Senior Manager, Gene Therapy Analytics & Tech

PTC Therapeutics, Inc; New Jersey; On-site; USD 147,000 - 173,000; Full time

Job summary

PTC Therapeutics, Inc in New Jersey seeks a Senior Manager, Analytical Sciences & Technology (AS&T), Operations - Gene Therapy to lead method transfers, improvements, and validation for commercial products in QC. This role requires coordinating with Analytical Development and other groups in a matrix environment.

You will manage data and documentation, oversee method performance and change control, and mentor direct reports while ensuring compliance with cGMP and regulatory requirements.

Qualifications

• Master's degree in molecular biology, virology, biochemistry, or related field and a minimum of 5 years of relevant and progressively responsible experience; or Bachelor's degree with minimum 7 years of experience.
• Special knowledge or licenses: gene therapy/biologics in-process testing, release testing, and potency assays.
• Strong knowledge of CMC analytical and regulatory requirements.
• Experience in laboratory operations, including quality metrics programs; budgeting, IQ/OQ, safety, and reporting to Senior Management.
• Proficiency with Microsoft Office.
• Excellent oral and written communication skills; ability to work independently in a fast-paced matrix environment.
• Hands-on experience writing/reviewing SOPs and analytical methods.
• Preferred: CMC technical writing certification and start-up experience.

Responsibilities

• Manages oversight of analytical data and documentation for routine release and stability testing and post-marketing commitments.
• Supports method review/approval, method performance trending, and change control in quality systems.
• Supports cGMP analytical improvement projects ensuring SOPs and validation reports meet global regulatory requirements.
• Assesses issues with resource management and failure investigation review.
• Establishes partnerships for multiple gene therapy programs and manages SOW/PO flow and data packages.
• Ensures timely testing at CTLs and organizes data in internal repositories.
• May coach and mentor direct reports.
• Performs other tasks as needed by management.

Skills

Analytical methods

CMC knowledge

Laboratory operations

SOP writing

Teamwork

Problem solving

MS Office

Communication skills

Education

Master's in biosciences

BSc with 7+ years experience

Job description

PTC Therapeutics, Inc in New Jersey seeks a Senior Manager, Analytical Sciences & Technology (AS&T), Operations - Gene Therapy to lead method transfers, improvements, and validation for commercial products in QC. This role requires coordinating with Analytical Development and other groups in a matrix environment.

You will manage data and documentation, oversee method performance and change control, and mentor direct reports while ensuring compliance with cGMP and regulatory requirements.