Feinstein Kean Healthcare (FKH) is a leading strategy/communication partner for innovative healthcare business and organizations of all types. We tend to work with those commercial entities and other organizations that are closest to emerging trends in science, medicine, business, policy and healthy consumer behaviors. Our clients therefore include many leading, global pharmaceutical, biopharmaceutical, diagnostic and device companies; personal genomics, nutrition and wellness companies and institutions; health information technology providers; contract research and health services firms; consulting organizations; advocacy groups and professional and industry organizations; academic medicine and government agencies. In other words, our work and relationships truly span the spectrum of health stakeholders -- which informs our work and expands the horizon of opportunities available to our talented professionals.

FKH is a 25-year old firm; we have always specialized in health sciences and health care, and are recognized for our work in breakthrough areas of science and medicine, and for category altering products and technologies. We are headquartered in Cambridge, Massachusetts, with offices in Edison, New Jersey and Washington, DC. FKH is an Ogilvy company, and participates with its Ogilvy and WPP colleagues to provide services to clients on a global basis. FKH offers a full range of strategic communication, marketing and related services that help clients to drive commercialization of their products, form partnerships, build coalitions with stakeholders, and improve the landscape with impact on policy.

Position Overview:

The Vice President will provide day-to-day management of communications strategies, teams and activities for FKH clients.  This person will be a member of the senior team for the FKH Healthcare Practice which represents a diverse array of clients and supports them in a wide variety of activities ranging from communications strategy development, messaging, media strategy and outreach, crisis communications, internal communications, coalition building and advocacy relations, regulatory communications, healthcare policy communications, etc.  This individual will join a team working for several clients which may include innovative early- and commercial-stage biotechnology companies,  pharmaceutical  companies, non-profit/advocacy organizations, government agencies or academic institutions.  The successful candidate must be able to manage multiple assignments and clients with a high degree of success and independence.  S/he will also enjoy working in a smart, dynamic, entrepreneurial, client-focused, team-oriented environment.

Essential Job Responsibilities:

• Develop and implement communications programs that help drive business/organization and communications objectives of clients 
• Provide broad understanding of the healthcare sector and drug development, approval and launch process, and have an ability to learn specifics of each client’s discipline 
• Produce thoughtful, accurate, and compelling health and science-related content for use in feature articles, news releases, video scripts, web content, etc.
• Oversee staff and financial management to ensure that account teams deliver on-strategy, on time and on-budget activities
• Play an active role in the development of junior staff through project assignments, guiding training programs, mentoring, etc.
• Be a key contributor in business development efforts in collaboration with other senior level members of the Feinstein Kean Healthcare team
• Lead and/or support thought leadership initiatives for the firm as necessary

• Provide client counsel that reflects deep knowledge and experience in healthcare industry, with a special emphasis on public health, advocacy relations (coalition building and partnership development) and social media campaigns

Attributes:  To perform the job successfully, an individual should demonstrate all of the following attributes:

• Consummate team player
• Excellent written and verbal communication skills
• Proven track record of leading teams
• Strong leadership skills and client counseling capabilities
• Strong project management skills including the ability to develop and manage budgets
• Strong client relationship skills
• Keen interest in healthcare, public health, science and life sciences
• Able to multi-task effectively
• Strong desire to learn new concepts and skills
• Impeccable attention to detail and deep committment to quality

• Significant interpersonal skills
• Intellectually quick with depth of thought
• Ability and desire to educate staff and help clarify difficult concepts

Required Skills, Knowledge, Must Haves, and Experience of the “A” Player:

• 10+ years of significant experience in healthcare/life sciences communications
• Domain knowledge in areas related to oncology, chronic disease, personalized medicine, and/or rare diseases desired
• Government client experience in a consulting or agency environment preferred
• Experience working w/biotech/biopharma clients (Maryland 270 corridor companies) a plus
• Experience with healthcare policy and/or health IT communications a plus
• Experience managing client relationships and working with a broad range of clients, including private sector and public sector
• Strong writing skills and editing skills a must
• Ability to develop public health and healthcare communications strategies
• Expertise in public health, advocacy relations, partnership development/coalition building and social media campaigns
• Depth and diversity of project experience and consistent track record of achieving communications objectives
• Experience in the management of client or external party relationships
• Excellent written and verbal communication skills as well as strong presentation skills
• Demonstrated leadership ability to grow existing accounts, as well as in developing new business
• Ability to monitor and manage client’s budgets and the team’s financial performance
• Strong people management and mentoring skills

Education (degrees, technical training, etc.):

• Bachelor’s degree required
• Advanced degree (MA, MS, MPH, PhD) strongly preferred

Technical Expertise (systems, sciences, technologies, etc.):

• Facile with MS Office including Word, Excel and PowerPoint
• Websites and digital communications including Web 2.0 experience a plus

Work Conditions (Travel requirements, etc.):

• 10-15% travel

Primary Contacts:

• FKH Team in all offices

To Apply

Please visit the careers section of our website at http://fkhealth.com/careers/current-opportunities/ and apply directly to this opportunity.   

Feinstein Kean Healthcare is an Equal Opportunity Employer.

Job Summary:

This position is to be an integral member of the medicinal chemistry team with project leadership responsibilities guiding external medicinal chemistry activities toward the discovery of novel CNS therapeutic agents. The position will report to the Director of Chemistry.

Key responsibilities include:

• Manage all aspects of a CNS medicinal chemistry discovery program, including novel target design and synthesis, SAR development and project leadership, from conception through recommendation
• Contribute to additional discovery programs as an active team member
• Communicate chemistry and project results at departmental meetings
• Contribute to the preparation of patent filings
• Provide intellectual leadership to program direction and departmental priorities
• Guide external chemistry resources through effective communication of science and program priorities
• Maintain EnVivo’s leadership role in CNS research by staying abreast of current scientific thought, trends, and opportunities through active pursuit of the literature, attendance at scientific meetings and engagement with the scientific community
• Interpret DMPK and biological data to advance new hypotheses and directions for iterative drug design
• Apply modern computational tools to help advance programs
• Maintenance of SAR tables and generation of data plots

Candidate:

The successful candidate will be able to lead a medicinal chemistry program to the identification of novel compounds with high efficacy and safety for the treatment of CNS disorders.

Requirements:

• Ph.D. in synthetic organic or medicinal chemistry with 7-15 years of relevant postdoctoral or industry experience
• Candidate will have demonstrated a high level of success in one or more drug discovery programs, preferably in the CNS area
• Experience with data mining programs such as Spotfire or Dotmatics
• Expert knowledge of medicinal chemistry and scientific principles
• Track record of significant scientific publications and patents
• Strong collaborative skills in interdisciplinary settings
• Desire to work in a small, team oriented, success driven environment where impact and influence of the individual are both maximized and valued

Lantheus Medical Imaging is a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents.  For more than 55 years, Lantheus has been dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The company’s proven success in discovering, developing and commercializing innovative medical imaging agents provides a strong platform from which to bring forward new breakthrough tools for the diagnosis and management of disease.

Lantheus imaging products include DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, the leading ultrasound contrast agent used in ultrasound exams of the heart, also known as echocardiographic exams; ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease; Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), a cardiac imaging agent that is the most successful radiopharmaceutical ever introduced and; TechneLite® (Technetium Tc99m Generator).

Lantheus has approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.

The ideal candidate will be part of the analytical development group and will perform method development, validation and transfer studies.  As an analytical lead for manufacturing site qualification, this role will provide analytical support to drug product manufacturing sites for analytical troubleshooting and OOS and deviation investigations.

Perform and author method validation and technical transfer protocols and reports. 

 The candidate will review contract manufacturing site documents including batch records, master formulas, raw material specifications and analytical methods.

 Responsibilities include: 

• Experience with HPLC and GC method development and validation.
• Experience with OOS/Deviation Investigations and CAPAs
• Troubleshoot technical issues and improve product quality by providing technical guidance to CMO.
• Work with contract manufacturing organizations in the development, optimization, technical transfer and validation of analytical methods and tests for small molecule drug substances and drug products.
•  Significant experience in analytical, process development and stability program for drug substances and drug products.
• Handling of and or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
• Fully experienced with cGMPs and all applicable regulations and guidance.
• Excellent verbal and written communication skills.
• Experience with Positron Emission Tomography (PET) imaging would be a plus.
• Ability to travel up to 20%.

 The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards.  Additionally, the incumbent will actively demonstrate and promote the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.

 Requirements include:

•  BS/MS. in Analytical Chemistry or related filed.
• Requires 7-10 years directly related experience with a BS. degree or 5 -7 years with a M.S. degree

 To apply for this position please visit the Career page at www.lantheus.com

Lantheus Medical Imaging is a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents.  For more than 55 years, Lantheus has been dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The company’s proven success in discovering, developing and commercializing innovative medical imaging agents provides a strong platform from which to bring forward new breakthrough tools for the diagnosis and management of disease.

Lantheus imaging products include DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, the leading ultrasound contrast agent used in ultrasound exams of the heart, also known as echocardiographic exams; ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease; Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), a cardiac imaging agent that is the most successful radiopharmaceutical ever introduced and; TechneLite® (Technetium Tc99m Generator).

Lantheus has approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.

The ideal candidate will lead analytical method development and stability studies in support of the development and characterization of drug substances and drug products.  Drive method development and validation for analysis of drug substances and drug products.  Represent the Analytical Development organization on cross functional internal and external teams.  The candidate will lead OOS/deviation investigations and establish appropriate CAPAs.  

The candidate will also support drug substance process development, impurity identification, control production of clinical phase materials, and qualification of initial commercial vendors.  Provide analytical support for drug substance and drug product manufacture at CMOs.  Author analytical CMC sections and internal Protocols and Finished Reports.

The candidate will be responsible for leading clinical phase stability testing programs, to meet FDA and GMP requirements.  This involves creating and managing the stability testing programs for API, API precursors, drug products, analytical standards and other materials as required by CMC development programs.  This position is responsible for review of all release and stability data for clinical materials, and for establishing and revising recertification dates of all materials.  This position also prepares the stability sections for IND amendments and annual FDA reports. 

Additional responsibilities include:

• Exceptional knowledge of analytical and organic chemistry. 
• Significant experience in analytical, process development and stability program for drug substances and drug products.
• Experience in drug substance and drug product vendor management
• Demonstrated skills in leading projects with an assigned team.
• Handling of and/or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
• Supervision of a group of one to five direct reports.
• Mastery of regulatory and GMP requirements for Pharmaceutical Development
• Experience with writing portions of the CMC sections of Regulatory filings
• Comprehensive analytical GMP experience with both drug substances and drug products.
• Excellent verbal and written communication skills.
• Experience with Positron Emission Tomography (PET) imaging would be a plus.
• Experience with OOS/Deviation Investigations and CAPAs

The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards.  Additionally, the incumbent will actively demonstrate and promote the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.

 Requirements include:

• MS/Ph.D. in Analytical Chemistry or related filed.
• Requires a minimum of 4 – 6 years directly related experience with a Ph.D. degree or 10+ years with a M.S. degree

 To apply for this position please visit the Careers page of www.lantheus.com

ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Job Summary:

Reporting to the Director, Operations, the successful candidate will manage the design, planning, construction and maintenance of equipment, machinery, buildings and other facilities.  This individual will have the highest responsibility for the technical infrastructure of ARIAD sites.

Key responsibilities:

• Participate in construction project meetings including site planning for new equipment
• Develop and script operating and maintenance procedures for the facilities’ infrastructure (mechanical equipment)
• Compile asset information for building mechanical and other systems
• Prepare in part, and contribute to the facility’s operating plan for each location
• Manage outsourced facility services, upgrades, and unplanned repairs
• Participate in the Safety Committee and demonstrate a leadership role in facility safety initiatives
• Participate in the preparation of facility operating budget
• Day-to-day contact with building landlord
• Other tasks as assigned

Basic Qualifications:

• Bachelor’s Degree in Facilities Management, Engineering or related field
• Minimum 5 years of  facilities management experience in a life science or equivalent facility
• Experience working in  Animal Care  Facilities, a Biosafety Level 2 environment or an equivalent regulated environment

Submitting a resume online at a job site could cause valuable screening information to be missed.

Click here to apply:

http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=216&company_id=16419&version=1&jobboardid=306

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

The Quality Control (QC) Microbiology Associate will perform the routine QC sampling and testing within the function of the Quality Control (QC) Microbiology Laboratory.

Key Responsibilities:

• Environmental monitoring of the HVAC and utility systems.
• Perform routine QC Microbiology sampling/testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications, following SOPs.
• Water sampling and associated water testing (such as chemical analysis to include visual appearance, heavy metals, nitrates, pH, conductivity, etc.)
• Sampling and testing of gas supplies to manufacturing suites.
• Trend environmental monitoring data.
• Write and revise SOPs, protocols and technical reports as necessary.
• Shipment of samples to contract testing laboratories and review of testing data reports.
• Review testing data of other QC Analysts, as applicable.
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP)
• Raising change controls and deviations related to QC and  assisting with non-conformance investigations

Other Responsibilities:

• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
• Troubleshooting equipment and microbiological testing methods
• Perform QC testing of in-process and product samples following Standard Operating Procedures (SOPs)
• Training of other Analysts within the department within scope of knowledge
• Maintaining microbiological isolates and performing identification, as required.
• Other duties, as assigned

Educational Requirements:

BA or BS in Microbiology or other related biological science. 

Experience and Skill Requirements:2-5 years of laboratory based experience in a testing capacity.

Knowledge of Microbiology techniques and technical experience, with a Microbiology Lab is preferred. The analyst will have good understanding of cGMP. Computer literacy (MS Word and Excel), good communication and organizational skills are required.

Medical Director/Senior Medical Director

TESARO is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products.

Position Summary

The Director/Senior Director will be responsible for developing the clinical trial strategy, designing clinical trials in consultation with expert clinicians in the medical community and colleagues at TESARO, helping to identify key sites for the studies, serving as a key strategic and medical point person during the conduct of the trials, monitoring safety of ongoing trials and leading efforts to analyze and present data from clinical studies. Reporting to the Chief Medical Officer, the selected individual will work closely with other physicians, scientists, regulatory professionals, statisticians and members of the clinical operations department to carry out these responsibilities. The   individual will respond to inquiries by practitioners and investigators, IRBs, regulatory bodies, and vendors. This person will work to establish relationships with key opinion leaders, external advisors and collaborators.

Responsibilities

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others as necessary for clinical protocol development, writing, and review
• In collaboration with TESARO clinical operations staff, consultants and CROs support clinical trial execution to achieve timely completion of clinical studies
• Assume medical responsibility for clinical trials. Actively participate in real-time medical monitoring of studies, including assessment of patient eligibility and responses to study design questions
• Provide safety monitoring in collaboration with CRO pharmacovigilance group of active clinical studies
• Collaborate with associates (and/or consultants) in Regulatory, CMC, Toxicology, Research, Pharmacology to progress clinical compounds from preclinical through Phase 1 – 3 clinical development, in a project team setting
• Participate in clinical study report writing and review, using his/her medical expertise to identify ways to best analyze and present data in a complete, accurate and scientifically sound manner
• Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data
• Other responsibilities that may apply, as periodically assigned by his/her supervisor

Education/Experience Requirements

• Doctor of Medicine degree (MD) or equivalent, MD/PhD preferred
• At least 5 years of clinical development experience as an employee within the pharmaceutical or biotechnology industry
• Experience with managing or participating in oncology clinical trials
• Successful academic research publication history or history of medical practice in a relevant field
• Experience presenting medical data and concepts to a variety of audiences (medical, scientific, vendors) in a credible and engaging manner
• Solid understanding of the clinical landscape relevant to oncology patients and health care practitioners in the field
• Daily user of Office tools (Word, Excel, PowerPoint, etc)
• Demonstrated application of critical thinking skills to problem solving, data analysis, and strategic planning
• Comfortable operating in a small company; proactive, self-sufficient and amenable to a fast paced, and dynamic  team oriented environmentProven ability to multitask, prioritize and execute per corporate needs and goals
• Focused on the completion of individual and team goal-oriented projects
• High degree of emotional maturity. Can work successfully in a demanding environment while constantly maintaining a professional demeanor

• Develop and validate methods to purify cells from cell debris.
• PhD in Cell Biology.
• 3 years industrial experience.
• Operate and maintain cell biology laboratory.
• Experience in immunoassay.
• Write and follow analytical test methods, validation protocols and reports in compliance with current regulatory requirements and industry standards.
• Maintain, follow, and update Standard Operating Procedures for the Quality Control laboratory.
• Maintains accurate records.
• Schedule method development and validation activities.
• Work with R&D and QC to ensure robust methods are developed and validated that serve the needs of both groups for process development as well as routines QC analysis.
• Participate in technical meetings with customers to address analytical development issues.

• Develop and validate methods to purify cells from cell debris.
• BS or MS in Cell Biology.
• 3 years industrial experience.
• Operate and maintain cell biology laboratory.
• Experience in immunoassay.
• Write and follow analytical test methods, validation protocols and reports in compliance with current regulatory requirements and industry standards.
• Maintain, follow, and update Standard Operating Procedures for the Quality Control laboratory.
• Maintain accurate records.
• Schedule method development and validation activities.
• Work with R&D and QC to ensure robust methods are developed and validated that serve the needs of both groups for process development as well as routines QC analysis.
• Participate in technical meetings with customers to address analytical development issues.

• Develop and validate immunoassay methods.
• BS or MS in Clinical Chemistry or equivalent.
• 3 years industrial experience.
• Cell biology experience.
• Write and follow analytical test methods, validation protocols and reports in compliance with current regulatory requirements and industry standards.
• Maintain, follow, and update Standard Operating Procedures for the Quality Control laboratory.
• Maintains accurate records.
• Schedule method development and validation activities.
• Work with R&D and QC to ensure robust methods are developed and validated that serve the needs of both groups for process development as well as routines QC analysis.
• Participate in technical meetings with customers to address analytical development issues.

Warp Drive Bio is driving the reemergence of natural products in the era of genomics to create breakthrough treatments that make an important difference in the lives of patients. Built upon the belief that nature is the world’s most powerful medicinal chemist, Warp Drive Bio is deploying a battery of state-of-the-art technologies to access powerful drugs that are now hidden within microbes.

At Warp Drive Bio, we are building a proprietary “genomic search engine,” where the search query line consists of DNA sequences that encode the chemomeme within biosynthetic gene clusters, and the search space is defined by the universe of all accessible bacterial genomes. We are focusing this innovative search engine on chemomemes having high pharmaceutical pedigree, novel and profound biological effects that tap into areas of high unmet medical need, and the ability to access targets that abiotic small molecules and monoclonal antibodies cannot.

Launched in 2011 through a groundbreaking strategic partnership with Sanofi and with financing from Third Rock Ventures and Greylock Partners, the company was founded by renowned scientist Dr. Gregory Verdine, along with Dr. George Church and Dr. James Wells.

We are currently hiring for the following positions:

• Mechanism Of Action Biologist
• Molecular Biologist
• Microbiologist
• Natural Products Chemist
• Sr. Computational Biologist

To be considered for this role, please submit your resume to careers@warpdrivebio.com

Note to Employment Agencies: Please do not forward any agency resumes. Warp Drive Bio is not responsible for any fees related to resumes that are unsolicited.

Warp Drive Bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Job Description:

GENEWIZ is seeking is seeking a National Sales Manager to grow and expand the GENEWIZ brand within an assigned region by managing an effective team of sales professionals.

Responsibilities:

• Achieve annual sales goals for defined region/territory/accounts.  Manage direct reports in their efforts to expand new client relationships and expand existing customers business
• Develop and implement an effective regional business growth plan
• Retain current business baseline revenue by managing relationships with customers
• Grow revenue and expand territory into new accounts
• Establish and maintain Key/Strategic Account Management Plan for designated Accounts
• Support managements Business Development initiatives by assisting in the identification and targeting of potential partnerships and collaboration opportunities.
• Train and hire an effective regional sales team
• Travel to company meetings, attend trade shows and follow through on various sales events as needed.
• Motivate, mentor and train team members through GENEWIZ best practices

Qualifications:

• A bachelor’s or above degree from an accredited academic institution in either a related science area or a related business area
• 7+ years of related sales experience (biotech or similar market) with a proven track record of managing sales personnel in closing complex technical sales
• Proven track record in managing high performance sales teams
• Willing and able to travel overnight as required (up to 50% of time depending on territory)
• Proven track record selling and managing sales into various size accounts, including academia,, research institutions, biotech, (small-large), pharma (small-large), and global/national accounts
• Proven track record with launching new territories, managing global/national strategic accounts and selling to high level contacts within an organization.
• Strong computer skills
• Excellent interpersonal communication skills, both written and verbal

 Please visit our website @ www.GENEWIZ.com

Position Summary

Perform the formulation and dispensing of pharmaceutical products according to current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs) in a clean room environment. Other duties to include the washing and sterilizing of supplies needed for production, as well as inspection, labeling and final packaging of product. Follows all Pharmalucence policies relating to job safety. Works under direct supervision and follows clearly described procedures.

Position Responsibilities

•  Formulate and dispense product in a clean room environment
• Wash and sterilize all equipment and stoppers, vessels, vials, etc.
• Inspect the product by performing visual checks, and label and package the product in boxes with inserts
• Configure labels using computer interface software, for thermal transfer
• Complete all necessary paperwork to conform with FDA regulations

 Education and Experience Required

•  High School Diploma required; BS in related field preferred
• Minimum 2-4 years related experience preferred
• Related experience in pharmaceutical environment
• Formal cGMP training
• Experience with aseptic fill/finish, formulation techniques
• Component prep experience
• Experience working in a controlled environment

 Skills/Special License(s) Required

• Aseptic, Fill/finish, Formulations Techniques
• Education in Life sciences or technical discipline
• Ability to visually inspect small products and print
• Good organizational and record keeping skills
• Computer operating knowledge

Please click here to apply:

https://home.eease.adp.com/recruit/?id=3122611

Position Summary

Perform the formulation and dispensing of pharmaceutical products according to current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs) in a clean room environment. Other duties to include the washing and sterilizing of supplies needed for production, as well as inspection, labeling and final packaging of product. Follows all Pharmalucence policies relating to job safety. Works under direct supervision and follows clearly described procedures.

Position Responsibilities

•  Formulate and dispense product in a clean room environment
• Wash and sterilize all equipment and stoppers, vessels, vials, etc.
• Inspect the product by performing visual checks, and label and package the product in boxes with inserts
• Configure labels using computer interface software, for thermal transfer
• Complete all necessary paperwork to conform with FDA regulations

 Education and Experience Required

•  High School Diploma required; BS in related field preferred
• Minimum 2-4 years related experience preferred
• Related experience in pharmaceutical environment
• Formal cGMP training
• Experience with aseptic fill/finish, formulation techniques
• Component prep experience
• Experience working in a controlled environment

 Skills/Special License(s) Required

• Aseptic, Fill/finish, Formulations Techniques
• Education in Life sciences or technical discipline
• Ability to visually inspect small products and print
• Good organizational and record keeping skills
• Computer operating knowledge

Please click here to apply:

https://home.eease.adp.com/recruit/?id=3122611

Position Summary

Perform the formulation and dispensing of pharmaceutical products according to current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs) in a clean room environment. Other duties to include the washing and sterilizing of supplies needed for production, as well as inspection, labeling and final packaging of product. Follows all Pharmalucence policies relating to job safety. Works under direct supervision and follows clearly described procedures.

Position Responsibilities

•  Formulate and dispense product in a clean room environment
• Wash and sterilize all equipment and stoppers, vessels, vials, etc.
• Inspect the product by performing visual checks, and label and package the product in boxes with inserts
• Configure labels using computer interface software, for thermal transfer
• Complete all necessary paperwork to conform with FDA regulations

 Education and Experience Required

•  High School Diploma required; BS in related field preferred
• Minimum 2-4 years related experience preferred
• Related experience in pharmaceutical environment
• Formal cGMP training
• Experience with aseptic fill/finish, formulation techniques
• Component prep experience
• Experience working in a controlled environment

 Skills/Special License(s) Required

• Aseptic, Fill/finish, Formulations Techniques
• Education in Life sciences or technical discipline
• Ability to visually inspect small products and print
• Good organizational and record keeping skills
• Computer operating knowledge

Please click here to apply:

https://home.eease.adp.com/recruit/?id=3122611

Position Summary

Perform the formulation and dispensing of pharmaceutical products according to current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs) in a clean room environment. Other duties to include the washing and sterilizing of supplies needed for production, as well as inspection, labeling and final packaging of product. Follows all Pharmalucence policies relating to job safety. Works under direct supervision and follows clearly described procedures.

Position Responsibilities

•  Formulate and dispense product in a clean room environment
• Wash and sterilize all equipment and stoppers, vessels, vials, etc.
• Inspect the product by performing visual checks, and label and package the product in boxes with inserts
• Configure labels using computer interface software, for thermal transfer
• Complete all necessary paperwork to conform with FDA regulations

 Education and Experience Required

•  High School Diploma required; BS in related field preferred
• Minimum 2-4 years related experience preferred
• Related experience in pharmaceutical environment
• Formal cGMP training
• Experience with aseptic fill/finish, formulation techniques
• Component prep experience
• Experience working in a controlled environment

 Skills/Special License(s) Required

• Aseptic, Fill/finish, Formulations Techniques
• Education in Life sciences or technical discipline
• Ability to visually inspect small products and print
• Good organizational and record keeping skills
• Computer operating knowledge

Please click here to apply:

https://home.eease.adp.com/recruit/?id=3122611

Org Marketing Statement  

 All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

This position is located in our Andover, MA site.

Role Description:  
The qualified candidate will operate within the Pharmacokinetics, Dynamics and Metabolism (PDM) group and provide hands-on quantitative biomeasure and biomarker support to discovery projects in the areas of immune disorders, inflammatory and genetic diseases. The senior level scientist will apply her/his biology expertise and deep technical skills to develop and implement flow cytometry, cellular and molecular biology assays to rapidly determine key quantitative, biological parameters (biomeasures) that inform systems pharmacology and PK/PD modeling & simulation efforts. Responsibilities include the generation of cellular and molecular biomeasures and biomarker data such as receptor expression analysis, internalization, turnover and occupancy, cell phenotyping and signaling. Experience in cell based assays, mechanistic pharmacology, target assessment, and translational biomarkers is desirable. The successful candidate will independently set laboratory objectives, independently plan laboratory activities and understand as well as influence therapeutic area tranlational strategies to use biomarkers in scientific decision-making. The candidate will influence through PDM teams and research units in a matrix environment.

Responsibilities:  
• The candidate will participate in all phases of flow cytometry laboratory operations including technology evaluations, the development of sample preparation, separation and detection methods, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making.
• The successful candidate will have experience developing partnerships in a matrix environment, influencing project strategies, and leadership in technology development and implementation.
• Proactively gathers input from colleagues, teams & management to avoid/address issues at functional level and participates on cross discipline matrix teams
• Excellent oral/written communication skills.
• Demonstrated ability to clearly & concisely communicate bioanalytical information.
• Responsible for “fit-for-purpose” assay development and must have the ability to effectively balance assay rigor against resource needs and study goals.
• Publications in peer-reviewed scientific journals and external / internal presentations are expected.

Qualifications:  
- B.S. (>8 years), M.S. (>6 years), or Ph.D. (>2-4 years) in relevant scientific field with industrial experience;
- Experience in development, characterization, and implementation of quantitative bioanalytical assays (e.g., flow cytometry and cell imaging) using wet sample preparation methods and instrumentation.

Other Information - Internal:  
• Ability to act decisively in a matrix environment.
• Rapidly seizes accountability and takes independent initiative.
• Ability to deal with project and organizational change while supporting the organization.
• Interested in personal development and professional growth.
• Aware of self and others.
• Experience and knowledge in operation of modern flow cytometry and cell sorting platforms and associated data systems.
• Knowledge and application of sample preparation methodologies as applied to flow cytometry techniques.
• Knowledge and application of immuno-analytical techniques.
• Experience with tissue preparation/tissue bioanalysis.
• Good understanding of biochemistry and cellular biology.
• Experience with molecular biology techniques such as Western blots, pulse chase experiments.
• Ability to coach and mentor colleagues and influence in a matrix environment.
• Good Written and oral skill.

To apply for this position, pleaseCLICK HERE

Inside Sales/Client Relations Representative     

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

The Inside Sales/Client Relations Representative has the responsibility for the client service/technical service activities in the In Vivo and In Vitro Toxicology and Chemistry labs.  This includes:

• Assist with technical issues with clients.
• Report results to sponsor, with a general knowledge of the pass/fail parameters in accordance with all ISO and GLP procedures.
• Field questions regarding sample sizes, turnaround times, test prices, and testing requirements.
• Provide support to field sales associate(s) and provide technical assistance, when required.
• Prepare quotes
• Redirect potential sponsor requests to appropriate field sales associates and/or study directors, wherever applicable.                                                                              
• Understand the test scheduling routine of each lab (Vivo, Vitro, Genetox, Cell, product Chemistry) and assist in ensuring on-time delivery, including special reporting, faxing, e-mail, etc.  Manage all information directly in the databases provided.
• Coordinate with the Document Control Manager responsible for test scheduling, for test data entry into the computerized lab schedule.
• Act as a liaison between assigned sales associates, lab technicians, study directors, and sponsors.
• Prepare non-GLP test requisition forms for sponsors, wherever required.
• Inside sales is required

 Candidates must have a bachelor’s degree, preferably in an area of the life sciences, or have strong interest in learning about the Scientific Industry.  Must have good verbal communication skills and an excellent telephone manner.  Solid computer skills are required.  Ability to analyze problems, conduct project reviews and develop appropriate solutions with others.  Strong organizational skills and follow-through; ability to work on several projects concurrently, interpersonal and project management skills.  Superior customer service experience is required, including quick responsiveness to customer requests. Sales experience is also required.

For more information about Toxikon, visit our website at www.toxikon.com

Submit resumes to:

Human Resources

Toxikon Corporation

15 Wiggins Avenue

Bedford, MA  01730      Email:           hr@toxikon.com

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

Toxikon is seeking an experienced outside sale person with successful selling skills. As a Technical Sales Representative, the appropriate candidate will provide Toxikon's testing services to assigned territories. We are seeking a self-starter with good presentation and excellent communication skills. This individual will spend time learning about Toxikon, our services, and systems; identify, analyze, contact, and provide testing services to new customers, and; generate leads, prepare quotes, request protocols, and work with customer service and laboratory staff.

The successful candidate will have a B.A., B.S, in life sciences or a strong understanding of life science testing and service industry and at least five years' sales experience. This position requires a strong understanding of the testing and service industry, including regulatory agencies, as well as the ability to converse with clients on testing & service needs (for pharmaceutical and medical device companies); prior CRO and/or lab experience preferred; experience with cold calls and client development required; proven ability to generate new accounts and account revenues of $5-10 million; must be self-motivated and a strong team player; excellent communication, presentation, organizational, and computer skills required, and; the ability to handle several projects concurrently is necessary. Solid computer skills, excellent organizational skills, and the ability to handle several projects concurrently are necessary. Travel required within New England with a home base at our corporate office in Bedford, MA.

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

Submit resumes to:

Human Resources

Toxikon Corporation

15 Wiggins Avenue

Bedford, MA  01730

Email:                  hr@toxikon.com

Toxikon offers a comprehensive benefits program including:  paid vacation, sick and personal time; 401(k) plan with company match; medical, dental, vision care, life, and short and long-term disability insurances; flexible spending accounts; employee assistance program; employee referral bonus; discount programs; and more.  Toxikon is an equal opportunity employer.

EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

KEY ACCOUNTABILITIES

· Accountable for developing and overseeing strategy to build and manage site relationships while overseeing site-level study start-up; conduct, and close-out activities across clinical studies for a given compound
· Develop and implement strategies for improving investigator relationship management including new ways to collaborate with investigators, SMOs and other investigator organizations
· To coordinate and facilitate the flow of information during the site nomination and selection process and during trial amongst all stakeholders. Ensure consistency and completeness of information exchanged
· As core member of the Clinical Operations Team, to act as a link between the COT and Clinical Account Managers (CAMs) in countries for communication regarding specific local site issues
· Consolidate information from the different Clinical Account Managers and provide them to the COT for a given program
· Oversee CROs performance per program at local level through the coordination with CAMs
· Participate as agreed within the Clinical Operations Team in Investigator Meetings
· Provide input and feedback on CRO proposed EC/HA submission plans
· Provide a surveillance plan for CRO oversight for given program covering activities to be performed at site level
· Provide input to CRO monitoring visit plan across sites/geographies
· Flag CRO performance issues in the regions and drive towards resolution
· SML might be assigned to several programs, working in several COTs with the corresponding tasks
· Coordination of CAMs across multiple geographies per compound
· Understanding of CRO work as well as critical Health Care stakeholders across geographies
· Working in a virtual environment 

STRATEGIC IMPACT

· To anticipate and mitigate issues or risks in regions and countries as well as with CROs

COOPERATION

Internally

· Clinical Operations Leads – alignment of regional activities to ensure program delivery
· Regional Clinical Operations – coordination of CAMs
· Clinical Services & Strategic Partnering – alignment on optimized CRO interaction
· Clinical Trial Management, line management and staff  – alignment on clinical operations strategy on COT
· Other R&D functions as appropriate

Externally

· Investigators & Site Staff
· Service Providers (CROs)
· Local/regional Patient Associations

EDUCATION

· Advanced life science (e.g., Biology, Chemistry, Pharmaceuticals) degree 

WORK EXPERIENCE

· At least 5 years’ experience in a clinical development environment in pharma, biotech company or CRO.
· Experience working directly with clinical trial sites and investigators
· Track record of establishing good relationship with sites and investigators
· Specifies personal skills and competencies required
· Solid experience in clinical trials and site interaction
· Solid scientific understanding and therapeutic drug expertise
· Very competent in relationship building
· Good negotiation skills
· Good problem solving and decision making skills
· Fluency in English (oral and written) – other languages appreciated
· Position requires both domestic and international travel potentially above 30% of time