Supervisor, Manufacturing Specialist

2 months ago

Philadelphia, United States Planet Pharma Full time

Overview

The Supervisor, Manufacturing Specialist oversees the manufacturing specialist group. This role will execute manufacturing change management at the facility, including manufacturing investigations, document authoring / editing and deviation management. The Supervisor will also oversee special projects related to continuous improvement or new product introduction in support of the manufacturing group.

Essential Functions and Responsibilities

  • Oversees and manage day to day activities of the Manufacturing Specialist Group.
  • Responsible to lead deviation and investigations related to manufacturing operations.
  • Review deviations, non-conformances, and CAPAs as required.
  • Partners with Quality and other cross-functional groups to address issues effectively and compliantly.
  • Manages external contractors who support deviation investigations and closure for manufacturing operations.
  • Coordinates with team members responsible for procedure and batch record changes to support remediation, continuous improvement, or new product introduction across clinical and commercial value streams.
  • Develops and provides monthly operations metrics and indicators focused on specialist team performance and across manufacturing value streams.
  • Identifies and manages projects for continuous improvement opportunities in manufacturing operations in collaboration with the Operational Excellence group and other manufacturing management members.
  • Maintains team capability and readiness via training, performance reviews, and hiring new manufacturing specialist when necessary.

Required Education, Skills, and Knowledge

  • Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
  • A minimum of 3 - 5 years of relevant operations experience for clinical and commercial production in the life sciences industry.
  • A minimum of 1 year in a supervisory role or corresponding experience in people management.
  • Solid knowledge of FDA regulations and GMP systems.
  • Solid knowledge of human error reduction strategies, right-first time execution, and just culture.
  • Demonstrated project management skills;
  • Excellent oral and written communication skills. Strong technical writing ability required.
  • Ability to motivate and mentor peers and staff as well as foster a culture of continuous improvement and operational excellence.
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description.
  • Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

Preferred Education, Skills, and Knowledge

  • Experience with cell therapy products is a plus.
  • PMP certification is preferred.
  • Fluent in Microsoft Project or comparable software is preferred.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

  • Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
  • Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
  • Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Must be able to lift and carry objects weighing 45 pounds.

Mental:

  • Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

Work Environment:

  • This position will work in both an office and a manufacturing lab setting.
  • When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
  • Able to work in cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors.

  • Manufacturing Operations Supervisor

    3 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Operations Supervisor to oversee the manufacturing specialist group at Planet Pharma. This role will execute manufacturing change management, including investigations, document authoring, and deviation management.Key ResponsibilitiesOversee and manage day-to-day activities of the Manufacturing...

  • Aseptic Manufacturing Training Program Supervisor

    4 weeks ago

    Philadelphia, Pennsylvania, United States R&D Partners Full time

    Job OverviewThe Aseptic Manufacturing Training Supervisor will oversee the development and execution of training programs for the aseptic manufacturing team. This role requires a strong background in cell culture, aseptic technique, and processing, as well as experience in leading and mentoring a team of training specialists.Key Responsibilities:Develop and...

  • Manufacturing Technician

    3 weeks ago

    Philadelphia, Pennsylvania, United States bioMerieux Inc. Full time

    A world leader in in vitro diagnostics, bioMerieux provides diagnostic solutions to improve patient health and consumer safety.As a Manufacturing Technician - Cassette Assembly Specialist, you will be responsible for manufacturing and assembling Commercial Products, specifically focused on Veriflow cassette assembly.Key duties include:Manufacturing and...

  • Manufacturing Documentation Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job Title: Manufacturing Documentation SpecialistPlanet Pharma is seeking a highly skilled Manufacturing Documentation Specialist to join our team. This role will be responsible for supporting the manufacturing process by creating and maintaining accurate and up-to-date documentation.Key Responsibilities:Support the manufacturing process by creating and...

  • Manufacturing Operations Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    MSAT Specialist RoleThe MSAT Specialist is a key member of the Planet Pharma team, responsible for ensuring the smooth operation of manufacturing processes. This role requires a strong understanding of cell culture and aseptic technique, as well as expertise in GMP systems within a manufacturing facility.Key ResponsibilitiesServe as a technical SME...

  • Manufacturing Documentation Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job Title: Manufacturing Documentation SpecialistAbout the Role:We are seeking a highly skilled Manufacturing Documentation Specialist to join our team at Planet Pharma. As a key member of our manufacturing operations team, you will be responsible for ensuring the accuracy and completeness of documentation related to our biopharmaceutical manufacturing...

  • Manufacturing Operations Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job Title: Manufacturing SpecialistPlanet Pharma is seeking a highly skilled Manufacturing Specialist to join our team.Job Summary:The Manufacturing Specialist will be responsible for supporting documentation, leading teams investigating nonconformances, and managing change controls associated with manufacturing areas and equipment.Key...

  • Supervisor, Aseptic Manufacturing Operations

    3 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryJoin Iovance Biotherapeutics Inc as a Supervisor, Aseptic Manufacturing Operations, where you will oversee the production process to ensure safe and compliant manufacturing practices. This role requires strong leadership skills, technical knowledge, and the ability to develop and implement effective processes.Key ResponsibilitiesSupervise and...

  • Biotherapeutics Manufacturing Technical Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job Title:Biotherapeutics Manufacturing Technical SpecialistJob Summary:We are seeking a highly skilled Biotherapeutics Manufacturing Technical Specialist to join our team at Planet Pharma. The successful candidate will have a strong background in cell culture and aseptic technique, with expertise in manufacturing process tech transfer. As a key member of...

  • Training Specialist Supervisor

    4 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job DescriptionIovance Biotherapeutics Inc is seeking a highly skilled Training Specialist Supervisor to join our team at the Iovance Cell Therapy Center (iCTC). As a key member of our Manufacturing Training Department, you will play a pivotal role in overseeing and executing training programs for our aseptic manufacturing team.Key Responsibilities:Oversee...

  • Materials Coordinator

    1 month ago

    Philadelphia, Pennsylvania, United States Amuneal Manufacturing Full time

    Materials Handler Job DescriptionAmuneal Manufacturing is seeking a reliable and skilled Materials Handler to join our team. As a key member of our operations team, you will be responsible for overseeing materials and inventory needs, ensuring safety and quality standards are met.Responsibilities:Offload, receive, and organize incoming materialsMaintain...

  • Manufacturing Operations Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States BioFire Diagnostics Full time

    **Job Summary**At BioFire Diagnostics, we are seeking a skilled Manufacturing Technician to join our team. The successful candidate will be responsible for manufacturing and assembling commercial products, specifically focused on Veriflow cassette assembly.**Key Responsibilities**Manufacture and assemble commercial products, including Veriflow cassette...

  • Manufacturing Operations Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job SummaryThe MSAT Specialist is a critical member of the Planet Pharma team, responsible for ensuring the smooth operation of our manufacturing processes. This role requires a strong understanding of cell culture and aseptic technique, as well as expertise in GMP systems within a manufacturing facility.Key ResponsibilitiesServe as a technical SME...

  • Manufacturing Documentation Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Documentation Specialist to join our team at Planet Pharma. This role will be responsible for ensuring the quality and accuracy of documents related to manufacturing processes.Key ResponsibilitiesLead teams investigating minor, major, and critical non-conformances and deviations, including gathering...

  • Supervisor Manufacturing

    3 weeks ago

    Philadelphia, United States WuXi AppTec Full time

    Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).• Understands, oversees, trains, coaches, mentors and...

  • Supervisor Manufacturing

    2 weeks ago

    Philadelphia, United States WuXi AppTec Full time

    Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). Find out exactly what skills, experience, and...

  • Supervisor Manufacturing

    3 weeks ago

    Philadelphia, United States WuXi AppTec Full time

    Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). • Understands, oversees, trains, coaches, mentors and...

  • Supervisor Manufacturing

    4 months ago

    Philadelphia, United States WuXi AppTec Full time

    Job DescriptionResponsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).• Understands, oversees, trains,...

  • Manufacturing Science and Technology

    4 weeks ago

    Philadelphia, United States Planet Pharma Full time

    $85,000/year - $94,000/year (Depending on previous experience) Monday-Friday, First Shift OverviewThe MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert. The MSAT Specialist reports to the Senior Manager, MSAT and EM and is responsible for manufacturing data analysis, contributing to deviation root cause analysis, and owning...

  • Manufacturing Science and Technology

    4 weeks ago

    philadelphia, United States Planet Pharma Full time

    $85,000/year - $94,000/year (Depending on previous experience) Monday-Friday, First Shift OverviewThe MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert. The MSAT Specialist reports to the Senior Manager, MSAT and EM and is responsible for manufacturing data analysis, contributing to deviation root cause analysis, and owning...