Senior Manager, Analytical Science & Technology - Gene Therapy

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 is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture! Site: www.ptcbio.com

Job Description Summary:

The Senior Manager, Analytical Sciences & Technology (AS&T), Operations - Gene Therapy is responsible for method transfers; method improvement; method remediation and method validation/verification and/or troubleshooting for commercial products within the Quality Control laboratories. She/he manages oversight of analytical data and all business-related documentation to and from vendors for routine release and stability testing and for post-marketing commitments for clinical and commercial products.

In cooperation with Analytical Development, the Senior Manager, AS&T- Gene Therapy is also responsible for assisting with investigating commercial product complaints/issues at all manufacturing sites, internal and external.

She/he may have direct reports.

She/he works cross-functionally in a matrix management environment that includes, but may not be limited to, Analytical Development (AD), Process Development (PD), Clinical and Commercial Manufacturing, Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, Supply Chain, and Discovery Research.

The Senior Manager, AS&T, Operations - Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Manages oversight of analytical data and all business-related documentation to and from vendors for routine release and stability testing and for post-marketing commitments for clinical and commercial products.
• Supports members of the AS&T team to manage analytical method review and approval, method performance trending, method improvement/ remediation, method versioning and specifications change control in quality systems.
• Supports AS&T in continuous current Good Manufacturing Practices (cGMP) analytical improvement projects. This includes, but may not be limited to, ensuring that method SOPs and validation reports are compliant with global regulatory requirements.
• Assesses issues with resource management and failure investigation review.
• Establishes and manages strategic partnerships for multiple gene therapy programs, organizing timely flow of statement of work (SOW), purchase orders (PO), analytical documents and analytical results/data packages.
• Ensure timely scheduling of testing at CTLs (Contract Testing Labs) as well as data and documents from CTLs are organized in internal repositories for multiple gene therapy programs.
• May manage, coach and mentor direct reports.
• Performs other tasks and assignments as needed and specified by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• Master's degree in molecular biology, virology, biochemistry, or related field and a minimum of 5 years of relevant and progressively responsible experience in these same areas or Bachelor's degree with a minimum of 7 years of relevant and progressively responsible experience in these same areas.

* Special knowledge or skills needed and/or licenses or certificates required.

• Knowledge with the analytical methods used for gene therapy or biologics in-process testing, release testing and characterization, with an emphasis on potency assays.
• Strong knowledge of CMC analytical and regulatory requirements.
• Demonstrated and applied experience in laboratory operations, including development and adherence to quality metric programs
• Demonstrated ability to contribute to departmental budgeting, capex procurement, IQ/OQ, safety, and status reporting to Senior Management.
• Applied knowledge of cGMP requirements as they pertain to analytical development and quality control testing.
• Knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, and molecular biology techniques.
• Experience overseeing clinical or commercial release testing within CROs/CMOs.
• Team oriented and able to manage assigned project responsibilities across various development stages.
• Hands-on experience writing/reviewing SOPs and/or analytical methods in support of quality systems.
• Proficiency with Microsoft Office.
• Excellent oral and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time-management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

• Small company and/or start-up experience.
• Experience in interactions with domestic and international Regulatory agencies.
• Ability to present and interact in cross-functional teams.
• Experience in managing statement of work (SOW), purchase orders (PO) and material inventory with external partners.
• Certification in CMC technical writing.

* Travel requirements

• 0 - 15%

Expected Base Salary Range: $146,800 - $172,700. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.

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EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.