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Senior Director, Production Value Stream Leader
2 months ago
Job Purpose:
This role is accountable for all manufacturing activities at GlaxoSmithKline, ensuring compliance with quality standards and regulatory requirements.
Key Responsibilities:
- Lead the management of clinical and commercial drug substance manufacturing to meet all quality standards for regulatory agencies.
- Oversee the production of multiple products across various biotechnology platforms, operating on a 24-hour/7-day basis.
- Recruit and develop a world-class manufacturing organization.
- Ensure full compliance against all applicable manufacturing regulations, including local policies, procedures, GSK QMS, and CFR/cGMP.
- Responsible for all operations, ensuring personnel, product, and equipment safety, maintaining compliant operations against all required GSK EHS/OSHA standards and applicable environmental regulations.
- Partner with the new product introduction lead for successful implementation of new products and processes into the facility production equipment and schedules.
- Establish production standards and resource requirements to meet delivery schedules.
- Direct the evaluation and implementation of Continuous Improvement and Operational Excellence methods and tools to improve overall production efficiencies and reduce costs.
- Drive cost of goods reductions across the product portfolio.
- Serve as a member of the Site Leadership team to drive overall site strategy and culture.
Why You?
Basic Qualifications:
We are seeking professionals with the following required skills to achieve our goals:
- Bachelor's degree in biological, chemical science, engineering, or equivalent technical discipline. Biotechnology, Biochemical Engineering, Chemical, or Mechanical Engineering preferred.
- 10+ years of experience in the biopharmaceutical industry, with an emphasis on commercialization and manufacture of biologics. 5+ years of large-scale cell culture or fermentation-based processing experience preferred.
- Experience leading large teams.
- Experience interfacing with regulatory agencies.
Preferred Qualifications:
If you have the following characteristics, it would be an asset:
- Master's or Ph.D. in biological science or biochemical engineering, desirable. Biotechnology, Biochemical Engineering preferred.
- Strong quality/compliance orientation and track record.
- Excellent communication skills with all levels of the organization.
- Strong influence and relationship-building skills with an emphasis on teamwork.
- Strong understanding of Industry 4.0 elements and maximizing the use of data.
- Strong understanding of Lean Six Sigma/Operational Excellence principles.
Why GlaxoSmithKline?
Uniting Science, Technology, and Talent to Get Ahead of Disease Together.
GlaxoSmithKline is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.
We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GlaxoSmithKline a place where people can thrive. We want GlaxoSmithKline to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.
