Veterinarian will provide and oversee veterinary care for the goat herd at LFB USA.  Ensure daily compliance with all laws, guidelines, and procedures associated with the following:  USDA, OLAW, AAALAC, IACUC, OSHA.

Specific Responsibilities:

1. Provide daily medical and surgical treatment as needed.
2. Assist with oversight and review of the overall herd health program.
3. Assist with implementation of LFB USA Farm biosecurity program.
4. Liaise with Director of Farm Operations for coordination of work forces.
5. Liaise with Supervisor of Veterinary Technicians for coordination of treatments/examinations.
6. Technical writing for Veterinary Services programs and policies.
7. Assist with qualification/health certification of transgenic milking does.
8. Assist with communication with USDA for inspection and reporting purposes.
9. Interpretation of diagnostic results.
10. Provide off-hours emergency care (every other week).
11. Provide direction to the Farm Staff in specific situations.
12. Provide assistance to Farm Staff for routine farm/husbandry issues on occasion.
13. Assist with consultation/communication with satellite facilities.
14. Make oral presentations as required.

Qualifications & Expereince:

A degree in Veterinary Medicine with associated licensure and 5+ years experience in the laboratory animal medicine or biotechnology fields. Must be USDA accredited or eligible for accreditation. Clinical
experience with Large Animals with a focus on ruminants.

The Director level Industrial Project Manager will lead project/s in late development or launch phase. He/she will submit an industrial strategy to top management, and manage at global level all project management tasks related to the program. He/she will serve as the interface between the Bioproduction Division and internal / external stakeholders with respect to the project assigned. His/she is responsible for successful project execution with respect to the quantities needed for clinical and commercial, timelines, and milestones, budget, and quality. His/her task is to orchestrate all resources, internal and external, needed for successful execution of the project, including all steps of the process (DS, fill and finish, packaging) and analytics. The latter includes external testing /service providers. The incumbent needs to set up efficient interfaces with all relevant departments within and outside the division and the company.

Responsibilities:

Establish the industrial strategy for the project, up to launch, coordinate an in-depth review by all key stakeholders, and present to senior management for approval. 

Establish an appropriate transversal project team, organize meetings at appropriate frequency (Q2W, Q4W), and prepare reporting for distribution to stakeholders (KPIs, Project outline, etc.)

Develop and manage project work plans and Gantts for assigned projects to meet contract deliverables and corporate objectives.  Orchestrate all general ATryn aspects of assigned projects including; financial, contractual, scheduling, risk analysis, tracking and reporting.  Identify issues and risks and bring to appropriate level of management for acknowledgement.

Direct the project execution, engage expertise of internal and external resources as needed, capture actions and decisions over the life cycle of the project assigned.

Orchestrate external contracting services, (manufacturing including fill and finish and packaging) contracting, proposal development, scheduling and monitoring of sample needs and monitoring, review of reports and data, approval for payments and resolution of financial and technical issues.  Will work closely with Regulatory and QC / QA. 

Management of tasks and working with other departments; developing and adjusting plans, conducting meetings, updating progress and budget items, identifying and leading resolution of issues. 

Track operations and overall project progress and expenses; compare to plan and budget;

• Create and update Gantt chart(s); provide monthly/quarterly      updates to Mgt / Finance / stakeholders
• Work with all departments to ensure project is adequately      resourced and costed

Maintain inter and intra-department, as well as external client/contractor, communications and documents related to projects (internal and external).

• Develop systems, practices and documents which identify critical      and non-critical hand-offs between departments
• Conduct routine meetings, for project resource planning,      individual project/task and technical/troubleshooting, issue minutes and      action items, ensure project tasks are initiated and follow timelines by      working with responsible department designees
• Drive team excellence, identify project risks, develop contingency      and mitigation plans
• Develop tools and models for setting up and executing projects      and/or external contractors

Manage internal system of Master Services Agreements; including participating in negotiations, finalization and implementation. Work with Legal and Operations departments to ensure meeting timelines and objectives. 

Working with QA and QC, communicate quality control and/or quality assurance guidance to projects and program plans. 

• Provide quality and organizational input to troubleshooting,      transfer and validation projects. 
• Manage flow of documents from external contractors through Quality      processes.
• Coordinate/participate in external contractor audits.

Identify issues related to project plans and tasks, bring to appropriate management level for consideration and assist in achieving resolution.  Identify present and future risks to project and develop work-around plans.

Close out of the project, including lessons learned, to foster a continuous improvement of industrial project  management.

Qualifications & Experience:

Minimum B.S science degree, advance degree preferred, plus 10 years in biotech industry with manufacturing, process development experience, including at least 3 years relevant project management experience.

Familiarity with Industrial processes, analytics, quality and regulatory CMC aspects. Project management tools, Microsoft Project or similar applications. Experience with contracts. Good knowledge of finance and accounting. 

Proven ability to lead and influence, in particular transversally. Build consensus; make clear recommendations after seeking input from experts, to ensure key decisions can be made in time. Highly structured, organized, management skills, individual and group communication skills including presentation to top management, attention to detail.  Capability to anticipate critical issues, present mitigating actions including different options. Hands-on, capable to write contracts (technical part) and understand legal aspects with support of experts.

Post-Doctoral Scientists

We are seeking highly motivated scientists to join the Discovery Technologies department at EMD Serono as post-doctoral fellows. These individuals will be responsible for developing a new state-of-the-art high throughput screening platform for bispecific antibodies against targets for our Immuno-oncology platform. The Post-Doctoral fellows will evaluate and develop different technologies for bispecific antibody discovery and isolation from immunized animals, as well as production, screening and functional testing of bispecific antibodies against targets in the Immuno-oncology space. These Post-Doctoral positions will also provide opportunities to expand knowledge and experience through research in an industry setting, while addressing important scientific questions.

Two Post-Doctoral positions are available, each for 2 years with the possibility of extension.

KEY TASKS & RESPONSIBILITIES

• Design and develop new cell-based assays to select the best combination of antibodies based on evaluation of immune-stimulatory and tumor-inhibitory activities

• Evaluate and develop technologies for bispecific antibody discovery (display technology, B cell cloning, engineering), preparing libraries for display, perform selection, B cell sorting and production and screening of bispecific antibodies

• Discover therapeutic candidates with the best combinations of bispecific antibody-and-targets

• Techniques will include vector cloning and expression systems, reporter gene assay, flow cytometry, immunological assays, cell line generation

CANDIDATE’S PROFILE

EDUCATION & LANGUAGES

• Ph.D. in Immunology, Immuno-oncology, Biology, or similar related field
• Fluent in written and spoken English

PROFESSIONAL SKILLS

• Deep  knowledge of Immunology and proficiency in hands-on experimental work with immune cells and assays preferred
• Strong research experience in immunology, cellular and molecular biology, protein engineering
• Track record of independently designing, executing, troubleshooting experiments
• Experience with antibody discovery technologies (display libraries, B cell cloning) is preferred but not required
• Experience with animal handling is a plus

PERSONAL SKILLS & COMPETENCIES

• Organized, highly motivated, innovative with critical thinking and problem solving skills.
• Strong team player
• Excellent oral and written communication skills
• Ability to work in intense, fast paced, interactive work environment
• Strong sense of initiative and interest in learning new technologies and new disease-relevant biology
• Good interpersonal skills essential to effectively work with colleagues  

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.

Equal Employment Opportunity

The Company is an Equal Employment Opportunity employer.

No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.

This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. 

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

Please apply directly to req# 109121 at https://career012.successfactors.eu/sfcareer/jobreqcareer?jobId=109121&company=merckgroup&username=

Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics.

Established as a wholly-owned subsidiary of Isis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a robust portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics.

SENIOR CLINICAL TRIAL MANAGER /
ASSOCIATE DIRECTOR, CLINICAL OPERATIONS

Reporting to the Executive Director, Clinical Operations, the successful candidate will manage clinical trial activities ensuring the timely completion of deliverables through development and management of the trial timeline and budget. Must be comfortable independently managing clinical trials through the use of vendor(s) delegated responsibilities for activities such as, monitoring, site management, clinical supplies, data management, biostatistics, medical writing, safety, regulatory affairs and quality assurance. In addition, the successful candidate interact closely with investigators and site staff through routine calls and site sponsor visits.

Essential Functions and Duties

• Responsible for effective global management of the study team and relationships with CROs, central labs, IRB’s, investigating sites and other external partners for multiple clinical trials. Coordinates the activities of all trial conduct partners and team members and proactively identify and manage risks.
• Participate in the development and/or review of all supporting documents for a clinical study – Investigator Brochures, Protocols, Informed Consent Forms, Study Operations Manuals, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc.
• Manage and lead Clinical Trial Meetings collaborating with cross-functional team members regarding operational activities pertaining to the execution of one or more clinical trial(s).
• Identifies investigational sites, participates in reviewing and approving qualified sites
• Create and review Request for Proposals, vendor specifications and participate in vendor selection process.
• Manages the negotiation of contracts, budgets and timelines with CROs, clinical sites, and other external partners
• Review study invoices and manage accruals monthly.
• Participates in the coordination of and training of team members and at investigator meetings.
• Reviews and approves corrective action plans at individual site and across study, may participate in internal/external study related audits
• Prepare and maintain assigned program files, study documentation and other regulatory documents.
• Provide management with routine updates regarding the status of ongoing studies.

Skills and Experience

• Minimum BA/BS Degree
• Minimum 3-5 years of Clinical Trial Management
• Must be willing to travel, both domestic and international.
• Demonstrated knowledge and understanding of FDA/EMA/GCP/ICH guidelines.
• Ability to provide appropriate leadership to clinical sites and vendors
• Detail oriented and good problem solving ability

Excellent salary and benefits package offered.
Please visit our parent company’s website, www.akceatx.com, to apply for this position. Reference Requisition #15-0096
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Isis Pharmaceuticals, Inc. and Akcea Therapeutics, Inc. are proud to be EEO employers.

Our “A” level research group located in the biopharma hotbed of the nation is looking for a talented QC scientist.  If you have the ability to work effectively in a collaborative team environment, see how your expertise can have an impact using cutting edge gene therapy.  This amazing opportunity is looking for someone who also meets the following requirements:

• BA / BS with approx. 2-5 years of industry experience in QC GMP environment with exposure to biologics programs
• Strong working knowledge of cGMP/ICH/FDA/EU regulations
• Experience with cell culture, qPCR, Flow Cytometry
• History of compiling and verifying data in the CMC sections of regulatory filings
• Experience with external vendors
• Excellent organizational and communication skills working across many levels

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

CHEMISTRY IS EVERYTHING™

Manufacturing Science and Technology Specialist (Downstream)

About Acceleron:

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

Position Overview: 

We are seeking an experienced and talented individual who thrives in a dynamic, fast-paced, team-oriented and collaborative environment.  The successful candidate will work in the Manufacturing Science and Technology group within the protein purification area and collaborate closely with the Process Development Protein Purification group. MSAT performs Pilot and GMP campaigns as well small scale experiments in the Development setting as needed. The group investigates new technology that would be useful for Acceleron, evaluates multiple options and is responsible for the implementation at Acceleron. The preferred candidate will have experience in single use manufacturing technologies. This position will also interact closely with the Development, Quality, Engineering and Materials Management groups. 

Job Responsibilities:

• Support scale up studies for process transfer between Pilot and GMP manufacturing
• Execute and demonstrate an understanding of protein purification techniques including column chromatography and various filtrations (virus removal, bacterial reduction, membrane, tangential flow)
• Perform Pilot and GMP runs at scale for multiple products
• Investigate new technology and purification techniques that will be useful in expanding and enhancing Acceleron’s platform manufacturing process.
• Assist in design and completion of purification studies to optimize processes to be used in the pilot or GMP facilities
• Keep up with technological advances by attending workshops and industrial exhibits
• Monitor, document and present purification process data
• Author SOPs, batch records, change controls, deviations, and support Engineering with PQ, IQ, and OQ activities
• Work closely with other groups (QA, QC, Engineering, Facilities) for campaign planning and execution (schedule, raw materials orders, testing, etc)
• Author technical reports for runs performed (Pilot and GMP campaigns)
• Interact closely with multiple interdisciplinary groups (QA, QC, Purification Process Development, Facilities, Cell Culture Development, etc)
• Support regulatory filings with manufacturing process descriptions and data summaries
• Interact closely with vendors for raw material procurement and new technology implementation
• Participate in internal and external audits
• Support tech transfer activities to CMOs in regards to MSAT activities

Basic Qualifications:

• B.S. with 5-9 years of experience or MS with 3-7 years of experience with Pilot or GMP production
• Industry experience (biotech or pharmaceutical) required, in GMP setting preferably
• Excellent knowledge of purification techniques (aseptic processing, column chromatography, virus removal filtration, tangential flow filtration etc)
• Experience drafting, reviewing and submitting required documentation relevant to GMP manufacturing
• Technical expertise and creative problem-solving ability
• Ability to work independently, with minimal supervision, and to manage multiple projects at one time
• Enthusiastic with a high-level of integrity and attention to detail
• Strong interpersonal communication skills, work in team and fast pace environment, under challenging timelines and hands-on troubleshooting, great organizational and time management skills

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

FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT:

www.acceleronpharma.com

Pipeline Support Role

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Associate Director, Patient Engagement

 Reporting to the Vice President of Patient Engagement, the Associate Director will support the company’s commitment to incorporating the perspective of people affected into the company’s research and development efforts. The qualified candidate will be responsible for developing and managing relationships with patient groups in support of the company’s CNS pipeline and will partner with the R&D functions internally to bring patient and caregiver feedback into the company’s research and development programs.

Job Responsibilities

 Develop relationships with patient advocacy, research advocacy and industry advocates in order to advance the company’s efforts to incorporate the perspectives of people affected into research and development efforts

• Serve as the internal liaison to the R&D functions supporting the company’s CNS pipeline; provide patient insights and feedback to product development teams including the development and refinement of patient questionnaires, clinical trial recruitment materials, etc.
• Manage and oversee patient or caregiver advisory boards to solicit feedback to inform the company’s drug development programs
• Develop and maintain a ‘virtual advisory board’ of patients and caregivers to solicit feedback on individual programs or development efforts and report back to the patient community on how feedback is used
• Attend medical meetings, and patient conferences to provide updates on programs; serve as a corporate resource to patient advocates and facilitate meetings with the company’s clinical staff
• Create slide decks and other materials to describe the company’s drug development efforts in an advocate-friendly manner; secure appropriate internal approvals
• Develop content to describe the company’s patient-focused efforts to external audiences
• Develop and implement project plans, budgets, metrics, timelines and status reports

Minimum Education & Experience Requirements:

• Bachelor’s degree, minimum 10 years experience in patient advocacy, science communications, clinical project management or related field
• Strong writing skills and the ability to translate complex science for lay audiences
• Good understanding of the drug development and regulatory process

• Good listening skills, demonstrated empathy, a conscientious, a team player with the ability to maintain composure in stressful situations

• Ability to work cross-functionally and build strategic alliances internally and externally
• Some business travel required

• Science background a plus

 Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Branded Products Role

 Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Associate Director, Patient Engagement

Reporting to the Vice President of Patient Engagement, the Associate Director will support the company’s commitment to building strong relationships with patients, caregivers and patient advocacy communities. The qualified candidate will be responsible for developing and managing relationships with patient groups for the company’s branded portfolio in addiction and mental health; partnering with the policy and market access teams to support access and reimbursement efforts and develop strategies to increase the company’s level of engagement with the patient community directly.

Job Responsibilities

• Conduct patient advocacy landscape assessment, define and build strategic partnerships to support the company and patient community with national organizations
• Identify and cultivate new partnerships with patient organizations and individual patient advocates
• Partner with Commercial and Communications colleagues on corporate programming to develop and implement broad educational or awareness efforts in the areas of serious mental illness and addiction
• Serve as the internal liaison to the commercial and clinical functions supporting the company’s branded medicines, VIVITROL and ARISTADA; provide patient insights and feedback to internal teams
• Educate the advocacy community on the company’s patient assistance initiatives and maintain an open dialogue with the advocacy community regarding issues of access and reimbursement to therapies
• Serve as a company spokesperson to the patient community on issues of price and access to therapy
• Manage and oversee patient or caregiver advisory boards to solicit feedback to inform the company’s programming
• Evaluate the competitive landscape to ensure the company’s initiatives align with others in the industry
• Identify opportunities and build company awareness and strategic relationships through participation in local advocacy events   
• Develop and implement project plans, budgets, metrics, timelines and status reports

Minimum Education & Experience Requirements:

• Bachelor’s degree, minimum 10 years experience in patient advocacy, communications or a related field
• Flexibility working under tight deadlines and ability to effectively plan, prioritize, execute, budget, follow up and anticipate challenges
• Good listening skills, demonstrated empathy, a conscientious, a team player with the ability to maintain composure in stressful situations

• Ability to work cross-functionally and build strategic alliances internally and externally
• Some business travel required

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Branded Products Role

 Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Associate Director, Patient Engagement

Reporting to the Vice President of Patient Engagement, the Associate Director will support the company’s commitment to building strong relationships with patients, caregivers and patient advocacy communities. The qualified candidate will be responsible for developing and managing relationships with patient groups for the company’s branded portfolio in addiction and mental health; partnering with the policy and market access teams to support access and reimbursement efforts and develop strategies to increase the company’s level of engagement with the patient community directly.

Job Responsibilities

• Conduct patient advocacy landscape assessment, define and build strategic partnerships to support the company and patient community with national organizations
• Identify and cultivate new partnerships with patient organizations and individual patient advocates
• Partner with Commercial and Communications colleagues on corporate programming to develop and implement broad educational or awareness efforts in the areas of serious mental illness and addiction
• Serve as the internal liaison to the commercial and clinical functions supporting the company’s branded medicines, VIVITROL and ARISTADA; provide patient insights and feedback to internal teams
• Educate the advocacy community on the company’s patient assistance initiatives and maintain an open dialogue with the advocacy community regarding issues of access and reimbursement to therapies
• Serve as a company spokesperson to the patient community on issues of price and access to therapy
• Manage and oversee patient or caregiver advisory boards to solicit feedback to inform the company’s programming
• Evaluate the competitive landscape to ensure the company’s initiatives align with others in the industry
• Identify opportunities and build company awareness and strategic relationships through participation in local advocacy events   
• Develop and implement project plans, budgets, metrics, timelines and status reports

Minimum Education & Experience Requirements:

• Bachelor’s degree, minimum 10 years experience in patient advocacy, communications or a related field
• Flexibility working under tight deadlines and ability to effectively plan, prioritize, execute, budget, follow up and anticipate challenges
• Good listening skills, demonstrated empathy, a conscientious, a team player with the ability to maintain composure in stressful situations

• Ability to work cross-functionally and build strategic alliances internally and externally
• Some business travel required

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Our client is an industry-leading specialty manufacturer of API located in the suburbs West of Boston.  They are seeking an experienced Analytical Chemist to lead research and development of robust analytical methods. 

Responsibilities include but are not limited to;
•  Lead PhD and BS/MS chemists in the development of analytical methods and their subsequent verification/validation.
•  Development of novel assays.
•  Write quality test methods, validation protocols, validation reports, technical      development reports.
•  Hiring, training, and assessment of team members.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have PhD or MS and several years of analytical method development experience, specifically with oligonucleotides.  Industry experience preferred, academic experience also welcome. 

The Hiring Manager has the flexibility to consider profiles ranging from junior to senior individual contributors and Group Leader level. 

Must be authorized to work in the US to be considered.  Relocation assistance is available to qualified candidates.  

Resumes to nuno@hireminds.com to be considered.  All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

The Regional Account Strategy Leader is a key member of the Payer, Access, and Distribution organization. The individual would be responsible for shaping regional payer strategies, developing segmentation & account plans by gaining critical customer insights, mapping communities of practice, regional health networks & GPOs. The lead will possess deep insights of the local oncology trends and practice patterns to determine their implications and guide strategic plans and be accountable for executing. The individual will have the responsibility to collect, analyze and present feedback on regional conferences and educational meetings and work to develop the AMCP Dossier and pricing analysis. The individual will also help with competitive insights and identify early market trends. In addition, the individual may assist in certain corporate programs as necessary.

The individual would possess significant experience regarding the development of strategies and tactical plans for the payer market and provider reimbursement support for the launch of Duvelisib. This individual will be responsible for developing payer-focused strategy and tactical execution for the launch of a novel oral product in oncology. 

Additionally, the person would need to have a strong business, new product launch and scientific acumen. Our ideal candidate would be driven, highly compliant, collaborative, and accountable to the success of the extended team and as well as the organization. Cross functional collaboration across the organization, sales and marketing teams will be critical for success.

Duties & Responsibilities:

• Mapping Communities of Practice, Health Networks and Key Accounts
• Development of Regional Segment and Multi-Channel Strategies
• Lead Dossier and Budget Impact Model development
• Develop training program and content for RASL team
• Plan and execute approved Ad Boards in compliant manner with broader commercial team
• Assess Regional Trends, Implications and Recommendation to Operational Strategy
• Assess launch plan and market access readiness
• Customer and Competitive Insights
• Develop Patient Advocacy Plans for the Central United States
• Recommend future speakers and formulate compliant plans

Qualifications

• Bachelor’s Degree, MBA preferred
• 12-15+ years pharmaceutical and biotech experience (access, sales, etc.)
• Oncology commercial experience preferred
• Ability to foster relationships, build alignment, negotiate and collaborate with internal and external stakeholders
• Prior launch and field experience would be a plus
• High energy, creativity, and aptitude for handling multiple tasks concurrently
• Strong teamwork, collaboration, communication and presentation skills required.
• Ability to travel (~50%)

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

Title : Industrial Post-Doctoral Associate

Education : PhD in Chemistry, Biochemistry, Biomedical Engineering, Pharmaceutical Chemistry or Chemical Engineering

Experience: 0-2 years of experience in an academic setting, or 0-1 years in the pharmaceutical industry

Potential applicants must be US Citizens or Permanent Resident Visa holders.

This is a permanent position as an employee of the company, allowing the freshly minted Ph.D. to train in the development of pharmaceutical drug products, while using his/her skill sets gained in academia to advance the company’s innovations. The successful candidate will be highly motivated, using creative out-of-the-box thinking to develop tissue adherent, drug delivery systems. As the incumbent learns and masters the skillsets appropriate in industrial pharmaceutical product development in analytics and formulation chemistry, he/she will appropriately be promoted to Research Scientist I, hopefully in less than a year, depending upon his/her mastery of requisite skill sets.

The incumbent will have a strong chemistry and engineering background, with knowledge of biomaterials, tissue-reactive polymers, cross-linking chemistry, biocompatibility and biodegradation. The candidate must have knowledge of the methodology needed to conduct drug release experiments from matrices. The candidate must be familiar with PLGA drug delivery systems, experience on what controls drug release from PLGA matrices is a plus. Experience and comfort using Agilent 1100 HPLC systems are plus points.

Integral BioSystems is a drug delivery CRO, assisting pharmaceutical companies develop 505b2 and ANDA drug products. Additionally, the company has innovative drug delivery programs to develop licensable products.

Our growing, internationally based client, focused on the innovative development of therapies for several orphan and ultra-rare diseases, has an amazing opportunity for a VP of Program and Portfolio Management. This is a fundamental cutting edge company and the right high caliber candidate will have an amazing chance to get in at the early stages of a company growing within a very exciting science.

This is an essential role leading a small portfolio of programs in the orphan disease drug development space from the lab through commercial approval. The ideal candidate for this role will have a broad exposure to pre-clinical & clinical, as well as commercial. This is a role that will work closely with the entire research and development teams, and interact significantly with senior internal and external management, so a strong sense of leadership is required to advance the programs efficiently. A methodical, and detail oriented approach as well as experience in orphan or enzyme/ERT programs is essential for this crucial hire.

Requirements:

• PhD or MBA in a scientific discipline and 10+ years experience with comprehensive knowledge of orphan drug development OR enzyme replacement therapies.

• Ability to summarize raw data into a concise, accurate and easily understandable form

• Proven track record in supervisory function

• Entrepreneurial spirit with team attitude & demonstrated leadership skills

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

CHEMISTRY IS EVERYTHING™

Primary Role:
The Regional Disease Education Manager (RDEM) is responsible for the implementation of the strategic initiatives developed by the leadership team. The RDEM will educate and raise awareness of specific Lysosomal Storage Disorders, Gaucher Disease and Hunters (MPS II) Syndrome, with health care providers in a defined geography to uncover patients that are appropriate for Shire's therapies. The RDEM will be expected to meet or exceed set expectations related to patient identification and the development of a robust sales funnel. Further, once an appropriate patient/provider is identified the RDEM will partner with the Regional Business Manager (RBM) to assist with the steps necessary to get the patient on drug.

Responsibilities:
This position will be responsible for all disease education related activities within their geographic responsibility, including achievement of MBO's, business planning in partnership with the RBM, and expense control. The RDEM will educate and inform HCPs on Gaucher Disease and Hunters (MPS II) Syndrome. They will describe signs and symptoms of the diseases and inform on the differential diagnosis process. They will educate HCPs on the appropriate treatment referral route. They will attend conferences and workshops as an exhibitor or presenter.

Education & Experience Requirements:
* Minimum of a Bachelor's degree in business or science related field is required
* Healthcare provider, Nursing, Genetic Counselor background preferred
Minimum of 4 years of sales experience required
* Minimum of 2 in specialty biologics preferred
Complex sales model experience is preferred
* A consistent track record of success (Top 20% performance), President's Club or other top tier awards preferred
* Experience providing complex disease education preferred
* Rare disease experience is a plus
* Demonstrated pioneering experiences required

Other Job Requirements:
* Candidate must live in territory
* Must work evenings and weekends as needed
* Extensive travel required and varies by territory
* Candidates must possess a powerful sense of urgency, a strong desire for results and a strong work ethic.
* Territory includes Illinois, Indiana and Nashville, TN

About Shire:
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Please apply at: Application URL:http://www.aplitrak.com/?adid=bHZhaWwuNjMwNjcuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

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.

The Pharmacovigilance Coordinator (Post marketing) will be responsible for providing tactical support to PV Operations group related to processing and reporting of post marketing adverse events. 

Responsibilities Include:

• Assist in processing and tracking of AEs
• Help maintain coordination of processes between PVG and other internal and/or external groups (e.g. CRO) for the timely and accurate transfer of files/data as required
• Perform AE case closure activities
• Perform AE reporting trainings to new hires and ARIAD departments, as necessary
• Assist and support the PV Postmarketing Operations group in performing reconciliation activities, contributing to case processing activities, as necessary, and performing literature review
• Assist in management and organization of the Sharepoint site and internal PV shared drive
• Scheduling of team meetings and recording meeting minutes
• Maintain organizational charts within PV department
• Assist in supporting audits/inspections; create and maintain audit-ready files including training files
• Perform other operational tasks in support of Safety Operations as required by Management

Job Requirements:

• Bachelor’s degree in life sciences
• A minimum of 2 years prior experience in a supporting operational/tactical role
• Detail-oriented and persistent with excellent organizational skills
• Proficient with Microsoft Word, Excel
• Familiarity with medical terminology
• Prior experience with providing operational support in a regulated environment and/or knowledge of US/Global regulations governing adverse event reporting is desired
• Familiarity or prior experience in safety databases or a similar database is desired

ARIAD Pharmaceuticals, Inc. provides equal employment and affirmative action opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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=598&company_id=16419&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.

Lab Support, a scientific staffing firm is currently recruiting for a QC Inspector/Tester to work on-site at a company that engineers, manufactures, and ships wires and cables. This company is located west of Worcester, MA.

Hours: 5pm - 5 am

SCOPE OF POSITION

Tests and visually inspects raw materials and manufactured products.  Ensures compliance with QWC and third party standards.  Prepares related documentation.

ESSENTIAL FUNCTIONS

• Inspects samples of product at the beginning of each job or after a change of critical process parameters, confirms compliance to product specifications and document results.
• Inspects incoming raw materials to confirm compliance with raw material specifications; documents results.
• Inspects finished product to confirm compliance to product specifications and document results.
• Communicates product and process deviation to supervisor and manufacturing.
• Calibrates or confirms calibration of equipment.
• Serves as back-up for other department members in their absence; some night shift work.
• Performs other related duties as requested or required.

BODY POSITIONING & PHYSICAL DEMAND (see physical requirements)

• Considerable amount of standing, walking, climbing stairs, some lifting up to 40 lbs. max., carrying of material and maneuvering reels weighing up to 70 lbs.
• Computer/keyboard work: manual/finger dexterity, keen eyesight, usually sitting position: several hours on weekly basis.
• Inspect material: keen eyesight, ability to make color distinctions, ability to inspect texture of product, good hand dexterity, good hand-eye coordination, standing and bending position, finger manipulation: on going during shift.

PACE & SCHEDULING

• Job pace is often fast and interrupted with other tasks

COMMUNICATION & INTERPERSONAL RELATIONS

• Requires in-person and telephone discussions with individuals or teams
• Requires coordinating with others in accomplishing work activities
• Requires ability to maintain emotional composure when interacting with others            

BASIC SKILLS

• Active Learning Understanding the implications of new information for both current and future problem-solving and decision-making.
• Active Listening Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
• Critical Thinking/Deductive Reasoning Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Able to apply general rules to specific problems in order to produce answers that make sense
• Strong Communication Expressing oneself clearly and positively, both verbally and in writing as appropriate for the needs of the audience
• Monitoring Monitoring/Assessing performance of oneself to make improvements or take corrective action.
• Reading Comprehension Understanding written sentences and paragraphs in work related documents.
• Time Management Managing one's own time and the time of others.
• Computer Proficiency Using scroll bars, a mouse, and dialog boxes to work within the computer's operating system. Being able to access and switch between applications and files of interest.
• ·        Organizing, Planning, and Prioritizing Work Developing specific goals and plans to prioritize, organize, and accomplish you work
• ·        Strong Communication Expressing oneself clearly and positively, both verbally and in writing
• ·        Problem Sensitivity The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem
• ·        Clerical Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology
• ·        Judgement and Decision Making Considering the relative costs and benefits of potential actions to choose the most appropriate one
• ·        Mathematical Proficiency Good numerical aptitude at basic arithmetic level (ability to detect errors through basic logic)
• ·        System Analysis Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes
• Systems Evaluation Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system

EDUCATION, EXPERIENCE & KNOWLEDGE

• Minimum two years experience in quality control role in a manufacturing environment
• Solid knowledge of measuring and testing equipment
• Strong problem – solving and decision making skills
• Ability to handle multiple tasks and to prioritize activities. Time management skills.
• Strong communication skills – written and oral with a focus on information sharing and documentation
• Ability to understand and follow work orders and written instructions
• Keyboard skills and familiarity with Windows and MS Office software
• Ability to work independently
• Accuracy and detail orientation
• Strong math skills and understanding of statistical data, graphs and process control
• Knowledge of cable products and cable manufacturing processes is preferred

REPORTING RELATIONSHIPS

• Reports to the Quality Assurance Supervisor

Clinical Coordinator will be  responsible for conducting analysis and generating results of completed studies. 

For details visit: http://www.cwsciences.com/Current-Openings/Clinical-Coordinator

Email resume to: jobs@cwsciences.com

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


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

The Medical Writing Department at Vertex Pharmaceuticals Incorporated (Boston, MA) is expanding and seeks Medical Writers and Senior Medical Writers to prepare clinical study documents and sections of regulatory submissions.  Applicants will possess outstanding skills in written communication, data analysis, data interpretation, and project management. Applicants must exhibit proficiency in interpersonal skills, teamwork, and organizational skills. Applicants will be familiar with drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
Preferred qualifications include a PhD (or equivalent degree) in a related field.

Preferred qualifications for Senior Medical Writer also include at least 3 years of experience with writing, editing, and reviewing clinical documents; experience working with respiratory disease and orphan diseases is highly desirable.

Apply at http://careers.vrtx.com/

Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our QC Department.

QC Supervisor-Electrophoresis-Portsmouth, NH

• Supervision of techniques including but not limited to: SDS-PAGE, qPCR, IEF, iCE, Appearance and UVIS spectrophotometry
• Schedules applicable testing and work activities and coordinates with internal and external customers as necessary.
• Ensures that the testing is released in a timely manner by supervising the review of laboratory data and the closeout of quality records.
• Oversees cGMP/technical training for staff. Ensures documentation for training files is up to date.
• Understands regulatory requirements and Lonza policies pertaining to area of responsibility.
• Perform annual reviews of direct reports.
• Provides motivational and team oriented atmosphere
• Supports QC projects and activities by authoring, reviewing, and approving records such as change controls, investigations, deviations, SOPs, and reports.
• Supports customer and regulatory agency interaction as required
• Works interdepartmentally to ensure that any issues are resolved and to provide communication on lab related activities
• Communicate effectively with Manager and other members of QC Management.

Qualifications:

• BS/BA, MS or PhD in scientific field or related
• 5+ Years experience in Supervisory role in biotech field
• 2+ Years in cGMP practices
• Excellent communication skills
• Ability to prioritize tasks according to business needs
• Ability to troubleshoot laboratory results and review data packets
• Good technical writing skills

      M/F/Disability/Veterans

Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

Must Have:
cGMP training/GXP documentation
Aseptic technique
Environmental Monitoring

Nice to Have:
BacT
Pyros Kinetic Endotoxin testing
MODA (lims system)
Gram Stain
Sterility and Bioburden
SOP writing


The QC Analyst III/IV performs complex quality activities in support of product production and releases. The position has interaction with other internal departments, including Apligraf Production, FortaFlex Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also has interaction with external entities including contractors and suppliers. The QC Analyst III/IV performs a wide variety of complex activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.
KEY RESPONSIBILITIES

•       Coordinate endotoxin, microbiologic, and water testing.
•       Perform and/or read environmental, personnel monitoring.
•       Perform and coordinate Bioburden and sterility testing of raw materials, and in-process samples.
•       Perform microbiology release testing of final product.
•       Prepare and send out samples for microbiological identification and/or mycoplasma testing.
•       Perform visual inspection of finished product.
•       Generate trend reports as they relate to quality testing.
•       Revise SOPs.
•       Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
•       Identify and implement issues and opportunities for improvements.
•       Participate extensively in high-level quality systems programs (CAPA, Exception Reporting, OOS’s, etc.).