Company
Biopharma
SeniorSpecialistExtractables&Leachable
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Specialist Extractables & Leachable. Skills: Extractables, Leachables, Risk Management, Regulatory Affairs. Conduct E&L risk assessments. Document E&L risk assessments”
What You'll Achieve.
Smooth transfer of commercial products; Ensure E&L testing is compliant; Ensure E&L testing is cost effective
Industry & Context.
Risk Management; Problem solving attitude
What They're Looking For.
Must Have
4+ years E&L experience, 4+ years Validation experience, 4+ years Risk Management experience, 4+ years Regulatory knowledge, Technical writing skills, Benchmarking skills, EHS-awareness, Proficient in English
Nice to Have
Interpersonal skills, Communication skills, Work effectively across diverse customer base, Awareness of FDA requirements, Awareness of US Pharma GMP, Awareness of GMP requirements related to packaging, Work effectively in matrix organization, Teamwork ability, Networking skills, Facilitation skills, Coaching ability, Mentoring ability, Training ability, Problem solving attitude, Can-do spirit, Customer focus, Propose solutions in critical situations, Prioritization skills, Execution skills in validation, Coordination skills in validation, Supplier interface
What You'll Do.
Conduct E&L risk assessments
Document E&L risk assessments
Create internal standards
Update internal standards
Advocate GSK E&L position externally
Manage risks escalation
Deliver technical information
Support business decisions
Support regulatory filings
Work with laboratories
Ensure E&L testing is scientific
Ensure E&L testing is compliant
Ensure E&L testing is cost effective
Participate to MSA process
Set up technical agreements
Set up technical audits
Interact with regulatory agencies
Present E&L GSK strategic topics
Define expertise lifecycle strategy
Establish expertise lifecycle strategy
Monitor new developments
Assess industry trends
Assess evolving regulatory expectations
Represent GSK in boards
Contribute to development of new standards
Maintain knowledge of global regulations
Maintain knowledge of global guidance
Maintain knowledge of inspection intelligence
Define GSK requirements
Propose global actions
Propose local actions
Ensure compliance with external requirements
Ensure compliance with internal requirements
Support sites in implementation
Provide expertise support
Write inspection responses
Support improvement initiatives
Support Quality Alerts
Develop mid-term vision
Develop long-term vision
Support sites to assess escalation needs
Share global learnings
Drive global strategy
Define GSK system standards
Define GSK process standards
Deploy process throughout network
Ensure standardization
Drive continuous improvement
Maintain global procedure
Deploy digitalization
How You'll Work.
Team & Collaboration
GSME support for division; Align E&L strategy with R&D; Interact with internal organization; Work with internal laboratories; Work with external laboratories; Interact with regulatory agencies; GSK E&L experts team; Partnerships; Joint Ventures
Communication Scope
Technical writing; Presentations
Process & Methodology
Risk Management, Validation
Full Job Description
Job Purpose * The job owner has a GSME role in Extractables & Leachables. * The job owner acts as primary GSME support for Medicines Large Molecules & Vaccines division including related CMOs. * The job owner aligns the E&L GSC strategy with R&D, who are accountable for new product development and commercialization, aiming for a smooth transfer of commercial products. * The job owner will conduct and document E&L risk assessments for biopharmaceutical manufacturing processes, container closure systems and dosing device (an interim until LSME network in Medicines Large Molecules division is in place and in use.) * The job owner has the task to create and/or update the relevant internal standards (GQP, GQSOP, GG etc.) related to E&L strategy deployed in GSC. * The job owner benchmarks internally and externally in the domain of expertise. * The job owner will advocate GSK E&L position externally through international working groups (A3P, ISPE, BPOG,…) and/or conferences. * The job owner manages risks escalation to the different parts of GSK. * This job aims at providing expertise and supporting the GSK network. * The job owner must deliver key technical information to business partners, to support business decisions and/or regulatory filings. * The job owner will work with internal and external laboratories to ensure E&L testing is delivered in a scientific, compliant and cost effective manner. * The job owner will participate to MSA process of GPROC to set up technical agreements and technical audits with potential E&L lab suppliers. * The job owner will interact directly with regulatory agencies during audits to present E&L GSK strategic topics. * The job owner acts as key contact person for Quality Regulatory Intelligence activities. * The job owner defines the expertise’s lifecycle strategy. * The job owner establishes the expertise’s lifecycle strategy. Key Responsibilities ** _Expertise / Technical_** **_Knowledge_** * Monitor and assess new developments, industr
Applying for this Senior Specialist Extractables & Leachable role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about this company?
Real rants from real employees. Read before you apply.