• Design, development and evaluation of candidate vaccine formulations against infectious diseases
• Formulations through physicochemical characterization

• BS/MS/PhD in Pharmaceutics, Pharmaceutical Chemistry, Chemical Engineering, with 0 – 2 years experience
• Expertise in Assay development to evaluate formulations (HPLC, particle size, agarose gel electrophoresis, in-vitro cell based assays
• Knowledge of polymer- and/or lipid-base gene delivery systems is a plus

**Multiple Openings

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

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

Commonwealth Sciences, Inc.

http://www.cwsciences.com

Responsibilities:

Execute experiments in close collaboration with Research and Technology Development team to establish Phase I-III clinical manufacturing process

Perform activities in support of definition of bulk purification processes for novel viral vaccine candidates (virus/virus-like particles, recombinant proteins)

Prepare technology development study protocols and reports in support of process transfer and regulatory documents

Purification and analytical techniques including: chromatography, ultrafiltration, centrifugation, SDS-PAGE, AKTA / HPLC

Education:

B.S./M.S. in Chemical/Biochemical Engineering or related discipline with 3+ years experience

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

Email resume to: jobs@cwsciences.com

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

Commonwealth Sciences, Inc.

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

Requirements:

BS/MS Chemistry/Biochemistry with 5 years of lab experience

Supervisory experience is a must
 

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

Email resume to: jobs@cwsciences.com

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

Commonwealth Sciences, Inc.

www.cwsciences.com

Duties:

• Provide animal husbandry (feeding, cleaning, watering, observing, handling, and moving of animals) to mice, rats, cotton rats, hamsters, and rabbits.
• Follow SOPs and protocols
• Operate laboratory equipment as pertaining to the work environment.

Education:

Associates/Bachelors degree preferred but nor required. AALAS certification preferred but not required.

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

Email resume to: jobs@cwsciences.com

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

Commonwealth Sciences, Inc.

www.cwsciences.com
 

Client of Aerotek is currently seeking a QA Compliance Specialist for an immediate opening.

Responsibilities will include reviewing documents such as CAPAs, SOPs, deviations, and change controls.

Requires GMP experience and document control experience in a Pharmaceutical or Biotechnology company.

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Visit www.genzyme.com.

This position is responsible for providing high quality clinical documentation to the Genzyme Rare Disease business. The purpose of this job is to create and to manage creation by others of any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format. This position is for an independent, proactive, very experienced medical writer with demonstrated leadership in preparing multiple key summary submission documents (i.e., Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) for the CTD and demonstrated experience managing the project work of other medical writers.

As an integral part of a clinical and/or study team, the position holder ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical documents using an electronic document management system. The position holder must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers.

MAJOR DUTIES & RESPONSIBILITIES:
- Work with and lead project teams to prepare clinical regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development under strict timelines.
- Manage the project work of other medical writers (internal and remote) to prepare clinical regulatory documents. This includes training and mentoring in addition to participation in assessing workload, managing work assignments, and fulfilling administrative responsibilities.
- Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
- Ensure a consistent style of presentation of clinical document to maintain quality and ease of review.
- Contribute to Clinical Cluster, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate efficient development and submission of products.

Qualifications
Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology. Detailed knowledge of requirements for preparation of key clinical regulatory documents (e.g., CSRs and CTDs.) Accurate and detail-oriented with excellent inter-personal skills. Native English speaker or have proven excellent spoken and written English. Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system. Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment. Demonstrated leadership, problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines.

Knowledge and Skills:Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology. Detailed knowledge of requirements for preparation of key clinical regulatory documents (e.g., CSRs and CTDs.) Accurate and detail-oriented with excellent inter-personal skills. Native English speaker or have proven excellent spoken and written English. Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system. Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment. Demonstrated leadership, problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines.

Formal Education And Experience Required:
Substantial experience (8-10 years) as a medical writer, or equivalent, and presenting relevant specialist qualifications (e.g., Ph.D. in life sciences). Experience leading teams to prepare clinical regulatory submission documents, including CTD Module 2 summaries. Demonstrated experience mentoring and managing the project work of other medical writers.

Knowledge And Skills Desirable But Not Essential:
Familiarity with written and oral French. Experience working on orphan diseases is desirable, as is submission experience with biological agents.

To apply for this position, please CLICK HERE

This role is key for medical supervision and medical management of clinical trials in the North American Region (US & Canada). The Medical Advisor (MA) is the medical link between Medical Operations (and/or Units/Customers) and (potential) investigators or experts/Key Opinion Leaders (KOL's) in North American Region. He/she should be the medical support in the territory for the studies he/she is allocated to. He/she should provide appropriate medical feed back to central clinical trial team especially to Clinical Study Director (CSD) and Feasibility Manager (FM)
- Conduct pre feasibility and/or assess the feasibility of international protocols in the North American Region by collecting information and documentation on the study to be performed and by conducting surveys with opinion leaders, experts or potential investigators as Health Authorities according to Clinical Study Director (CSD) and Feasibility Manager (FM) (Medical Operations) requirements and timing.- Serve as "Medical" liaison and ensure appropriate collaboration with the Global team (CSD, FM…) Serve as first-line medical support to the CRU team e.g.: answer medical questions from investigating sites, Ethics Committees, monitoring teams (MTs), study managers. Conduct appropriate review of patients' data (e.g. patient profiles, e-CRF data,…) especially for critical cases (outcome events, related SAEs, AEs with pre-specified monitoring,…) in order to support MT and CSO and get data quality.

Knowledge And Skills Desirable But Not Essential:
- Ability to speak English, French and Spanish
- Qualification in a medical specialization (Oncology) strongly preferred
- Understanding of country specific medical guidelines in area of responsibility to allow for development of appropriate strategies

To apply for this position, please CLICK HERE

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Senior Process Engineer

The Technical Operations group is seeking a Sr. Process Engineer to fill a Person-in-Plant (PIP) role at its contract manufacturing organization (CMO) located in McPherson KS. The Sr. Process Engineer will monitor Genzyme manufacturing operations for cGMP compliance, adherence to validated procedures and to provide first line technical support for this vendor. The Sr. Process Engineer will report and resolve manufacturing issues as part of a multifunctional team and will act as subject matter expert for resolution of manufacturing exceptions and CAPA's.
Job responsibilities include design and execution of process and yield improvement studies as well as implementation of study recommendations with a focus on continuous process improvement. This individual will assist in the process transfer of key Genzyme products as part of a multifunctional transfer team. The position will be based local to the CMO and will require periodic travel to Genzyme's facilities in the Metro Boston MA area.
 
Responsibilities:
The PIP delegate will work with the cross-functional team (CMO QA, Corporate Validation, Supply Chain) to ensure an uninterrupted product supply for multiple key products manufactured at the CMO. This individual will monitor filling, visual inspection and packaging operations and assist in sample and drug product shipment to Genzyme/Sanofi facilities as required. A key role is to report out discrepancies and deviations observed and to provide training and resolution to ensure a consistent and compliant manufacturing environment.

This person will be an integral part of the Tech Transfer Team throughout the planning and execution phases for tech transfer of Genzyme's proprietary drug products between the internal manufacturing sites and CMO's. A key responsibility will be to ensure processes and manufacturing operations at the CMO are consistent and compliant with established Genzyme Corporate Quality Standards and relevant regulatory requirements.

Specific responsibilities include the following:

• Provide technical support and guidance for the design, scale-up, optimization, monitoring, and/or operation of the established manufacturing process validated at the CMO
• Track and trend key process inputs and yields to determine opportunities to improve process yields. Present data at quarterly business reviews
• Implementation of process improvement opportunities
• Ensure compliance to Genzyme Corporate standards and cGMP's
• Provide status updates to the CMO Operations team and the Product Managers and escalate issues when appropriate
• Serve as a Technical Operations contact with the CMO and work with Hospira Contract Manufacturing group and internal groups for resolving issues and potential conflicts
• Provide continued on-site support at selected CMO to include resolution of manufacturing exceptions and implementation of approved CAPA.
• Support regulatory submissions related to the CMO tech transfer.
• Codify process knowledge relevant to the manufacturing processes employed at the CMO

Basic Qualifications:

• BS degree in Chemistry, Biology, Pharmacy or related science
• 5-10 years' experience in a manufacturing environment for small volume parenteral with specific knowledge of key unit operations including batch formulation, sterilization, depyrogenation, filtration, lyophilization and visual inspection

Successful Candidates Should Also Possess:

• Ability to work independently in a CMO environment with a flexible production schedule and to manage and support multiple projects and activities
• Experience with process and product transfer activities; participation in GAP analysis and FMEA risk assessments
• Demonstrated experience with design, execution and close out of process improvement studies
• Working knowledge of US and EMA guidelines for aseptic processing and current regulatory expectations
• Knowledge of current innovations and technology trends in aseptic processing
• Excellent written and verbal skills and demonstrated ability to liaise between internal QC, supply chain and manufacturing disciplines and CMO Contract Manufacturing and Quality functions

To apply for this position, please CLICK HERE

The Administrative Support Manager provides oversight to the world of administrative assistants, a group of 30+ individuals who assist the Broad’s scientific and administrative workgroups. This position is responsible for implementing training and career development learnings for the administrative assistants, as well as working with managers to promote administrative best practices and to meet their administrative needs. This position also manages partner relationships involved with providing certain administrative services, such as travel and catering; oversees administrative processes and Administration intranet content and recommends changes when appropriate.Provides oversight and leadership to administrative support staff. Serves as advisor to and advocate for administrative assistants (AAs), and as a resource to AAs and supervisors. Manages partner relationships involved with administrative services (such as travel, catering, record storage); manages the administrative budgets for catering. Provides oversight of administrative services and functions, including monitoring work flow of administrative processes, recommending changes and ensuring Administration intranet content is current. Supervises two administrative assistants directly.

Key Responsibilities:

Leadership and oversight of administrative support function:
- Organize and implement training program and orientation geared to AAs; plan agenda for monthly meetings for AAs; maintain web site targeted to AAs. Serve as resource for AAs in all administrative matters, including Broad policies and procedures
- Advise managers on AA issues and ensure that each group’s unique needs are reflected in the delivery of administrative processes, tools and services
- Partner with managers and other internal Broad groups to assess AA effectiveness, promote administrative best practices, and recommend appropriate plans to optimize the AA function across the Institute
- Work with Human Resources in the recruitment process of AAs to promote consistent standards and core responsibilities. Evaluate job descriptions for AAs for consistency, appropriate standards and core responsibilities; continually monitor for appropriateness and consistent applicationOversight of administrative services and functions, particularly those used by administrative assistants:
- Monitor work flow of administrative processes, such as travel arrangements, payment of catering bills, candidate interviewing process, to streamline and ensure compliance with Broad policies.
- Manage the partner relationships involved in administrative services - particularly travel, catering, mail services and record storage. Track Broad business with preferred vendors to ensure the best price; serve as a resource to travelers in using Broad preferred travel agency; work with Facilities on common issues and on managing efficiency and effectiveness of mail services
- Monitor effectiveness of administrative processes and procedures, recommend changes and coordinate development of new process and procedures, when appropriate; coordinate annual review and update of administration policies
- Monitor Administration portion of intranet to ensure content is current and produce or coordinate up-dates when appropriate
- Supervise a floating AA who provides coverage during gaps in service throughout the Institute and assists with special projects; supervise AA providing support to administration directors
- Manage the administrative budgets for catering costs

- Bachelor’s degree or equivalent with 5+ years of progressive experience in an administrative management/business services role
- Previous supervisory experience preferred; experience in a research setting preferred
- Demonstrated success working in a highly collaborative and complex environment with ability to provide oversight both directly and indirectly as needed
- Strong communication skills, both verbal and written; strong interpersonal skills, including the demonstrated ability to influence others and to build working relationships
- Strong customer service skills, including excellent problem solving skills and the ability to implement change
- Strong organizational skills and attention to detail
- Ability to be flexible, to multitask and to work in a fast paced and challenging environment

To apply for this position, please CLICK HERE

The Broad Institute of MIT and Harvard is seeking a highly motivated individual to perform analysis of new datasets generated by RNA, ChiP and RIP sequencing experiments that support the overall research objective of an integrative computational and experimental lab in a fast-paced and dynamic environment. This research group recently identified a new class of mammalian genes termed lincRNAs that exert their regulatory influences on the genome in unknown ways. Our goal is to identify linc RNA-protein, linc

RNA-DNA, and lincRNA-RNA interactions. Collectively, this research experience will allow a candidate to work both independently and amongst a highly collaborative team participating in the challenging and incredibly exciting field of lincRNA biology. The Broad Institute provides a vibrant research environment with close links to top academic institutions across the Boston Area and provides the potential for your contributions to be used and recognized worldwide.The successful candidate will interact with members of various Broad platforms to ensure proper experimental design, analysis and technical concerns are met. This person will help develop and implement algorithms to analyze new data and integrate it with other data sets already available. The candidate will also help with the generation of tools needed for manipulating and preparing data for display; transferring data to external collaborators and data repositories; and will also help maintain, support, and document shared tools, code base, and data sets.

KEY RESPONSIBILITIES / ESSENTIAL FUNCTIONS
- Use existing computational pipelines to analyze new data sets essential to the overall project success.
- Design and assists in developing statistical methods and computational algorithms for analyzing large-scale datasets.
- Analyze results and identify methodological problems. Adjust algorithms as needed to ensure project completion in a timely fashion.
- Gather, summarize and report all experimental results to manager.
- Consults with other senior scientists or scientific literature as needed.
- Assist with preparation and presentation of data.Required: Bachelor’s degree in bioinformatics, mathematical, physical, or other computer science related field.Preferred: Masters degree in bioinformatics, mathematical, physical, or other computer science related field.

- Significant experience in computer programming and computational biological applications. A strong
- background in statistics and biology.
- Excellent skills in at least one programming language required, preferably Python or Java. Additional experience or
- potential in R and MATLAB are also preferred.

To apply for this position, please CLICK HERE

Scientific Director- Bioanalytical Lab Sciences—Greater Boston Area

This position manages 20+ Pre-Clinical Drug Discovery Scientists and Lab Technicians conducting High-Throughput Non-GLP discovery research focused on small molecule PK/PD analysis. The role requires a strong technical background in bench scientific "hands-on" experience as well as a strong ability to manage people, projects, and direct strategy within a growth business unit.

Act as primary contact for the department with respect to new contracts, providing project outlines and pricing, in collaboration with Client Services/Account Management. Responsible for coordinating the feasibility and pricing of applying a wide variety of scientific principles and concepts to client projects.  Supervise scientific staff in the department and provide guidance with the planning and execution of scientific research and/or critical development strategies.  Assign work to scientific staff and oversee the work flow within the department.  Plan and execute laboratory research. Provide scientific and innovative thinking with advanced level of technical skill and insight.  Keep abreast and maintain a broad knowledge of state-of-the art principles and theories.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

-Act as primary contact for new contracts, providing project outline and pricing, in collaboration with Client Services/Account Management. Develop and maintain client/sponsor relationships.

-Provide scientific and innovative thinking with advanced level of technical skill and insight.

-Develop strong relationships with key accounts and represent service capabilities to clients and business partners.

-Evaluate study requirements, timelines and prices with Sponsors and other internal resources and sites.

-Produce a high quality work product acceptable to project management, on time and within budget.

-Participate in business development opportunities; work toward expanding existing business and developing new business opportunities.

-Coordinate with Client Services/Account Management, Field Sales Representatives and Internal Staff with respect to client/Sponsor negotiations.

-Responsible for coordinating the feasibility and pricing of applying a wide variety of scientific principles and concepts to client projects.

-Provide guidance with the planning and execution of scientific research and/or critical development strategies.

-Act independently as a project manager and Study Director – develop, design, validate, interpret, prepare GLP compliant reports (as appropriate) and conduct assays and studies as assigned.

-Develop and maintain tracking system of study assignments and progress.

-Maintain a broad knowledge of state-of-the art principles and theories.

-Develop business leads to ensure the company’s financial success.

-Direct activities of assigned group(s) to ensure optimum performance of the group/function.

-Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.

-Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.

-Integrate activities with those of other major organizational units (e.g. segments, departments, functions).

-Develop and recommend departmental budget and authorize expenditures.

-Develop and oversee the implementation of departmental training programs, including orientation.

-Support the policy of equal employment opportunity through affirmative action in personnel actions.

-Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].

-Perform other related duties as required.

QUALIFICATIONS:

Education: 

PhD or international equivalent in a science related field required. Bioanalytical/Biochemistry, Mass Spectrometry, Pharmacology, Chemistry, and other related fields.

Experience: 

-8 or more years’ experience in the contract research or pharmaceutical industry conducting scientific research. Experience in a non-GLP (discovery) Bioanalysis environment required. Management experience required. Experience with financial business planning and project management experience preferred.

-Excellent verbal and written communication and organizational skills are required.

-Demonstrated independent analytical and problem-solving abilities. 

-Demonstrated proficiency in managing a laboratory area.

 -Demonstrated knowledge and full understanding of GLP regulatory requirements and industry standards.

-Ability to develop and maintain client/sponsor relationships and direct client/Sponsor programs.

-Ability to interact appropriately with all levels of employees. 

-Ability to work effectively as a member of a team. Ability to work in a dynamic, detailed driven environment.

-Ability to apply leadership, negotiation, interpersonal, and managerial skills.

-Ability to handle multiple projects, prioritize work and meet deadlines.

-Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software.

*Trident Search, LLC will be in contact with highly qualified applicants who meet the general requirement of the position as a first priority. We will respond to all others in due time.  Thank you for your understanding and we look forward to speaking with you soon. 

Director-Quality Management & Compliance-ePRO/GxP

Department: Quality Assurance

Reports to: Chief Scientist & Quality Officer

Location: Cambridge, MA

The Director of Quality Management and Compliance has the responsibility, accountability, and authority to plan, direct, and administer the company’s quality system, including the establishment, implementation, and maintenance of company quality system policies and procedures, monitoring programs, and evaluating in-house and supplier programs through audit.

 Position Responsibilities:

 -Maintain overall Quality Management System.

- Ensure ongoing regulatory compliance of all policies, processes, equipment, products and deliverables.

-Track quality related commitments made through CAPA system and provide updates to management.

-Evaluate current processes and recommend improvements with the goals of increased efficiency, improved product/service quality, process automation, and regulatory compliance.

-Establish, implement and manage audit program including internal audits, supplier audits and client audits. Support preparation for and conduct of audits by regulatory authorities, clients and third parties, coordinate response and track on going commitments.

-Periodically update management on all quality system and compliance issues. Conduct formal periodic reviews of the quality system with management.

-Act as Quality System Management Representative for all ISO 9001:2008 related issues.  Review and approve validation packages for Core Product and eStudy design and delivery projects where necessary.

-Provide direction and recommendation throughout the development life cycle.

-Oversee all quality system follow-up including responses to clients, audits and other inspections

-Maintain understanding of all current issues and changes in US and international GxP regulatory compliance activities.

-Manage the overall quality department budget including training and/or similar for employees to remain current in all US and international GxP regulations and guidance.

-Oversee Document Management Process and System, and provide expertise to associates working on quality system documents.

-Design and implement a supplier management system that includes auditing, corrective actions and periodic assessment of issues that affect quality.

-Create an overall corporate training program that includes not only training on relevant SOPs in support of ISO registration, but also includes job related training, periodic corporate regulatory training and effectiveness measures.

 Education Minimum: A Bachelor’s Degree. Advanced degree in Computer Science/Engineering, Measurement Sciences, etc. though none specified.

 Required Skills and Experience:

 -A minimum of 7 years’ experience in Pharmaceutical or biotechnology industry with at least 5 years of experience in leading role as Quality Assurance of computer systems and/or software

-Experience with interpretation and practical application of US and international GxP regulations, procedures and guidelines that govern quality systems, development and delivery of software and services for clinical trial investigations

-Training and certification as a quality auditor or equivalent work related experience

-Lead experience implementing and maintaining a quality system in a regulated environment

-Experience with ISO 9000 standards and implementation

-Strong writing, presentation, and general communication skills

-Project management experience

-Strong organizational and administrative skills

-Ability to handle a variety of tasks and juggle multiple assignments

-Ability to travel to domestic and international locations.

 *Trident Search, LLC will be in contact with highly qualified applicants who meet the general requirement of the position as a first priority. We will respond to all others in due time.  Thank you for your understanding and we look forward to speaking with you soon.

Regulatory Operation Manager
-Regulatory Strategy/Global Program Management/Clinical Development

+ Due to successful 14 years of continuous successful business relationships and a demand for regulatory expertise there exists one or two opportunities with this company at this level.

Location:
-Remote-based role within Massachusetts or other New England state (Corp HQ in Metro-West area of Boston), Periodic visits to client locations as needed.

Relationships:
-Reports To: Principal Consultant/Managing Director/Chief Operating Officer

-Directly Supervises: Consultants

-Provides Work/Direction: Consultants

-Works Closely with: Principals and Consultants, Independent
Consultants, Clients.

External Relationships:
-Diverse Portfolio of Pharmaceutical, biotechnology, medical
device and life sciences service organizations and collaborators.

Overview:

To provide best-in-class, high-level, strategic consulting expertise across multiple functions managing Clinical Development from a Regulatory perspective to clients in the biotech, pharmaceutical, medical device, & life sciences industry. Partnering with clients at all levels of corporate structure in order to identify, assess, and implement effective strategy improvements. Identifying business development opportunities with new and existing clients. Management of cost-effective resources with both internal & external resources.

Key Accountable Responsibilities:

-Collaborates with the Principal Consultant/Managing Director to understand the client expectations, internal team organization and roles and responsibilities. Communicates with assigned team members, and creates and provides deliverables within the scope of work and/or the engagement plan’s timeline and budget, ensuring the deliverables meet quality and timeline expectations and are prepared and received by the client to those expectations.

-Assists Principal Consultants with assessments of the infrastructure, strategy, structure, product development capabilities, efficiencies and systems of relevant client organizations.

-Creates reports with recommendations for client engagements and obtains input from the remainder of the team to ensure inclusion of comprehensive findings and recommendations.

-Works directly with the Principal Consultant/Managing Director to design an approach for fulfilling or expanding engagements as applicable. Contributes to and understands the scope of the total project.

-Assists with communicating new resource requirements and skills needed to expand the project and revises as necessary through collaboration with Principal Consultant and team members.

-Participates in strategic networking and business development efforts for the company as defined in personal goals. When new opportunities for business are identified or defined by client, ensures they are communicated to Principal Consultant to investigate further.

-Performs ongoing independent assessments as outlined above on new projects and/or ongoing expansion of relevant client engagements, communicating the findings to the Principal Consultant and applying the findings to the project engagement plan moving forward as applicable.

-Contributes to creation of engagement debriefs/lessons learned with team and Principal Consultant/Managing Director.
-Deepens trust-based relationships with clients and communicates real or potential changes in client relationships to Principal Consultant/Managing Director on an ongoing regular basis.

-Maintains billable time expectations on assigned projects as defined by Principal Consultant/Managing Director, and proactively communicates changes in expectations in a timely manner.

Core Skills:
-Client focused approach to work.
-Relevant technical skills in at least two of the following- regulatory, clinical, program management, quality systems.
-Excellent interpersonal, verbal and written communication skills with specific experience in scientific, medical or technical writing.
-A flexible attitude with respect to work assignments and new skills acquisition.
-Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
-Willingness to work in a matrix environment and to value the importance of teamwork.

Education:
-Bachelor's degree in a life science, business, or management.
-Advanced degree preferred.

Language Skills:
-Must be proficient in English.
-Additional language skills a plus.

Work Experience:
-Typically the equivalent of 5-7 years’ work experience in a biotech, pharmaceutical or medical device company, or other area of the healthcare industry in regulatory affairs/program management/clinical development/quality systems.
-Experience working in an industry based service organization a plus.

*Trident Search, LLC will be in contact with highly qualified applicants who meet the general requirement of the position as a first priority. We will respond to all others in due time. Thank you for your understanding and we look forward to speaking with you soon.

Searching for an experienced chemist from a laboratory operations background in QC / R&D to lead analytical experiments using HPLC.

Requirements:

- Bachelor's or Master's Degree in Chemistry or scientific background.
- 3-5 years experience in QC/R&D background using HPLC and other analytical instruments.
- Experience in Formulations Development and/or Analytical Testing.  Experience in a Quality Control environment would be acceptable.
- Experience leading product development team meetings, preparing agendas, schedules and minutes, managing execution and holding team members accountable
- Attention to detail, proactive attitude, sense of urgency and ownership over the project
- Industry experience in a GMP environment.  Familiarity with change control, investigation, deviation and CAPA processes.

Company Profile:
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

Senior Clinical Research Associate
Home Based – Multiple positions and locations
Position Summary
As a Senior Clinical Research Associate (Senior CRA) at PAREXEL, you have the opportunity to be a true clinician and work on complex therapeutic studies. In addition you will act as the on-site resource for the other study team members.
You will have the greatest impact on drug and medical device clinical trials by working on-site with the clients, focusing on the clinical trial, while leveraging the resources of our in-house monitoring team. Because of our unique structure, you will spend less time on the administrative aspects of the trial, and will be able to focus on what you were trained to do – developing close relationships with the sites and having a positive impact on the success of the trial.
Our travel model encourages efficiency so you have more time for meaningful work activities. We are also organizationally and technologically equipped to support your focus on the clinical aspects of your work whether you are on the road or in your office.
We are seeking independent professionals who have the ability to see the big picture and communicate effectively. If you are organized, have strong attention to detail, are able to build lasting relationships with internal and external clients, and demonstrate excellent communication skills – we want you to be the new face at PAREXEL.
To qualify, you should have at least 3 years of on-site clinical monitoring experience.
Our management is committed to our internal environment of excellence, offering development opportunities and sponsoring initiatives for those employees who bring professional level skill and dedication to their careers. At PAREXEL, you will maximize your ability to reach your personal development and professional career goals.
Discover a career at PAREXEL, where exciting challenges and opportunities await you.

Requirements
• Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
• Strong regulatory knowledge including GCP
• Excellent interpersonal, verbal and written communication skills
• Sound problem solving skills
• Looks for win-win solutions to solve problems
• Gives others appropriate latitude to make decisions
• Carefully weighs the priority of project tasks and directs team accordingly
• Understands the strengths and development areas of team members
• Enlists the support of team members in meetings goals
• Ability to successfully work in a team environment
• Ability to lead a virtual, global team as required
• Sound presentation skills
• Consultative skills
• Ability to make appropriate decisions in ambiguous situations
• Ability to solve problems by using a logical, systematic, sequential approach
• Client focused approach to work with the ability to interact professionally within a client organization
• Ability to prioritize multiple tasks and achieve project timelines
• Effective time management in order to meet daily metrics or team objectives
• Shows commitment to and performs consistently high quality work
• Able to take initiative and work independently
• Sense of urgency in completing assigned tasks
• Able to travel up to 65% on average
• Holds a driving license where required
Education
• Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
Language Skills
• Competent in written and oral English
Minimum Work Experience
• Substantial monitoring experience or equal experience in clinical research
Please apply through our corporate website below
We are hiring in all regions!!

http://jobs.parexel.com/home-based/clinical-research-associate/jobid2176925-senior-clinical-research-associate-jobs

Company Profile:
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
Clinical Research Associate
Home Based – Multiple positions and locations
Position Summary
As a Clinical Research Associate (CRA) at PAREXEL, you have the opportunity to be a true clinician and work on complex therapeutic studies. In addition you will act as the on-site resource for the other study team members.
You will have the greatest impact on drug and medical device clinical trials by working on-site with the clients, focusing on the clinical trial, while leveraging the resources of our in-house monitoring team. Because of our unique structure, you will spend less time on the administrative aspects of the trial, and will be able to focus on what you were trained to do – developing close relationships with the sites and having a positive impact on the success of the trial
Our travel model encourages efficiency so you have more time for meaningful work activities. We are also organizationally and technologically equipped to support your focus on the clinical aspects of your work whether you are on the road or in your office.
We are seeking independent professionals who have the ability to see the big picture and communicate effectively. If you are organized, have strong attention to detail, are able to build lasting relationships with internal and external clients, and demonstrate excellent communication skills – we want you to be the new face at PAREXEL.
To qualify, you should have at least 1.5 years of on-site clinical monitoring experience.
Our management is committed to our internal environment of excellence, offering development opportunities and sponsoring initiatives for those employees who bring professional level skill and dedication to their careers. At PAREXEL, you will maximize your ability to reach your personal development and professional career goals.
Discover a career at PAREXEL, where exciting challenges and opportunities await you.

Requirements:
• Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
• Strong regulatory knowledge including GCP
• Excellent interpersonal, verbal and written communication skills
• Sound problem solving skills
• Ability to successfully work in a ('virtual') team environment
• Sound presentation skills
• Consultative skills
• Client focused approach to work, ability to interact professionally within a client organization
• Ability to prioritize multiple tasks and achieve project timelines
• Able to take initiative and work independently.
• Sense of urgency in completing assigned tasks
• Able to travel a minimum of 65% on average
• Holds a driving license where required
• Effective time management in order to meet daily metrics or team objectives
• Shows commitment to and performs consistently high quality work

Education
• Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience

Language Skills
• Competent in written and oral English

Minimum Work Experience
• Substantial monitoring experience in clinical research

Skills:
• Ability to communicate with professional medical personnel.
• Understanding of the drug development process.
• Ability to complete tasks in an accurate and timely manner.
Physical Requirements: Ability to travel an average of 60-65%.

Please apply through our corporate website below.
We are hiring in all regions!!
http://jobs.parexel.com/home-based/clinical-research-associate/jobid2176937-clinical-research-associate-ii-jobs

Acetylon Pharmaceuticals Inc. is a Boston-area company, formed in 2009 to commercialize innovative drug discovery technology emerging from collaborative research at Harvard University and the Dana-Farber Cancer Institute.  Acetylon is pursuing the clinical development and commercialization of the next generation, selective, small-molecule Histone Deacetylase (HDAC) inhibitors with enhanced therapeutic effectiveness and improved safety profiles.   The company is well-funded and is located in a newly built facility in the South Boston Seaport area.

We are seeking highly talented, motivated and energetic team members to join us to pursue an exciting opportunity to develop HDAC inhibitors for the treatment of neurodegenerative diseases in addition to other therapeutic targets.

Title:  Research Scientist

Responsibilities: 

• Independently design, carry out and analyze cell based assays for protein misfolding, cell toxicity and microtubule function in cell lines and primary neuronal cells
• Work closely with outside contract research and academic collaborators to design and execute animal models
• Evaluate and initiate new drug discovery projects aligned with the commercial and scientific interests of Acetylon
• Present results at scientific meetings and establish contacts with leading researchers in the fields of neurodegeneration and HDACs
• Preparation of grants for funding of research

Background:

• PhD in Biochemistry, Cell Biology, Molecular Biology or other related area, or MS plus 5 years experience in biopharma
• Strong background in culture of cell lines and primary cells, particularly neurons
• Well versed in biochemical and cell biological techniques, including western blot, ELISA, immunofluorescence microscopy, and qRT-PCR
• Experience in animal models of neurodegenerative disease is desirable
• Experience in histone deacetylase research and small molecule development is desirable
• Can function with minimal supervisory guidance in a fast-paced environment
• Excellent communication and writing skills
• Experience in writing grants is a plus

This position is responsible for the development and validation of new and existing manufacturing processes and overseeing day-to-day manufacturing activities.

Essential Duties and responsibilities:

• Responsible for the development and validation of new processes through IQ, OQ, & PQ requirements
• Project management and execution of cost reduction projects both internally as well as externally working with vendors
• Develop process improvements, work instructions and optimize manufacturing processes utilizing 5S and other Lean Manufacturing techniques
• Lead the development and execution of formal training programs for the production personnel
• Responsible for day-to-day activities such as NCMRs and CAPAs Direct engineering change orders for originator to final approval
• Lead the development and upkeep of preventive maintenance programs
• Responsible for writing validation plans, execution, and writing of sound data/stats supported technical reports
• Evaluate and recommend capital equipment requirements to best meet the needs of the company
• Assure the high quality, high volume production of implants and associated instruments
• Other duties assigned

Qualifications:

• Bachelors Degree in Engineering
• 8+ years of experience in manufacturing process support in the medical device industry
• Medical Device/cGMP experience
• Experience with development and validation of manufacturing processes
• Experience developing and managing projects and ensure deadlines and commitments are met
• Experience with identifying manufacturing opportunities that will improve processes and reduce cost of goods.

Skills Abilities, Competencies Required:

• Understanding of ISO 13485, QSR regulations, GMP and Design Controls
• Knowledge of statistical analysis (Green Belt preferred)
• Good knowledge of CNC machining and grinding processes
• Good knowledge of plastics Good CAD-SolidWorks and fixturing design experience
• Demonstrated ability to influence cross-functional teams
• Strong verbal and written communication skills
• Strong project management skills
• Demonstrated ability to communicate with all levels of the organization
• Ability to work in a team environment and execute job responsibilities with minimal direct supervision, at a high level, and have high attention to detail
• Investment casting experience preferred

If interested or know of anyone interested, please connect with John Bogosian via email jbogosian@kingbishop.com or call 781-983-2649. We appreciate referrals and have a referral program for successful hires.

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.

Summary

In this position you will be responsible for managing the regulatory document planning and submission process for all regulatory documents, paper and electronic; contributing to implementation of electronic submission solution; interacting with cross functional areas within ARIAD Pharmaceuticals and ARIAD Europe and development partners; and, maintaining departmental archives.

Duties and Responsibilities

The Director of Regulatory Operations will be responsible for ensuring ARIAD Europe prepares and submits regulatory documents in compliance with agency requirements and guidance documents in a timely manner.

• Build and lead the European Regulatory Operations team
• Maintain in depth knowledge of regulatory and technical requirements
• Contribute to implementation and maintenance of electronic submission solution including roll out of training and development of user guides and procedures
• Prepare and execute timelines for submission of regulatory documentation including identification and resolution of potential issues to ensure physical integrity and accuracy of all documents and to avoid timeline impact
• Represent Regulatory Operations on cross functional submission planning teams
• Contribute to development of company standards and templates for regulatory submissions
• Ensure paper and electronic submissions comply with all requirements
• Ensure consistency within and across submissions
• Interact with regulatory agencies to obtain concurrence for electronic submission strategy
• Manage the assembly, review, and internal approval of submissions
• Contribute to the continuous improvement of the submission process
• Contribute to the growth and development of the regulatory operations function to meet corporate goals
• Assess business trends, pending regulations, and emerging technologies for potential corporate impact, and contribute to the development of strategies to integrate the evolution of regulatory requirements
• Oversee and maintain European archives and logs for all regulatory agency communications
• Provide input to the budget plan for Corporate and Regulatory Affairs Plan
• Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
• Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Requirements

BS degree, preferably in a science or business related field. Minimum of 7 years direct pharmaceutical/biotechnology regulatory operations experience with submission of an eCTD preferred, clear understanding of submission content and format requirements, excellent verbal, computer, and communication skills. A strong commitment to business ethics and an understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

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=255&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.

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.

Summary

Supports regulatory objectives, advice, and strategy in alignment with department and corporate goals. Plans and manages regulatory document preparation for regulatory submissions in Europe. Keeps abreast of evolving regulatory procedures and practices.

Duties and Responsibilities

The Manager of Regulatory Affairs Europe will be responsible for ensuring that ARIAD Pharmaceuticals is executing regulatory strategies in Europe and supporting interactions with regulatory authorities appropriately.

• Support the development of regulatory strategies including Scientific Advice, Orphan designation and registration procedures and plans to advance ARIAD products through the regulatory review and approval process.
• Communicate effectively with teams, senior managers, affiliates and consultants.
• Review and interpret regulatory correspondences
• Interact proactively with other ARIAD functions, contract research organizations, partner companies, and health authorities
• Plan and support the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle
• Support pricing team for preparation of submissions
• Support marketing team for launch preparation and throughout the product lifecycle
• Review and provide regulatory advice for documents prepared by other departments.
• Coordinate and support regulatory activities with affiliates and consultants
• Support ARIAD functions for interactions with regulatory authorities and for regulatory submissions
• Manage reporting obligations
• Contribute to improvements in department operating procedures
• Remain current with evolving regulatory procedures and practices, and provide guidance to ARIAD project teams
• Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
• Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Requirements

BS degree, preferably in a scientific discipline with a minimum of 7 years pharmaceutical / biotechnology experience with a minimum of 5 years regulatory experience including one full submission or line extension through authorization. Experience in interactions with regulatory agencies. Experience with clinical trial applications. Expert project management and interpersonal skills is a requirement, as well as excellent written and verbal communication ability. Familiarity working with electronic document management and submission platforms is desired. Experience in oncology, preferably with successful MAA/ line extension submissions. A strong commitment to business ethics and an understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

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=256&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.