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
The Quality Analytical group is seeking a highly motivated candidate to support projects for raw materials and small molecule identification at the Andover site. The work includes performing method qualifications/validation/verification activities, method improvements, and troubleshooting analytical methods for raw materials. The candidate will also support small molecule identification in support of manufacturing. The candidate will review and approve technical documents and provide input to lab and manufacturing investigations

Responsibilities
Key responsibilities:
The qualified candidate must have the experience and ability to participate in multiple projects within the Analytical group. Responsibilities include:
* Perform qualification/validation of analytical methods for raw materials
* Support characterization of protein products and reference materials by LC-MS
* Drive and manage method validations, investigation, and analytical studies. Write technical documents such as protocols and technical reports.
* Collaborate with routine QC testing lab and manufacturing on troubleshooting and investigational activities
* Implement new analytical technologies
* Optimize existing QC assay methods and technologies
* Lead project meetings

Qualifications
* Ph.D in chemistry, biochemistry or related discipline with 2 plus years of experience.
* MS degree in chemistry, biochemistry or related discipline with 10 plus years of experience
* Knowledge and experience with HPLC, GC, FT-IR, SEM, and Raman preferred
* Knowledge and experience with LC/MS required
* Extensive knowledge and experience of compendia such as USP/NF, EP, JP
* Strong technical writing skills
* Strong oral and written communication skills
* Candidate must be self-motivating and be able to adapt to rapidly changing project priorities.
* Knowledge of cGMP and industry standards
* Continuous improvement tools desired

PHYSICAL/MENTAL REQUIREMENTS
Normal sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.). Position is first shift Monday through Friday.

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=SmltLlRhdm9saWVyaS44OTE0Mi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Job Summary

The Chemist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures.  Duties will include analysis of pharmaceutical products using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development.

Requirements:

Education:        A Bachelors degree in Chemistry or a related field discipline is required.

Experience:      1-5 years

This position is 2nd shift full-time opportunity. Shifts include: Tuesday through Saturday 8:30 am-5:00 pm or Monday through Friday 1:00 pm - 9:00 pm.

Primary Duties and Responsibilities:

1. Prepares and analyzes products to determine chemical and physical properties.
2. Documents work in a clear and organized manner.
3. Follows all safety rules and regulations and conducts periodic safety audits.
4. Follows all cGMP rules and regulations.
5. Will perform work under partial supervision and will provide over site to projects and assist other Chemists as needed.
6. Works under partial supervision with chemists and other client personnel regarding research, procedures performed, related results and prepares reports.
7. Is a subject matter expert in some techniques and will mentor others.  Work to learn and improve on others techniques and tasks.
8. Performs data generation, analysis and more complicated problem solving with a minimal rework.
9. Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting.
10. Works under partial supervision to ensure all work performed is performed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.
11. Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.
12. Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.
13. Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.

Minimum Skills Requirements:

• Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently. 
• A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
• Must have excellent organizational, verbal communication and technical documentation skills.
• Solid computer skills.
• Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
• Must be a team player with integrity and concern for the quality of Company products, services and staff members.

For more information on Boston Ananlytical, please visit us at www.bostonanalytical.com. To apply for this position, please click here.

Job Summary

The Chemist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures.  Duties will include analysis of pharmaceutical products using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development.

Requirements:

Education:        A Bachelors degree in Chemistry or a related field discipline is required.

Experience:      1-5 years

This position is 2nd shift full-time opportunity. Shifts include: Tuesday through Saturday 8:30 am-5:00 pm or Monday through Friday 1:00 pm - 9:00 pm.

Primary Duties and Responsibilities:

1. Prepares and analyzes products to determine chemical and physical properties.
2. Documents work in a clear and organized manner.
3. Follows all safety rules and regulations and conducts periodic safety audits.
4. Follows all cGMP rules and regulations.
5. Will perform work under partial supervision and will provide over site to projects and assist other Chemists as needed.
6. Works under partial supervision with chemists and other client personnel regarding research, procedures performed, related results and prepares reports.
7. Is a subject matter expert in some techniques and will mentor others.  Work to learn and improve on others techniques and tasks.
8. Performs data generation, analysis and more complicated problem solving with a minimal rework.
9. Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting.
10. Works under partial supervision to ensure all work performed is performed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.
11. Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.
12. Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.
13. Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.

Minimum Skills Requirements:

• Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently. 
• A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
• Must have excellent organizational, verbal communication and technical documentation skills.
• Solid computer skills.
• Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
• Must be a team player with integrity and concern for the quality of Company products, services and staff members.

For more information on Boston Ananlytical, please visit us at www.bostonanalytical.com. To apply for this position, please click here.

In this position the Senior Chemist will conduct quantitative and qualitative analyses of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures.  Duties will include analysis of pharmaceutical and related products using HPLC, UPLC, GC, LC/MS, Dissolution, AA, UV-Vis, and Wet Chemical Analysis .  Method development and validation is also a major part of this role. In addition, the Senior Chemist will supervise, train and assist other Chemists on an as needed basis.

Primary Duties and Responsibilities:

• Designs and develops experiments, processes, and methods for the solution of technical problems.  Able to work with a degree of independence.
• Prepares and analyzes products to determine chemical and physical properties, identity, content and purity.
• Conducts research on manufactured products to develop, improve and validate test procedures.
• Troubleshoots instrument and
• Confers with chemists and client personnel regarding research, procedures performed, related results, and prepares technical papers and reports.
• Documents work in a clear and organized manner, with a high attention to detail
• Follows all safety rules and regulations and conducts periodic safety audits.
• Ensures all appropriate work is performed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration and United States Pharmacopeia methodologies.
• Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.
• Performs work at a level to be considered subject matter expert.  As subject matter expert, confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.

Minimum Skills Requirements:

• Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
• Strong oral and written communication skills
• Strong organizational skills and attention to detail.
• Ability to be an effective hands-on leader.
• Method development and validation particularly in HPLC, LC/MS, UPLC and GC.
• Dissolution, compendia chemistry methods for raw materials and Karl Fischer are a plus.
• Familiarity with chromatography data systems, ELNs, and LIMS.

This position requires a MS or PhD degree in Analytical Chemistry or a related field with 5+ years of experience.  Knowledge of cGMP is a must.  Previous method development and validation experience required. Experience with LC/MS and Empower software extremely desirable.

To find out more about Boston Analytical, visit us at our website at www.bostonanalytical.com. To apply for this position, click here.

Req ID:  5564BR

Position title:  Human Resources, Manager

Department:   Human Resources

Location:   US-Marlborough, Massachusetts

Job type:   Full-time

Summary of Responsibilities:

The Human Resources, Manager will engage with managers and employees to provide support in the areas of employee relations, performance management, case management, talent development, and metrics analytics. Additionally, the individual will work closely with the HR Business Partners and other HR colleagues on HR initiatives that support business objectives. This position requires a high level of confidentiality, discretion, rigor and a passion for excellence to support the business.

Essential Functions:

 • Serve as point of contact for managers and employees regarding HR policies, procedures, and programs in close partnership with other HR functions in a manner that conveys consistent messaging and administration 
• Assist and support HRBP’s with various HR related functions including employee relations, performance management, employee engagement and recognition, corrective action, talent & succession planning, compensation, staffing and metric analytics. 
• Provide guidance and counsel to managers regarding applicable legal and regulatory compliance issues, company policy and effective management of their employees. Seek guidance of HR Business Partners as needed and apply prudent judgment when matters require escalation. 
• Under direction/guidance from appropriate HRBP, manage employee relations inquiries. Evaluate issues and support resolution process including ownership of assigned investigative steps and action plan development and follow up in conjunction with Compliance and Legal colleagues (as appropriate) consistent with internal policies and practices. Provide coaching to key stakeholders within context of employee relations and performance improvement related discussions. 
• Prepare and present investigative reports to Compliance Investigation Committee (CIC) following prescribed protocols. 
• Coordinate aggregation and reporting of HR related information such as employee relation activities, performance, compensation, promotions, turnover, etc. 
• Analyze exit interview data for trends and make recommendations for changes, as appropriate. 
• Ensure timely and effective administration of human resources programs; build collaborative relationships across organization, to provide consistent and efficient services. 
• Recommend new approaches, policies, and procedures to affect continual improvements in efficiency of HR processes and services. 
• Manage leaves and third party vendor and support to affect proper out-bound and in-bound transition activities. Provide status reports on a routine basis and partner with Benefits colleagues regarding trends/usage level. Participate in vendor selection as part of cyclical benefits review process. 
• Perform other duties and responsibilities as directed.

Minimum education requirements:   Bachelors

Experience required:  5 - 7 Years

Knowledge & skills (general and technical): 

• Solid understanding of all applicable state and federal employment laws 
• Proven track record of successful interpersonal problem solving skills and coaching 
• Strong verbal and written communications skills 
• Well organized and capacity to work independently in a collaborative environment 
• Strong time management, multi-tasking and strong follow up skills 
• The ability to prioritize as well as remain flexible in a fast paced environment 
• Demonstrated proficiency in MS Office Suite with strong ability to quickly learn new systems and processes. 
• Experience with HRIS systems such as Workday, as well as proficiency using web conferencing technology a plus. 
• Must possess strong analytical skills. 
• Must possess strong presentation skills and professionalism to project a professional image, both internally and externally. 
• Minimum of 5 years of experience in HR as well as working in a fast paced customer/client centric professional environment. Previous life science or pharma/biotech experience preferred. 
• Commercial experience preferred 
• PHR or SPHR preferred

Confidential Data:  All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance:  Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements:  Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Reporting to the Chief Business Officer, this role will work in cooperation within the Business Development and Alliance Management team in supporting the management and optimization of current and anticipated alliances with key partners.

Required Skills:

• Primary responsibility is to lead the alliances and collaborations on Akebia’s pipeline.
• Starting with vadadustat global alliances, including the collaboration with Mitsubishi Tanabe Pharma Corporation announced in December 2015.
• Future collaborations on existing Akebia programs, and on in-licensed programs.
• Ensure that key goals for each alliance is achieved by the partners, oversee Akebia’s contractual obligations, and be the go-to person internally and for our partners for alliance-related matters.
• Work closely with and support cross-functional teams to prepare for interactions with our partners. Be familiar and close enough to details of the programs (internally and at the partner) to deal with the partners on the various day-to-day issues and opportunities arising from the collaborations.
• Drive and/or assist in the review and creation of inter-company communications and develop agendas, manage the partner meetings and document the key discussion points and decisions taken at these meetings. Identify issues as they arise internally, or as a result of partner interactions, and work with team leadership and other necessary stakeholders to formulate a position/strategy and participate/drive resolution process.
• Develop a deep understanding of contractual elements pertinent to each alliance
• Clearly and concisely communicate (both written and verbally) alliance issues and possible resolution to the various internal and partner stakeholders.
• Leverage a thorough understanding of the research, development and commercialization of new drugs through past experience, and be well grounded in the scientific, development, regulatory and commercial concepts inherent in both early and late-stage development programs.
• Work closely with a variety of functions, including but not limited to research, development, regulatory, commercial finance and legal to ensure that the relevant points of view from the key stakeholders are incorporated into all situations and analyses.
• Develop (along with the Chief Business Officer) and deliver the vision for the Alliance Management function as we continue to evolve as a company. Develop external and partnering growth strategic plan, in line with the company long range plan and commercial planning for new pipeline products, including hiring and management of additional headcount as required.

Required Experience:

• Bachelor Degree required.
• MBA, MSc or PhD a plus (not a requirement).
• Fluent in Japanese is a plus (not a requirement).
• Prior experience in alliance management with a Japanese partner is a strong plus.
• Extensive experience in pharmaceutical alliance management across development stage: pre-clinical, clinical and pre-launch/commercial.
• Minimum of 5 years of successful experience in a public company.
• Proven experience in leading cross-functional product teams.
• Experience in renal, metabolic, cardiovascular disease a plus (but not a requirement).
• Good understanding of R&D, drug-development processes.
• A prior industry experience in new product planning is a plus (but not a requirement).
• Excellent communication skills, with strong ability to build and communicate business rationale.
• Strong leadership, relationship management and negotiation skills.
• Ability and desire to work in biotech: small teams, fast pace, fast changing environment.
• Combination of strong strategic thinking with the ability and desire to implement tactical plans. (strategize and lead, but also execute directly).
• Enjoy working in teams.

If you are looking for a challenging, fast-paced, and collaborative job, look no further! Our client is an industry-leading biopharmaceutical company focused on gene therapy. They are looking for a motivated, independent, and detail-oriented individual with good problem solving ability to join their cellular process development team. You will have the opportunity to perform the following: mammalian cell culture; transduction of T-cells with lentiviral vectors; and subsequent analysis with flow cytometry/FACS methods.

Requirements:

• BS/MS in cell biology, immunology or related discipline with 2-7 years relevant industry experience
• Willingness to work with lentiviral vector and human biological samples
• Well versed in a variety of cell based methods with a strong understanding of tissue culture, cell biology, FACS/flow cytometry, and general laboratory techniques

 If you've just been described, apply today!

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

CHEMISTRY IS EVERYTHING™

Director, DMPK and Toxicology

BIND Therapeutics is a clinical-stage nanomedicine company developing a pipeline of Accurins™, its novel targeted therapeutics designed to increase the concentration and duration of therapeutic payloads at disease sites while reducing exposure to healthy tissue. BIND is leveraging its Medicinal Nanoengineering® platform to develop a pipeline of Accurins targeting hematological and solid tumors and has a number of strategic collaborations with biopharmaceutical companies to develop Accurins in areas of high unmet need. BIND's lead drug candidate, BIND-014, is a prostate-specific membrane antigen (PSMA) -targeted Accurin that contains docetaxel, a clinically-validated and widely-used cancer chemotherapy drug.  

BIND has announced ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd. and Merck & Co., or Merck (known as Merck Sharp & Dohme outside the United States and Canada) and Macrophage Therapeutics (a subsidiary of Navidea Biopharmaceuticals) to develop Accurins based on their proprietary therapeutic payloads and/or targeting ligands. 

BIND Therapeutics is seeking a dynamic and experienced Director of DMPKand Toxicology to join a team of highly motivated scientists.  The Director will assume primary responsibility for leadership in providing knowledge of pharmacokinetics and bioanalytical expertise to BIND’s discovery and development teams. The successful candidate will have broad subject expertise including pharmacology, pharmacokinetics and expertise through the design, execution and interpretation of in-vivo studies. 

DMPK Responsibilities:

• Develop bioanalytical methods for nanoparticle-based medicines; encapsulated and free payloads (small molecules, nucleotides and peptides)
• Work with in vivo pharmacologists on early pharmacokinetic and biodistribution studies for pipeline assets
• Responsible for basic PK modeling, calculation of standard PK parameters and human dose predictions
• Management of external CROs for GLP IND-enabling studies
• Establish and liaise with key consultants and collaborators on PK assay development, study design and execution
• Design, conduct and analyze studies to elucidate nanoparticle fate, disposition, and PK with the ability to bridge from animal studies to the clinic
• Apply understanding of PK/PD to design studies that define the appropriate dose & schedule for pipeline assets
• Apply state-of-the-art DMPK expertise for human dose prediction modeling for IV and SC delivery
• Assist project teams in developing clinical PK/PD plans
• Ideal candidate will have prior nanoparticle DMPK experience

Toxicology Responsibilities:

• In consultation with project teams and physicians, design, operationalize and interpret studies to define pipeline asset toxicities, therapeutic index, monitoring strategies and overall risk/benefit assessment
• Accountable for the non-clinical toxicology strategy to support the clinical development plan
• Interface with drug metabolism and pharmacokinetic experts to characterize the full pharmaco- and toxico-dynamic properties of nanoparticles
• CRO selection & oversight: principle accountability for delivering critical project data through a network of external study providers. Selection, study design, troubleshooting, data analysis and interpretation, QC/audit and oversight of study reports
• Coordinate with external CROs for non-GLP and GLP analysis of pipeline assets; nanoparticles, payloads, metabolites and biomarkers in biological samples
• Establish and liaise with key consultants and collaborators on toxicology study design, execution and results interpretation
• Ideal candidate will have prior nanoparticle toxicology experience

Requirements:

• Must have 10+ years of experience in the pharmaceutical / biotechnology industry with PhD, or equivalent experience, in Pharmacology, Pathology or relevant discipline
• Prior experience with nanoparticle based delivery systems strongly preferred
• Proven expertise in successfully selecting and managing CROs to provide high quality, timely and on budget studies
• The successful candidate thrives in a fast-paced, interdisciplinary environment; is self-motivated and flexible, and has a track record of finding innovative solutions to complex problems in both team and individual settings
• Demonstrated strong written and verbal communication skills with the ability to clearly and persuasively articulate complex concepts and strategies to a diverse audience
• Candidates who are enthusiastic team players that have a passion for making a difference in the discovery and development of life-saving medicines are encouraged to apply

BIND has a vibrant and engaging culture of innovation and team work and we are continuing to build a top-tier team of scientists and engineers to rapidly advance our R&D programs in a fast-paced, exciting and fun work environment. We offer a robust benefits package including premium health/dental plans, 401(k) retirement plan, incentive stock options, 3 weeks’ vacation, professional development, laboratories outfitted with the latest equipment, an often-used ping pong table, and frequent social opportunities.

Please forward your CV/resume to Careers@BINDtherapeutics.com
BIND Therapeutics, Inc. 325 Vassar Street, Cambridge, MA 02139
www.BINDtherapeutics.com

Requsition: 171172BR

The Cardiovascular & Metabolic Disease Group at the Novartis Institutes for Biomedical Research is committed to discovering innovative treatments for cardiovascular and metabolic disorders. The successful candidate will be responsible for leading a laboratory of BS/MS level scientists to perform in vivo mechanistic, pharmacodynamic, and disease relevant efficacy studies in multiple animal models to advance the project portfolio. In addition, there will be opportunities to develop new animal models and conduct target identification/validation studies for new targets. The ideal candidate will be capable of leading a project within a complex, fast-moving, multi-disciplinary program aimed at treating cardiovascular and/or metabolic diseases. Along with the ability to innovate, excellent communication and analytical skills are required. The specific requirements for the position are: • An excellent track record of scientific achievement • Expertise in cardiovascular physiology or metabolism • Experience in cardiovascular or metabolism animal models • Strong command of scientific literature, and knowledge of key scientists in the area of cardiovascular physiology or metabolism

PhD and/or MD with postdoctoral experience and a minimum of three years of research in physiology, pharmacology or closely related discipline. The successful candidate will be an innovative scientist who is results-oriented and able to excel in a fast-track environment. He or she will be a strategic thinker who interacts and collaborates with peers and management in identifying and achieving discovery goals from both scientific and strategic perspectives.

Requsition: 171169BR

There is an immediate opening for an experienced scientist to join our cardiovascular and metabolic disease research team. The candidate would be responsible for in vivo pharmacology studies, including in vivo model development and compound screening in pharmacodynamic and efficacy models. Additional experience with ex vivo or in vitro assays would be an advantage.
The candidate will be expected to work both independently and collaboratively as part of an in vivo pharmacology team. In addition, the candidate will be expected to contribute to experimental design, independent data analysis and interpretation, and generation of internal reports.

BS/MS in pharmacology, physiology, neurobiology, cell biology, molecular biology, or related fields, with at least 5 years of relevant experience. The candidate must have extensive hands-on experience in in vivo pharmacology, preferably in animal models of cardiovascular or metabolic diseases. Industry experience is a plus.
The candidate must be highly self-motivated, work in teams, possess good interpersonal skills and have excellent oral and written communication.

Requsition: 171175BR

Novartis Cardiovascular and Metabolism department is looking for a highly motivated and capable individual to join the Biochemistry group. The candidate will be responsible for developing biochemical, biophysical, and bioanalytical assays to characterize potential therapeutic molecules. Additional responsibilities include timely documentation of work and presentations in cross-functional project teams.

B.S. or M.S. in Biochemistry, or related life science field. Experience in enzyme kinetics, biochemical and biophysical assay development is desirable. Knowledge and hands-on experience with GPCR targets and cellular assays are a plus. In addition, experience in enzyme/protein purification and modern biophysical/analytical techniques, such as fluorescence spectroscopy, surface plasmon resonance (SPR), calorimetry, and LC-MS are a plus. Must be self-motivated and detailed-oriented. Must have excellent written and oral communication skills and demonstrate ability to work both independently and as part of a team and exhibit strong problem solving skills.

Marketing Intern

Summary:
Vittamed Corporation is a growing international medical device manufacturer focused on neurodiagnostics and monitoring.  Headquartered in Lexington, MA, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused atmosphere.  We are currently searching for a dynamic Marketing Intern to join our US office. This intern will be responsible for all primary and secondary market research supporting Vittamed’s commercial activities.

Responsibilities:

• Manage primary and secondary market research projects supporting the needs of the business as required
• Support the development and maintenance of market insights for company
• Incorporate market research and secondary information into strategic insights to inform decision-making
• Contribute to the development of marketing materials (e.g. brochures, flyers, etc.)
• Website improvements
• Maintain accurate, timely and effective records of all lead generation activity in Salesforce.com

 Qualifications:

• 3-5 years’ experience developing and implementing primary / secondary market research projects
• Excellent problem solving and analytical skills
• Excellent verbal and written communication skills
• Excellent project management skills
• Medical Device industry experience preferred
• Bachelor's degree in Business or Scientific field; Master’s degree preferred

 Contact:

For additional information about Vittamed, please visit www.vittamed.com

Resumes and cover letters can be sent to mmckeon@vittamed.com

Role Objective:

• The Manager, Sales Operations is responsible for sales force effectiveness and Sales Incentive Compensation (IC) planning, processing and management.

Key Responsibilities:

• Hands-on management of sales force optimization programs including segmentation, sizing, alignments and targeting for multiple sales forces
• Manage ongoing territory alignments by continuous refining to streamline and drive efficiencies
• Recommend and optimize appropriate performance metrics, KPI’s and sales compensation plans
• Assist in the design, management and execution of all aspects of sales incentive compensation program including generating goals, IC reporting, attainment calculation and payouts as well as special incentive programs, contests, etc.
• Manage sales performance reporting including field sales reports and sales management dashboards

Requirements:

• Bachelor’s degree in a relevant field
• 6+ years of pharmaceutical experience, including
  • 2+ years sales operations related functional responsibilities
  • 2+ years SFE and IC implementation
  • Experience developing, managing sales incentive compensation programs 
  • Advanced knowledge of Access, Excel, PowerPoint
  • Experience of working closely with sales teams, senior management and internal stakeholders to support development of sales strategies, tactics and ongoing performance management
  • Experience as an SFE Analyst within the pharmaceutical industry or broader healthcare industry preferred but not essential
  • CRM management experience a plus
  • Start-up experience a plus
  • Ability to work independently but collaboratively in a fast paced environment
  • Strong communicator and team player

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for strategic regulatory activities related to SAGE’s clinical development programs.

Roles and Responsibilities

• As a member of the program teams, provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
• Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
• Organize and manage regulatory meetings with health authorities.
• Review materials for compliance with advertising and promotion regulations.
• Perform regulatory strategic assessments for new product candidates and new indications.
• Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
• Manage contract staff and vendors as needed to support regulatory activities.
• Provide create and innovative solutions while being an advocate for compliance.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

• 7-10 years of experience in Regulatory Affairs related to development of pharmaceuticals, CNS experience preferred
• Bachelor of Science in a scientific discipline, MS or PhD preferred
• Strong knowledge of eCTD elements and structure
• Strong regulatory writing skills and use of Microsoft WORD
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Possesses strong written and verbal communication and presentation skills.
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
• Excitement about the vision and mission of Sage

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for quality document management and training.

Roles and Responsibilities

Documentation Management           

• Participate with Quality/Regulatory leadership in the development of the Quality Manual, process mapping and Quality Documentation infrastructure for a growing and multi-product business.
• Develop and implement process maps/workstreams for efficient documentation workflows.
• Actively promote the requirements and capabilities of the Quality Documentation System throughout the organization with current and future strategies for the Quality Documentation System (EDMS, cloud-based computerized systems).
• Author, review and approve controlled written standards, including Master Production Records, Standard Operating Procedures, Specifications, Qualification/Validation Protocols, Test Methods, and Deviations and Change Control Documentation related to the Quality Management System.
• Provide oversight and linkage to Training curricula for on-time operations in compliance with GxP, regulatory requirements and Quality Manual/procedures.
• Participate and contribute to Quality/Regulatory budget for Documentation and Training.
• Provide support during internal and external audits related to Regulatory and internal audits for Documentation/Training.

Training Management

• Lead, manage and execute an Annual Training Plan for all GxP employees in line with current and future Quality/Regulatory strategies.
• Identify associate capability &/or training needs by consulting with business managers, human resources and conducted needs analysis.
• Develop training curricula for employee functions for GCP/GLP/GMP processes
• Conduct instructor led training programs including the “why” for presenting complex issues to a diverse audience. Assess training effectiveness to ensure transfer of skills and knowledge into associate work behavior
• Lead the creation, review and update of a Learning Management systems: for programs, content, while working with internal stakeholders and systems experts to track and deploy eLearning as appropriate.
• Develop and present formal recommendations for enhancements, upgrades and business process changes related to Documentation and Learning Management Systems.
• Establish and deploy timely metrics for Documentation and Training Management leading to action plans for Quality Council/meetings for continuous improvement.
• Use expertise in the latest learning and development methods and adult learning theory to shape and design learning programs through networking and benchmark, identify best industry practices

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills and ability to develop relationships with key stakeholders.  Ability to communicate issues in a simple way and to orchestrate plans to resolve issues and risks.

• B.S/B.A. in an engineering, operations or science degree
• 10+ Quality Assurance experience including 5 years experience in Documentation/Training eLMS systems
• Possess in-depth knowledge of GCP/GLP/GMP regulations, principles, concepts, industry practices and standards
• Strong knowledge of quality assurance processes and procedures including sterile/solid dosage manufacturing
• Extensive knowledge of instructional design theory, adult learning principles and methods for curriculum design
• Proficient in validation / computerized system validation / Part 11 requirements with demonstrated experience in implementation of a Document Management System (User Requirements, beta-testing, writing/executing protocols) while building internal and external relationships with vendors, consultants and key stakeholders 
• Excellent knowledge in MS Office, Visio, MS Project, eLMS, EDMS systems and database software
• Excellent interpersonal, problem solving, risk analysis and negotiation skills
• Effective organization, communication, and team orientation skills
• Ability to coordinate timelines with internal customers and external clients and vendors
• Strong team player that has a customer service approach and is solution oriented
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Possesses strong written and verbal communication skills
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
• Excitement about the vision and mission of SAGE

Exosome Diagnostics develops biofluid-based molecular diagnostic tests for use in personalized medicine. Exosomes and other microvesicles are shed into all biofluids, including blood, urine and cerebrospinal fluid, forming a highly enriched source of intact nucleic acids. Exosome Diagnostic’s proprietary technology makes use of this natural enrichment to achieve high sensitivity and specificity for detecting rare transcripts of the genes responsible for cancers and other diseases.

We are expanding our R&D facility in Cambridge MA and are looking for an experienced Senior Bioinformatics Scientist. This position will be responsible for providing key technical, statistical and intellectual input into the analysis of sequencing and array data generated from biofluid-based exosome RNA. 

This is a responsible position with the great opportunity for personal and professional development and the chance to influence and contribute in the dynamic working environment of a rapidly growing company. We are developing a cutting edge technology for molecular diagnostics in personalized medicine for patients with cancer, neurodegenerative and other diseases.

This position requires an individual with an entrepreneurial mindset who is adaptable and able to fill different roles and responsibilities. The ideal candidate must be experienced in the field of next generation sequencing data analysis and preferably also microarray data analysis. We expect that you will have a background of bioinformatics or biostatistics and in molecular biology or similar.

Key responsibilities include:

• Analyzing Next-Gen Sequencing and Microarray data from exosome RNA derived from clinical samples.
• Deriving genetic signatures as biomarkers and evaluating their statistical validity.
• Developing new algorithms and tools or modifying existing as needed.
• Assisting in the design of key experiments and company-wide projects to advance the development and understanding of the molecular biology of exosomes.
• Providing assistance and training to aid the development of other team members.
• Contributing data and analysis to intellectual property filings and publications.
• Presenting analysis and interacting with the rest of the company’s scientific staff and key stake holders, including our collaborator network of world-class hospitals and universities.

Qualifications:

• PhD in Bioinformatics, computer science, molecular biology or in other relevant field and 3+ years of experience preferably in industry or biotech.
• Proficient in the use of bioinformatics tools and requisite programming skills with experience working with genomic data analysis, especially analysis of sequencing data
• A strong candidate will have experience with Unix, Perl or Python, and R Bioconductor programming. 

Desired Skills:

• Ability to work in a fast paced environment with multiple projects and frequent deadlines.
• Scientific publication record in leading journals and are current on scientific literature.
• Are disciplined, organized and understand the importance of documenting your work.
• Are systematic, meticulous, can work independently and are deadline focused.
• Are looking for an opportunity to contribute to significant research outside of large corporate structures.
• Have an excellent work ethic with high energy levels.

 What we offer:

• Competitive salary and benefits package.
• An attractive location in the vibrant Boston/Cambridge community of biotech and academic research.

At Exosome Diagnostics, we are translating cutting edge science into real clinical products to benefit patients and doctors. We are developing and commercializing clinical in-vitro diagnostics with our industry partners Qiagen, Eli Lilly and other leaders in personalized medicine, offering the potential for significant corporate growth and enhanced career development. We encourage the honest exchange of ideas and a culture of collaboration within the company, to help the exceptional people who work here to excel and to reach company goals.

How to apply: Interested candidates should submit a resume (Word or PDF format) to careers@exosomedx.com.

Please put [2677724](Senior Scientist Bioinformatics) in the subject line.

Position: Executive Assistant

Job Code: 15-200
Reports to: Chief Medical Officer

Location: Waltham, MA

ABOUT CERULEAN PHARMA INC.

Cerulean Pharma Inc. (NASDAQ: CERU) is committed to improving treatment for people living with cancer. We apply our Dynamic Tumor Targeting Platform to create a portfolio of Nanoparticle Drug Conjugates designed to selectively attack tumor cells, reduce toxicity by sparing the body's normal cells, and enable therapeutic combinations. Our first platform-generated candidate, CRLX101, is in multiple clinical trials in combination with other cancer treatments, all of which aim to unlock the power of combination therapy. The U.S. FDA recently granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma. Our second platform-generated candidate, CRLX301, is in a Phase 1/2a clinical trial. For more information, please visit www.ceruleanrx.com.

POSITION OVERVIEW

The incumbent provides top notch administrative support to assigned executives/ departments.  Applies thorough knowledge of company operations, policies and procedures.  Handles details of a highly confidential and critical nature.  Collects and prepares information for use in discussions/meetings of executive staff and outside individuals.  May prepare presentation materials for board of director meetings.  Makes high level contacts of a sensitive nature inside and outside the company.  Exercises judgment within generally defined practices and policies in selecting experience in working with senior-level executives within and outside the company, customers, vendors, visitors and other dignitaries.

PRINCIPAL RESPONSIBILITIES

• Provide executive administrative support to Chief Medical Officer and Vice President of Clinical Operations. 
  • Manage complex and dynamic executive calendars in MS outlook with pragmatism and collaboration;
  • Arrange intricate global travel with service providers using discretion, practical judgment, cost/benefit analysis and high attention to detail.  Complete expense reports, tracking their progress and timely processing;
  • Prepare, monitor, coordinate and expedite purchase requisitions and services for the Clinical team; review invoices for accuracy prior to payment, perform data entry necessary to input expense information into spreadsheet format for the maintenance of records and preparation of reports as needed;
  • Manage high level contacts including flow of confidential information;
  • Track non-study invoicing costs, i.e. advisory boards, KOL meetings, training, department T&E;
  • Manage invoice receipt from finance and distribution around department for review and accrual verification;
  • Track advisor meeting attendance and manage advisor/consultant payments;
  • Provide CDA and consulting agreement templates to new advisors, consultants, and vendors;
  • Prepare PO requests for newly executed and updated agreements;
  • Communicate corporate meeting calendar due dates e.g. deliverables for BoD, finance, IR/BD, etc.  Ensure functional area members are aware of relevant due dates.
• May provide light administrative support to the Clinical Team.
• Oversee and ensure smooth operation of the first floor office space:
  • Keep Office Manager apprised of needs for supply inventory, any health or safety issues on first floor;
  • Ensure departmental occupants keep common rooms appropriately clean, etc.;
  • Ensure appropriate security measures are in place each  evening;
  • Sort departmental mail.
• Pitch in to help when other administrative staff is out or require additional help.
• Other administrative duties as assigned.

QUALIFICATIONS

• Bachelor’s degree or equivalent preferred.
• 5 – 10 years of administrative experience; past experience of supporting executives strongly preferred.
• Meticulous attention to detail.
• Proficiency in MS Outlook Work, Excel, PowerPoint.
• Must have high level of interpersonal skills and ability to interface with all levels of management and staff.
• Good natured, flexible to changing priorities and skilled at multi-tasking
• Collaborative work style with ability to interface with all levels of management and staff.
• Excellent and professional oral, written and phone communication skills.
• Commitment to excellence through receiving feedback and growing with the company.

Reporting to the Senior Vice President of Regulatory Affairs, the VP of Regulatory Affairs will be a leader and key member of a dynamic team who is responsible for managing and directing the regulatory strategy and implementation for several programs in diverse areas of development, with a focus on rare diseases.  Working with direct reports, the VP will identify the key strategic regulatory drivers for early and late stage programs for submissions (from IND to NDA) to US and international regulatory agencies. 

Responsibilities include setting priorities, providing strategic input, identifying and assessing regulatory risks, understanding global imperatives including market-related drivers, interfacing with regulatory authorities, keeping up with US and global regulatory requirements and guidances, and providing oversight and review of key regulatory documents.  This role will also be required to present and defend regulatory plans to Senior Management.

A proven leader with a minimum of 15+ years pharmaceutical/biotechnology industry experience, 10+ years regulatory experience working on biotech programs.

• Deep knowledge and understanding of regulatory requirements and environment, especially in the US
• Demonstrate strategic thinking and implementation in overall drug development, with experience in rare diseases
• Strong scientific background and understanding
• Able to drive strategic thinking and plans for successful regulatory outcomes
• Dynamic individual with excellent written and communication skills
• Ability to skillfully and appropriately manage, develop and mentor people
• Ability to set priorities, work independently and deliver in a timely manner
• Experience with IND and NDA submissions
• Experience in interfacing with regulatory authorities
• Demonstrate strong organizational skills
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel in a matrix environment
• Attention to detail

PhD or PharmD degree preferred.  Life/Health Sciences preferred.

Primary Role:
Provides senior level administrative support, which will often involve contact and exposure to highly confidential materials and information.

Responsibilities:
40%:
Greets visitors, answers and directs phone calls to appropriate areas and answers routine inquiries. Coordinates and prepares outgoing mail, including express packages Prepares routine and non-routine correspondence, memoranda, reports, spreadsheets, presentations, agendas and meeting minutes. Contacts company employees at all organizational levels to gather information. Maintains electronic and paper filing systems. Coordinates with HR dept on candidate interviews, selection, references, temporary consultants. Provides travel, schedule and meeting coordination. Submits and ensures that expense reports are managed in a timely fashion.

30%:
Manage department calendars and schedules as requested. Coordinate travel plans as requested. Coordinates meetings including reserving rooms, audio/visual equipment, catering and other resources. Provides general office support.

20%:
Ensures office equipment such as printers, copiers, and faxes remain in working order. Orders and maintains appropriate levels of office supplies. Coordinates with IT for all technical issues. Coordinates with Facilities on staff moves, new hires, or general repairs. Acts as back-up support to other Groups for Administrative staffing absences or work overflow. Participates in department projects and initiatives.

10%:
Creates and distributes meeting materials for projects and specific meetings. Formats and edits meeting materials and presentations as requested. Compiles and analyzes information and reports relevant to department projects

Education & Experience Requirements:
o High school diploma/ equivalent; Bachelor's degree preferred
o 5-8 years of related experience
o Must have experience supporting senior level management in a complex global environment;

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=c21vdXNzZWF1LjQ4NTQ4LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

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
The Bioanalytical Nucleic Acids group within Pharmatherapeutics (PTx) Clinical Research focuses on exploratory biomarker analysis for programs within Pfizer's PTx organization.

This position focuses on the evaluation and application of a broad range of cutting edge genomic technologies to explore nucleic acid based biomarkers of disease and pharmacological activity to impact Pfizer's Precision Medicine strategy for clinical decision making. The ideal candidate will have a broad technical skill-base in the area of Next Generation Sequencing (NGS) technologies and excellent communication skills allowing for the planning and execution of work internally as well as externally with partner contract research organizations (CROs).

Responsibilities
Maintain an up to date assessment of the strengths, weaknesses, and technical feasibility of the expanding landscape of NGS-based molecular applications (such as RNA-seq, Immuno-Seq, metagenomics, liquid biopsies/ cell-free nucleic acids/ exosomal nucleic acids, single cell technologies, etc.) which will include continued interactions with technology platform vendors.

Provide subject matter expertise through close collaboration with Clinical and Research Scientists from the Inflammation& Immunology and the Cardiovascular and Metabolic Disease Research Units allowing for the development of exploratory biomarker strategies that effectively deliver an understanding of the pharmacologic response, stratification of patient response, and classification of disease.

Application of the most appropriate and cost-effective NGS-based technologies to biomarker strategies from preclinical models to Proof of Mechanism (POM) and Proof of Concept (POC) clinical studies. Support the management of external vendors, the qualification/validation of NGS-approaches, and review/QC of data produced.

Establish close collaborative ties with Genetics, Computational Biology and Bioinformatics teams to develop appropriate hypotheses and data analysis processes for a robust, integrative analysis of genetic/ genomic/ NGS data into precision medicine models of drug response and disease biology.

Utilize/manage internal lab capabilities to conduct and support technology development/assessment and preclinical biomarker hypothesis generation.

Assist with planning and managing of external work with CROs, internal lab activities, data QC and transfer of data to internal computational or statistics groups.

Qualifications
PhD (or equivalent) in relevant science related subject.

This role requires skillful experience in the design, planning, execution of molecular biology based analyses and preferably experience with downstream analysis of NGS results.

Preferably 2+ years of experience in supporting NGS-technology based profiling projects with an emphasis on clinical applications. The role requires collaboration across Pfizer departments, with external investigators and with external CROs. Both project management and bench-level work will be required.

Experience in a biotech/ pharmaceutical setting and prior experience in the inflammation/ autoimmune disease or CVMED scientific domain with an understanding of disease biology at the molecular level is preferred (but not required).

Proficient in the use of standard and specialized software programs (e.g., Excel, PowerPoint, GraphPad, Spotfire or Expressionist) for data transformation, visualization and basic statistical analysis of multivariate data. Experience with R, familiarity with command line executing scripts, and with UNIX/Linux would be beneficial.

Prior experience working in a matrixed environment will also be highly desirable.

Ability to work in a team environment, coordinate parallel activities and rapidly respond to changing priorities. A highly collaborative, innovative and critical mindset with the ability to communicate complex concepts clearly to diverse audiences such as clinicians and pre-clinical scientists.

Technical skills requirement:
* Extensive knowledge in the NGS field, including solid understanding of the rapidly expanding applications for various sample types and diverse biological questions.
* Ability to conceptualize big data analysis approaches for integrative analysis of diverse clinical and molecular readouts.
* Identifies, proposes and develops new technologies and methodology concepts
* Critical thinker with the ability to provide rigorous scientific critique on project ideas, technology and molecular biology protocol selection, data QC and interpretation of results.
* Management of vendor relationships.
* Proficient in verbal and written communication.

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=TWVnYW4uSGFycmlnYW4uMjY2MDMuMzE2N0BwZml6ZXIuYXBsaXRyYWsuY29t