PD (Ops) Senior Scientist – Materials Attributes and Technologies (Framingham, MA) - Replimune

Replimune Group

Framingham, MA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 05/24/2021
  • Website: replimune.com
  • Company Address: 18 Commerce Way, Woburn, MA, 01801

About Replimune Group

Replimune is working to advance the science of oncolytic immunotherapy to improve on existing therapies and help treat more patients with a variety of tumor types. Oncolytic immunotherapy uses viruses that have been modified to selectively replicate in and kill tumors.

Job Description


About the job

Key Responsibilities

    Serve as a materials subject matter expert to support manufacturing operations with technical evaluation of change controls, deviations, corrective, and preventative actions, and supplier change notifications.

    Lead technical material risk assessments to consider impact to supply, processes, products, and customers

    Build and oversee a material trending program to monitor material performance, potential process performance shifts as a result of change notifications, and consistency of quality attributes.

    Lead process characterization experiments and process validation exercises.

    Provide technical expertise to troubleshoot material issues within drug substance and drug product production. Be an active permanent member of site material review board.

    Drive continuous improvement in our cGMP process steps by identifying and implementing process improvements through technological innovation and application of alternative technologies

    Collaborate with QC Analytical team to evaluate, test, and assess extractables and leachables from plastic component materials used in the production process
    Actively contribute to cross functional teams to achieve production site and company goals in support of commercial production readiness
    Assist with authoring sections of applicable regulatory filings
    Additional duties and responsibilities as required

Other Responsibilities

    Practices and promotes safe work habits and adheres to safety procedures and guidelines
    Provide technical representation during internal and external audits
    Keeps up to date with current technologies and trends in biologics manufacturing operations and support

Education Requirement

    Master’s degree in applicable field (chemical engineering, materials science, etc.) and 4 to 6 years of related work experience

OR

    Bachelor’s degree in applicable field (chemical engineering, materials science, etc.) and 6 to 8 years of related work experience

Experience And Skills Requirements

    Minimum of 2 year working in a materials science role, preferably in a biologics drug substance and/or drug product process development / manufacturing support role.
    Experience with single-use manufacturing technologies
    Demonstrated ability to work in cross-functional teams across the business.
    Strong organizational skills and attention to detail.
    Excellent written and oral communication skills and strong team player

EEO & Employment Eligibility

Replimune 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, ancestry origin, disability or veteran status. Replimune 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.

Recruitment/Staffing Agencies

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.