Process Research Director jobs in Worcester, MA

Process Research Director manages the design and implementation of manufacturing processes. Researches and develops methods to increase productivity, decrease costs, maintain quality and consistency in current products, and discover new products. Being a Process Research Director requires a bachelor's degree. Typically reports to a top management. The Process Research Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Process Research Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Associate Director Process Validation
  • EasyHiring
  • Groton, MA FULL_TIME
  • We are a recruiting company EasyHiring, which is looking for candidates for our partners for a position Associate Director Process Validation in Groton, MA to work in the Devens, MA.

    Position Summary

    Come, join the Cell Therapy Development & Operations (CTDO) Division, and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies. The Viral Vector Commercial Network Manufacturing Science and Technology (MS&T) group plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.

    We are looking for an Associate Director for our Viral Vector Commercial Network group. The successful candidate will lead efforts related to vector manufacturing technologies from process performance qualification to GMP manufacturing. The Associate Director will be responsible for overseeing the lifecycle management, process robustness initiatives, process monitoring, manufacturing technical support, including cross-departmental collaboration to enable facility fit of new technologies, development of process documentation (Batch Records, Forms, etc.), training of personnel, change control ownership, and other quality system related deliverables as well as development and support of PPQ strategies and commercial manufacturing. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Associate Director will play a key role in product lifecycle management, including strategic development, characterization, commercialization, and evolution of cell therapy products. This position reports to the Senior Director of the Viral Vector Commercial Network group.

    Key Responsibilities

    • Lead MS&T activities at the viral vector manufacturing site to establish uninterrupted commercial vector manufacturing and supply.
    • Leads, Manages, and Coaches process engineers.
    • Develop and implement validation policies to define robust process validation program within the cell therapy product lifecycle.
    • Participate in generation and approval of PPQ enabling deliverables generated during late-stage process development and characterization.
    • Author CMC content for regulatory filings and participate in formal agency meetings.
    • Coordinate responses to health authority questions on process validation that require a coordinated response or implementation across cell therapy manufacturing.
    • Establish the foundation for technical process leadership for routine commercial batches and on time closure of all quality system records such as deviations, CAPAs and change controls.
    • Lead the development, understanding, and management of tools/templates to monitor vector manufacturing process performance and lead the understanding and improvement of process capability.
    • Deliver the implementation and execution of process control strategies, including execution of process risk assessments and continued process verification (CPV) thereby ensuring the manufacturing process is in a state of control.
    • Ensuring compliance with internal standards and regulatory requirements for process and production related investigations.
    • Develop and maintain strong relationships with the manufacturing site and their vendors.
    • Ensure permanent inspection readiness and actively support regulatory inspections.
    • Lead and deliver on harmonization across the cell therapy manufacturing network.
    • Share operational best practices and process learning with the rest of the manufacturing network.

    Qualifications & Experience

    • Degree in Biochemical, Chemical, Biomedical Engineering or Cell Biology/Immunology discipline with 8 years of experience
    • Experience with cellular therapies is desired but not required.
    • Prior management experience desired.
    • Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, manufacturing support and technology transfer.
    • Flexibility to work within manufacturing schedules and ability to travel to manufacturing site.
    • Ability to work in a self-driven, performance/results oriented, fast paced matrix environment. Excellent communication, writing, sense of urgency, teamwork, and presentation skills.
    • Proven project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required.
    • Strong interpersonal skills required to work with teams in different functions and organizations.
    • Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
    • Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab) strongly suggested.
    • Detail oriented with excellent verbal and written communication skills.

    Travel 20-30% of the time is possible.

    Job Type: Full-time

    Work Location: On the road

  • 18 Days Ago

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Associate Director Process Validation
  • EasyHiring
  • Marlborough, MA FULL_TIME
  • We are a recruiting company EasyHiring, which is looking for candidates for our partners for a position Associate Director Process Validation in Marlborough, MA to work in the Devens, MA.Position Summ...
  • 17 Days Ago

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Senior Research Scientist; Cell Line Process Development
  • Careers|CURIA
  • Hopkinton, MA FULL_TIME
  • SENIOR RESEARCH SCIENTIST, CELL LINE PROCESS DEVELOPMENT in Hopkinton, MA Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. We are ...
  • 13 Days Ago

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Clinical Research Project Director
  • UMass Chan Medical School
  • Worcester, MA FULL_TIME
  • PLEASE APPLY DIRECTLY TO THE JOB LISTING HERE: https://careers-umms.icims.com/jobs/43517/research-project-director/job?mode=view GENERAL SUMMARY OF POSITION: Under the general direction of the Princip...
  • 3 Days Ago

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Research Project Director
  • UMass Med School
  • Worcester, MA FULL_TIME
  • Research Project Director Minimum Salary US-MA-Worcester Job Location 2 weeks ago(5/19/2023 12:19 PM) Requisition Number 2023-43517 # of Openings 1 Posted Date Day Shift Exempt Overview GENERAL SUMMAR...
  • 1 Month Ago

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Research Project Director
  • University of Massachusetts Medical School
  • Worcester, MA OTHER
  • Overview GENERAL SUMMARY OF POSITION: Under the general direction of the Principal Investigator or designee, the Research Project Director is responsible for coordinating the daily operations of child...
  • 1 Month Ago

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0 Process Research Director jobs found in Worcester, MA area

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Head of Research Services
  • Harvard University
  • Cambridge, MA
  • Basic Qualifications * ALA accredited master's degree in library science/information science/archives or equivalent educ...
  • 3/28/2024 12:00:00 AM

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Director, preclinical Research
  • CardioFocus
  • Marlborough, MA
  • Job Title: Director, Preclinical Research CardioFocus is recruiting for a Director, Preclinical Research, based in Marlb...
  • 3/28/2024 12:00:00 AM

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Senior Clinical Research Director, I&I (GI)
  • Sanofi
  • Cambridge, MA
  • Senior Clinical Research Director, Early Development The Senior Clinical Research Director (Sr CRD) supports several ear...
  • 3/28/2024 12:00:00 AM

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Sr. Research Director, Statistics, Psychometrics, and Assessment Innovations
  • Boston College
  • Chestnut Hill, MA
  • Boston College Introduction Founded in 1863, Boston College is a Jesuit, Catholic university located six miles from down...
  • 3/28/2024 12:00:00 AM

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Associate Director, Animal Research Protection Program
  • Brown University
  • Providence, RI
  • Job Description: About Brown Brown University (https://www.brown.edu/about) is a leading research university distinct fo...
  • 3/27/2024 12:00:00 AM

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Head of Research Operations
  • Takeda
  • Cambridge, MA
  • Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Take...
  • 3/24/2024 12:00:00 AM

Neuroscience Research Director
  • 先声药业
  • Cambridge, MA
  • Simcere Pharmaceutical Group is a pharmaceutical company driven by innovative R&D. We are committed to "Providing Today'...
  • 3/24/2024 12:00:00 AM

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Dir/ Senior Director, Clinical Research Scientist 2020393
  • Stratacuity: Proven Scientific Placement
  • Waltham, MA
  • Location: Waltham, MA (Hybrid) Therapeutic Area: Immuno-oncology Job Overview: Seeking a Clinical Research Scientist wit...
  • 3/24/2024 12:00:00 AM

Worcester has a total area of 38.6 square miles (100 km2), 37.6 square miles (97 km2) of land and 1.0 square mile (2.6 km2) (roughly 2.59%) of water. Worcester is bordered by the towns of Auburn, Grafton, Holden, Leicester, Millbury, Paxton, Shrewsbury, and West Boylston. Worcester is known as the Heart of the Commonwealth, because of its proximity to the center of Massachusetts. The city is about 40 miles (64 km) west of Boston, 50 miles (80 km) east of Springfield, and 38 miles (61 km) northwest of Providence, Rhode Island. The Blackstone River forms in the center of Worcester by the conflue...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Process Research Director jobs
$186,601 to $270,660
Worcester, Massachusetts area prices
were up 1.6% from a year ago

Process Research Director in Birmingham, AL
In many ways, research starts with a problem that management is facing.
December 24, 2019
Process Research Director in Binghamton, NY
Our primary research team communicates directly with people involved in deals to validate information and gather hard-to-find details.
January 21, 2020
Process Research Director in Bergenfield, NJ
The chart shown in Figure well illustrates a research process.
January 01, 2020