Current jobs related to Manufacturing Specialist - philadelphia - Planet Pharma

  • Manufacturing Documentation Specialist

    2 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

    2 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...

  • Supervisor, Manufacturing Specialist

    1 month 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...

  • Manufacturing Documentation Specialist

    2 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

    2 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...

  • Lead Manufacturing Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Manufacturing SpecialistWe are seeking a Manufacturing Specialist to become a vital part of our team at WuXi AppTec. In this role, you will oversee the production of Master and Working Cell Banks, facilitating the creation of Cell & Gene Therapy products, as well as the final product fills in compliance with current Good Manufacturing Practices (cGMPs).Key...

  • Manufacturing Operations Specialist

    6 days 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

    6 days 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...

  • Manufacturing Science and Technology

    2 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

    2 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 Documentation Specialist

    6 days ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job DescriptionJob Title: Manufacturing Documentation SpecialistJob Summary: We are seeking a highly skilled Manufacturing Documentation Specialist to join our team at Planet Pharma. The successful candidate will be responsible for supporting the development and maintenance of high-quality documentation for our manufacturing operations.Key...

  • Manufacturing Specialist

    3 weeks ago

    Philadelphia, United States Planet Pharma Full time

    Manufacturing Specialist needed!Essential Functions and Responsibilities:Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.Lead teams investigating minor, major and critical nonconformance's and deviations, including gathering...

  • Custom Magnetic Shielding Specialist

    6 days ago

    Philadelphia, Pennsylvania, United States Amuneal Manufacturing Full time

    Amuneal Manufacturing Corporation is seeking a highly skilled Custom Magnetic Shielding Specialist to join its Technical Products Division. This role involves working directly with customers to develop and implement custom magnetic shielding solutions for various industries.The ideal candidate will have a strong understanding of magnetic shielding principles...

  • Manufacturing Specialist

    1 month ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job DescriptionOverviewIovance Biotherapeutics Inc is a leading immune-oncology company focused on developing and commercializing novel cancer immunotherapies based on TIL. Our team is seeking a highly skilled Manufacturing Specialist to join our GMP manufacturing operations. The successful candidate will be responsible for supporting the development and...

  • Manufacturing Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job Title: Manufacturing Specialist - Document ControlPlanet Pharma is seeking a highly skilled Manufacturing Specialist to support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.Key Responsibilities:Lead teams investigating minor, major, and critical non-conformances and deviations, including gathering...

  • Training Specialist

    1 month ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job Title: Training Specialist - Cell Therapy ManufacturingWe are seeking a highly skilled Training Specialist to join our team at Planet Pharma. As a Training Specialist, you will be responsible for developing and delivering training programs for our manufacturing technicians.Key Responsibilities:Develop a comprehensive understanding of our cell therapy...

  • Manufacturing Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Specialist to join our team at Planet Pharma. The successful candidate will be responsible for supporting documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.Key Responsibilities:Support documentation, including drafting and approval of SOPs, Batch Records,...

  • Metal Fabrication Specialist

    5 days ago

    Philadelphia, Pennsylvania, United States Amuneal Manufacturing Full time

    At Amuneal Manufacturing, we're dedicated to delivering exceptional quality and craftsmanship in every product we create. With a focus on exploration, research, and investment, our team of skilled professionals is committed to pushing the boundaries of innovation and excellence.As a Metal Fabrication Specialist, you'll play a critical role in our production...

  • Manufacturing Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Planet Pharma is seeking a skilled Manufacturing Specialist to support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.Key Responsibilities:Lead teams investigating minor, major and critical non-conformances and deviations, including gathering information through structured root cause analysis.Own and manage...

  • Manufacturing Specialist

    2 weeks ago

    philadelphia, United States Planet Pharma Full time

    615374 Manufacturing SpecialistDirect HirePhiladelphia, PAEssential Functions and ResponsibilitiesSupport documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.Lead teams investigating minor, major and critical nonconformances and deviations,...

Manufacturing Specialist

2 months ago

philadelphia, United States Planet Pharma Full time

614183 Manufacturing Specialist

Direct Hire

Philadelphia, PA

Essential Functions and Responsibilities

  • Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
  • Lead teams investigating minor, major and critical nonconformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
  • Own and manage change controls associated with manufacturing areas and equipment.
  • Participate in technology transfer, conference calls and sharing of technical information.
  • Coordination of front-end document requests with supporting departments.
  • Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
  • Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
  • Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
  • Attends the weekly management meeting to discuss timelines and weekly priorities.
  • Contribute to projects to ensure timely initiation and completion of work.
  • May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
  • Troubleshoot issues and prioritize workload to solve moderately complex problems, including on the floor troubleshooting support as needed.
  • Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  • Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff.
  • Must adhere to core values, policies, procedures, and business ethics.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
  • Perform miscellaneous duties as assigned.


Travel

  • May require up to 10% travel, based on business need.


Required Education, Skills, and Knowledge

  • Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Demonstrated strong technical knowledge of aseptic processing in cleanroom environments is a must.
  • Ability to build relationships quickly and credibly. Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing department representing a variety of personalities and experience levels.
  • Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
  • Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
  • Ability to work successfully in a fast-paced, team-oriented environment.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Excellent presentation skills, both written and verbal.
  • Understands and complies with quality standards and requirements as documented.
  • Must have strong written and verbal communication and organizational skills.
  • Strong computer skills, problem solving and attention to detail.
  • Familiarity with data and sample management required (LIMS/MES)
  • Able to work independently with minimal supervision.
  • Must adhere to core values, policies, procedures, and business ethics.
  • This position is currently for regular work week hours (1st shift M-F)
  • Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).


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%) 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 deadlines.

Work Environment:

  • This position will work in both an office and a manufacturing cleanroom setting.
  • When in the lab, must be able to work in cleanroom 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.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

***Pay rate is commensurate with experience. Target pay rate range is $75-85K.***