Please visit our careers site to see all of our openings in Cambridge, MA

www.lifetech.com/careers

The Enterprise Solutions Group within Life Technologies is a global provider of end-to-end solutions for establishing Genomic Medicine Infrastructure at the population-scale, with a global base of customers at the level of national governments. The operational portions of these projects involve large-scale genetics studies to catalog normal and disease variation in entire populations.  Studies will utilize state-of-the-art laboratory facilities deployed by the Enterprise Group, which integrate and leverage Life Technologies broad product portfolio of Life Science tools, including the Ion Torrent semi-conductor sequencing technology. Data will consist primarily of human genome sequence data from gene panels, exomes and whole genomes.

 We are seeking highly motivated individuals who will make a large impact on human disease.  You will be an integral part of an enthusiastic and dedicated team of Bioinformaticians and Software Engineers working towards solving genetic disease utilizing Next Generation Sequencing in collaboration with geneticists and medical research collaborators.  This job is an exciting opportunity for someone willing to take on design, validation and data analysis of gene-panel and genome-scale re-sequencing projects aimed at clinical research and clinical applications. This person will participate in large population-wide studies of genetic disease using gene-panels and whole genome re-sequencing, utilizing their knowledge of existing algorithms, statistical techniques, and a variety available open source and commercial software. This position also requires an understanding of complex scientific problems in order to implement novel algorithms and solutions when needed.

 Responsibilities:

* Support the specification of highly multiplexed amplicon sequencing panels for various disease-associated genes utilizing the Ion Torrent AmpliSeq Design technology in collaboration with clinicians and geneticists.

* Integrate and optimize existing panel design algorithms, variant detection, annotation, and reporting bioinformatics tools.

* Collaborate with sequencing teams and clinical researchers to qualify panel performance.

* Conduct statistical analysis for gene-panel human re-sequencing projects.

* Provide rapid and responsive bioinformatics support to population study projects for gene panels and genome re-sequencing.

 Qualifications:

* MS/PhD in Bioinformatics, Computer Science, Human Genetics, Computational Genetics, Biology, or related field. Software Engineering is not required, but experience in Software Development practices is a plus.

* Experience with primer design, SNP tag selection, Gene Panels, with related experience on NGS and/or CE platforms a plus.

* Experience with analysis of human re-sequencing experiments from primary analysis to resulting genetic interpretation.

* Expertise in scripting languages (Python, Perl), mathematics software (R, Matlab, Mathematica), and object-orient programming (with Java/C++).

* Experience with a Linux/Unix development environment.

* Excellent written and verbal communications skills.

* Highly motivated and able to work with minimal supervision in a collaborative, team-oriented environment.

* Desire to continuously learn new things across disciplines of genetics, biology, software engineering, bioinformatics and statistical analysis.

SANOFI PASTEUR, The vaccine business of Sanofi US HAS the following contract opportunity available in our discovery US Cambridge location.

A Post Doc/TEMPORARY SCIENTIST role

Position Description:  This Scientist position is a contract opportunity; a 3-year grant to fulfill our commitment to a Bill & Melinda Gates Foundation funded initiative to develop a novel vaccine against HIV.

The person selected for this role will be spending most of his/her time on the HIV vaccine project,  (development of vaccine candidates for HIV), performing a large amount of planned experimental work. This is critical for us meeting the aggressive goals and timelines of the grant.  

This HIV project is very challenging, both technically and in terms of aggressive timelines. The success in this position will require excellent technical skills, high productivity, creativity, efficient technical trouble shooting, and communication skills to efficiently communicate with supervisor and other team members, to learn and efficiently implement techniques, optimize methods, generate a large amount of high-quality data, and analyze results. 

Accountabilities: Standard for a bench scientist/postdoc, but the anticipated results and contributions will be critical for this very important grant and our success as members of an outstanding international consortium.

Education / Skills Required: PhD or MS, with experience in Molecular biology/Virology/Vaccine research or equivalent, with a minimum 2 years of hands-on research experience in an R&D environment.

Experiences with viruses (preferably RNA viruses) and cell culture are a plus.  Excellent molecular biology skill set, tissue culture techniques, knowledge of viruses and viral  assays a plus.

Certifications:  A record reflecting relevant skills and scientific productivity (publications, conference presentations) is desirable.

 Interested applicants may apply via email: 

diane.reilly-robles@sanofipasteur.com

Our client is seeking a Regulatory Operations Specialist to provide R&D electronic document management coordination & services (templates, formatting, proof-reading, publishing, and archiving) for R&D regulatory documents by supporting the business implementation and life cycle management of electronic document management systems (EDMS). In this position you will also execute and maintain processes for Regulatory Affair’s global submissions, correspondences, and commitments in accordance with Good Documentation Practices.  This position requires a BA/BS degree and experience with the following: eCTD Software System; Microsoft Word and Adobe Acrobat desktop publishing techniques for regulatory submission documents; Documentum based products; and industry standards for desktop publishing regulatory submission documents.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

Looking for a candidate to join a chemistry group performing analytical testing in a GMP/GLP environment.

Requirements:

BS/MS Chemistry or related field with knowledge of wet chemistry and/or dissolution testing.

Candidates must live  local and be a US Citizen or Green Card Holder

Email resume to:  jobs@cwsciences.com

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

Commonwealth  Sciences, Inc.

www.cwsciences.com

Looking for a candidate to assist the lab manager in supervising a small chemistry group. Responsibilities will include training of technicians, troubleshooting issues that arise and keeping the team on track.

Requirements:

BS/MS Chemistry/Biochemistry with 5 years of lab experience
Supervisory experience is a must

 Candidates must live local and be a US Citizen or Green Card Holder

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

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

Position: Quality Assurance/Documentation Specialist

Daktari Diagnostics, Inc. is a Boston-based company developing innovative diagnostic tests for global health conditions. The core technology combines microfluidics with electrochemical sensing. Our initial product, a point-of-care CD4 testing system for use in HIV disease staging worldwide, will provide a CD4 cell count result in less than 10 minutes from a finger stick of blood, anywhere in the world. This handheld system includes a disposable assay cartridge comprised of molded plastics, microfluidics, integrated sensors, and chemistry, and a low-cost electromechanical instrument.

The QA Specialist assists and supports the organization with compliance and ongoing conformance to the quality systems and ISO 13485:2003.  Specifically, performs evaluation of internal controls, communications, and maintenance of documentation as related to compliance with internal and external, quality standards. Participates in the development, documentation, maintenance, and improvement of the Quality Management System, including quality policies, processes, procedures and controls that monitor system performance and ensures conformance to established standards necessary to maintain quality of products and sustainable customer satisfaction.  Documentation coordinator for all aspects of documentation and change controls. 

Primary Responsibilities

• Maintain internal controls over quality policies, procedures, and specifications, ensuring effective versions of procedures are available to employees for implementation
• Facilitate changes to SOPs, policies, training materials, and other documents
• Demonstrate strong  proficiency in the application of the Corrective And Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources
• Maintain data within the electronic QMS database, providing routine status reports and updates to current CAPA system activities
• Update quality/compliance trends or failures
• Perform review of development batch records for completeness as per the requirements and internal procedures
• Support ISO 13485 compliance and inspection readiness within organization
• Provide ongoing support and review of Quality System documents including Procedures, Work Instructions, Forms and design history file documents  and other applicable quality standards, regulations, corporate policies and guidelines
• Perform Local Data coordinator duties within the electronic QMS systems, creating and maintaining master data for finished products, to ensure compliance to corporate policies and standards
• Assist during ISO 13485:2003 and customer audits

Requirements

• BS in Scientific Discipline
• Minimum of five years of experience working in an In Vitro Diagnostic or Medical Device company with a focus on ISO 13485 Quality Systems; experience with product development a plus
• Minimum of two years of experience in Quality Assurance
• Demonstrated knowledge of Quality Assurance activities and ISO regulations as they relate to product development, manufacturing, and technology transfer
• First-hand experience in planning, writing and reviewing Standard Operating Procedures
  Exceptional interpersonal, problem-solving, and written/verbal communication skills

Daktari Diagnostics is a dynamic, start-up environment committed to bringing the highest quality medical diagnostics to everyone, everywhere.

Please contact work@daktaridx.com for more information. Please reference code Q01.

Our client is currently seeking a qualified candidate to perform responsibilities as a Facilities Manager. This is a great opportunity to join a growing company in the Biotechnology/Medical Device industry that is revolutionizing patient treatment in the orthopedic arena.  

The Facilities Manager will interface with vendors to ensure the smooth operation of water systems, air systems, generators, and the scheduling of calibrations of equipment and preventative maintenance in a clean room environment.  

Responsibilities:  

• Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, GMP’s, and safety
• Responsible for adherence to all operating procedures, protocols, policies, regulatory requirements, GMP, and safety guidelines
• Responsible for proper operation of all Clean Room services and equipment
• Responsible for maintenance and repair of water systems, air systems, equipment
• Responsible for scheduling and overseeing any related calibrations
• Analyze equipment breakdowns to determine Root Cause and recommend actions to prevent repeat occurrence
• Communicate potential equipment problems to Vice President of Operations to allow scheduling of repairs; and suggest equipment and system improvements  

Requirements:  

• Bachelor’s degree
• 5+ years of previous facilities experience; experience in pharmaceutical, biologics and/or medical device industries is preferred
• Biologic materials waste management experience
• Good understanding of GMP and clean room maintenance
• Experience effectively managing and/or partnering with contractors/vendors
• Excellent interpersonal skills
• Good communication skills, both verbal and written
• Ability to adapt to changing requirements and priorities
• Ability to function well under pressure, and expend effort to meet schedules and deadlines

Please submit resume to: careers@biomedicalsearch.com

Our client is a worldwide leader in the development and manufacturing of medical surgical technologies. This is a great opportunity if you want to join a stable and fast growing innovation leader!

Responsibilities

• Actively participate in the product development cycle to drive supplier selection process.
• Engage suppliers to establish appropriate qualifications, validations, inspection plans and gauging for both new products and changes to released product.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment with respect to suppliers.
• Establish incoming inspection requirements and revise as necessary.
• Lead problem solving efforts to identify and resolve difficult quality issues that may be a result of supplier processes to ensure production of safe and effective medical devices.
• Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
• Mentor suppliers in the performance of machine and process capability and performance studies.
• Lead the implementation of changes and upgrades to systems, procedures, and processes to improve product quality.
• Provide well-written reports and supporting documentation.
• Assist in the development and assessment of the supplier program.
• Address problems and recommend solutions to supplier quality.
• Support disposition of nonconforming product at the Material Review Board meetings.
• Interface with suppliers to ensure product specifications are met and control plans are implemented.
• Lead supplier audits and assessments, and ensure identified non-conformances are resolved in a timely manner.
• Identify and implement supplier corrective and preventive actions to improve quality and reduce incoming quality NCMR’s.
• Promote continuous improvement through the use of such tools as Lean, Six Sigma and Kaizen.
• Follow all Quality System Practices, policies and Standard Operating Procedures to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
• Foster good working relationship with co-workers and able to work collaboratively in a team environment with general supervision.
• Able to prioritize assignments and manage time effectively, and maintain positive attitude when handling multiple project demands.

Requirements

• B.S./B.A. in Engineering or similar related field
• 5+ years of previous experience in a supplier quality position in a regulated environment
• ASQ Certified Quality Engineer preferred
• Six Sigma Black Belt preferred Electrical design and/ or fabrication experience

Please contact: careers@biomedicalsearch.com

Our client is currently seeking a qualified candidate to perform responsibilities as a SVP of Operations. This is a great opportunity for anyone looking to continue/pursue a VP level (member of Sr. Management) position for a growing company in the Biologics industry.

The SVP will oversee Operations and Supply Chain Management, with key responsibilities to include:

• Assess the current supply chain vendors capability to determine their viability for supporting  future growth of the company Identify and contract with additional vendors as necessary to ensure support of manufacturing scalability. 
• Establish operations standards for cost control, waste reduction, quality standards, on-time production delivery, material usage and shipping and receiving. 
• Oversee facilities management, capacity planning, production scheduling, safety, and customer care. 
• Select and implement an ERP system to support operations and manufacturing processes. 
• Direct implementation and execution of manufacturing policies and practices throughout organization. 
• Recommend and implement strategic changes in manufacturing and operations strategy. 
• Establish planning cycle and provide leadership through cycle completion. 
• Provide leadership for problem resolution to facilitate prompt improvements of production issues. 
• Ensure compliance with FDA and Regulatory Agencies. 
• Ensure compliance with State and Federal regulations. 
• Establish metrics for all key manufacturing indicators. 

Candidates must meet the following criteria:

• 10-15 years previous experience Managing Operations in FDA regulated environment (Biologics, Pharmaceutical or Medical Device industry preferred.) 
• Masters Degree in Engineering or Industrial Technology preferred. 
• Strong business knowledge of Manufacturing Operations, Product Development, Finance, Supply Chain, Regulatory Compliance, Quality Control and GMPs. 
• Familiar with ERP functions and able to establish production plan into MRP. 
• Knowledge of GMP, Lean Manufacturing and Project Management skills. 
• Ability to resolve production issues with operations and engineering teams. 
• Ability to ensure manufacturing efficiency by labor cost, overtime, quality, yield, scrap and through put analysis.

 If you know of anyone or if you are interested in this opportunity, please contact John Bogosian at jbogosian@kingbishop.com or 781-983-2649. 

Position Description:

We have an immediate opening for a Scientist / Sr. Scientist in biochemical assay development and optimization.

The Scientist / Sr. Scientist will participate in interaction with QA/QC and Manufacturing to generate relevant SOPs, DHRs and other control documents as projects are transferred to Manufacturing. The Scientist / Sr. Scientist will also participate in design of QC assays and generate appropriate QA documents for product manufacture, playing a significant role in the Design Control process throughout product development, presenting at Design Control meetings, generating Design Inputs, Design Outputs, Risk Analysis documents and Failure Modes Analysis documents.  The Scientist / Sr. Scientist will assist in clinical trial protocol development and assist senior management with FDA regulatory compliance issues. 

Position Requirements:

Requires PhD in biology or chemistry with 2-4 years industrial experience with in vitro Diagnostic Assay Development.  Knowledge of GLP, GMP and QA/QC protocols and regulatory compliance is required.  Strong background in biology and biochemistry is essential.  Research backgrounds with blood proteins and/or in bacteriology are strongly preferred.  Hands-on experience with automated liquid handling instrumentation highly desired. 

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)

The Quality Control Operations Manager is part of Technical Operations  which manages all CMO activity for the global manufacture and release of products.  The QC Manager reports to the Director of Quality Control and Analytical Development, and will be responsible for all functions of quality control related to the manufacture and release of commercial product worldwide. They will be responsible for all cGMP data released from the QC department at all CMO’s and provide support to method transfer and validation, and stability activities.

RESPONSIBILITIES:

• Manages the QC operations.
• Continual review of Standard Operating Procedures regarding equipment and test methods used in QC at CMO’s.
• Creation/Maintenance of Product Specifications.
• Write and/or review test procedures, standard operating      procedures, analytical development reports, and analytical validation      reports.
• Works under cGMP FDA regulations for analysis of the company’s      products
• Coordinates and monitors plans for reductions in testing for existing and new products.
• Maintain a state of compliance within the Quality Control Department.

Education:

• Minimum a bachelor’s degree in chemistry, biology, engineering, or other related field.

Experience:

Minimum of 5-7 years QC experience in the field

Operation and understanding of word processing, spreadsheets, and data management and presentations using MS Power Point

Research Associate/Senior Research Associate - Drug Discovery

RaNA Therapeutics is an energetic, rapidly growing early stage biotechnology company in Cambridge, MA founded by leading scientists from Industry and Massachusetts General Hospital. RaNA’s mission is to discover and develop drugs to improve health for patients by modulating disease-associated epigenetic patterns, thereby restoring normal expression of individual targeted genes.

We are currently seeking a highly motivated and talented Senior Research Associate or Research Scientist to join our Drug Discovery group.  This position will be primarily responsible for in vitro experimental design, screening and downstream processing.  Additional responsibilities may include supporting in vivo efficacy and mechanistic studies.

Qualifications:

• The candidate must have a BS/MS degree in biology, biochemistry or related area with three to five years of research experience and understanding of molecular biology and tissue culture techniques.
• Strong experience with cellular and molecular biology techniques, including cell culture, qRT-PCR, ELISA, RNAi approaches, tissue handling, RNA isolation and in vitro systems.
• RNA purification techniques a must.
  • Strong data analysis skills are required.
  • Experience with in vivo work and immunology is a plus.
  • Demonstrated ability to troubleshoot technical assays, instruments and protocols.
    • Ability to multitask and work independently and collaboratively as part of an interdisciplinary team in a matrix environment with 15-20 scientists. Excellent organizational and time management skills, the ability to generate high quality data under tight deadlines.
    • Ability to interact well across the organization and with external collaborators.
    • Candidates must live in the Greater Boston area.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA employee benefits package include health/dental insurance, retirement plan, paid vacation, and much more.

We are seeking a Senior Manager/Associate Director of Investor Relations to create, plan and execute Infinity Pharmaceuticals’ investor relations program to effectively deliver Infinity’s messages to financial audiences to support the company’s strategic goals and to create value for Infinity and its shareholders.  This individual will report to the Director, Corporate Communications and Investor Relations. 

Investor Relations is an important channel of communications to Wall Street, and the Sr. Manager/Associate Director of Investor Relations may be asked to take on a variety of responsibilities as needed.

Responsibilities will include, but are not limited to, the following: 

• Playing a key role driving investor relations strategy, message development and annual communications plan
• Executing investor relations tactics to achieve plan objectives, including buy-side and sell-side targeting, planning road shows, developing content for and executing analyst days/special events, and attending banking conferences
• Effectively building and maintaining relationships with institutional investors
• Enhancing relationships with sell-side analysts and promoting positive sell-side coverage
• Developing and maintaining the corporate presentation while ensuring a clear and compelling investment thesis
• Managing the development and execution of content for quarterly financial results calls
• Drafting press releases and Q&A documents
• Working with the Finance and Legal team on required SEC filings
• Developing reports and briefings to senior management and board of directors
• Serving as a point of contact for institutional investors and analysts

Required Skills and Competencies

• At least 7 years investor relations experience.
• Strong communicator, oral and written: clear, crisp, insightful, persuasive. Confidence to develop and present ideas is critical.  Ability to work collaboratively with others to finalize content is critical.
• Ability to support corporate finance / M&A activities.
• Ability to multi-task, work independently, and meet deadlines.
• Demonstrated ability to interact with senior management.
• Ability to learn company story to support being a point of contact for Wall Street.
• Demonstrated experience researching communications strategy and tactics and making recommendations as it relates to new situations
• Strong analytical capability and demonstrated knowledge of financial markets.
• Product launch experience required.
• Experience in biotech or pharmaceutical industry preferred. 
• Bachelor’s Degree required; MBA or advanced degree in a financial discipline preferred.

To apply, please visit our website at http://www.infi.com/careers-opportunities.asp

Blue Stream Laboratories, Inc. is an advanced analytical and formulations laboratory that seeks to redefine contract research services by providing the highest level of technical expertise and excellence in customer service for providing solutions to product development challenges for the biopharmaceutical and biotechnology industries.

Responsibilities:

Blue Stream Laboratories seeks a highly-motivated and proven sales professional who is ready for an exciting, entrepreneurial environment and who thrives in the fast-paced venue of the sales professional  and who wants to become part of a dynamic and success-driven team.

The candidate for this position will be self-motivated to achieve high levels of sales production, and also self-disciplined to maintain good client records and manage multiple-point communications through sales closure for complex service programs. The candidate for this position will believe in a consultative and service-driven sales approach, cultivating long-term relationships with biotechnology and pharmaceutical clients. The candidate will be evaluated against multiple sales metrics; the most important is dollar volume increase of quarterly & annual sales.

The candidate will be responsible for every phase of field sales management: lead generation, account introduction, needs assessment, quote generation (assisted by internal resources), program negotiation, scheduling of client visits to Blue Stream, closure of new business, and post-closure maintenance of relationship.

The candidate will also be expected to identify and participate in select regional conferences by attending the exhibit booth, and/or coordination of Blue Stream service / technical presentations.

As Blue Stream Laboratories is a service –driven corporation, excellent communication is essential with both external clients, as well as internal points of contact.

Qualifications:

Education:

• Bachelor's or Master’s degree Biology, Biochemistry, or related scientific discipline
• MBA preferred, though not essential

Experience:

• Three (3) or more years of proven sales experience in West Coast selling B2B - primarily to Biotech and Pharmaceutical clients
• Two (2) or more years of laboratory experience in biotechnology or the biopharmaceutical/pharmaceutical industry desirable, but not necessary
• Familiarity with cGMP regulatory requirements for the development of biopharmaceuticals is an advantage

Other requirements:

• Excellent communication and writing skills are essential
• Travel up to 40%
• Computer and electronic-communication literate
• Valid Driver’s License

SeraCare Life Sciences has served the global life sciences community, with distinction, for 25 years.  We develop and manufacture the highest quality, biologically-based products backed by expertise in virology, serology, immunology, and molecular biology.

Position Summary:

This position is responsible for the primary product management and contribution to the IVD R&D business unit, including but not limited to molecular controls and reference materials, next generation sequencing controls, genetic testing controls, and related plasma-based products used in the development and manufacture of IVD assays and by the clinical end-users as in kit controls or validation processes.  Responsibilities include developing and managing the breadth of the product line, from development, launch, growth and sunsetting with a focus on increasing the profitability of existing products to introducing new products and programs to drive growth.

You will interface internally with R&D, manufacturing engineering, quality, and sales and externally with customers to define product requirements.  You will also work with marketing communications to develop and execute effective downstream marketing strategies.  You will be the internal and external advocate for the products, working with the sales channel and key customers to achieve success.

Qualifications:

A Bachelor’s degree in the life sciences is required; a Doctorate or Master’s degree is preferred.  A minimum of 5 years marketing or marketing and sales experience with 10 years of life sciences industry experience is essential.  Proven track record of developing and implementing strategic marketing and sales plans to increase sales and profitability is required.  Experience in the BioPharma and/or Diagnostics Industry is required.  Must have proven ability to conduct market research, resolve complex customer issues, and understand the IVD R&D space.  Demonstrated ability to accept and overcome difficult challenges and be able to manage risk effectively is vital.  Experience working within small to mid-size companies where administrative infrastructure is minimal and a willingness to lead by example and contribute individually is preferred.  A high quality of written and oral communication skills and the proven ability to meet deadlines and work independently along with a high degree of creativity is essential for success.  Must be able to read, write, speak fluently and comprehend the English language.  Overnight domestic and international travel (approximately 25%) will be required to meet the needs for this position.

SeraCare Life Sciences, Inc. is an Equal Opportunity Employer, M/F/D/V

To apply please click on the link below:

http://ch.tbe.taleo.net/CH05/ats/careers/requisition.jsp?org=SERACARE&cws=1&rid=242

Candidate will provide and manage regulatory support to the company in order to obtain marketing authorizations for commercial products, provide input into all stages of the company's development and portfolio products, develop strategies to ensure a complete and rapid development, manage the preparation of Regulatory Documentation, and various other management responsibilities.  

Requirements:  

• BS/MS in scientific field with 5+ years of experience in Pharmaceutical Regulatory Affairs at least 1 of which in a management capacity.
• Knowledge of worldwide regulatory procedures and requirements.
• Experience providing regulatory input and coordinating with various departments regarding regulatory submissions.
• Experience coordinating regulatory procedures such as clinical trials applications, IND submissions and amendments, marketing and manufacturing authorization applications, variations, annual reports, renewals, etc.  

Candidates must live local and be a US Citizen or Green Card Holder  

Email resume to:  jobs@cwsciences.com

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

Commonwealth Sciences, Inc.

www.cwsciences.com

Company Overview

Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating often fatal, rare diseases.

Position Description

This critical position will be accountable for successfully executing the launch and growth of the Juxtapid (lomitapide) capsules in the US. Overall responsibilities will be to execute key  tactics, campaigns and activities as well as managing the investment resources required for the launch. The individual will lead the key aspects of product management and support the Field-force, Sales Operations, Customer Care and other commercial departments to achieve near and long term commercial objectives. Position will report to Director, US Marketing and is located in Cambridge, MA. Role will be an individual contributor.

Key Responsibilities

• Contribute to decisions on promotion and awareness mix and channeling for effective communications
• Support development of strategic long-range business plans
• Partner with commercial operations to conduct market research and competitive intelligence and analyze quantitative and qualitative data for market characterization and customer segmentation
• Identify and manage resources (budget tracking and agency management)
• Help evolve the brand positioning, messaging and differentiation through the launch cycle
• Facilitate learnings to accelerate launches in other markets WW
• Work closely with Regulatory, Medical, Scientific affairs and Manufacturing and IT personnel to align and execute key launch activities
• Respond and support needs of internal and external customers
• Establish strong relationships and develop collaborative partnerships with key stakeholders in the field of familial hypercholesterolemia
• Assist with development and implementation of sales training and sales operations

Qualifications and Experience

• 3-5 years of commercial experience in brand management/marketing in the biotechnology/pharmaceutical industry
• Expertise in brand marketing/product management is required
• Successful track record of US product launch experience is preferred
• Experience working in a start-up and/or mid-cap sized company preferred
• Orphan or rare disease experience, and an authentic commitment to working closely with patient community
• Previous cardiovascular disease experience is preferred
• MBA preferred, degree in marketing, business, biological science or pharmacy discipline
• Proven ability to lead and develop exceptional relationships and have an impact on influence others
• Successfully establishing and leading cross-functional high-performance teams 

Contact

Qualified candidates are encouraged to submit a resume and cover letter to Human Resources in care of careers@aegerion.com

Agency Notification: While Aegerion highly values its relationships with our Recruitment Partners we ask Recruiters to send any information regarding your firm or interest to Erica Lupien, elupien@aegerion.com.  Please do not call during our posting process. Thank you.

Applicants MUST have experience in bringing a product to market

Position Description:

This position will develop new products and revise existing products and processes. The Scientist will establish and support analytical programs for raw materials and components ensuring proper categorization.  Duties involve evaluating products for transfer to manufacturing. The Scientist will communicate with the Development and Manufacturing teams in support of protocol drafting and testing as analytical and QC release techniques and products are transferred.

Responsibilities:

• » Immunoassay development from lab to product (US and EU regulatory)
• » Development of antibody products including
• » Understands and applies knowledge of a variety of Immunoassay development processes.
• » Help to establish purification and analytical methods for characterizing proteins
• » Prepares technical reports and oral presentations
• » Applies project management skills and independently manages and organizes work
• » Support of GMP and ISO regulations, and implements these in support of product development and transfer.
• » Works across departments and teams and trains junior staff.

Requirements:

• » Degree in biology, biochemistry or chemistry (Masters w/ 5-7 or PhD with 2-5 yrs. experience.
• » Recent demonstrated expertise in the development of immunoassays (concept to market).
• » Strong analytical and problem solving skills, (Design of Experiments, Statistical Process Control) to design and perform complex experiments and analyze data .
• » Experience in sample handling, including blood and other tissues.
• » Familiar with GMP and ISO regulations, and an understanding of product transfer processes.
• » Previous product development experience working within a quality system and experience with ELISA preferred.
• » Extensive experience protein purification, column chromatography, protein conjugation, and analytical method development.
• » Excellent oral and written communications
• » Good project management skills with an ability to manage and organize work around multiple and changing priorities.
• » Experience in training junior staff desirable

Company Background 

Aegerion Pharmaceuticals, Inc. (NASDAQ: AEGR) is an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat severe lipid disorders.  The Company’s lead product, Juxtapid, was approved by FDA in December 2012.  Juxtapid is indicated to treat patients with a rare genetic lipid disorder called homozygous familial hypercholesterolemia, or HoFH. 

Position Description

The Vice President of Investor Relations will report to the Chief Financial Officer and will be responsible for proactively developing, implementing and managing Aegerion’s comprehensive investor relations and corporate communications program.

Major Responsibilities:

• Articulate an in-depth understanding of  Aegerion’s business, its strategy, commercial plan, pipeline and financials
• Establish, build  and maintain relationships with  institutional investors and sell-side analysts as well as individual investors to provide a comprehensive and current perspective of the organization to enhance the value and marketability of the company
• Proactively manage investor pipeline and research new investor contacts
• Maintain and communicate competitive intelligence and analysis on all industry peers to senior management
• Track analyst estimates/consensus vs. internal forecasts and strategize the appropriate webcasted communications to ensure that the Company is positioned to meet expectations
• Manage timely preparation of earnings releases and quarterly earnings scripts
• Prepare team for Q&A based on investor inquiries
• Provide information necessary for the preparation of the Annual Report and other financial communications; drive production of the 10-k wrap annual report
• Develop and maintain a rolling schedule of investor relations events, including anticipated investor conferences, earnings calls, investor panel events, analyst days and non-deal roadshows
• Respond to day-to-day inquiries from investors
• Develop investor presentations and non-deal road show presentations
• Develop and implement a strategic annual shareholder communication plan
• Execute the annual analysis for and creation of periodic feedback reports about the company's stock price, relative stock price, brokerage analysts' estimates and perceptions, oral perceptions and opinions from analysts and investors, industries and peer companies, and the stock market
• Manage company’s participation in investment conferences including preparation of external presentations and designation of 1-1 meetings
• Manage company’s quarterly non-deal road show schedules including all geographic and account specific targeting, presentations and utilization of the sell-side
• Manage Investor Relations portion of the company website
• Provide Regulation Fair Disclosure training to all designated company spokespersons
• Effectively manage utilization of outside integrated public relations Agency
• Identify and prepare for strategic CEO interview opportunities with top-tier press and financial news networks
• Facilitate internal reviews of key messaging, including the ability to build consensus

Requirements and Qualifications:

The ideal candidate will possess the following qualifications, skills, competencies:

Education:

• Bachelors or Masters Degree in Finance/Business Administration

Experience:

• A minimum of 10-12 years of Investor Relations experience is required
• Pharmaceutical or biotechnology  industry is essential
• Experience leading the investor relations strategy and programs of a public company
• Strong understanding of SEC disclosure rules and regulations is a must
• Understanding of business/financial and biotech trade media relations is preferred

Skills & Competencies:

• Demonstrated strategic competencies that enable highly capable leadership of Aegerion’s Investor Relations platform to drive value
• Proactive and high energy leadership
• Developed knowledge and reach within the life sciences industry specifically within the investor base with strong nurtured and trusting relationships and reputation
• Strong analytical skills with the ability to perform quantitative and qualitative analysis 
• Excellent writing skills, including the ability to craft powerful and engaging messages
• Demonstrated planning and project management capabilities that will drive strong short and long term execution
• Ability to work at a strategic level with members of the senior management team, and to drive results
• Strong PC skills with expertise in Word, Excel and PowerPoint is required
• Commitment to operational excellence

Contact

Qualified candidates are encouraged to submit a resume and cover letter to Human Resources in care of   careers@aegerion.com

Agency Notification: While Aegerion highly values its relationships with our Recruitment Partners we ask Recruiters to send any information regarding your firm or interest to Erica Lupien, elupien@aegerion.com.  Please do not call during our posting process. Thank you.