Sr. Manager, Drug Product Finishing Operations

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Aldevron one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

At Aldevron we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team youll help bring life-changing innovations to lifeimpacting millions around the world. We bring together deep scientific expertise an unwavering commitment to quality and a collaborative spirit to drive progress. Whether youre launching your career or bringing years of experience we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potentialone discovery at a time.

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The Sr. Manager Drug Product Finishing Operations leads Aldevrons post-fill Drug Product Finishing capability including Visual Inspection labeling and future packaging serialization semi-automated inspection and related operations. This position reports to the Vice President Manufacturing responsible for GMP Production is part of the Manufacturing department and is an on-site role.

In this role you will have the opportunity to:

Build and scale the Finishing Operations strategy organization operating model capacity plan and capability roadmap including future packaging serialization automated inspection ID grading kitting final assembly and expanded labeling capabilities.

Lead Finishing leaders inspectors trainers and support roles; establish hiring training qualification requalification performance succession and retention plans.

Own daily execution staffing scheduling shift coverage area and equipment readiness product flow reconciliation documentation completion material status staging handoffs chain of custody and time-out-of-temperature tracking.

Lead Visual Inspection as a dedicated capability and transition labeling execution into Finishing while preserving independent Quality controls.

Define user requirements and support capital projects vendor selection qualification validation maintenance calibration technology transfer and operational handoff.

Assess new products formats and technologies for inspect ability labeling packaging defect-kit readiness equipment fit staffing cycle time sample needs and operational risk.

Support deviations investigations corrective and preventive actions change controls risk assessments audits regulatory inspections client discussions readiness reviews metrics budgets resource priorities and continuous improvement.

The essential requirements of the job include:

Bachelors degree in life sciences engineering operations business or a related field.

10 or more years of progressive experience in pharmaceutical or biologics manufacturing operations quality engineering validation or a related technical function including Drug Product finishing or execution.

2 or more years of leadership experience managing people major programs or cross-functional implementation. Experience indirectly leading and influencing associates and leaders outside of their span of control will be a critical skill.

Experience with Visual Inspection and at least one related Drug Product finishing capability such as labeling packaging serialization ID grading or release readiness.

Experience standing up or expanding facilities equipment or capabilities through qualification validation and commercial handoff.

Experience with batch readiness material handoffs chain of custody product status storage and transport controls time-out-of-temperature management and compliant documentation or data-integrity controls.

Experience leading investigations corrective and preventive actions change controls risk assessments and continuous improvement in a current Good Manufacturing Practice environment.

Travel Physical & Environment Requirements

Ability to travel as required for vendor client facility and business needs.

Ability to routinely work in Drug Product and Finishing areas including cleanrooms or controlled areas requiring personal protective equipment and gowning and near refrigerated or temperature-controlled product.

Ability to see talk hear sit stand walk for extended periods use computers and manufacturing systems and occasionally lift or move up to 25 pounds.

Ability to occasionally support operations outside normal business hours.

Reasonable accommodations may be made as required.

It would be a plus if you also possess previous experience in:

An advanced degree in life sciences engineering operations business or a related field.

FDA and EMA inspections client audits and DEA requirements when controlled substances are in scope.

A contract development and manufacturing organization supporting products from early clinical development through commercial readiness.

Aldevron a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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