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Career postings for the Massachusetts Biotechnology Council

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  • 11/20/15--23:19: Operations Manager
  • 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 people leader in manufacturing operations is responsible for management of a group whose primary focus is on the execution of manufacturing processes, technical assessment of processes including technology transfer, maintaining a culture of compliance, innovation, and continuous improvement within their assigned Asset Group.
    * The people leader will need to guide the people in their group with process and technical knowledge to lead troubleshooting activities, provide investigations support, analyze process data, and identify and implement process improvements and a culture of continuous improvement.

    Responsibilities
    * Oversight of a production group of ~12 people, ensuring compliance to regulations. Responsible for coaching/mentoring both technical and non-technical staff.
    * The person will have approximately 9-11 non-exempt and 1-3 exempt people reporting to them.
    * This person will have regular interactions with the Engineering, Quality, Technical Services, and Operational Management departments.
    * Knowledgeable in operations processes including solution preparation, fermentation, and purification. Familiarity with DMAIC processes, investigation processes, and automation a plus.

    Qualifications
    * BS in a science discipline with 10+ years relevant experience
    * MS in a science discipline with 8+ years relevant experience
    * Additional requirements are at least five years in a cGMP environment with increasing responsibility. Management experience is also highly desirable.

    PHYSICAL/MENTAL REQUIREMENTS:
    * Able-bodied; must be able to climb flights of stairs, and be standing for ~1-2 hours at a time.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
    * 1st Shift Rotating position 6 am - 6 pm

    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=SmltLlRhdm9saWVyaS42NjYxMS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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  • 11/20/15--23:22: Principle Scientist
  • 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 Quality Analytical group is seeking a highly motivated candidate to support tech transfers activities for multiple Monoclonal Antibody products at the Andover site. The work includes designing, reviewing and approving method qualifications/validations/verification activities. The candidate will write regulatory filings, review and approve technical documents, and provide input to specifications. The candidate will also be responsible for troubleshooting and method improvements for established products at the site.

    Responsibilities
    Key responsibilities:
    The qualified candidate must have the experience and ability to participate in multiple tech transfers within the Analytical group. Responsibilities include:
    * Validation of analytical methods for in-process, drug substance and drug product samples
    * Support characterization of monoclonal antibody products and reference materials
    * Drive and manage method validations, investigation, and analytical studies
    * Collaborate with routine QC testing lab and manufacturing on troubleshooting and investigational activities
    * Write and review regulatory filings in support of BLA
    * Responsible for post approval commitments (revalidations, specification adjustments, method changes)
    * Support pre-approval audit inspections

    Qualifications
    * Ph.D in chemistry, biochemistry or related discipline with 4 plus years of experience.
    * MS degree in chemistry, biochemistry or related discipline with 12 plus years of experience
    * Extensive knowledge and experience with monoclonal antibodies.
    * Techniques include ELISA, iCE, Bio-assays, CE, UV and HPLC (Peptide map and Oligosaccharide)
    * Previous experience in method validation and tech transfer
    * Strong technical writing skills
    * Strong oral and written communication skills
    * Candidate must be self-motivating and be able to adapt to rapidly changing project priorities.
    * Knowledge and understanding of cGMP and industry standards

    PHYSICAL/MENTAL REQUIREMENTS:
    Normal sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.). Position is first shift Monday through Friday.

    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=SmltLlRhdm9saWVyaS45NzUzMC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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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
    This position resides in the Formulation Design and Development group within Drug Product Design. The primary responsibility is to provide drug product formulation and manufacturing process design expertise in order to deliver the R & D portfolio, including hands-on support for dosage form development activities. Responsible for commercial formulation and manufacturing process design of pharmaceutical oral dosage forms (both immediate and modified release) for new drug candidates. May serve as Drug Product Lead on matrix Pharm Sci Project Teams, and leads appropriate Drug Product Sub-Team activities.

    Responsibilities
    * Leverages strong understanding of biopharmaceutics principles to design, assess and interpret experimental data, then uses the resulting information to inform selection of the optimal drug delivery strategy.
    * Designs and implements appropriate in vitro dissolution experiments to help predict the in vivo bioperformance of the drug product and translates this understanding to maximize the performance of the final drug product.
    * Utilizes appropriate predictive models and Science of Scale approaches to understand mechanical and physico-chemical characteristics of pharmaceutical compounds and formulations to drive decisions and assess performance.
    * Ensures the chemical and physical stability of dosage forms by collaborating with analytical chemists in the design of insightful and appropriate stability assessments.
    * Writes and provides guidance to writers of regulatory documents supporting drug product development, including relevant drug product sections of CTD applications and associated queries to regulatory agencies.
    * Plays a key role in cross-functional teams representing the department and works closely with colleagues in partner lines (e.g. analytical, chemistry, regulatory colleagues).
    * Provides laboratory support as needed to progress the projects.
    * Effectively mentors and develops other scientists outside of direct reports
    * Maintains an awareness of and contributes to current scientific literature; actively applies new concepts as appropriate.
    * Additional responsibilities include leading or supporting departmental initiatives such as new technology development and continuous improvement projects.

    Qualifications
    MINIMUM: BS + 8 years experience, MS + 5 years experience, or PhD in Pharmaceutics, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering or Biophysics

    DESIRABLE: PhD with 0 to 4 years experience in Pharmaceutics, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering or Biophysics preferred

    DESIRABLE: Experience in oral formulation development, preferably including drug delivery technologies (e.g. modified release). Demonstrated knowledge about the three pillars of drug development - biopharmaceutics, stability and manufacturability. Broad technical knowledge and experience with issues related to the design and development of pharmaceutical dosage forms, related scientific problem solving, and regulatory strategy and documentation. Capability and willingness to design, execute (hands-on), analyze and interpret laboratory experimentation. Strong organizational skills, interpersonal, written, and verbal communication skills. Solid scientific understanding of physical pharmacy, such as solubility and dissolution kinetics, as it relates to dosage form design and bioperformance. Strong scientific leadership and direction of new technology initiatives. Established record of scientific achievement (publications, patents). Candidate should be able to work effecti
    vely as part of cross-functional teams and embrace team work.

    PHYSICAL/MENTAL REQUIREMENTS:
    Requirements typical of office and laboratory supervision work. The position may require some infrequent travel to meetings and/or project development/manufacturing sites.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=TWVnYW4uSGFycmlnYW4uNDgyMTMuMzE2N0BwZml6ZXIuYXBsaXRyYWsuY29t


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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
    * This position will provide support for the Validation Program and Validation projects at Pfizer Andover site.
    * The Validation Scientist / Validation Engineer is expected to utilize their own subject matter expertise (SME), as well as collaborate with other site validation SMEs, to define, standardize and support the validation programs and procedures in compliance with corporate, regulatory, and industry standards and regulations.
    * The incumbent in this position will be responsible for supporting and implementing the established validation approach and is accountable for supporting the site's successful adherence to the Validation Master Plan, Validation SOP's, and the integration of the Master Plan with the Strategic Planning Process.
    * The incumbent will be expected to partner with the SME's of the site Quality Assurance Validation group to ensure all validation strategies and validation executions meet all applicable Pfizer quality and compliance standards, local SOP's, as well as applicable regulatory standards. The incumbent will be responsible for providing Validation supporting during regulatory inspections. The incumbent will support the development, implementation and maintenance of system(s) for tracking and measuring validation status, resource utilization and effectiveness.
    * The Validation Scientist / Validation Engineer will also be responsible for supporting the development the next generation validation program.

    Responsibilities
    * This position will provide support to the Cleaning/Disinfectant validation, Sterilization validation, Equipment validation, Instrumentation validation and Shipping validation.
    * Foster a Quality and Compliance culture for the validation program
    * Support the validation program and procedural changes that enhance safety, compliance, and overall operational efficiency.
    * Continuously evaluate and identify opportunities for improvement in existing validation programs and procedures.
    * Support on site governance team that oversee or impact validation program and procedures.
    * Accountable for the quality and robustness of validation program and procedure design.
    * Represent validation program during audits and inspections

    Qualifications
    * The position requires BS engineering or science with 5+ years of experience in the area of validation activities supporting manufacturing and development operating in regulated environment. Candidate is required to be experienced with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15) and or Medical Device Validation requirements (CFR 811)
    * Experience also required, background in problem solving, negotiations, project management/support in a matrixed reporting environment. Six Sigma certification or background is 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=SmltLlRhdm9saWVyaS42ODEzMi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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  • 11/22/15--02:40: Scientist - Pharmacology
  • Kaleido Biosciences, Inc. has an immediate opening for a Scientist in pharmacology. 

    Kaleido Biosciences is pioneering a novel category of therapeutics to systematically modulate the human microbiome for the treatment of disease and the promotion of health. Kaleido Biosciences was founded by VentureLabs, a unit of Flagship Ventures which has launched over 25 breakthrough companies including Seres Therapeutics, Symbiota, Pronutria, and Moderna Therapeutics.

    Position summary:

    Kaleido Biosciences, Inc. is seeking an exceptional, highly motivated Scientist to play a key role in the company’s efforts to ascertain the effect of novel therapeutics in animal models of disease including effects on the microbiome. This individual will join a dynamic, highly collaborative team that combines significant drug discovery experience with leading edge knowledge of microbiome biology and computational approaches. 

    Key Qualifications

    • Proven track record of management of outsourced studies required
    • Ability to think critically and creatively as part of a fast-paced research team
    • Highly organized and detail-oriented individual with demonstrated ability to develop/evaluate protocols/methodologies
      • Master’s (plus at least 5 years industry pharmacology experience) or PhD (plus 0-2 years relevant industry or academic pharmacology experience) degree in animal sciences, pharmacology, or related field
      • Excellent collaboration, communication and interpersonal skills
      • Experience with preclinical toxicology/tolerability studies a plus

    Responsibilities

    • The successful candidate will work closely with senior personnel as well as independently to design and execute pharmacology studies at external vendors/academic labs to support research activities and project goals
    • Shared oversight of the logistics of outsourced pharmacology and toxicology studies, including contracts, study design, scheduling, coordination between different labs, formulation and shipping/receiving of samples
    • Assist in the evaluation of data from pharmacology/toxicology studies
    • Determine value and feasibility of the implementation of new animal model systems (academic and contract research organization)

    Compensation:

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


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    Kaleido Biosciences, Inc. has an immediate opening for a Senior Research Associate in pharmacology. 

    Kaleido Biosciences is pioneering a novel category of therapeutics to systematically modulate the human microbiome for the treatment of disease and the promotion of health.

    Kaleido Biosciences was founded by VentureLabs, a unit of Flagship Ventures which has launched over 25 breakthrough companies including Seres Therapeutics, Symbiota, Pronutria, and Moderna Therapeutics.

    Position summary:

    Kaleido Biosciences, Inc. is seeking an exceptional, highly motivated Senior Research Associate to play a key role in the company’s efforts to ascertain the effect of novel therapeutics in animal models of disease including effects on the microbiome. This individual will join a dynamic, highly collaborative team that combines significant drug discovery experience with leading edge knowledge of microbiome biology and computational approaches. 

    Key Qualifications

    • Proven track record of management of outsourced studies
    • Ability to think critically and creatively as part of a fast-paced research team
    • Highly organized and detail-oriented individual with demonstrated ability to develop/evaluate protocols/methodologies
      • Bachelor’s (plus 2-5 years industry experience) or Master’s (plus 0-2 years industry experience) degree in pharmacology, animal sciences or related field, plus 3-5 years laboratory experience
      • Excellent collaboration, communication and interpersonal skills

    Responsibilities

    • The successful candidate will work closely with senior personnel as well as independently to design and execute pharmacology studies at external vendors/academic labs to support research activities and project goals
    • Shared oversight of the logistics of outsourced pharmacology and toxicology studies, including contracts, study design, scheduling, coordination between different labs, formulation and shipping/receiving of samples
    • Assist in the evaluation of data from pharmacology/toxicology studies
    • Determine value and feasibility of the implementation of new animal model systems (academic and contract research organization) 

    Compensation:

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

     


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  • 11/23/15--09:00: QA Auditor
  • Chemic Laboratories, Inc. has an opening for a QAU Auditor with cGMP/GLP auditing experience. Please contact lcw@chemiclabs.com for details about the position.


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    VL32, Inc. has an immediate opening for a Research Associate/Senior Research Associate in chemistry.  VL32 is pioneering a novel category of therapeutics to systematically modulate the human microbiome for the treatment of disease and the promotion of health. VL32 was founded by VentureLabs, a unit of Flagship Ventures which has launched over 25 breakthrough companies including Seres Therapeutics, Symbiota, Pronutria, and Moderna Therapeutics.

    Position summary:

    VL32, Inc. is seeking an exceptional, highly-motivated Senior Research Associate to play a key role in the company’s efforts to build a high throughput platform to allow application of drug discovery principles to the study of the microbiome.  This individual will join a dynamic, highly-collaborative team that combines significant drug discovery experience with leading edge knowledge of microbiome biology and computational approaches. 

    Key Qualifications

    • Proven hands-on experience with up to date synthetic chemistry techniques, particularly those associated with carbohydrate synthesis and degradation. 
    • Experience with modern carbohydrate analytical and purification methods, including anion exchange chromatography, size exclusion chromatography, MALDI mass spectrometry, and NMR spectroscopy
    • Ability to think critically and creatively as part of a fast-paced research team
    • Highly organized and detail-oriented individual with demonstrated ability to document procedures and results in a laboratory notebook
    • Degree in organic, medicinal, or food chemistry plus relevant industrial experience: Bachelor’s (plus 5-10 years industry experience) or Master’s (plus 3-5 years industry experience).
    • Excellent collaboration, communication and interpersonal skills

    Responsibilities

    • The successful candidate will work closely with senior personnel as well as independently to design and execute experiments that support research activities and project goals
    • Develop analytical methods for the characterization of a novel class of therapeutics
    • Design and synthesize bioactive chemical matter as part of a multi-disciplinary research team
    • Assist in the development of high throughput synthesis and purification workflows
    • Analyze data and generate oral and written reports on performed experiments. Present results to team

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    VL32, Inc. has an immediate opening for a Research Associate in chemistry.  VL32 is pioneering a novel category of therapeutics to systematically modulate the human microbiome for the treatment of disease and the promotion of health. VL32 was founded by VentureLabs, a unit of Flagship Ventures which has launched over 25 breakthrough companies including Seres Therapeutics, Symbiota, Pronutria, and Moderna Therapeutics.

    Position summary:

    VL32, Inc. is seeking an exceptional, highly-motivated Research Associate to play a key role in the company’s efforts to build a high throughput platform to allow application of drug discovery principles to the study of the microbiome.  This individual will join a dynamic, highly-collaborative team that combines significant drug discovery experience with leading edge knowledge of microbiome biology and computational approaches. 

    Key Qualifications

    • Bachelor’s or Master’s degree in organic, polymer, or food chemistry with a strong record of academic achievement
    • Experience with up to date synthetic chemistry techniques; industrial or academic research experience a plus (0-5 years)
    • Preferential consideration to candidates with experience in carbohydrate synthesis and analysis
    • Experience with modern analytical and purification methods, including HPLC, mass spectrometry, and NMR spectroscopy
    • Ability to think critically and creatively as part of a fast-paced research team
    • Highly organized and detail-oriented individual with demonstrated ability to document procedures and results in a laboratory notebook
    • Excellent collaboration, communication and interpersonal skills

    Responsibilities

    • The successful candidate will work closely with senior personnel to design and execute experiments that support research activities and project goals
    • Design and synthesize bioactive chemical matter as part of a multi-disciplinary research team
    • Reliably execute scale-up campaigns (100+ grams) to support on-going pre-clinical studies
    • Perform high-quality analytical chemistry to characterize novel chemical matter
    • Assist in the development of high throughput synthesis and purification workflows
    • Analyze data and generate oral and written reports on performed experiments. Present results to team

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    General Scope and Summary

    SAGE Therapeutics is searching for a creative, resourceful, integrative thinker and leader for a highly-visible role in the Nonclinical Development Department. The successful candidate will be responsible for designing and overseeing nonclinical safety testing programs for assigned clinical candidates.  They will also be a program leader leading a multi-disciplinary team to advance select compounds from development nomination through to first in human trials. The successful candidate will also help in the development of annual budgets and making strategic departmental decisions. This position regularly interacts in an independent manner with all levels and disciplines of the organization including Discovery Research, Clinical, Regulatory, CMC, Technical Operations, and Quality Assurance.

    Specific Roles and Responsibilities Include:

    • Independently lead a multi-disciplinary program team to advance select compounds from development nomination through to IND/CTA filing and initiation of Phase 1 clinical trials.
    • Collaborate with Discovery Research in the screening and selection of candidate compounds for progression into development
    • Design safety testing programs (including safety pharmacology and toxicology testing) for assigned IND/CTA and clinical stage candidates
    • Contract research laboratory (CRO) selection/study director interactions/monitoring, study result interpretation, and report finalization
    • Serve as lead Nonclinical representative on select program teams/subteams
    • Prepare all relevant nonclinical regulatory documents including written and tabulated study summaries in Common Technical Document (CTD) format, Annual Reports, Investigator Brochures, integrated summaries for regulatory submissions, and respond to queries from Regulatory Authorities
    • Determine qualified levels of impurities to set drug substance/drug product specifications at all stages of clinical development
    • Participate in regulatory meetings/interactions. Prepare nonclinical CTD summaries for NDA/MAA filings and respond to queries from Regulatory Agencies

     Experience, Education and Specialized Knowledge and Skills

    • Ph.D. with 8+ years as a toxicologist within the pharmaceutical industry; DABT certification and experience in safety pharmacology and pharmacokinetics preferred
    • Experience in drafting nonclinical written and tabulated CTD sections for worldwide regulatory submissions
    • Working knowledge of GLP requirements and worldwide guidelines for nonclinical safety testing
    • Strong leadership skills; ability to independently lead a multi-disciplinary team
    • Strong analytical, leadership, as well as written and verbal communication skills
    • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
    • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient
    • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
    • Strong team player that has a customer service approach and is solution oriented
    • Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
    • Travel will be required and is anticipated at a maximum of 20%

     


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  • 11/23/15--04:49: Cell culture scientist
  • bioVolutions is a rapidly growing Massachusetts Contract Development and Manufacturing Organization (CDMO) specializing in Perfusion-based Cell Culture for rapid biologics production. The successful candidate will assist our lead scientist in implementing state-of-the-art projects in a fast paced environment. Competitive salary and benefits included. Please send your resume to info@biovolutions.com. 


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  • 11/23/15--04:50: Cell culture scientist
  • bioVolutions is a rapidly growing Massachusetts Contract Development and Manufacturing Organization (CDMO) specializing in Perfusion-based Cell Culture for rapid biologics production. The successful candidate will assist our lead scientist in implementing state-of-the-art projects in a fast paced environment. Competitive salary and benefits included. Please send your resume to info@biovolutions.com. 


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  • 11/23/15--06:34: Director, Data Management
  • The Director, Data management, provides oversight of Clinical Data Management and Data Standards operations, including budget oversight, hiring personnel, managing personnel matters, and conducting performance evaluations for relevant staff. With the Manager and/or Associate Director, as applicable, the Director, Data Management, provides oversight of training activities to ensure that Clinical Data Management and Data Standards personnel receive adequate training to perform job responsibilities. The Director, Data Management, assists with resource allocation and the development of business proposals related to Data Management and Data Standards.  The Director, Data Management provides oversight of project-related data management and data standards tasks, and performs project-related tasks, as required.

     

    Primary Duties + Responsibilities

    • Develop and manage the yearly departmental budget for Data Management and Data Standards.  Meet with finance and the Executive team on a regular basis to present status updates on the department including the budget, resources, and process improvement initiatives.
    • Work with Clinical Data Managers (CDMs) and Data Standards Programmers to routinely monitor project activities against scopes of work to ensure operations are consistent with scope and assist with identifying changes in project scope or efficiencies to maintain timelines and budget.
    • Evaluate and monitor resources and develop resource allocation plan for all projects.
    • In concert with other senior staff, assess staffing and compensation requirements, assist in hiring and ensure appropriate training of Data Management and Data Standards personnel.
    • Support the development and implementation of Data Management and Data Standards Standard Operating Procedures (SOPs), guidelines, policies, procedures and ensure personnel are trained appropriately.
    • Oversee the implementation and management of data management systems and evaluate process improvements and innovative methods for clinical data management.
    • Interact with clients to provide a high standard of customer service and ensure complete understanding of Veristat’s data management and data standards responsibilities.
    • Represent Data Management and Data Standards in marketing efforts by developing project bid proposals, participating at bid defense meetings or performing client presentations as requested.
    • Facilitate communication and promote teamwork among team members.
    • Maintain a good working knowledge of clinical drug development, data management and data standardization in order to effectively serve as a department resource, develop training materials for Data Management and Data Standards personnel, conduct training sessions or otherwise enhance the skills and expand the knowledge of department personnel.

     

    Experience + Requirements

    • 10+ years of directly-related clinical data management/data standards or related experience; 3+ years of supervisory experience, to include data management and/or clinical operations.
    • Bachelor’s Degree required; focus in a health-related field or Registered Nursing degree preferred.
    • Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines (e.g., CDISC SDTM Implementation Guideline) as well as of medical terminology, clinical trials, and clinical research all required.
    • Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical/biotech companies.
    • Skilled in use of computer technology, including clinical trial databases and applications and ability to learn new applications.

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    The Senior Data Standards Programmer conducts CDISC SDTM programming activities for clinical research projects from study start-up through submissions to regulatory agencies, works collaboratively across departments to produce quality deliverables within an agreed project timeline and budget, and assists with development and maintenance of optimal strategies to increase productivity and quality, while decreasing cycle times and costs. The Senior Data Standards Programmer may also serve as an SDTM migration lead within a project and/or program and provide guidance and expertize to clients and vendors on how to resolve technical issues at both a project and program level.   

     

    Primary Duties + Responsibilities

    • Participate on projects dealing with the assessment, design and/or implementation of data standards (e.g. CDISC SDTM and CDASH).
    • Perform Gap Analysis on studies requiring migration to CDISC standards to ensure all documentation and datasets necessary to perform the migration activities are present and without issue. Work with the migration team and client to resolve any issues.
    • Annotate case report forms (CRFs) according to the CDISC Implementation Guideline for migration to SDTM.
    • Follow standardized SDTM migration programming procedures to create quality Standard Data Tabulation Model (SDTM) compliant SAS datasets and Define.XML documents.
    • Assist in the development of Standard Operating Procedures (SOPs) and standard documents related to the implementation of data standards.
    • Ensure review of applicable project deliverables (e.g. protocol, case report forms, annotated case report forms, database structure, and statistical analysis plan) for consistency with data standards.
    • Liaise with Data Management, Biostatistics, and Programming personnel.
    • Assist with time and resource management for the completion of deliverables. Assist in the development and maintenance of a metadata repository.

     

    Experience + Requirements

    • Bachelor’s degree in a science or related field required. Master’s degree preferred.
    • At least 5 years of CDISC implementation experience and at least 5 years of SAS programming experience. Knowledge of XML programming is a plus.
    • Excellent working knowledge of CDISC SDTM Implementation Guidelines/Process.
    • Excellent knowledge of regulatory requirements and drug/device development process, especially on electronic data submissions requirements.
    • Extensive exposure to clinical trial data, SAS datasets, and database specifications.

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  • 11/23/15--06:41: Sourcing Analyst
  • CLIENT: BIOTECH COMPANY

    Compensation: $$$

    Position Summary  

    • The Sourcing Analyst will work closely with Category Managers in the Global Procurement organization to develop complex sourcing events.
    • This will involve building e-sourcing events by inputting large data sets into an advanced sourcing optimizer tool, and then running these live events with external parties.
    • Once the event returns with supplier responses and bids, the analyst will leverage the optimizer tool for deep analysis of data collected.
    • This includes developing various business scenarios based on guidance from the Category Manager, the business stakeholder and the individual’s own insights from reviewing the data.
    • These large sourcing events involve the purchase of goods or services for categories including but not limited to Marketing, IT Hardware and Software, Professional Services, Human Resources, Finance, R&D, Raw Materials and Facilities..
    • Candidate should have strong business communication skills and be comfortable working with large data sets. This includes strong Microsoft Excel and PowerPoint skills.
    • Ability to learn new processes and systems quickly will be very beneficial.
    • Any experience in a procurement or sourcing role with a pharma/ biotechnology company is preferred.
    • Candidate should also be very comfortable with current technologies.

    Primary Responsibilities

    • Build online sourcing events within the sourcing optimizer tool under the guidance of Category Managers and internal stakeholders
    • Build reports and presentations providing the status of sourcing events and present these updates to relevant stakeholders
    • Prepare event summary reports and recommend various purchase scenarios based on data collected
    • Support suppliers and external parties to answer questions and facilitate their bid submission
    • Communicate with the software provider to resolve any technical issues
    • Maintain an archive of detailed and organized records of completed sourcing events, and leverage this data to support future events.
    • Work with Sourcing team to help enforce Global Procurement Policy across the organization.

    Experience and Qualifications

    • Proven experience with detailed data analysis
    • Ability to quickly assess and draw conclusions from complex data sets
    • Advanced Microsoft Excel knowledge, and proficient with other MS Office products including Outlook and PowerPoint
    • Detail oriented, with a track record of completing projects on time
    • Exceptional interpersonal, organizational, and verbal and written communication skills
    • Team player with a positive attitude and ability to hit the ground running

    Requirements          

    • Bachelor’s degree required, analytical-focused degrees preferred.
    • 2+ years of experience

    Knowledge of:

    • Typical Sourcing/buying practices, including the RFx process
    • E-Sourcing software
    • Supply Chain/Procurement principles and practices

    Skill and Ability to:

    • Communicate clearly through verbal and written communication
    • Work independently toward goals, and manage multiple projects simultaneously
    • Analyze complex data sets based on guidance from others and based on your own insights

    Supplemental Functions:

    • Support our contract lifecycle process as necessary or assigned.
    • Perform other job related duties as necessary or assigned to assist Global Procurement operations.

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    About the role:

    • Define and drive the process development strategy for creating robust bioreactor processes for the production of lentivirus in HEK293 cells that are suitable for cGMP production.
    • Apply engineering concepts to the scale up and scale down of mammalian cell culture processes, including transient transfection.
    • Design and apply DOE studies to develop and characterize cell culture processes.
    • Mentor and lead lab activities to troubleshoot activities with associate scientists in the lab. 
    • Lead technology transfer of developed process to an external GMP CMO.
    • Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs as needed.

    About you:

    • BS in (Bio)Chemical engineering or biological sciences with 10+ years, MS with 8+ years, or a PhD with 2+ years of industrial experience in mammalian cell culture process development.
    • Experience with bioreactor operation and troubleshooting at multiple scales is required.
    • Experience with technical transfer to pilot plant or cGMP manufacturing for clinical stage products is preferred.
    • Experience with vaccine manufacturing or virus production is preferred.
    • Familiarity with the following a plus: cell line development, gene therapy, disposable reactors, AMBR bioreactors, media development, perfusion, and depth filter clarification.
    • Should be highly motivated, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
    • Ability to execute and follow-through to completion and documentation.Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
    • Independently motivated, detail oriented and good problem solving ability.
    • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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  • 11/23/15--08:42: Financial Analyst
  • Job Description:

    Assist Manager/Senior Manager/Director in leading financial plan and close cycles for income statement areas of responsibility. Lead financial planning and analysis support for assigned functions. Manage monthly financial close and variance analysis for assigned functions. 


    ACCOUNTABILITIES:

    • Lead semi-annual financial planning processes for assigned functional teams, resulting in highly accurate submissions including cost center detail, management presentation book page summaries and supporting analyses as required. 
    • Develop financial models and analytical tools to support function objectives and projects. Assist driving strategic decisions through NPV analysis, ROI modeling, and other financial metrics. Provide critical thought that may help drive strategic decisions and make recommendations to Senior Management. 
    • Serve as financial representative on key cross-functional teams and proactively provide support and advisory services. 
    • Drive the development and use of the financial planning system for assigned functions. Create, leverage and deploy financial models for own use and those of other finance staff. Document models and processes and work to creatively and continuously improve the planning process. 
    • Manage the monthly financial close process including identifying and resolving discrepancies in actual transactions in SAP versus planned activity and instructing accounting to initiate correcting entries as necessary, on an ongoing basis. 
    • Work with local and regional finance teams to develop detailed explanation for variances between actual and plan on a monthly basis for assigned functional areas. 
    • Design and distribute monthly reporting packages to senior management, summarizing functional area financial results. Design and implement solutions to streamline processes and create operational efficiencies. Educate functional management on the use of reporting tools and finance concepts. 
    • Additional duties and responsibilities as assigned.


    Minimum 1-3 years experience as financial analyst.
    SAP knowledge is a high on the requirement list


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    SAGE Therapeutics is searching for a creative, resourceful, integrative thinker and leader for a highly-visible role in the Nonclinical Development Department. The successful candidate will be responsible for designing and overseeing nonclinical safety testing programs for assigned clinical candidates.  They will also be a program leader leading a multi-disciplinary team to advance select compounds from development nomination through to first in human trials. The successful candidate will also help in the development of annual budgets and making strategic departmental decisions. This position regularly interacts in an independent manner with all levels and disciplines of the organization including Discovery Research, Clinical, Regulatory, CMC, Technical Operations, and Quality Assurance.

    Specific Roles and Responsibilities Include:

    • Independently lead a multi-disciplinary program team to advance select compounds from development nomination through to IND/CTA filing and initiation of Phase 1 clinical trials.
    • Collaborate with Discovery Research in the screening and selection of candidate compounds for progression into development
    • Design safety testing programs (including safety pharmacology and toxicology testing) for assigned IND/CTA and clinical stage candidates
    • Contract research laboratory (CRO) selection/study director interactions/monitoring, study result interpretation, and report finalization
    • Serve as lead Nonclinical representative on select program teams/subteams
    • Prepare all relevant nonclinical regulatory documents including written and tabulated study summaries in Common Technical Document (CTD) format, Annual Reports, Investigator Brochures, integrated summaries for regulatory submissions, and respond to queries from Regulatory Authorities
    • Determine qualified levels of impurities to set drug substance/drug product specifications at all stages of clinical development
    • Participate in regulatory meetings/interactions. Prepare nonclinical CTD summaries for NDA/MAA filings and respond to queries from Regulatory Agencies

     Experience, Education and Specialized Knowledge and Skills

    • Ph.D. with 8+ years or MS with 10+ years as a toxicologist within the pharmaceutical industry; DABT certification and experience in safety pharmacology and pharmacokinetics preferred
    • Experience in drafting nonclinical written and tabulated CTD sections for worldwide regulatory submissions
    • Working knowledge of GLP requirements and worldwide guidelines for nonclinical safety testing
    • Strong leadership skills; ability to independently lead a multi-disciplinary team
    • Strong analytical, leadership, as well as written and verbal communication skills
    • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
    • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient
    • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
    • Strong team player that has a customer service approach and is solution oriented
    • Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
    • Travel will be required and is anticipated at a maximum of 20%

     


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    Infinity is seeking a highly motivated individual to join the Purchasing/Procurement team. In this role you will be responsible for working cross-functionally on all purchasing related activities including but not limited to purchase orders, order inquiry, order placement, fulfillment, follow up post-delivery and invoice payment.  In this heavily customer oriented position, you will work cross-functionally to provide high quality customer service to our research, development and general business functions. This is a contract role with the potential to convert to permanent.

     

    Responsibilities:

    • Provides support for assigned departments including assistance with general operational activities (administrative support, supplier evaluations, ad hoc projects such as research assistance, responding to queries, drafting & delivery of presentation materials).
    • Supports existing processes, and develop process improvements to enhance departmental productivity and efficiency.
    • Works with Strategic Sourcing and Legal team members as part of the contracting process (i.e. Purchasing Contracts, RFPs, RFQs) for all vendors.
    • Understands and communicates department policies and procedures, particularly related to Sarbanes-Oxley (SOX) requirements.
    • Resolves basic contract and purchase order differences with suppliers.
    • Partners with Accounts Payable on resolving any invoice discrepancies.
    • Reviews requisitions in accordance with business requirements and budgets.
    • Assists in preparing RFPs and soliciting competitive bids, quotations and proposals with pertinent specifications, terms and conditions for all goods.
    • Expedites deliveries and conduct follow-up procedures when necessary.
    • Maintains agreement files, equipment records and/or specifications.
    • Prepares periodic activity reports.
    • Assisting in organizing annual information on capital equipment, expenditures, service contract renewals, etc. for annual budget process.

    Qualifications

    The qualified individual will be a highly motivated self-starter that works well both in teams as well as independently. 

    • Bachelor or Associate Degree, or equivalent work experience, plus 3-5 years’ experience in functional area (e.g. purchasing, strategic sourcing, etc.) or related field.
    • Excellent verbal, written and oral communication skills.
    • Strong attention to detail.
    • Demonstrated success working in a team environment.
    • Flexibility and ability to react promptly to multiple short term deadlines and manage competing priorities.  Proven ability to manage multiple projects / tasks effectively.
    • Ability to function independently on basic research projects, including sourcing/procurement of equipment/supplies.
    • Strong computer skills required: Microsoft Word, Excel, Outlook and PowerPoint.
    • Knowledge of Oracle and various reporting tools or similar systems preferred.
    • Fundamental knowledge of Sarbanes-Oxley (SOX) in a biotech/pharmaceutical company preferred
    • Excellent customer service skills, both internally and externally.

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


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  • 11/22/15--22:33: Quality Control Analyst IV
  • My 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™


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