Scientist/Senior Scientist, Process Development

17 hours ago

Waltham MA United States Muraloncology Full time
Scientist/Senior Scientist Process Development

Job Category: Research and Discovery

Requisition Number: SCIEN001055

  • Posted: October 3, 2024
  • Full-Time
Locations

Location: Waltham, MA 02451, USA

Description

At Mural Oncology , we are leveraging our industry-leading protein engineering platform to reimagine cytokine-based immunotherapies for the treatment of cancer. For more information, please visit Mural Oncology’s website at .

The Mural Oncology team brings together oncology expertise and passion to make an impact on patients' lives. We are seeking a highly motivated and experienced data professional to join our team.

Position Summary:

This position will execute the development of novel active pharmaceutical ingredients (API) within the immuno-oncology biologics pipeline from the early Process Development stage through GMP production (Clinical Phase 1-3). The candidate will join a diverse and dynamic team of experienced scientists and engineers in a brand-new lab space.

They will support internal purification process development (downstream) and will support technical oversight for associated activities occurring at external contract development and manufacturing organizations (CDMOs).

A solid background in biological engineering is required with a focus on column chromatography, tangential flow filtration, viral clearance strategies, scale-up, and technology transfer. The successful candidate will have experience working with biological entities (e.g., mAbs, fusion proteins), resins in flow-through and bind-and-elute mode. Experience with high throughput chromatography systems is highly desirable. The incumbent is expected to integrate Design of Experiments (DoE) principles, implement experimental design with a focus on process understanding and robustness, interpret data, participate in cross-functional teams, and write technical reports.

The candidate should have strong communication and interpersonal skills, be able to multi-task, and have a commitment to continuous learning.

The appointment will be at the Scientist or Senior Scientist level, commensurate with experience. The incumbent is expected to spend ~80% of their time in the wet lab.

Responsibilities include but are not limited to:

  • Operate process development equipment following applicable site safety guidelines
  • Prepare buffers/solutions to support small scale experiments
  • Support scale-down model qualification and process characterization efforts, including impurity clearance studies in preparation of process performance qualification (PPQ)
  • Hands-on wet lab execution of small-scale chromatography runs for different resins and modalities
  • Develop and execute filtration studies
  • Design and execute resin screening studies for early process development of novel assets
  • Support technology transfer to and production at CDMOs
  • Contribute to technical oversight of downstream development activities at CDMOs
  • Closely interact with Upstream team and support implementation of harvest methodologies (depth filtration, sterile filtration)
  • Implement scale-up strategies for all downstream unit operations internally and at CDMOs with a focus on process understanding, identification of critical process parameters, and process optimization
  • Keep abreast with new technologies in the field, and identify, implement, and deploy novel technologies where aligned with business needs
  • Write technical reports and deliver presentations to technical, CMC and broader project groups

Minimum Education & Experience Requirements:

  • A degree in Biological, Chemical, or Industrial Engineering is required. The appointment will be made commensurate with experience:
    • Process Development Scientist: Ph.D. with 3+ years or M.S. with 5+ years or B.S. with 8+ years
    • Process Development Senior Scientist: Ph.D. with 5+ years, or M.S. with 8+ years, or B.S. with 10+ years.

Knowledge/Skills Needed:

  • Team player with good interpersonal skills
  • Excellent written and oral communication
  • Experience with different chromatography unit operations and modalities is a must
  • Hands-on experience in designing, optimizing, and executing novel bioprocesses
  • Proven ability to apply scientific principles to design, execute, and interpret experiments

Additional Desired Knowledge/Skills:

  • Experience with statistical design of experiments (DoE) strongly preferred
  • Tech transfer experience
  • Process Characterization experience
  • Experience with automated and semi-automated unit operations
  • Pilot lab or pharmaceutical cGMP manufacturing experience

Personal Attributes Needed:

  • Motivated self-starter
  • Ability to work independently
  • Ability to travel (15%, for CDMO visits/person-in-plant)

Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Mural Oncology also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Mural Oncology is an E-Verify employer.

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