Cleaning Validation Manager

• 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.

• 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

• 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

Team Horizon