Summary

Support pharmaceutical manufacturing plant/equipment/utilities maintaining compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements

Responsibilities and Tasks

Develops and maintains records on pharmaceutical manufacturing equipment, utilities, and systems to maintain operations and validation Completes execution of PMP programs consistent with cGMP engineering maintenance requirements Interacts with and directs vendors for manufacturing improvement/plant maintenance (i.e. HVAC, Clean Utilities, trades) primary support for Security/System Monitoring/Fire System, janitorial services, and waste water certifications Performs non-routine and off-hours tasks as necessary Supports area validation/calibration/certification efforts and the transfer of new processes to the manufacturing area Solves simple to complex problems related to equipment or process Performs equipment/utility/plant validation as needed Reviews and updates maintenance SOP’s for plant/equipment/utilities Follows all company policies related to job safety Works with supervision using some standard procedures as well as troubleshooting and decision making Troubleshoots manufacturing equipment/plant/utility problems Supports operations improvement/maintenance projects Performs improvements/maintenance as required to support all operations Interacts with and directs operations support vendors (i.e. HVAC, Clean Utilities, trades, Security/System Monitoring/Fire System, Janitorial, Grounds/Plowing) Supports validation maintenance program Executes validations for manufacturing equipment and processes as needed Maintains records for operations plant/equipment/utilities Monitors steam utility per MA State requirements Maintains records for waste water requirements Supports janitorial services and plant waste stream Executes filter integrity testing in process equipment

Knowledge Skills and Abilities

Knowledge of pharmaceutical Plant/Maintenance/manufacturing Operations or related environment Experience with Building Automation Systems Ability to read & creates engineering drawings HVAC / Boiler License preferred HAZMAT training Formal cGMP training Proficient with use of hand tools and power equipment Ability to plan, prioritize and organize diversified workload Familiarity with use of computers and MS Office

Education and Experience

High school diploma required; A.S or B.S. in related field preferred Minimum 6-8 years related experience

Pharmalucence is an Equal Opportunity Employer

Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you need help applying online, please contact joyce.robbins@sunpharma.com or call

Joyce, HR Assistant at 781-275-7120

Our biotechnology client is a world leader in improving lives.  Their highly collaborative and growing small team is on the hunt for an experienced QC Analyst with great attention to detail who has embraced the importance of good documentation.  This is not your average QC role as you will have an opportunity to branch out of routine for analyses, and also be put in a position to supervise and lead projects.  The most qualified individuals will understand the importance of data traceability as well as willing to calibrate instruments on a daily basis.

Responsibilities:

• Supervise a group of QC analysts

• Help with laboratory and quality investigations

• Execute SOPs in a GMP setting

• Implementation of cGMP’s and application to QC

• Willingness to lead projects, troubleshoot and repair analytical instruments

• Update and create detail oriented documentation concerning analytic tests, logs, and protocols

Requirements:

• Bachelor’s Degree in Physical or Chemical Sciences

• More than 5 years in cGMP environment

• Capability to use MS Suite

• Experience with HPLC, GC and commonly used analytical methods

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™

Our client, a local clinical stage oncology focused company is seeking a Clinical Supply & Materials Manager. This company is private, extremely well-funded and is working with multiple collaborations to bring life changing medications to the market.  This is a unique & not to be missed opportunity to lead all clinical supply activities for multiple trials in a newly created position for this small, but growing organization.

The selected individual will be in charge of overseeing all clinical supply for multiple trials, as well as non-drug product materials & clinical samples (blood and tissue) necessary for those trials. The ability to work independently but also effectively collaborate & thrive in a team atmosphere is a necessary trait desired for this key hire. This individual should also be naturally detail oriented and possess strong organizational & external communication skills. Oncology specific experience not required but preferred.

Position Requirements:

•Possess strong leadership & organizational traits

•B.S. degree in related sciences; 3 years of experience related to clinical supply management.

•Strong & effective oral and written communication skills.

•Ability to problem-solve; react to potential problems, identifies alternatives and resolves or recommends actions.

The program manager, companion diagnostic development (CDx), will facilitate the execution of multiple cross-functional work-streams at Foundation Medicine leading to the development, approval, and marketing of FDA-regulated diagnostic products. Using sound Project and Portfolio Management principles, the program manager will manage resources, scope, tasks, scheduling, stakeholders, and risks on multiple projects. Additionally, the program manager will use their scientific expertise, evaluating and documenting existing assay systems, leading development of detailed specifications for new systems, and recommending optimization protocols. The position will require close collaboration with various stakeholders including business owners, senior management, external partners, vendors, and software engineering and laboratory staff.

• Manage cross-functional project teams from project inception to product launch, including defining product requirements, design and implementation of technical workflows, and performance of validation and verification activities
• Lead development of product documentation in fulfillment of QSR design control, including CDx assay requirements, functional specifications, use cases, sequence diagrams, flow charts, etc.
• Work with Quality and Regulatory dept. to ensure that all documentation meets audit and accreditation standards
• Collaborate with IT project management, enterprise IT architects, software engineers, and business owners to adapt required computer systems to companion diagnostic products
• Provide system control and operational protocol recommendations
• Ensure that projects are well defined, clearly documented, and adhere to QSR and FMI processes and standards
• Clearly defines and communicates project and program resource requirements and drives transparent prioritization and coordination of CDx development projects
• 3+ years of laboratory experience

• 3+ years performing project management and business analysis within the Diagnostics or Biotech industry
• Familiarity with GxP and firm grasp of validation documentation skills and principles
• Demonstrated success leading cross-functional teams and collaborative projects
• Excellent verbal and written communication skills
• Demonstrated ability to expertly lead groups to consensus in defining complex system and workflow requirements

Desired Skills and Experience

• Experience working with typical oncology specimens (e.g. FFPE, Blood, Bone Marrow)
• Experience operating complex instrumentation (NGS, qPCR, lab automation)
• Experience in a Quality System Regulations (QSR) compliant laboratory preferred but not required
• Experience working in a startup environment
• Ability to manage direct reports in project management or business analysis roles, as needed
• Ability to step in and fill gaps in project resourcing by being a contributor

• BS, MS, or equivalent, in Molecular Biology, Biochemistry, Genetics, Cancer Genomics is preferred
• PMP Certification is a plus

Apply Here

PI92490892

KSQ Therapeutics, Inc. has an immediate opening for a Senior Scientist: Target Discovery position with cell and molecular biology expertise in Cambridge, MA.  Founded by pre-eminent scientific leaders, KSQ Therapeutics, Inc. is a drug discovery company employing cutting-edge functional genomics technology to identify novel pathways and targets involved in oncology, immunology and neuroscience.  We are developing this platform to uncover novel drug targets, mechanisms for drug efficacy and resistance to identify transformative single agent and combination therapies to benefit patients.  We are looking for driven individuals who want to contribute to our fast growing company as a member of the founding scientific team.  KSQ is backed by Flagship Ventures and Polaris Partners, two of the premier life science venture capital funds with over 30 years combined experience in launching and growing new biotechs.

Position summary:

KSQ Therapeutics, Inc. is seeking an exceptional and highly motivated Senior Scientist: Target Discovery to conduct functional genomics studies in mammalian cells using lentiviral transduction and participate in target ID and drug discovery efforts.  This person will directly influence the company’s efforts to build a novel platform to identify key pathways involved in human disease.  As part of the founding team of scientists at KSQ, this individual will have key cell biology and molecular biology responsibilities, joining a dynamic, enthusiastic, highly interdisciplinary, and collaborative team.

Key Qualifications

• B.S./M.S. with 6+ years of relevant experience in cell biology, molecular biology, virology or a related field.
• Proven hands-on experience with standard mammalian cell culture and molecular biology techniques.
• Experience with transfection, production of lentiviral and cell line stocks and transduction of mammalian cells.
• Experience with modern techniques for probing gene function (CRISPR knockouts, shRNA, CRISPR knock-in) preferred.
• Experience with molecular cloning (restriction enzymes, Gibson/goldengate assembly, bacterial transformation, construct and primer design, gene synthesis, etc.) preferred.
• Experience with pharmaceutical target validation or drug discovery, including standard cell biology experimental design and molecular techniques (western blotting, qPCR, immunofluorescence, IHC, etc.)
• Excellent lab practice and sterile technique is absolutely required.
• Ability to think critically and creatively as part of a fast-paced research team.
• Commitment to quality, attention to detail, and team player mentality is a must.

Responsibilities

• The successful candidate will work as part of an interdisciplinary team contributing to the design and execution of experiments that support our research activities and project goals
• Participate in various aspects of this new company from building out the capabilities to contributing to generating data in a fast and efficient manner

Compensation

A competitive overall compensation package including: competitive base salary, bonus potential and stock options.

Contact Information

To learn more about this exciting career opportunity, please forward your resume and background information in confidence to Wade at KSQJobs@ksqtx.com.

KSQ Therapeutics, Inc. has an immediate opening for a Senior Scientist: Sequencing position with deep sequencing expertise in Cambridge, MA.  Founded by pre-eminent scientific leaders, KSQ Therapeutics, Inc. is a drug discovery company employing cutting-edge functional genomics technology to identify novel pathways and targets involved in oncology, immunology and neuroscience.  We are developing this platform to uncover novel drug targets, mechanisms for drug efficacy and resistance to identify transformative single agent and combination therapies to benefit patients.  We are looking for driven individuals who want to contribute to our fast growing company as a member of the founding scientific team.  KSQ is backed by Flagship Ventures and Polaris Partners, two of the premier life science venture capital funds with over 30 years combined experience in launching and growing new biotechs.

Position summary:

KSQ Therapeutics, Inc. is seeking an exceptional and highly motivated Senior Scientist: Sequencing to conduct functional genomics studies in mammalian cells using lentiviral transduction and participate in target ID and drug discovery efforts.  This person will directly influence the company’s efforts to build a novel platform to identify key pathways involved in human disease.  As part of the founding team of scientists at KSQ, this individual will have key cell biology and molecular biology responsibilities, joining a dynamic, enthusiastic, highly interdisciplinary, and collaborative team.

Key Qualifications

• B.S./M.S. with 5+ years of relevant experience in DNA sequencing
• Proven hands-on experience with standard and molecular biology techniques.
• Familiarity with Illumina platform for next-gen sequencing (Miseq, NextSeq, HiSeq)
• 2+ years of experience generating and troubleshooting NGS library preps (RNAseq, Exome, Whole Genome, PCR Amplicon, FragSeq).
• Familiarity with automated platforms for liquid handling and automated sequencing library preps preferred.
• Previous experience with sample tracking systems/LIMS preferred.
• Familiarity with tools for aligning and counting NGS reads
• Excellent lab practice and organization is absolutely required.
• Ability to think critically and creatively as part of a fast-paced research team.
• Commitment to quality, attention to detail, and team player mentality is a must.

Responsibilities

• The successful candidate will work as part of an interdisciplinary team contributing to the design and execution of experiments that support our research activities and project goals
• Participate in various aspects of this new company from building out the capabilities to contributing to generating data in a fast and efficient manner

Compensation

A competitive overall compensation package including: competitive base salary, bonus potential and stock options.

Contact Information

To learn more about this exciting career opportunity, please forward your resume and background information in confidence to Wade at KSQJobs@ksqtx.com.

Sr Research Associate– Animal Studies/ Immunology

Location: Cambridge, MA

Job Code: KLT -O1-2015-10

Kanyos Bio is searching for a Research Associate/Sr Research Associate in Immunology to provide expertise in developing our unique immune tolerance platform and translate into clinical for targeted therapies for type-1 diabetes and celiac disease.  This individual will design and execute pivotal proof of concept studies in pre-clinical models of autoimmunity, and assist in cross-functional development of our research strategy. This person will interact with other team members to design and execute in vivo/in vitro pharmacology studies aimed at defining the activity and mechanism of action of compounds .Significant cross-functional collaboration with a talented and dedicated group of scientists including biochemists, cell biologists, immunologists, will ensure a diverse exposure to the drug discovery process.

Principal Duties and Responsibilities

Perform basic and intermediate veterinary technical and husbandry tasks independently, including the following:

-Administration of selected agents by IV, IM, SC, PO, IP routes

-Blood sampling techniques via multiple routes

-Proficient animal restraint techniques

-Experience with rodent breeding strategies

Execute studies to define target biology in mouse models of autoimmunity, both in vitro and in vivo

Optimize and perform in vivo and in vitro cell based assays

Maintenance of laboratory records/notebooks, procedures and summaries of data

Generation of high-quality data reports, with suggestions of future work to management and project teams

Qualifications:

-BS/MS in Biology, Pharmacology, Animal Science or related field with 2-4 years relevant experience in an industrial setting,

-AALAS certification at the ALAT level. Uncertified candidates will be required to receive certification at the ALAT level within 12 – 18 months or show that certification has been substantially completed. LVT/RVT qualification is a plus.

- Strong experience in animal handling is required including compound administration by multiple routes, harvesting tissue and blood samples, surgical and necropsy techniques.

- Cell culture: experience in culturing and manipulating mammalian cell lines; experience in transfections and culturing of primary mammalian cells is advantageous.

- Experience with pharmacodynamics assays of mouse tissue and cell culture samples, including Western Blotting, ELISA/Mesoscale, immunohistochemistry and flow cytometry, is a plus

Contact:

To apply, please send your cover letter and resume to: careers@kanyos.com (Job Reference KLT-01-2015-10) Applicants should be legally entitled for employment in the United States.

Kanyos Bio is an early-stage immunotechnology company focused on developing targeted therapies for type-1 diabetes and celiac disease. Our technology originated at EPFL (Ecole Polytechnique Fédérale de Lausanne) in Switzerland with our sister company, Anokion.  Kanyos Bio and Anokion are collaborating in this effort with Astellas Pharma.  As an independent affiliate, Kanyos Bio aims to develop antigen-specific, disease-modifying therapies for patients with type-1 diabetes and celiac disease by leveraging the immunotechnology expertise of Anokion and the clinical translation experience of Astellas.

Sr Research Associate– Animal Studies/ Immunology

Location: Cambridge, MA

Job Code: KLT -O1-2015-10

Kanyos Bio is searching for a Research Associate/Sr Research Associate in Immunology to provide expertise in developing our unique immune tolerance platform and translate into clinical for targeted therapies for type-1 diabetes and celiac disease.  This individual will design and execute pivotal proof of concept studies in pre-clinical models of autoimmunity, and assist in cross-functional development of our research strategy. This person will interact with other team members to design and execute in vivo/in vitro pharmacology studies aimed at defining the activity and mechanism of action of compounds .Significant cross-functional collaboration with a talented and dedicated group of scientists including biochemists, cell biologists, immunologists, will ensure a diverse exposure to the drug discovery process.

Principal Duties and Responsibilities

Perform basic and intermediate veterinary technical and husbandry tasks independently, including the following:

-Administration of selected agents by IV, IM, SC, PO, IP routes

-Blood sampling techniques via multiple routes

-Proficient animal restraint techniques

-Experience with rodent breeding strategies

Execute studies to define target biology in mouse models of autoimmunity, both in vitro and in vivo

Optimize and perform in vivo and in vitro cell based assays

Maintenance of laboratory records/notebooks, procedures and summaries of data

Generation of high-quality data reports, with suggestions of future work to management and project teams

Qualifications:

-BS/MS in Biology, Pharmacology, Animal Science or related field with 2-4 years relevant experience in an industrial setting,

-AALAS certification at the ALAT level. Uncertified candidates will be required to receive certification at the ALAT level within 12 – 18 months or show that certification has been substantially completed. LVT/RVT qualification is a plus.

- Strong experience in animal handling is required including compound administration by multiple routes, harvesting tissue and blood samples, surgical and necropsy techniques.

- Cell culture: experience in culturing and manipulating mammalian cell lines; experience in transfections and culturing of primary mammalian cells is advantageous.

- Experience with pharmacodynamics assays of mouse tissue and cell culture samples, including Western Blotting, ELISA/Mesoscale, immunohistochemistry and flow cytometry, is a plus

Contact:

To apply, please send your cover letter and resume to: careers@kanyos.com (Job Reference KLT-01-2015-10) Applicants should be legally entitled for employment in the United States.

Kanyos Bio is an early-stage immunotechnology company focused on developing targeted therapies for type-1 diabetes and celiac disease. Our technology originated at EPFL (Ecole Polytechnique Fédérale de Lausanne) in Switzerland with our sister company, Anokion.  Kanyos Bio and Anokion are collaborating in this effort with Astellas Pharma.  As an independent affiliate, Kanyos Bio aims to develop antigen-specific, disease-modifying therapies for patients with type-1 diabetes and celiac disease by leveraging the immunotechnology expertise of Anokion and the clinical translation experience of Astellas.

Sr Research Associate– Animal Studies/ Immunology

Location: Cambridge, MA

Job Code: KLT -O1-2015-10

Kanyos Bio is searching for a Research Associate/Sr Research Associate in Immunology to provide expertise in developing our unique immune tolerance platform and translate into clinical for targeted therapies for type-1 diabetes and celiac disease.  This individual will design and execute pivotal proof of concept studies in pre-clinical models of autoimmunity, and assist in cross-functional development of our research strategy. This person will interact with other team members to design and execute in vivo/in vitro pharmacology studies aimed at defining the activity and mechanism of action of compounds .Significant cross-functional collaboration with a talented and dedicated group of scientists including biochemists, cell biologists, immunologists, will ensure a diverse exposure to the drug discovery process.

Principal Duties and Responsibilities

Perform basic and intermediate veterinary technical and husbandry tasks independently, including the following:

-Administration of selected agents by IV, IM, SC, PO, IP routes

-Blood sampling techniques via multiple routes

-Proficient animal restraint techniques

-Experience with rodent breeding strategies

Execute studies to define target biology in mouse models of autoimmunity, both in vitro and in vivo

Optimize and perform in vivo and in vitro cell based assays

Maintenance of laboratory records/notebooks, procedures and summaries of data

Generation of high-quality data reports, with suggestions of future work to management and project teams

Qualifications:

-BS/MS in Biology, Pharmacology, Animal Science or related field with 2-4 years relevant experience in an industrial setting,

-AALAS certification at the ALAT level. Uncertified candidates will be required to receive certification at the ALAT level within 12 – 18 months or show that certification has been substantially completed. LVT/RVT qualification is a plus.

- Strong experience in animal handling is required including compound administration by multiple routes, harvesting tissue and blood samples, surgical and necropsy techniques.

- Cell culture: experience in culturing and manipulating mammalian cell lines; experience in transfections and culturing of primary mammalian cells is advantageous.

- Experience with pharmacodynamics assays of mouse tissue and cell culture samples, including Western Blotting, ELISA/Mesoscale, immunohistochemistry and flow cytometry, is a plus

Contact:

To apply, please send your cover letter and resume to: careers@kanyos.com (Job Reference KLT-01-2015-10) Applicants should be legally entitled for employment in the United States.

Kanyos Bio is an early-stage immunotechnology company focused on developing targeted therapies for type-1 diabetes and celiac disease. Our technology originated at EPFL (Ecole Polytechnique Fédérale de Lausanne) in Switzerland with our sister company, Anokion.  Kanyos Bio and Anokion are collaborating in this effort with Astellas Pharma.  As an independent affiliate, Kanyos Bio aims to develop antigen-specific, disease-modifying therapies for patients with type-1 diabetes and celiac disease by leveraging the immunotechnology expertise of Anokion and the clinical translation experience of Astellas.

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Preclinical Biostatistician

Position Summary

We are seeking an experienced and motivated Biostatistician to join our fast-growing company to develop protein-based vaccines for the prevention and treatment of infectious diseases and cancers. The successful candidate will provide significant statistical expertise in preclinical study design and data analysis in the vaccine development and discovery research. He/She will also provide support and collaboration in analyzing large and complex data sets generated by Genocea’s ATLAS platform. The Biostatistician will have the opportunity to work on developing novel statistical methodologies and/or improve the current methodologies. He/She will contribute to the science through independent and collaborative research resulting in presentations and publications.

Responsibilities

• Serve as key biostatistician on preclinical study design and data analysis to identify novel protein candidates for vaccines
• Help build statistical capabilities in vaccine development and discovery research by providing strategic input to analyze large and complex data sets from high throughput platforms.
• Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions.
• Develop and maintain good working relationships with discovery and clinical scientists, statisticians, computational biologists, and external collaborators to drive program decisions as part of a multidisciplinary team.
• Proactively seek input and review from other experts within and outside the group on various projects and research activities, and share technical information when appropriate.
• Propose opportunities for productivity improvements and implementation plans.

Required Skills

• Strong basis in statistical concepts and expertise in statistical methodologies such as predictive modeling and inference, machine learning methods, mixed effects models, multivariate analysis, etc.
• Strong statistical programming skills with standard software, including R and SAS
• Excellent communication, presentations and report writing skills, and the ability to explain complex technical details in simple language.
• Work well in a team as well as independently, and be able to take leadership role with regard to methodological elements in projects.
• Background in immunology and oncology would be a great asset
• Background in analyzing high-throughput dataset would be a plus

Education & Experience Required

• PhD in Biostatistics or Applied Statistics
• >1 year relevant academic/industry experience on topics related to immunotherapy, oncology, drug discovery, clinical genomics or other applications

To apply for this position, please CLICK HERE

Using extensive knowledge of customer needs and market trends, the Product Marketing Manager is accountable for developing and implementing the strategic direction and global marketing tactics to drive the revenue and brand growth for a range of target enrichment products, within the New England Biolabs’ NEBNext product portfolio.

Primary Responsibilities:

• Act as a champion for the given range of products, both internally and externally, to achieve the goals set for the products.
• Maintain a strong knowledge of the market trends and customer needs for target enrichment technologies, including pre-defined and custom content. This will include managing close relationships with key opinion leaders (KOLs) in the field, as well as deploying appropriate market research activities to ensure that this knowledge is both up-to-date and of the necessary level of detail.
• Develop and implement marketing strategies that match customer needs with the specific benefits of the products to create unique and sustainable market positions.
• Identify new product and market opportunities related to target enrichment, and work with multiple departments internally to realize them.
• Develop and manage the implementation of creative promotional tactics that align themselves with the buying process of the customer, and drive brand awareness and product revenue growth.
• Propose and support the optimum channel through which to market and sell the different products.
• Manage all aspects of the product lifecycle and ensure appropriate post-launch support.
• Propose and manage product pricing.

Qualifications and Experience: 

• Master’s degree or higher in one of core life science disciplines; biochemistry, genetics, molecular biology, etc.
• MBA or equivalent on-the-job training.
• Minimum of ten years’ experience in the life science industry, with at least two years’ experience focused on target enrichment or the use of these types of technologies in pre-clinical and clinical settings.
• Experience in developing novel, growth strategies for complex product portfolios.
• Experience developing and launching multiple new products, including managing the development of their promotional, pricing and channel tactics.
• Experience managing the lifecycle of a range of products from idea conceptualization through launch, and growth and maturity.
• Proven leadership skills, with ability to motivate and direct a cross-functional team.
• Strong communication and presentations skills; both written and verbal.
• Broad knowledge of the life science market, including the clinical and pre-clinical markets with depth in next generation sequencing.
• Strong project management skills and the ability to multi-task, prioritize and manage multiple projects simultaneously.
• Good understanding of core principles of marketing and how to best apply them to the target enrichment market.
• Basic understanding of the selling process and how it is used effectively with varying product types in different segments of the life science market.
• Ability to travel, including overseas, up to 30% of time.

New England Biolabs is an Equal Opportunity/ Affirmative Action Employer of Minorities, Females, Disabled and Protected Veterans

 Candidates may apply online at www.neb.com or by accessing the following link: Product Marketing Manager, Target Enrichment

New England Research Institutes (NERI) was founded in 1986 and has grown to become a clinical research organization with a global reputation for high-quality research, innovative thinking, and the use of state-of-the-science tools and techniques. NERI continues to be a leader in public health research, clinical trials management, epidemiology, and state of the art media and dissemination research.

NERI's growth and success has been driven by strong leadership, disciplined attention to scientific integrity, and its ability to attract and retain exceptionally talented staff members. The depth of experience, skill, and expertise that the entire NERI staff brings to each project is what sets NERI apart from other research organizations and is what continues to propel NERI through the 21st century.

We currently have an opening for a full time Receptionist/Office Assistant. Qualified candidates for this position will be able to work independently and direct callers to their destination or relay messages.

Knowledge, Skills and Abilities:

• Strong customer service experience.
• Greet and sign-in all visitors and direct them as needed.
• Operates telephone system consisting of several incoming lines for a busy office environment.
• Orders and maintains spreadsheet for all office supplies and office access cards.
• Good organizational skills with the ability to adapt and adjust to changing priorities.
• Positive attitude and the ability to work well with others.

Qualifications:

• High School diploma or general education degree (GED); or 1 year related experience and/or training; or equivalent combination of education and experience.
• Strong organizational, communication and interpersonal skills (especially phone and email to act as liaison between customers/clients and internal employees).
• Familiarity with Microsoft Office Suite – Word, Excel PowerPoint and Outlook.
• Familiarity with multiline phone system preferred.

If interested, please visit us at www.neriscience.com.

NERI is an Equal Opportunity Employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identify and expression, age, disability, Vietnam era or other eligible veteran status, or any other protected factor. NERI is a VEVRAA Federal Contractor.

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://neriscience.applicantpro.com/jobs/318858-19107.html   

POSITION SUMMARY

The Protein Purification Technician II performs assigned manufacturing and process development duties in a current Good Manufacturing Practice (cGMP) environment.

RESPONSIBILITIES

Job performance will involve a variety of activities including:

• Executes development scale purification protocols as directed.
• Works with standard scientific equipment as described in relevant procedures; AKTA Prime, AKTA Pilot and Purifier with associated Unicorn software, UV spectrophotometer, balances, chromatography columns, PAGE, autoclaves, pH meter, refrigerators, freezers, biohazard safety cabinets.
• Records results in batch records; required to have meticulous organization and record keeping skills.
• Prepares buffers and media.
• Communicates as a team member with other functional groups, via face to face, email and written reports.
• Assists with investigations, root cause analysis, and corrective action/preventative action (CAPA) implementation.
• Maintains protein purification batch master program to ensure quality standards are met.
• Maintains and operates machinery used in manufacturing based on specific procedures.
• Cleans work area, machinery and equipment and maintains work area in an orderly manner.
• Stocks lab areas with supplies as needed, inventories supplies and places orders.
• Keeps up-to-date with required training and development and improve job skills.
• Interprets operating requirements and monitors gauges and instrumentation.
• Additional duties as assigned.

EXPERIENCE

• 2-5 years related life sciences experience or equivalent combination of education and experience.

KEY ATTRIBUTES

• Drive and Determination
• Demonstrated Scientific “problem solving” skills, translated into consultative selling process where the “win” is for both the client and the company
• Strong Molecular Biology Applications background
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company
• Strong communication and presentation skills

EDUCATION

• Bachelor’s degree from four year college or university and/or combination of skills and training

POSITION SUMMARY

The Quality Engineer will report to the Quality Assurance Manager. S/he represents Quality within cross-functional teams to coordinate documentation and ensure compliance for instrument IQ/OQ, assay Verification/Validation activities and Risk Management. Position responsibilities also include monitoring Engineering Change Controls and data trending to provide corrective action solutions that drive continuous improvement.

RESPONSIBILITIES

Job performance will involve a variety of activities including:

• Work in collaboration with product development to ensure that the designs, procedures and outcome of the project are acceptable in quality.
• Support the creation and the maintenance of Risk Management plans including dFMEAs, pFMEAs and Control Plans.
• Write or review and approve equipment IQ/OQ and assay Verification/Validation studies in collaboration with cross-functional teams.
• Conduct and support investigations of manufacturing nonconformities, recommend, develop and implement effective corrective actions.
• Applies statistical methods for analyzing data to evaluate the current process and process changes and solve problems. 
• Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics
• Participates on audits conducted by regulatory agencies and/or customers.
• Participates in supplier evaluation and selection assessments.
• Maintains a working knowledge of industry standards. Knows and follows the ISO quality system guidelines. 
• Performs external vendor audits to ensure ISO and/or FDA compliance.
• Additional responsibilities may be assigned as needed.

EXPERIENCE

• Between 4-6 years of overall QA experience in an ISO and/or FDA regulated environment, with at least 2 years in direct QE role.
• Experience with ISO 13485 certification, (FDA 21CFR 820 and 21CFR Part 11 also desired).
• Experience with Risk Management per ISO 14971:2012 desired.
• Experience in a Good Manufacturing Practice (GMP) environment.
• ASQ certified Quality Auditor and/or Quality Engineer - CQE, CRE, PE, CRA and/or Lean Six Sigma Certifications are highly desirable.

KEY ATTRIBUTES

• Drive and Determination
• Positive external and internal relationship management skills
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company
• Proven ability to thrive in a change oriented environment
• Must be proficient in MS Office (Word, Excel, PowerPoint);

EDUCATION  

• Bachelor's degree preferably in a life science discipline, or equivalent experience.
• ASQ CQE, CQM, or CQA preferred.

POSITION SUMMARY

The Quality Control Technologist II performs assays on products to ensure product quality standards are met.  

RESPONSIBILITIES

Job performance will involve a variety of activities including:

• Perform assays for product qualification with minimal errors
• Adhere to predefined quality control work instructions and make suggestions for improvements
• Compile paperwork and submit data from assays accurately with minor troubleshooting as necessary
• Participate in continuous process improvement activities
• Perform rotation schedule designed to enhance the QC group functionality
• Work with analysts on projects as determined by the Quality Control Manager
• Ability to adapt to a fast paced quality control process by organizing and prioritizing responsibilities
• Analyze and report on simple assays
• Provide assay training
• Assist with new assay development, inventory management and 6S compliance
• Perform additional duties as assigned

EXPERIENCE

• At least 2 years’ experience in product qualification (QC); or equivalent combination of education and experience.

GROWTH EXPERIENCE

• Ability to learn and acquire new molecular biology skills in order to complete more complex assay testing
• Understand the quality control process in order to meet ISO compliance standards
• Increase ability to troubleshoot assays and procedures
• Provide constructive feedback on QC improvements

KEY ATTRIBUTES

• Drive and determination
• Strong Molecular Biology applications background
• Positive relationship management skills
• Strong written and communication skills
•  Ability to thrive in a start-up/fast-paced/change oriented environment
•  Demonstrates scientific “problem solving” skills
• Self-Starter                
  • Driven to perform
  • Self-directed with minimal management assistance.
  • Able to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved

EDUCATION

• Bachelor's degree from a four year college or university in Biology or Biochemistry and/or combination of experience and training.

New England Research Institutes (NERI) was founded in 1986 and has grown to become a clinical research organization with a global reputation for high-quality research, innovative thinking, and the use of state-of-the-science tools and techniques. NERI continues to be a leader in public health research, clinical trials management, epidemiology, and state of the art media and dissemination research.

NERI's growth and success has been driven by strong leadership, disciplined attention to scientific integrity, and its ability to attract and retain exceptionally talented staff members. The depth of experience, skill, and expertise that the entire NERI staff brings to each project is what sets NERI apart from other research organizations and is what continues to propel NERI through the 21st century.

We currently have an opening for a full time Statistician I. In that position, the Statistician I will:

• Conduct statistical analyses outlined and supervised by Senior Statisticians;
• Manipulate and creates complex datasets;
• Clean datasets to identify outliers, assigns missing values, etc.;
• Summarize results of requested analyses in table and graphic format;
• Perform quality assessment on colleagues' statistical programming.

Qualifications:

• Master's degree in Statistics, Biostatistics or a closely allied field with substantial statistical preparations and practical experience in data analysis in clinical research;
• Knowledge of statistical methodology and analysis;
• Ability to write sections of collaborative manuscripts and/or full papers;
• Proficiency in SAS or related statistical software;
• Excellent communication skills---both oral and written.

If interested, please visit us at www.neriscience.com.

NERI is an Equal Opportunity Employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identify and expression, age, disability, Vietnam era or other eligible veteran status, or any other protected factor. NERI is a VEVRAA Federal Contractor.

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://neriscience.applicantpro.com/jobs/318987-19107.html   

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
We seek a highly motivated individual with Ph.D. in systems biology/pharmacology modeling, biochemical engineering or other related field and a demonstrated track record in scientific publication. The postdoctoral fellow will be located in Cambridge (MA), a world-class center of pharmaceutical and biotech research. The individual will build quantitative systems pharmacology model(s) to yield an understanding of inflammatory bowel disease to understand how certain cytokines and pathways correlates with efficacy and safety observations and to inform target selection and clinical trial design. The individual will work in a highly stimulating and multi-disciplinary environment and will have interactions with biologists, precision medicine scientists, clinical pharmacologists, clinicians and systems pharmacology modelers. In addition to building computational models, the individual will also have an opportunity to influence experimental designs towards data generation.

Responsibilities
* Create a multi-scale systems model describing cell trafficking and cytokine modulation on based on literature data and in-house information
* Apply data mining tools to obtain information on intracellular pathways relevant to inflammatory diseases
* Identify relevant data (in-vitro, in-vivo preclinical and clinical trial data) for model identification, optimization, and validation
* Design experiments aimed towards generating data for model validation and testing of relevant hypotheses effectively communicate model results and outcomes to scientists in non-quantitative disciplines
* Write scientific publications and present at internal and external scientific meetings

Qualifications
* Ph.D. degree in mathematics, engineering or other disciplines related to quantitative pharmacology or equivalent experience with a strong emphasis on biopharmaceutical modeling and simulation.
* Previous experience in building systems biology/pharmacology models, including ordinary differential equation (ODE) based models is required.

TECHNICAL SKILLS REQUIREMENTS* Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation
* In depth, hands-on knowledge of the state of the art modeling and simulation software and applications in the area of PKPD and systems modeling and simulation (i.e. MatLab, Simbiology toolbox, S-plus, R or comparable applications)
* Capable of rapidly and efficiently building implementing ODE based models of biological systems, and applying parameter estimation and optimization techniques
* General familiarity with modeling techniques beyond ODEs, e.g. partial differential equations, Bayesian modeling, population modeling will be a plus
* Proven track record in scientific communication and writing manuscripts
* Good understanding of in vivo animal models and drug discovery process is a plus

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.

Please apply at: Application URL:http://www.aplitrak.com/?adid=ZWRkeS5uaWNvbGFzLjgyNjcyLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ

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
* Source of cognitive neuroscience and computational expertise within the translational neuroscience space, Quantitative Medicine (QM) and the NPRU
* Coordinates and contributes to the delivery and analysis of a QM plan for all relevant NPRU programs prior to compound nomination
* Assist project teams in establishing quantitative relationships between pharmacological and disease-relevant outcomes, including cognitive processes, with their underlying anatomical, circuitry or biochemical substrates.
* Assist in the generation of rigorous translational relationships between preclinical and clinical outcomes including participation in the design, implementation and analysis of translational studies at both the clinical and preclinical level.
* Provide expertise on data analytic methods as applied to cognitive data and functional mapping.
* Member of a team of neuroscientists (both preclinical and clinical) working in support of the needs of NPRU and aligned with the overall research strategy of the organization.
* Maintain cutting edge knowledge of the clinical neurocognitive and translational neuroscience field; be aware of major advances and emerging trends.
* Provide support to key projects in the Business Units that require the knowledge of neurocognitive and computational neuroscience for late phase application.

Responsibilities
* Responsible for scientific quality, experimental design and interpretation of projects involving cognitive assessments particularly in the late preclinical to early clinical space.
* Where relevant, provides expertise in neurocognition and functional outcome measures to support review committees and major decision points in the drug development process.
* Provides a point of contact for data analysis expertise, to support cutting edge analytical procedures.
* Responsible for establishing and managing external collaborations (academic and industrial) to specified timelines and milestones.
* Contributes to the development of strategies that integrate knowledge of neurocognitive with other biological data (proteomics, metabolomics, genetics, imaging etc) that underpin the development of systems biology/systems medicine.

Qualifications
* PhD in a relevant discipline (experimental psychology preferred; strong background in cognition essential)
* Minimum of 6 years relevant research in the field of cognitive neuroscience

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.

Please apply at: Application URL:
http://www.aplitrak.com/?adid=amVmZnJleXN0b25lLjI2Nzk3LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ

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 Neuroscience and Pain Research Unit (NPRU) has recently established a state-of-the-art, open access, optical microscopy facility, and now that image acquisition workflows are well established, the team has ambitious goals to also provide image analysis support. To that end, the Lab Operations line, within the NPRU, is adding a Computational Scientist to their preclinical optical microscopy team to focus on image analysis workflows supporting preclinical drug discovery programs.

This Computational Scientist will be an integral member of the Lab Operations team, which broadly supports the NPRU portfolio of programs at various stages across all the disease areas of interest. The primary goal will be to enable project teams to accurately and efficiently quantitate pre-clinical microscopy data to drive robust decisions around target mechanisms and validation, compound effects, biomarkers and assay development.

In this position, the successful candidate will work within a large matrix environment, collaborating across multiple groups including discovery biology, preclinical imaging, research statistics, and informatics.

Responsibilities
· Collaborate with scientists, including Neurodegeneration, Neuroinflammation and Psychiatry project teams to analyze and present results of the experiments employing various optical microscopy and video imaging modalities
· Implement and apply innovative image analysis methods and develop algorithms to analyze complex, multi-dimensional images to help drive data-driven drug discovery and development decisions
· Work with scientists to understand the biology and improve existing or derive new endpoints, utilize prior information and develop 'fit-for-purpose' approaches.
· Use computational expertise to prepare internal and external reports, presentations, and manuscripts

Qualifications
PhD or equivalent in quantitative discipline such as Computer Science, Physics, Applied Mathematics, Bioengineering, and Electrical Engineering with major focus on biological image analysis of complex, optical microscopy and multi-dimensional data. Research experience with algorithm development and computational modeling using complex data are preferred.

· Strong background in image analysis including linear and nonlinear filtering, morphological image processing, 2D and 3D segmentation, registration techniques
· Expert level knowledge of image analysis for time-lapse and video data, along with multi-dimensional optical microscopy data
· Experience with development and validation in biomarker studies
· Broad understanding of biology, preferably with an emphasis in Neuroscience.
· The attitude of self-directed scientist; demonstrated ability to multitask
· Exceptional communication skills; ability to explain modeling concepts to non-experts
· Demonstrated ability to work effectively as a part of a team
· Demonstrated ability to effectively deal with ambiguity and change

Technical Skill Requirements
· Expert level knowledge of scientific programming in MATLAB, ImageJ and Python, along with low level languages C/C++/Fortran
· Good knowledge of statistical programming using R
· Hands-on experience with high-performance computing, Linux environment, scripting, are preferred.

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.

Please apply at: Application URL:http://www.aplitrak.com/?adid=amVmZnJleXN0b25lLjc0OTkyLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ