Associate Director, Analytical Sciences
Associate Director, Analytical Sciences
Location: London, UK
Reporting to: Director, Analytical Sciences
We are looking for an Associate Director - Analytical Sciences to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies. The incumbent will oversee a team within the Analytical Sciences department dedicated to managing analytical method development and lifecycle activities at Orchard’s Contract Development and Manufacturing Organisations (CDMOs) and Contract Testing Laboratories (CTOs).
The ideal candidate will have demonstrated leadership qualities and have significant experience of analytical methodology development and lifecycle management, in addition to significant experience of delivering high-quality regulatory submissions. The incumbent will work collaboratively with both internal and external stakeholders to ensure timely and robust implementation of appropriate product quality attribute strategies and represent the Analytical Sciences function on CMC and other cross-functional teams.
Key Elements and Responsibilities
Other duties may be assigned as required.
1. Lead the Analytical Sciences development team, managing analytical activities at CDMOs and CTOs to ensure product quality and compliance with applicable ICH/FDA/EMA and other global health authority requirements and associated expectations.
2. Lead Quality by Design implementation of science-based, phase appropriate, and risk-based analytical development to support qualification and validation of methods for use in clinical programmes.
3. Provide expert support for reporting, investigation and resolution of analytical quality activities encountered during method development and / or GMP production activities (e.g. CAPAs, deviations, change controls).
4. Broad experience in statistical analytical tools to design appropriate strategies and specifications for starting materials, vector, and drug products, etc suitable for IMPD/IND to commercial applications. as well as experience on cross-functional teams for CQA identification and analysis.
5. Drive innovation to improve analytical method design and throughput.
Regulatory Submission and Lifecycle Management Responsibilities
- Be an analytical subject matter expert, to author and/or review relevant sections of CMC documentation in support of regulatory submissions, amendments and interactions with regulatory authorities.
- Support inspection readiness activities and associated Health Authority Inspections.
- Support and develop internal and external procedures to meet Orchard and regulatory requirements.
- Develop strategies to link and prioritise analytical activities.
- Ensure internal and external capabilities, skills and capacities meet Orchard’s requirements and drive acceleration of pipeline progression with demonstrated understanding of risk/benefits.
- Drive and lead trending of batch analysis data and associated strategies.
- Represent Analytical Sciences on CMC team(s) as required.
People and Team Management
- Manage and develop a team of analytical scientists supporting development and delivery of analytical methods for lot release and characterisation of Orchard’s gene therapy products.
- Line management of staff to ensure work is executed and delivered to a consistently high quality and to agreed timelines.
- Manage team performance through goals, development plans and other KPIs.
- Maintain required team training and skills to execute duties.
- Engage with other key functions across Orchard.
The ideal candidate will have in-depth experience in development and lifecycle management of analytical methods gained in cell-based or biological therapies with significant applied experience in authoring regulatory submissions and responding to regulatory authority questions.
The candidate will possess:
- Minimum of eight years of experience in the biotechnology or pharma industry with a primary focus on the development, qualification, validation and application of analytical methods for product development, characterization and GMP testing to commercial.
- Extensive experience and knowledge of multiple analytical techniques for cell therapy or biologics, suitable for a QC environment including, but not limited to, techniques such ddPCR, ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, HPLC, cell culture and cell-based assays.
- Demonstrated ability to work in partnerships with internal stakeholders to deliver appropriate control strategies for products.
- Practical experience of managing, supporting and maintaining successful external partnerships with CDMO/CTO through the product lifecycle.
- Practical experience of use of Design of Experiments (e.g. JMP, Design Expert) and other analytical statistical tools in analytical method development and specifications setting would be highly advantageous.
- Significant experience of analytical section authoring for regulatory submissions including preparation of responses to regulatory agency (FDA and EMA) questions on submission documentation.
- Demonstratable, in-depth knowledge of US and European Pharmacopeia analytical methods and associated requirements.
- Demonstratable, in-depth knowledge of FDA, EMA, GMP, WHO and ICH analytical regulatory requirements.
- Proven experience in performance management of individuals and teams including proven ability to develop direct and matrixed line reports and provide mentoring both within and outside the team.
- Proven leadership of cross-functional CMC development and other high performance teams.
- This position requires on-site presence at CMDOs and contract vendors. Therefore, ability to travel is a pre-requisite.
Skills and Abilities
- Excellent interpersonal skills
- Outstanding organizational skills
- Excellent written and oral communication skills
- Creative problem solver
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- A minimum Ph.D or equivalent experience in Biological Sciences, Bioengineering, Pharmacology or an associated discipline.
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.
We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
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.