Senior Manager, Quality Engineering (GTM)

Job Description

The Sr Manager, Quality Engineering for Gene Therapy Manufacturing (GTM) will be a key team member for start-up and operation of Biogen’s newest facility. This leader will build, recruit, develop, and lead Quality Engineering function responsible for GTM start-up and routine operations, supporting the design, outfitting, and qualification of the facility, systems, and utilities. This position will report in to the Head of GTM QA&QC and will be the Quality site subject matter expert for the facility, systems, and utilities as well as the champion for data integrity.

What You’ll Do

· Recruit, coach, and develop team members and their career paths

· Lead Quality aspects of GMP facility, systems, and utilities validation projects and lifecycle management

· Partner with stakeholders to investigate and resolve deviations and exceptions, including determining root cause, product impact, and appropriate corrective and preventive actions

· Monitor and mitigate compliance risks for GTM facilities and systems

· Champion embedding of Data Integrity principles in all GMP systems and processes

Who You Are

You are a Quality Professtional with proven experience supporting the GMP production of complex biological therapies that will change patients’ lives. You are a passionate people leader who values and drives culture. You are agile and willing to flex to support the needs of a dynamic start-up environment.

Qualifications

Required Skills

· Bachelor’s degree in Chemical/Biological Sciences, engineering, or related field, or equivalent experience

· A minimum of 7 years of experience

· At least 5 years proven leadership of high-performing teams

· Experience in CMC Quality for biological molecules (proteins, mAbs, etc..)

· Advanced knowledge of CMC product development, operations, quality systems, and regulatory compliance

· Excellent technical writing, presentation, and oral/written communication skills.

· Ability to lead through complex issues, assess risks, and problem-solve to effectively drive cross-functional decisions

Preferred Skills

· At least 5 years experience in a GMP-regulated environment

· Experience in gene therapy or advance therapy medicinal product (ATMP) CMC Quality



Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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