Team Horizon is seeking a Cleaning Validation Manager on an initial. As SME you will provide cleaning validation expertise and leadership to a team of specialists supporting technology transfer, cleaning validation, and routine monitoring of commercial manufacturing for Upstream and Downstream manufacturing.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Excellent contracting rates on offer.
What you will be doing:
Minimum of 10 years’ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in Cleaning Validation of cell culture unit operations and/or downstream unit operations.
Previous experience of cleaning cycle development or cleaning cycle improvement in a technical role is advantageous.
Proven expertise in leadership including demonstrated ability to drive for results and lead innovation and change.
Comprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.
Ability to drive for results independently and adapt to rapidly changing priorities.
Experience of leading Cleaning Validation teams is advantageous.
Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external.
Detail orientated.
Technical writing competency.
Self-driven, able to prioritize, and to orchestrate multiple activities at once.
Consistently demonstrate sound business judgment when making decisions.
Ability to deal with ambiguity and complexity and influence others across levels of the organization
What you need to apply:
Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable.
Experience of authoring CMC sections of regulatory submissions
Previous leadership experience of Cleaning Validation activites
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