative on relevant project teams, and as the regulatory CMC contact with FDA and other regulatory authorities for CMC related issues.


Duties and Responsibilities:
• Monitor changes to development plans and design globally compliant CMC regulatory strategy for products at all stages of development with minimal supervision
• Drive global CMC regulatory submission activities (IND, CTA, NDA, BLA) and health authority interactions (meeting requests and briefing documents)
• Represent Regulatory Affairs at various project team and working group meetings
• Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
• Interface with Millennium Quality systems in compliance with Corporate SOPs.
• Evaluate analytical procedures, specifications documents, comparability protocols, validation protocols, and stability protocols for consistency with relevant global regulations and guidelines.
• Ensure the quality and content of all submissions to health authorities
• Act as direct point of contact with FDA and other regulatory authorities for CMC related issues


Qualifications:
Experience: A minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful. Must have a minimum of 5-7 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry.

Other: Demonstrate knowledge of drug development process and knowledge of FDA, EU, Canada, and ROW regulatory requirements. Demonstrated project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).

A career with Randstad at Millennium Pharmaceuticals, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time.

Position Summary: This Senior Manager position is established to play a key role in the planning and management of regulatory submissions to global health authorities. This individual is expected to provide leadership within Regulatory Affairs and all other data generating departments to ensure timely filing and approval of assigned programs.


Duties and Responsibilities:
• Responsible for the implementation and execution of global regulatory strategies
• Represents the function at clinical trial working groups and at the clinical sub-team levels. May represent the function at other sub-teams as assigned
• May represent the regulatory function at the global core team
• May be the regulatory therapeutic representative on the labeling committee
• Accountable for submission of IND’s, CTAs and other major regulatory submissions, including Briefing Packages and Annual Reports to INDs, CTAs, NDAs and BLAs
• Is expected to communicate directly with FDA on most issues and may be the lead regulatory representative at FDA meetings for the assigned products of responsibility

Qualifications:
Experience: A minimum 4-year degree in a scientific or technical discipline; advanced degree preferred. Must have a minimum of 5-7 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry.

Other qualifications: Management experience is a plus. Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements. Knowledge of EU, Canada, ROW and Post-marketing a plus. Direct experience in interacting with regulatory authorities; experience interacting with DDMAC is a plus. Candidates must be able to influence others and demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).

A career with Randstad at Millennium Pharmaceuticals, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time.

JOB TITLE
Director, Regulatory Affairs

POSITION SUMMARY
This Director position is established to play a key role in the planning and management of regulatory submissions to global health authorities.

This individual is expected to provide leadership within Regulatory Affairs and all other data-generating departments to ensure timely filing and approval of assigned inflammatory bowel disease programs.

DUTIES & RESPONSIBILITIES
Direct management of assigned inflammatory bowel disease programs;

driving all submission activities (IND/CTA, trial maintenance, NDA/BLA) and health authority interactions (meeting requests and briefing documents);

represent Regulatory Affairs at various project strategy team and working group meetings;

assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines;

contribute significantly to the development of regulatory strategy plans;

liaise with partnering companies to ensure regulatory alliance;

act as direct point of contact with FDA and other regulatory authorities for general issues;

mentor and coach junior regulatory staff and other team members.

QUALIFICATIONS
Basic qualifications:
A BS degree in a scientific or technical discipline plus a minimum of 8 years experience in Regulatory Affairs is required.

Previous experience in leading submission teams for marketing application and/or clinical trial applications is also required.

Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements.

Direct experience in interacting with regulatory authorities.

Candidates must be able to influence others and demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).

Candidates must have late stage development and/or registration experience.

Preferred qualifications:
Knowledge of US, EU, Canada, ROW and post-marketing experience is a plus.

Advanced degree preferred.

Reporting to the President and COO, the VP Scientific Ops will be responsible for aligning the Company’s commercial objectives with scientific operations, designing programs to achieve these goals, and overseeing the execution of these plans through the Product Development, Manufacturing, Quality Control, and Product Management teams.  The VP will also be responsible for designing key performance indicators for the operating units under his management, driving continuous improvement throughout the production-focused team by analyzing performance against defined metrics and reporting the performance of these units to the senior leadership (President/COO and CEO).  The VP will be required to understand the scientific basis of Enzymatics’ business (development, production, testing, and fulfillment of protein-related products and services) and the requirements of operating the business under an ISO 13485/9001 Quality Management System that is harmonized with the FDA’s 21 CFR 820. Enzymatics is a flexible, high-growth company and the VP must possess a strong grasp of forward-looking managerial accounting principles as they apply to a biologics manufacturing organization. The VP must be a highly collaborative, adaptable, and personable leader who can coach a team through rapid expansion phases and changes in business focus while holding employee development, morale, and engagement in high regard.  The VP should develop his subordinates to assume future leadership positions within the company as well as foster creativity and innovative ideas throughout each department.

Responsibilities:

• Developing and implementing operating plans based on the Company’s strategic objectives
• Measuring, monitoring and analyzing operating unit and departmental performance based on defined metrics
• Regular reporting of departmental performance to senior management
• Ensuring compliance to ISO 13485/9001 standards, and all relevant customer and statutory requirements
• Fostering effective cross-functional communication and collaboration in a rapidly evolving, matrix environment
• Scaling scientific operational unit to sustain 5-10X revenue growth while maintaining critical competitive advantages of speed to market, flexibility, agility, low production costs and high compliance (ISO 13485)

 Qualifications 

• A Bachelor’s degree is required.
• An advanced degree is a plus (equivalent experience in lieu of advanced degree acceptable)
• 15+ years’ operations management experience with at least five years at the Director or higher level managing and leading within a high-compliance (ISO/FDA) sector of the scientific tools industry.
• Should have led companies on a growth trajectory from $20M to >$100 M in global revenues.
• Proven experience in driving companies through sustained periods of high growth in an evolving business.
• Deep understanding of managerial accounting, manufacturing best-practices (6 Sigma, Lean, Operation Excellence).
• Experienced, collaborative leadership ability.

The Novartis Institutes for BioMedical Research (NIBR) is seeking an Associate Administrative Assistant to the Office of the President. This newly-created position will work alongside the Senior Executive Assistant and under the general supervision of the Associate Director for Administration in the Office of the President to provide general administrative support, including processing of financial transactions, routine document preparation, file management, and serving as office liaison to two high-level science advisory boards. This three-person administrative support team will coordinate efforts to streamline work processes to achieve timely results in this active, outcome-driven office. The position is located at our Cambridge, MA headquarters.
Major Accountabilities:

• Process financial transactions via Novartis financial systems
• Liaise with expanded group of colleagues to plan and implement high-level science advisory board meetings
• Serve as office receptionist, including answering main office phone and greeting visitors
• Update office databases on a routine basis
• Maintain office files, both electronic and hard-copy
• Create, edit and proof-read documents as requested
• Photocopy, scan and fax documents as requested
• Order, organize and monitor office supply inventory
• Distribute incoming mail, flagging priority items as necessary; prepare outgoing mail
• Maintain office area, keeping it clean and free from clutter
• Assist Associate Director for Administration and Senior Executive Assistant with administrative duties as requested, to include special projects.

Minimum Requirements:

The ideal candidate possesses interpersonal maturity, good judgment, and attention to detail. To be successful in the position, a candidate must have a sense of humor, a flexible nature, and an eagerness to learn new things, all within a supportive team environment. The successful candidate will be proactive, efficient, with strong organizational and time management skills. S/he will be able to interact effectively with all levels of employees, including international colleagues. S/he will be proficient with e-mail, word processing, spread sheet, and presentation programs. In addition, s/he will be resourceful, able to solve problems, obtain information from the Intra-/Internet, and learn new software applications quickly.
Candidates must have at least 3 years of experience working in a customer-facing role; Bachelor’s Degree preferred, but Associate’s Degree considered; excellent verbal and written communication skills; proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and use of the internet. The ability to handle confidential information in a mature and professional manner is critical.

To apply please submit your resume directly through our website:

http://nibr.com/careers/jobs.shtml