Iovance Biotherapeutics

Iovance Biotherapeutics

Manager, Manufacturing Operations

Philadelphia, Pennsylvania · Senior · Contract

Sponsorship not specifiedDetected 13 days ago
Project ManagementSupply ChainHRPerformance ManagementHRISIntellectual PropertyGMPFDA RegulatoryCRISPRCell CultureLaTeXLeadershipCommunicationProblem SolvingMentoringWritingOSHAGxP

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odds of building a lasting career here

37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 408 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • This individual is directly responsible for the teams whose goals are to produce products on the manufacturing floor.
  • The Manufacturing Manager is also responsible for the development of staff, to accommodate Iovance's needs as a growing organization.
  • Week 1: Shift A: Sunday to Wednesday from 1700 to 0430

Responsibilities

  • Oversees the Manufacturing Operations team to support clinical and commercial production.
  • Develop schedules for manufacturing that meet monthly and quarterly targets. Ensure resources are adequate to complete operations and fully optimized from an operational excellence perspective.
  • Lead critical level investigations as related to the manufacturing and initial validation steps. Approve deviations, non-conformances, and CAPAs as Partner with Quality to address these issues effectively and compliantly.
  • Identify, lead, and implement continuous improvement opportunities for process and production related items.
  • Continuously seek and support new approaches, practices, and processes to improve the efficiency and effectivity of the operation.

Requirements

  • When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
  • Minimum BS. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • Demonstrated technical knowledge of aseptic processing in cleanroom environments a
  • Solid knowledge of FDA regulations and GMP.
  • Solid knowledge of human error reduction strategies, and right-first time execution.

Nice to have

  • Ensure resources are adequate to complete operations and fully optimized from an operational excellence perspective.
  • Expert level in visual management, KPIs, huddle boards etc.
  • A highly effective "First time right" program is required for autologous cell
  • Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per
  • Supervision and development of direct reports, mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
  • Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.
  • Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
  • Ensure the department understands and complies with quality standards and requirements as documented.

Skills

  • Demonstrated project management Excellent oral and written communication skills. Strong technical writing ability.

Benefits

  • Develop and provide monthly manufacturing metrics and "Health of the Operations"

Company info

  • In this postion, one provides guidance and oversite to the process and production as well as timely document review, ensuring material is made in a safe and compliant manner and meeting company targets.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA

Equal opportunity

  • If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
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This listing is sourced directly from Iovance Biotherapeutics's careers page and normalized into a canonical job model.