Overview:

ERT is the leading cloud platform solutions provider that captures quality efficacy and safety endpoints, harmonizes data from any clinical source system, and delivers real-time insights for optimum trial performance – innovating better health for over 40 years and tomorrow. ERT’s combination of technology, services, and consulting increases the accuracy and reliability of patient data and improves the efficiency of the clinical development process throughout the product lifecycle.  ERT provides sponsors and CROs with the most widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments (COAs including patient, clinician, and observer reported outcomes).  ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.

ERT is hiring a Design Assurance Engineer who will be responsible for compliance with established GMP/ISO quality management system requirements.  Will work closely with Product Management, Research & Development, Marketing, and Quality Management to build-in, establish and ensure compliance with local and international regulatory regulations.  

Responsibilities:

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Proactively develops and implements regulatory documentation and procedures to maintain compliance with FDA 21 CFR 820, ISO 13485, and international medical device regulations.
2. Supports and provides regulatory expertise to assigned product development projects (eCOA, Respiratory and/or Cardiac Safety) from technical approach to post marketing phase.
3. Supports the creation of Regulatory Strategies and Plans for assigned products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.
4. Supports the preparation and submission of 510(k)s and other product submissions according to FDA and country specific guidelines.
5. Supports the development of European Technical File and Declaration of Conformity documents (MDD, RoHS, etc.) and Canadian licensing submissions according to international guidelines. 
6. Reviews and edits product labeling plans, labeling, and marketing communications.

OTHER DUTIES AND RESPONSIBILITIES:

1. Team member supporting the revision of various regulatory and quality compliance SOPs and work instructions to ensure compliance with local and international regulation.
2. Part of inter-disciplinary team defining the Design Transfer and Validation activities throughout the product lifecycle and internal processes.
3. Prepare and submit Medical Device Reports (MDR's) and EU Vigilance reports to the FDA and international regulatory bodies.
4. Participate in the data analysis for post market surveillance activities.
5. Assist in the development, maintenance, and implementation of CE Technical Files in accordance with the Medical Device Directive (MDD).
6. Assist with international regulatory product registrations.

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.

QUALIFICATIONS AND SKILLS NEEDED:

1. B.S. or equivalent in Engineering, Life sciences, or other similar technical field is required. Master’s degree preferred.
2. 2-4 years of experience working with Medical Devices.
3. Experience in the Medical Device industry strongly preferred, may consider other FDA regulated industry.
4. Excellent analytical, organizational and communication (English language) skills
5. Detail oriented.

We are 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 law. 

Position Summary
We seek a meticulous in vitro contract biologist to perform high throughput ELISA assays in support of the advancement of Moderna's mRNA technology platform and pipeline.

Responsibilities:
* Receive, organize and process serum samples for subsequent analysis
* Perform and optimize a variety of high throughput ELISA assays on an automated robotic liquid handling workstation
* Analyze data and communicate results to collaborators
* General laboratory assistance including lab equipment maintenance, preparation of reagents, and the ordering and receiving of laboratory supplies
* Closely collaborate with other members within the research and development group and broadly with departments throughout the company

Minimum Qualifications:
* BS with at least 2 years of industry experience performing ELISA assays
* Hands on experience with serum sample processing
* Experience with high throughput analysis using robotic workstations
* Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment

Preferred Qualifications
* BS with at least 5 years of industry experience performing ELISA assays

Competencies:
* Attention to detail
* Operates independently
* Teamwork
* Effective communication (oral and written)
* Ability to multitask and adapt to a dynamic environment

Why Join Moderna
Moderna is pioneering messenger RNA Therapeutics™, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate, including more than 250 patent applications covering novel nucleotide chemistries and drug compositions. The company plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures.

Founded in late 2010 by Flagship VentureLabs, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca and Alexion Pharmaceuticals.

Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please apply at: Application URL:http://www.aplitrak.com/?adid=YWxsaXNvbi5tYXllci42NTk3My4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t

Primary Role
The candidate will be responsible for laboratory work, with an emphasis on protein, peptide and antibody conjugation and related analyses including independent planning, designing and execution of scientific experiments, and interpreting and presentation of scientific data. Responsibilities may also include design and expression of protein therapeutics to enable site specific modification including production and purification. This role may also involve assay development surrounding the evaluation of therapeutic protein conjugates in preclinical studies.

The candidate may have project coordinator responsibilities for Protein Engineering Discovery Projects (internal or external) and will actively provide scientific expertise to Discovery and Development teams as needed. Success in this role will also be measured by the candidates ability to conduct literature research, to provide strategically relevant and scientifically reliable information and data that supports the company's goals. A good candidate should have an excellent team oriented spirit that is demonstrated by working toward common business goals with fellow scientists, being flexible with assignments and adaptable to the changing needs of projects. This person must be self-motivating and hard-working. Attention to detail is required.

Responsibilities
70% Research Activities including experimental planning and direct laboratory activities, relevant and necessary literature review.
20% Communication with supervisor regarding experimental designs and results. Communication with members of Discovery Biology and Discovery Therapeutics Departments. Helping of team members to succeed in scientific experiments. Consultation with outside experts and collaborators.
10% Report writing and record keeping.

Education & Experience Requirements
A Ph.D.in Life Sciences with emphasis on protein biochemistry, conjugation chemistry, molecular biology or a related field with 3-5 years of relevant industrial or post-doctoral experience. A Master's Degree with 7 years of industrial experience, or a Bachelor's degree with 10 years of experience.

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.

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Primary Role:
Delivers leadership and excellence in manufacturing processing and scheduling to meet site demands. Manages the floor operations to ensure safety and compliance with cGMPs are maintained at all times. Oversees the planning, implementation and maintenance of manufacturing operations for new and/or existing products and technologies in a cGMP environment. Collaborate with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Integrate best practices, where appropriate, into manufacturing. Ensures the efficiency of material, equipment and personnel in day to day operations. Monitor departmental operating expenses (OT, Equipment, Supplies) and assist in developing budgets.

Responsibilities:
60%:
* Responsible for daily operations on the production floor, including
scheduling, staffing, training, material use and troubleshooting to ensure
that all operations are in full compliance with applicable MBRs/FPs, SOPs,
and safety guidelines.
* Develop technical expertise in area of responsibility and provide technical
instruction on new/improved processes to appropriate audiences, primarily
Manufacturing personnel
* Will monitor and control labor (absence, vacation and OT) and other group

25%:
* Responsible for interviewing and selecting candidates
* Provide effective leadership through:
* Assess performance and make recommendations for annual programs
* such as Talent Review and Year End Compensation
* Individual goal setting/performance reviews
* Ensure appropriate staffing levels and skill sets are maintained
* Effectively manage employee performance issues and corrective actions
* Ensure the use of safe work practices and behaviors
* Recognize and appreciate employee contributions and support workforce diversity
* Ensure that employees are working in a safe and compliant manner

Training:
* Ensure that staff Individual Training Record (ITR's) targets are met
* Schedule and track training attendance
* Evaluate training effectiveness
* Day to day training and coaching employees

15%:
* Issue deviations or investigations of various complexities and work with
cross-functional departments to evaluate root cause, close them and
implement appropriate corrective actions.
* Provide technical expertise to resolve manufacturing issues and interact
with support groups to ensure production targets are met and product and
process comply with cGMPs, product licenses and corporate policies.
Ensure operational metrics and business systems (ERP, Inventory) are
maintained.
* Revise, author and review Standard Operating Procedures/Batch Records

Education & Experience Requirements:
* Bachelor's of Science degree and 2-4 years related industry experience or an equivalent
level of education and/or related experience is acceptable.
* Experience as a Lead or Supervisor in a GMP Manufacturing facility required
* Experience in executing moderate to complex schedules preferred
* Experience with systems such as SAP, LIMS and TrackWise is a plus

Key Skills, Abilities, and Competencies:
* Must possess effective leadership skills
* Operational knowledge of aseptic technique, clean-in-place (CIP) and steam-in-place (SIP)
and general biopharmaceutical production equipment
* Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMEA) to
ensure inspection readiness of department.
* Good interpersonal skills and ability to work in a team environment
* Effective communication skills throughout all levels of the organization
* Proven organizational and time management skills.
* Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates
composure under pressure.

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=bGF1cmVuZC43NzA0MC4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ

Role Description
* WRD-Procurement site lead for Andover site in Massachusetts providing strong leadership in Scientific Services Category for all Bio Therapeutic Partner lines as well as for Material, Business Process & Operations categories.
* A strong Scientific Sourcing leader capable of bringing transformational business and supplier strategies that drive increased value in a financially constrained environment
* Act as key Procurement business partner for Andover site WRD researchers and lead the site for Scientific Services, Materials, Capital & related categories.
* Establish a right atmosphere for all the WRD clients at the Andover site by serving as a problem solver for Procurement related questions and concerns
* As a Category Strategy Manger and Cross Category Team lead, oversee the scientific services support for BTX- Pharmaceutical Sciences groups based in Andover, MA, Saint Louis, MO and Pearl River, NY sites. Set Sourcing Strategy, and lead a group of team members across the sites
* Partner and collaborate with Cambridge Site Lead and team members to develop and implement synergistic site based strategies for Material, Global Operations, Capital and Procurement Business Operations categories
* Develop and maintain strong relationships with internal stakeholders and WRD sourcing groups such as Bio therapeutics & Vaccine Outsourcing Group (B&VO), External Research Solution (ERS), External Research Development & Innovation (ERDI) and Business Development (BD) groups to insure that Research sourcing requirements are met and supplier performance is maintained at the appropriate service levels
* Develop and maintain strong relationships with key suppliers and support wider WRD GP sourcing initiatives.
* Partner with BTX Global Biotechnology Therapeutics, BTX-Pharmaceutical Sciences, and BTX- PDM-NBE researchers to develop strategies on Scientific Services sourcing

Responsibilities
* Responsible for leading strategic management of Material and Scientific Services spend (Outsourcing) for all the WRD Research & Partner lines based in Andover, MA as well as BTX Partner lines based in Kendal, MA.
* Provide a comprehensive coverage for BTX Pharm Sci Services category working in close collaboration with Pearl River, NY and St Louis, MO site leaders
* Act as key procurement business partner for the Material Category at Andover site and implement Global strategies developed with the Global Material Category leaders and team members
* Act as key procurement business partner for the BTX- Partner lines, BV &O and other WRD sourcing groups such as External Research Solution (ERS) to provide procurement support in any capacity and facilitate the linkage and connectivity between clients and wider GP organization as needed.
* Act as a Key "On the grounds "Procurement business contact" for Andover site researchers for Scientific Material category and help direct them to the appropriate WRD Procurement contacts, as needed.
* Develop and enhance Procurement relationships with customers and Senior Site Leaders at Andover and Kendall to proactively identify opportunities and drive continuous improvement within assigned categories.
* Identify, develop and implement novel scientific services business strategies and deliver & track savings.
* Partner with clients to facilitate spend analytics, value propositions, bid packages, contract execution, supplier relationship management, and best practice objectives.
* Provide non-category specific assistance to the Procurement Team or Management in supporting the goals of the Department.
* Effectively deploy global policy, procedures and systems while minimizing the operational impact to WRD.

STRATEGIC SOURCING PROCESS
* Working with appropriate colleagues in BTX Partner lines and relevant sourcing groups, this person should be able to manage the overall sourcing of complex scientific activates for Scientific Services in the Biologics lines. Working closely with the BV&O and other sourcing groups, this person also needs to be able to enable the sourcing of projects through domestic and international CRO's, by ensuring that effective business terms are in place.
* Lead and/or participate in scientific services strategic sourcing initiatives including supplier negotiations, contract development and execution. Maintain/update strategies for assigned spend category as required.
* Work with Research & Development Lines/Clients to identify opportunities and initiate strategic sourcing processes that leverage Pfizer's global spend.
* Develop market expertise in assigned spend categories and remain current on supply market trends, best sourcing practices, scientific and technological trends and business conditions that affect the supply market and/or supplier economics.
* In coordination with the overall category strategy, apply the Procurement sourcing process to the fullest extent, select suppliers, develop implementation plans, determine key implementation performance criteria and review work performed by project team members.
* Ensure savings are captured via implementation of strategies in assigned spend areas.
* Work synergistically with other sites, divisions and procurement colleagues in areas of spend overlap.

TRANSACTIONAL AND TACTICAL PROCUREMENT
* Plan, prioritize and perform supplier negotiations on all one-off purchases and annual spend over $100K that are not covered by an existing agreement. Contracts over $500K reviewed with Procurement management. Manage category spend and executes contracts in compliance with Procurement Policy and Procedures. Ensure customer requirements, cost and risk are balanced.
* Responsible to provide monthly report of activities and sourcing initiatives. Ensure savings and value add are captured and reported.
* In concert with customer, develops new supply solutions and improve internal processes.

SUPPLIER PERFORMANCE MANAGEMENT
* In collaboration with the WRD Lines, develop and implement plans for evaluating performance of high priority new and existing suppliers in assigned category.
* Lead and/or participate on global teams(s) that evaluate supplier performance in assigned category.
* Facilitate the resolution of quality and/or service issues with the involvement of appropriate colleagues.
* Ensure contract terms are supported by both the supplier and Pfizer.
* Work with Line sourcing colleagues to ensure suitable relationship management occurs for key suppliers / strategic alliances.
* Develop and enhance Procurement relationships with suppliers to optimize cost and service.

PARTICIPATE IN CATEGORY STRATEGY MANAGEMENT
* Ensure savings are achieved via implementation of strategies in assigned WRD spend areas.
* Ensure savings and value add (e.g. Line productivity improvements) are captured and reported in a timely manner.
* Drive annual productivity improvements in assigned category.
* Maintain and review on periodic basis, global/national supplier contracts.
* Prepare and deliver an annual category review to GP leadership

CLIENT ENGAGEMENT/CUSTOMER RELATIONSHIP MANAGEMENT
* Establish internal and external business relationships with senior leadership and integrate purchasing into the core business process of Pfizer WRD.
* Uses high levels of tact, influence and persuasion to achieve communication objectives.
* Provide standardized and custom reports to meet customer needs
* Meet with appropriate Finance representatives on a periodic basis to review forecasted budget by cost center; including discussions on budget implications of Sourcing initiatives.
* Act as "point of contact" for designated clients and hand off to others as appropriate.
* Prepare reports and make presentations to site client/management regarding strategy and implementation or recommendations or results.

Qualifications
EDUCATION AND EXPERIENCE
* Bachelor's Degree in Business discipline, Supply Chain Management, or other related field is preferred. Additional qualifications/knowledge in Biology or related field is highly desirable.
* Advanced degrees e.g. PhD, MBA and/or C.P.M. certification highly desirable, with prior experience in Biologics
* Minimum seven to 10 or more years 'experience in complex, ideally R&D environment., pharmaceutical experience preferred
* Ability to lead implementation of Global Strategic Sourcing projects and become familiar with the specific requirements and processes of the Procurement and Sourcing functions
* Strong familiarity with legal contracts and ability to independently negotiate on legal and commercial terms beneficial to Pfizer.

TECHNICAL SKILLS REQUIREMENTS

* The ideal candidate will have prior experience working in or supporting a Drug Discovery organization. This person will be expected to work closely with scientists and leaders and sourcing project managers within the broader WRD organization to meet the strategic scientific services needs of WRD.
* Proficient with Procurement tools, concepts, and practices such as total cost analysis, market analysis supplier management, and corporate procedure compliance.
* Applies supplier performance evaluation methods and associated metrics for suppliers
* Strong negotiation skills with ability to lead strategic supplier negotiations
* Uses technology to monitor external trends in particular supply area(s) under study
* Must have strong analytical skills

PHYSICAL POSITION REQUIREMENTS
* Local travel between regional WRD sites as required
* Occasional travel to other Pfizer WRD sites and domestic and international suppliers - less than 10% of time

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Performs administrative duties for executive management including providing senior level support to the SVP, Head of BioTherapeutics R&D and the Neuroscience &Pain Research Unit.

Interfaces regularly with department members as well as colleagues from related functions and will be expected to interact appropriately with scientists, academic collaborators, vendors and all visitors. Requires learning and execution of internal procedures of Pfizer, ensuring 100% adherence to compliance regulations. Exemplary organizational skills, strong computer and internet skills, flexibility, excellent interpersonal skills, project coordination experience, and the ability to work well with all levels of internal management and staff are critical for success in this role.

Responsibilities
Manage day-to-day operational and administrative duties to support the Head of BioTx and NPRU
* Able to work flexible hours and to be accessible after hours as needed
* Manage hectic calendar and meeting schedules, using prioritization skills and a high level of interpersonal refinement - Conserves executive's time by reading, researching, and routing correspondence; drafting letters and documents; collecting and analyzing information; initiating telecommunications Plan and optimize all travel plans for the Head of BioTx and NPRU
* Coordinate logistics and materials for meetings and presentations including offsite and all hands meetings Draft memos, letters, e-mails, documents and other responses as directed by the Head of BioTx and NPRU and BioTx & NPRU Head of Portfolio, Strategy and Communication.
* Produces information by transcribing, formatting, inputting, editing, retrieving, copying, and transmitting text, data, and graphics.
* Attend meetings, take & transcribe notes, derive action plans and follow up with all attendees to reinforce the meeting purpose, outcome and expected responses/actions
Prepares reports by collecting and analyzing information.

Gain a thorough understanding of all corporate goals, needs, personnel, processes and procedures Review and process expense reports and invoices

Assist and perform ad hoc duties for the Head of BioTx and NPRU.
* Maintain professional knowledge base and seek opportunities to enhance skills and abilities; seek new areas of responsibility and perform new tasks; recommend process improvements
* Handle all duties with a high degree of integrity, professionalism and confidentiality
- Welcomes guests and customers by greeting them, in person or on the telephone; answering
or directing inquiries.
- Demonstrate commitment to providing customer-focused quality service Perform other duties as assigned by the Head of BioTx and NPRU and BioTx & NPRU Head of Portfolio, Strategy and Communication.

Qualifications

EDUCATION AND EXPERIENCE -
* Minimum of high school diploma or equivalent and 7-10 years administrative experience that demonstrates ability to carry out tasks proficiently and to complete quality work on a timely basis with excellent attention to detail.
* College degree strongly preferred with a minimum of 5 year work experience.
* Experience as an administrative assistant or project manager required; preferred C-level executive support experience.
* A healthcare or science background is beneficial.
* Proficiency in SharePoint; Microsoft Outlook, Excel, Word, PowerPoint, Project

Preferred Experience:
* Demonstrated communication skills, interpersonal and influencing skills at a global, cross-line level.
* Strategic planning and business analysis skills.
* Demonstrated success supporting large and complex projects.
* Demonstrated ability to transform collections of ideas into finished products and to manage a wide variety of activities while accounting for changing priorities.
* Understanding of the drug discovery environment and scientific disciplines and how they fit into NPRU strategy.
* Experience within the pharmaceutical research and development industry.

TECHNICAL SKILLS REQUIREMENTS -
* Superior attention to detail and able to multi-task and change priorities quickly
* Strong sense of urgency and efficiency in completing work
* Exemplary time management and prioritization skills
* Must be able to maintain composure under pressure and manage unforeseen situations
* Excellent judgment, problem resolution and decision-making skill
* Excellent communication skills (verbal and written)
* Ability to identify, propose and develop new solutions to further the effectiveness of the Head of BioTx and NPRU.
* Excellent organizational skills with the ability to plan and execute projects
* Knowledge of the tools and processes used to develop the appropriate resources to support exploratory research
* Proven track record of leading and delivering on multiple projects in parallel

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Org Marketing Statement

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The Senior Scientist will be responsible for hands on laboratory activities related to development of Cell based assays, including Neutralizing Antibody activity assays. This is a laboratory focused position based in Andover, MA.
* Responsible for laboratory focused hands on Cell based assay qualification and sample testing as needed
* Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assays including Cell based, in support for non-clinical and clinical investigations
* Influence the advancements of biotherapeutic science externally and internally
* Responsible for providing appropriate documentation to ensure highest compliance level as the supported bioanalytical work includes regulated non-clinical and clinical phase

Responsibilities
* Laboratory focused position
* Responsible for development, troubleshooting, qualification and application of various type of cell based assays
* Includes support of immunogenicity evaluations, mainly Neutralizing antibody cell based assay protocols
* Interaction with internal and external groups, including interaction with various vendors responsible for generation of mAb and poly-Ab reagents
* Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making
* Proactively gather input from literature, colleagues and additional resources to assist in driving projects forward

Qualifications
* BS with 10+ years of experience or MS with at least 7+ year relevant experience.
* Industry experience with a focus in biotherapeutics development
* Familiarity with GLP/GCP regulations

PHYSICAL/MENTAL REQUIREMENTS:
Laboratory based position requiring sitting, standing, walking etc.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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OVERALL RESPONSIBILITY
Reporting to the Manager of Data Analytics Sponsored Research of the Broad Institute, this position provides data support to the Office for Sponsored Research ensuring timely and accurate data entry in a variety of systems related to sponsored research operations, including all aspects of pre and post award data entry. The ideal candidate is highly detail orientated with excellent communication skills and demonstrated ability to learn new processes and systems. Excellent mastery of Excel, excellent organizational skills, respect for deadlines and ability to work with a variety of people in a deadline driven, fast paced environment with minimal supervision. Reporting skills are a plus.

CHARACTERISTIC DUTIES
- Upkeeps all data bases related to the enterprise systems in support of sponsored research at the Broad Institute including COEUS, CAYUSE, EARS, SAP and excel based systems
- Cultivates relationships and communicates regularly with OSR staff to ensure data integrity supporting in a matrixed fashion all Grant Administrators and staff in OSR
- Works closely with the Manager of Data Analytics and the OSR staff to streamline processes and increase productivity and timely entry of data into the Broad systems of record
- Familiar with Sponsored Research administration and sponsor rules and regulations as well as the processes involved in preparing and submitting grants and contracts at an academic, or research institution
- Assists with special requests from OSR staff on sponsored activities, as needed, including affiliate salary billing arrangements Provides monthly sponsored research reports to OSR leadership and relevant offices
- Provides ongoing input to contribute to the development of best practices in sponsored research operations
- Ability to work closely with Broad business system technical support to trouble shoot issues related to data integrity Experience with SAP a plus OSR designated tester for the for the Cayuse implementation Bachelor’s degree or equivalent of experience and education
- Experience working in a grant supported institution or business
- Computer literate and proficient in the use of personal computers, spreadsheets and word processing applications
- Experience with query tools or grants management tools a plus.

- Knowledge of Broad systems and data processes as they relate to Sponsored Research data a plus
- Excellent communication and interpersonal skills
- Excellent organizational skills and attention to detail
- Works independently with minimal supervision; respects deadlines
- Enjoys working in a fast-paced and challenging environment, and with all levels of institute staff

The Broad Institute will not offer visa sponsorship for this opportunity.

EOE / Minorities / Females / Protected Veterans / Disabilities

To apply for this position, please CLICK HERE

The position resides within the Broad Infectious Disease Program. The candidate uses their scientific expertise to develop and execute lab processes for analysis of bacterial organisms. Works with team management and scientific staff on process design, Illumina library construction and evaluation.

CHARACTERISTIC DUTIES
- Collaborates with manager and scientific staff to successfully complete IDP goals, including library design, construction and testing.
- Responsible for acquiring the in-depth knowledge and hands-on expertise in all required molecular biology procedures. Demonstrates flexibility to execute tasks requiring various skill levels.
- Performs analyses of current processes and identifies opportunities for improvement. Proposes and evaluates changes in molecular biology procedures to ensure output of high-quality genomic reagents.
- Responsible for execution of production and development projects that require extensive molecular biology expertise and extensive troubleshooting.
- Uses discretion to plan project requirements and timelines.
- Identifies and solves methodological problems and adjusts experimental protocols to ensure successful project completion in a timely fashion.
- Interacts and coordinates with vendors to address and investigate novel molecular biology reagents, techniques and equipment.
- Compiles and analyzes all experimental data in a timely fashion, and adjusts design as necessary. Discusses problems with team Manager in a timely manner.
- Expected to independently consult relevant scientific and technical literature on a regular basis and to actively seek engagement in group meetings, project-related discussions and brainstorming meetings with other groups/members of the sequencing platform.
- Other related tasks as required by Manager.

EDUCATION
- A bachelor’s degree and a minimum of 2 years of relevant professional experience in molecular biology or related field required. A Master’s degree with 0-2 years of experience preferred.

EXPERIENCE
- Minimum of 2 years of relevant professional experience in a molecular biology environment required. Experience in a high-throughput laboratory a plus.
- Solid knowledge of DNA cloning, PCR and microbiology is preferred.
- Solid knowledge of RNA approaches (RNA-Seq) is preferred.
- Strong background in the latest molecular biology and genomics methodologies a must.
- Excellent critical thinking and analytical skills required.
- Excellent communication skills and the ability to interact with multidisciplinary staff in a fast-paced environment required.
- Must be able to handle a variety of tasks, effectively solve problems, and shift priorities rapidly.EOE / Minorities / Females / Protected Veterans / Disabilities

To apply for this position, please CLICK HERE

CLIENT:: Biotech Company

The Quality and Compliance Oversight Senior Associate II supports the Quality and Compliance Oversight Associate Director and Manager and is responsible for tracking, managing and reporting the quality and compliance metrics across the SABR organization and establishing processes and tools to drive continuous quality improvement. Key responsibilities include performing periodic reviews of quality and compliance KPIs and metrics, performing the QC of root cause analysis and trending of critical quality related issues such as Late Case Investigations and managing the late case investigation process. The Quality and Compliance Oversight Associate may also support PV Regulatory Intelligence activities. 


1. Perform the tracking and management of SABR quality and compliance metrics as well as the development of quality dashboards / reports for dissemination to Senior Leadership and partners 

2. Perform the QC of the following activities: 
a. Root cause analysis of critical quality related issues such as Late Case Investigations 
b. Trending of critical quality related issues such as Late Case Investigations 

3. Developing and implementing processes and tools to drive continuous quality improvement of data, processes or products across SABR 

4. Manage the late case investigation process 

5. Execute PV Regulatory Intelligence activities* 
a. Support the development of the intelligence gathering process and tools; monitor and capture PV regulatory intelligence 
b. Coordinate evaluation of proposed, new, emerging regulation / requirements / policy changes 
c. Attend regulatory intelligence meetings / committees as required 

B.A. or B.S. degree or equivalent required, science degree preferred. Candidates with an MD will not be a fit for this role. 

• 3-5 years of safety, pharmacovigilance and quality experience required 
• Experience with late case investigation 
• Strong English language written and verbal communication skills 
• Audit and inspection experience is a plus 
• Knowledge of Post-Marketing and Clinical Trial Pharmacovigilance regulations 
• Direct experience in GCP compliant quality systems 
• Regulatory affairs, quality assurance or clinical departments experience is preferred 

The employee must have strong knowledge of pharmaceutical R&D regulatory affairs, project management skills, drug safety knowledge, meeting facilitation and documentation skills. The position also requires leadership skills that provide solutions to complex problems across SABR functional areas, working closely with all stakeholders.

Look for a QC/QA professional, ideally with audit experience, GCP and PV experience. 

SABR =Safety and Benefit Risk Management

Seeking highly motivated Quality Control Team Leader to join a well-established company located in the Greater Boston Area. If you take pride in the work you do and are looking to join a team of talented individuals look no further. You will have the ability to lead the QC analysts in their day to day activities and manage the daily activity schedule.  Ideal candidates with have extensive experience working in a GMP-QC lab environment and be able to troubleshoot any lab issues as they arise to maintain compliance and the accuracy of results. 

Key Requirements:

• Minimum BS degree (Chemistry or related field) and 8+ years or MS degree and 6-8 years experience in a GMP-QC laboratory
• Experience with authoring reports such as CAPA, deviations, SOP, OOS and EM investigations
• Ability to Train or obtain training for QC associates for activities they will be performing
• Should have demonstrable experience in HPLC, GC, CE, NMR, LCMS, and USP testing as well as Wet Chemistry.
• Great skill in documentation and organization.

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™

This position is full-time direct hire.  This is mainly a home based position and  travel is expected 4-6 days per month. The majority of the travel is on the East Coast.

This company is growing rapidly and will offer a variety of growth opportunities

Skills Required

• BS/MS Life science degree, or equivalent qualification or experience
• 5+ years of GCP Audit experience.
• Must have site and vendor GCP audit experience
• Must be able to travel 4-6 days per month in the U.S
• Must be able to lead GCP audits when necessary

We are looking for an Analytical Development Scientist with experience developing and validating HPLC methods.

Responsibilities:

• Developing/optimizing various analytical methods.
• Providing analytical testing/characterization support for the cell culture and upstream and downstream process development projects
• Method Transfers
• Writing proposals, protocols and reports when needed.

Qualifications:

• Masters/Ph.D. degree in life science, biotechnology or related field with 3 or more years’ experience or BSc with 7 or more years of experience in a biotechnology or biopharmaceutical industry environment;
• Proven background in chromatography and developing HPLC based methods;
• Experience in performing SDS-PAGE/Western blot, spectroscopic and other analytical methods commonly used for protein/biologics products
• Experience/knowledge of ELISA and/or other immune-based assays is favorable;

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. 

Qualifications:

• B.S. with 3-7 years of GMP experience or MS with 1-3 years of experience with Pilot or GMP production
• Excellent knowledge of purification techniques (aseptic processing, column chromatography, virus removal filtration, tangential flow filtration etc)

Responsibilities:

This person will be leading developmental project teams in design, optimization and characterization of purification processes for manufacture of monoclonal antibodies, bispecific antibodies, antibody fragments and non-antibody based proteins.

Requirements:

• MS/PhD with 5+ years of process development experience in biopharmaceutical industry
• Experience in process chromatography, ultrafiltration / diafiltration, and other separation technologies is required.

Responsibilities

• As a regional leader within our A&E Practice, this role leverages life science industry experience in engineering, design, and construction.
• Execute projects and coordinate multiple engineering/design disciplines and subject matter experts in development of high quality design and construction documents.
• Lead architectural, engineering and design efforts in alignment with industry standards and client requirements. Develop construction documents for competitive bid and successful implementation.
• Manage interaction and communication within Design Group and client project team by providing technical direction, making critical decisions, and communicating effectively.

Education

• BS or MS in Engineering or Architecture. Professional Registration preferred.

Experience

• The successful candidate shall have recent experience managing architectural and engineering/design of capital projects, for manufacturing facilities in the biotech, pharmaceutical, and/or medical device industries.
• Project director, program management, or project management experience for manufacturing facilities with design responsibility for biologics/pharmaceutical manufacturing, hygienic utility systems (WFI, clean steam, sterile air), aseptic process/cleanrooms, or pilot/clinical scale operations.
• Qualified candidates will have experience authoring technical documents, developing engineering standards, approving detail design drawings, and interfacing directly with regulatory agency, municipality, clients and project teams to deliver turnkey projects.

Skills

• Engineering consulting experience leading technical teams responsible for design and implementation of manufacturing facilities for commercial production of biologics, pharmaceuticals, medical devices, or chemical intermediates (API).
• Familiarity with engineering standards, traditional engineering design disciplines, life science industry practices, and regulations related to design and construction trades in project director, principal engineer, or senior project manager role.
• Professional Engineering License preferred.
• Commercial or pilot scale biopharmaceutical manufacturing facility design and construction experience with facility & utility system qualification experience preferred.
• Subject matter expert in a key engineering discipline with design experience for mechanical-HVAC, chemical-process utilities (WFI/PW/Clean Steam), or architecture/construction management-biologics facilities is a preferred plus.

Responsibilities:

• Will perform quality control reviews of clinical documentation and review/edit documentation for technical accuracy.
• Ensure documentation is in compliance with regulatory guidelines.
• Review, write and approve departmental Standard Operating Procedures.
• Review data for completeness and provide error trends to department team.

 Background:

• Bachelor's degree preferred and must have 2+ years quality documentation experience. 
• Knowledge of regulatory and industry standards and GXP. 
• Experience with SOP's and LIMS a plus.

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.
http://www.cwsciences.com

Research Associate will execute bacterial sub-cloning, mammalian cell culture, and aseptic technique. Will also document and effectively communicate interpretation of data and results validation of assays.

Requirements:

• BS in Biology or related field with experience working with mammalian cell lines.
• Experience with molecular biology techniques is a plus.
   

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.
http://www.cwsciences.com

Analytical Scientist will develop analytical methods as well as be responsible for formulation development. 

Responsibilities:

• HPLC, ELISA and gel electrophoresis.
• Assist process development group and write technical reports.
• Analyze data and draw conclusions.

Requirements:

• BS/MS in Chemistry, Biochemistry, or related field with 5+ years experience with analytical methods.
• Experience with HPLC, ELISA, and gel electrophoresis techniques.

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.
http://www.cwsciences.com

Responsibilities:

• Will develop in vivo assays and perform microsurgical techniques.
• Responsible for cell culture, ELISA, and RT-PCR.
• Execute biological experiments and prepare SOPs for assays.
• Maintain accurate documentation and communicate results to project teams.

Requirements:

• BS in Biology or related area.
• Must have 2+ years hands-on experience with in vivo models and experience with microsurgical techniques.
• Must have experience with cell culture, RT-PCR, and ELISA.
• Proven track record in assay development.

Required Skills: microsurgery, in vivo

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.
http://www.cwsciences.com