Director - Manufacturing

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A Brief Overview
The Clinical Vector Core (CVC) is a division of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT) at the Children's Hospital of Philadelphia. The CCMT fosters a multidisciplinary approach to develop cures for debilitating and life threatening genetic disorders using innovative gene and cell therapy approaches.

CVC operations include manufacturing, quality control testing, and certification of Investigational Drugs for gene therapy pre-clinical and early-phase clinical studies in compliance with FDA's current Good Manufacturing Practice regulations and other regulatory standards and guidelines applicable to early-phase clinical trials.

This role is responsible for leading the cGMP-compliant and non-cGMP manufacture of clinical and non-clinical drug substance and drug product for early phase clinical trials. This position interfaces with QA to ensure compliance with applicable regulations. The successful candidate will be part of the CVC management team, responsible for overseeing operations and compliance in all departments, and will be responsible for scheduling and projecting resources and requirements for the manufacturing team, communicating with internal and external clients, vendors and service providers, and collaborating with individuals in various parts of the organization to manufacture industry-leading medicine for patients, and reporting progress.

What you will do

• Manage the manufacturing and process development operations for drug substance and drug product.
• Manage over $2M annually in materials for manufacturing.
• Oversee, either directly or indirectly, manufacturing incidents and investigations, corrective and preventive actions (CAPA), process variances and deviations.
• Ensure timely completion of manufacturing change controls, CAPAs, deviations and other controlled documents.
• Ensure that facilities are inspection ready including staff compliance with cGMP and all related elements such as documentation (including standard operating procedures [SOP] and validation protocols), training, reports and records.
• Develop short- and long-term goals for the manufacturing and process development efforts in support of product manufacturing, regulatory submissions, and program-driven milestones.
• Effectively help recruit, retain, develop and lead a manufacturing team.
• Lead and direct filing activities for regulatory agencies including assisting quality assurance in representing the site during agency inspections and in the formulation of inspection responses, and assisting QA with vendor audits.
• Develop and implement metrics to track, manage and accomplish assigned goals, objectives and projects.
• Communicate and escalate operational status regularly, and facilitate team meetings.
• Collaborate across functions to drive manufacturing excellence, share best practices and lessons learned

Education Qualifications

• Doctorate - Required
• Doctorate in Biology, Medicine, Chemistry, Engineering or related field - Preferred

Experience Qualifications

• At least ten (10) years of GMP manufacturing experience in biologics - Required and
• At least five (5) years of leadership, management or supervisory experience - Required
• At least ten (10) years of biologics manufacturing experience for early phase clinical trials in a cGMP facility operating in a cleanroom or FDA compliant environment - Preferred
• At least seven (7) years of leadership, management or supervisory experience - Preferred
• At least five (5) years of manufacturing experience in a chemical, pharmaceutical, medical device, or related environment - Preferred

Skills and Abilities

• Advanced knowledge of current Good Manufacturing Practice (cGMP) regulations
• Advanced knowledge of European cGMP regulations (Annex 1, 11, 15, 16)
• Advanced knowledge of related international standards including ISO-14644
• Advanced knowledge of FDA guidances relevant to the manufacture of investigational new drugs for human use and aseptic processing
• Advanced knowledge of related government regulations including FDA Title 21 of the Code of Federal Regulations Part 11
• Excellent verbal and written communications skills
• Excellent critical thinking / problem-solving skills
• Excellent interpersonal skills
• Excellent time management skills
• Excellent organizational skills
• Excellent project management skills
• Strong leadership skills
• Strong strategic planning skills
• Ability to gather, analyze and make recommendations/decisions based on data
• Ability to be on-call to trouble shoot and resolve problems

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.

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SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.