Senior Manager, Quality Control

Orchard Therapeutics (www.orchard-tx.com), is global, fully integrated biotech company. Orchard's mission is to transform the lives of patients with rare diseases through innovative gene therapies. The company is developing ex-vivo autologous hematopoietic stem cell gene therapy to restore normal gene function in primary immune deficiencies, metabolic diseases, and hematological disorders.

Orchard has a deep pipeline of 5 clinical-stage transformative gene therapies, one approved product and multiple preclinical programs entering the clinic beginning in 2019. Data from the clinical studies show profound efficacy and multi-year durability across 5 different clinical indications with >150 patients treated. The company is anticipating regulatory submissions for 3 products over the next 3 years. The company has built capabilities and established partners to manufacture and deliver near-term products globally, with commercial opportunities in excess of $1 billion annually across the 5 lead clinical indications. In addition, Orchard plans to build internal manufacturing capabilities for world-wide patient supply.

Job summary

We are seeking an enthusiastic, highly motivated, and team-oriented individual for the newly established position of Senior Manager, QC, reporting to the Director, QC, within the Global GMP Quality team, to be based at the London office. In this role, the incumbent is responsible for ensuring that laboratory processes provide high quality analytical support for manufacturing operations while ensuring compliance to protocols, cGMP, and safety regulations.

The incumbent will engage with Cell and Gene Therapy Technologies, Quality Assurance, Regulatory, and other departments on a variety of activities. Such activities include investigations associated with product deviations/OOS/OOT, analytical methods, material specifications, stability testing and review of QC data packs. The incumbent will support Orchard's clinical and commercial products and provide QC expertise and project support to the Global GMP Quality team to develop and execute strategies to meet the team goals.

This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Requirements

Key Elements and Responsibilities

• Provide QC support for raw materials, in-process, final products and stability samples.
• Coordinate QC activities and ensure timelines for the QC group are met.
• Work with external vendors/contractors to ensure that samples are analysed, and results reported in a timely fashion.
• Oversee QC activities at CDMOs and CTOs, including the review and approval of test records/forms, final reports, SOPs and COAs.
• Work with Regulatory & Quality Assurance to ensure that all applicable EMA regulations are followed and properly documented.
• Lead the QC group on deviation and OOS/OOT investigations.
• Perform data review and process trending for acceptability to Orchard's Standard Operating Procedures and policies.
• Support the QC department by identifying and troubleshooting issues that may affect laboratory, facility systems or processes and other support to daily QC operations.
• Write and execute protocols using approved QC test methods in support of the development, qualification and technology transfer of analytical methods for Orchard's products.
• Author and/or review study reports.
• Manage Stability programmes.
• Perform method and equipment validation and training.
• Troubleshoot instruments/methods. Review and/or create process trending charts for QC.
• Attend project related team meetings and address items pertaining to projects as assigned by Director QC, or Senior Director Global GMP Quality.
• Perform internal auditing of QC areas, and Discovery/Process Development Laboratories
• Assist QA in internal/external audits and regulatory inspections

Leadership capabilities

Setting Strategy

• Contributes to the goals for the QC function
• Seeks and analyses data from a variety of sources to support decisions
• Takes a creative approach to developing new and innovative ideas

Executing for Results

• Sets clear and challenging goals and tenacious and accountable for driving results
• Manages complex QC related issues and communicates decisions effectively to internal stakeholders
• Demonstrates an aptitude for continuous improvement by being open to feedback and self-improvement

Collaborations and Influence

• Creates collaborative and trusting relationships internally and externally
• Strong verbal, presentation, and written communication skills. Can concisely articulate and deliver effective presentations on complex QC/Analytical issues

Required knowledge

• Extensive experience in the biotechnology or pharma industry with a primary focus on the analytical QC testing of complex biologics
• Experience with the validation and implementation of analytical techniques in a QC environment, including FACS, High Content Analysis (HCA), ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, cell culture and cell-based assays a plus
• Experience of the characterization and QC release testing of viral vector-based and/or cell-based products a plus
• Sound understanding and demonstrated application of statistical methods/tools
• In depth working knowledge of cGMPs, EU/US pharmacopoeia, ICH guidelines and applicable EU/US regulatory requirements for testing and validation of biological products.

Skills & Abilities

• Creative problem solver, with clearly demonstrated problem-solving skills
• Well-organized and detail oriented with good verbal and written communication skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment

Education

• BSc or higher degree in biology, biochemistry or other relevant scientific discipline.

Orchard Therapeutics is an Equal Opportunity employer.

RECRUITERS

All employment offers and CV's are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.