2 days old
2018-02-162018-03-17

Senior Manufacturing Associate / Associate Production Manager BMF Clinical Fill Finish Operations, DPO

Teva Pharmaceuticals
West Chester, PA
  • Job Code
    18-20739
Careers - Teva Pharmaceuticals in the US -Senior Manufacturing Associate / Associate Production Manager BMF Clinical Fill Finish Operations, DPO

Senior Manufacturing Associate / Associate Production Manager BMF Clinical Fill Finish Operations, DPO

Location US-PA-West Chester
Requisition #
18-20739
# Positions
1
Category
Research & Development - Pharmaceutical

Overview

Located in West Chester, PA, Teva Biopharmaceuticals, USA is responsible for the development of CMC Biologics.  Teva Biopharmaceuticals, USA is a division of Teva Pharmaceuticals, with over $20 billion in annual revenue.  The rapidly growing staff of Biologics CMC, now nearly a hundred, specializes in the development of innovative biologics, biosimilars, and extended half-life bio-betters.  We currently are developing products in various stages of clinical development from IND through BLA filing.  TBU combines the financial stability of a large company with a small-company mentality emphasizing scientific-rigor and flexibility within a Regulatory and Quality context.

Responsibilities

  • RESPONSIBILITIES (Senior Manufacturing Associate):

    • Lead the execution of all clinical drug product (DP) batches; directly accountable for right first time quality.
    • Perform all activities supporting the production of sterile DP, including but not limited to: operation of the filling line, formulation of buffers and dilution, preparation of components and supplies including use of the autoclave and part washer, documentation (batch records, logbooks, etc), routine in-process analytical testing, visual inspection, cleaning of critical process equipment, and batch record review.
    • Perform front line supervision of shared plant manufacturing resources and DPO product scientists during GMP clinical production.
    • Provide training on SOP’s, aseptic technique, and activity-based competency assessments.
    • Author and maintain SOP’s required to support clinical GMP production of sterile DP.
    • Perform Deviation investigations and implementation of CAPA’s.
    • Perform ongoing validation activities and change controls.
    • Responsible for the development of batch records, test protocols, sampling plans.
    • Supports technical troubleshooting of the filling line and resolution of atypical events during clinical manufactures.
    • Supports operation of a non-GMP development Lab, including preparation of ence standards, tox fills, and other early product development studies.

    ADDITIONAL RESPONSIBILITIES (Associate Production Manager):

    • Coordinate resource allocation/sharing with BMF upstream, downstream, and media/buffer prep managers.
    • Work with formulation scientists to facilitate tech transfer of products from the lab into the clinical DP facility.
    • Mentor less experienced staff on sterile manufacturing operations and GMP; help to build institutional knowledge around sterile fill/finish within Teva WC and the BMF.
    • Maintain the DP facility in an “audit ready” state at all times, including facilities and documentation.
    • Develop and maintain Training curriculums
    • Primary operations contact for internal & external audits.
    • Supports ongoing continuous improvement / risk assessment activities required to operate and maintain the GMP DP facility.
    • Supports upstream/downstream/cell banking manufacturing operations as-needed.

Qualifications

  • QUALIFICATIONS (Senior Manufacturing Associate):

    The ideal candidate for the Senior Manufacturing Associate level role will possess up to 5 years’ experience in a GMP production environment, with strong pence for experience in aseptic fill finish operations, and show proficiency in the following areas:

    • Hands-on production experience in aseptic processing and the manufacture of sterile drug products.
    • Thorough understanding of GMP’s and the regulatory requirements for working in a GMP environment.
    • Basic understanding of microbiology and HVAC as they relate to the manufacture of sterile drug products.
    • Excellent planning, verbal and written communication skills; proficiency in good documentation practices essential.
    • Highly motivated, dynamic individual, with ability to work both independently and in a team environment, to build productive relationships within and across departments.
    • Impeccable personal integrity and a commitment to transparency.
    • Proficient in Microsoft Office Suite of Programs.
    • BS degree in a related field, or equivalent experience.

    ADDITIONAL QUALIFICATIONS (Associate Production Manager):

    The ideal candidate for the Associate Production Manager level role will possess up to 10 years’ experience in a GMP production environment, with strong pence for aseptic fill finish operations, and a demonstrated progression of increasing responsibilities and business impact.  In addition to the proficiencies listed for the Senior Manufacturing Associate, the Associate Production Manager candidate will also possess:

    • Superior knowledge of GMP requirements and global regulatory expectations related to aseptic processing and the manufacture of sterile medicinal products.
    • Thorough understanding of microbial risks to aseptic operations, and current industry best practices in technology and processes to prevent contamination of sterile drug products.
    • Familiarity with the concept of Grade A continuity and good aseptic techniques.
    • Leadership/supervisory experience in a GMP environment.
    • Familiarity with the complex technical equipment used in the production of sterile drug products.
    • Ability to use root cause analysis to develop robust solutions to technical and process manufacturing issues.
    • Experience in buffer formulation and dilution, equipment troubleshooting & repair, and/or manual visual inspection of parenteral products a plus.
    • Experience in scheduling, budgets, and production forecasting.
    • Familiarity with and commitment to continuous improvement methodology and data-driven business decision making.
    • Ability to collaborate cross-functionally (operations, QA/QC, project management, development, etc) to influence peers and senior business leaders using science based data and expert knowledge of regulatory/compliance requirements.

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Senior Manufacturing Associate / Associate Production Manager BMF Clinical Fill Finish Operations, DPO

Teva Pharmaceuticals
West Chester, PA

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Senior Manufacturing Associate / Associate Production Manager BMF Clinical Fill Finish Operations, DPO

Teva Pharmaceuticals
West Chester, PA

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