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    Associate Director, Downstream Process_ Technical Specialist

    Msd
    12+ years
    Not Disclosed
    Hyderabad
    10 Aug. 21, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Associate Director, Downstream Process Technical Specialist

    Location: Europe, Middle East, Africa, Latin America & Asia Pacific
    For U.S., Canada & Puerto Rico residents, please click here.

    Role Overview

    The Associate Director, Downstream Process Technical Specialist, will lead technical operations for biologics drug substance manufacturing with external partners. This role involves managing technical transfers, supporting continuous commercial manufacturing, and resolving manufacturing issues. The Specialist will work closely with platform leads and external partners to ensure smooth operations, regulatory compliance, and continuous improvement. The position requires domestic travel to partner sites and effective remote communication skills.

    Primary Responsibilities

    • Technical Leadership

      • Report to the platform lead or delegate and provide independent oversight and coordination of technical issues with External Partners.
      • Support facility start-ups, technical transfers, and global technical operations for ongoing commercial manufacturing.
      • Troubleshoot manufacturing issues and conduct investigations using scientific problem-solving methods.
      • Develop and implement plans to address process performance and capacity needs.

    • Process and Quality Management

      • Collaborate with Biologics Quality Operations and Focused Factory teams to support the product lifecycle.
      • Review and approve process change requests, deviations, protocols, and Master Batch Record updates.
      • Ensure adherence to Quality, Compliance, and Safety standards by following the Manufacturing Division Quality Management System (QMS).

    • Regulatory and Compliance Support

      • Understand and apply regulatory requirements to develop efficient solutions.
      • Minimize duplication of efforts between External Partners and the company’s systems.
      • Design and validate processes, including cleaning processes, buffer and product intermediate hold times, and comparability limits.

    • Continuous Improvement

      • Participate in and support continuous improvement initiatives with external partners.
      • Design and establish Annual Product Quality Reports and Critical Process Variables (CPVs).
      • Manage product life cycle and campaign reviews to ensure process compliance.

    Education and Experience

    • Minimum Qualifications

      • Bachelor’s or Master’s degree in Chemical/Biochemical Engineering, Biotechnology, Pharmaceutical Science, Life Sciences, or equivalent.
      • At least 12 years of experience in downstream processing, including large-scale chromatography systems, mixing vessels, and UF/DF systems.
      • Proven experience with scale-up, process design, and tech transfer activities in large-scale DSP manufacturing.

    • Preferred Qualifications

      • Experience with high-performance organizational tools, manufacturing digitalization, computer system validation requirements, and process validations.
      • Knowledge of cleaning validations, process troubleshooting, and establishing hold times and comparability limits.

    Additional Information

    • Work Location: Flexible
    • Employee Status: Regular
    • Relocation: Not Applicable
    • VISA Sponsorship: Not Applicable
    • Travel Requirements: Flexible
    • Shift: Not Applicable
    • Valid Driving License: Not Required
    • Hazardous Materials: Not Applicable
    • Job Posting End Date: [Insert Date]

    Application Instructions

    Current employees, contingent workers, and search firm representatives should apply or refer to specific application instructions linked above. Note that unsolicited assistance from search firms is not accepted, and no fees will be paid for candidates referred without a valid agreement.

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