Senior Manager - GMP Manufacturing

Location
London, United Kingdom
Posted
May 29, 2021
Ref
C01E92E651
Required Education
Bachelors Degree
Position Type
Full time
Location: London UK

Reporting to: Vice President, External Development and Manufacturing

Job summary

Responsible for the manufacturing management of GMP plasmid, Vector Products (VP) and Drug Products (DP) by Orchard's Contract Development and Manufacturing Organisations (CDMO).

Key Elements and Responsibilities
  • Ensure the CDMO GMP plasmid, VP and DP manufacturing schedules are aligned with the Orchard Finance and Global Supply Chain (GSC).
  • Manage and/or administer all CDMO manufacturing financial transactions including POs and invoices associated with the manufacture of plasmids, VP and DP. This includes working with other Orchard teams such as Cell and Gene therapy technologies (CGTT) and Quality control (QC) to manage the POs and invoices for stability study and retention sample storage for example.
  • Ensure the Regulatory pathway necessary for Orchard to disposition all GMP plasmid, VP and DP batches are defined, agreed, and communicated to all relevant parties in advance of the batch manufacture.
  • Ensure the Quality release strategy is defined, agreed, and communicated to all relevant parties prior to the commencement of all GMP plasmid, VP and DP batches. E.g. Ensure release specifications and planned deviations are attached to the batch POs.
  • Ensure the CDMO uses the correct quality grade starting material for the manufacture of all GMP plasmid, VP and DP batches.
  • Ensure cost effective GMP DP processing at CDMOs in terms of managing the CDMO resources to Orchards financial benefit. E.g Exclusive transduction Suites and teams, over time, weekend working etc.
  • Act as the 'gate-keeper' between Orchard GSC and the CDMO's ensuring alignment between both parties within the days leading up to plasmid, VP and DP batch manufacture. Efficiently and effectively manage any last-minute manufacturing changes, issues or cancellations.
  • Work with the CDMO to track the ongoing manufacture and release of all GMP batches and, in as far as possible, highlight any perceived risks or issues before they arise.
  • Ensure the GMP plasmid, VP and DP batch CDMO Release and Orchard Disposition systems are coordinated thereby ensuring the use of these batches within the required timelines.
  • Ensure the GMP plasmid, VP and DP batch CDMO Release and Orchard Disposition systems are coordinated with the Orchard Financial systems.
  • Work with the manufacturing Science and Technology (MSAT) and Quality Assurance (QA) teams to ensure all 'in process' issues associated with the manufacture of any GMP plasmid, VP and DP batches are dealt with in an efficient, effective, compliant, and timely manner.
  • Ensure the Regulatory status of each GMP plasmid, VP and DP batch manufactured is defined and meets the requirements set out at the outset of the batch. Manage the batch storage and subsequent use accordingly.

General
  • Assist with the review and analysis of MSA's, QTA's, technical and supply agreements from a GMP manufacturing perspective.
  • Play an active role in developing and implementing the Orchard Manufacturing Strategy. Work with the CDMOs to execute the Orchard manufacturing strategy consistently and reliably.
  • Understand the CDMO's GMP manufacturing strengths and work with the CDMOs to improve any constraints.
  • Be an Orchard SME for the interpretation of CDMO MSA and QTA's as they relate to GMP manufacturing issues.
  • Develop integrated management systems to manage the CDMO GMP manufacturing performance using Operational Excellence best practice. Ensure the system clearly identifies objectives, risks and risk mitigations, change and continuous improvement.
  • Monitor the CDMO manufacturing team performance and provide data/fact based, timely feedback and periodic reports to both organisations when required
  • Work with the other key Orchard teams such as Global Supply Chain, Quality and Regulatory, CGTT, Procurement and Finance and CMC Life cycle management to set up and implement the integrated management systems.
  • Monitor and manage the CDMO manufacturing Key Performance Indicators and develop a Continuous improvement culture
  • Work with Orchard teams such as Analytical and regulatory to maintain a detailed understanding of current regulatory requirements to supply vector and drug product to different regulatory territories such as US and EU.
  • Play an active role in working with the CDMO to apply any future regulatory changes to current manufacturing processes
  • Other activities as may be assigned

Requirements

Required knowledge
  • Experience in the development or manufacture of cell and gene therapy products.
  • Good working knowledge of FDA, EMA, MHRA, GMP and ICH regulatory requirements
  • Proven relationship management experience in the biologics contract manufacturing or similar industry.

Skills & Abilities
  • Collaborative, easily able to form alliances. A good team player with a hands-on approach, able to quickly establish credibility, build rapport and trust and influence and maintain effective working relationships with co-workers, managers, and personnel from external organisations across multiple organisational levels
  • Highly effective communicator able to build relationships throughout the organisational hierarchy, with strong oral and written communication skills
  • Ability to effectively Chair cross functional, multi-organisation meetings
  • Excellent integrity, driven to deliver quality results on time and in a highly ethical and professional manner
  • Resilient and able to work well under pressure, able to prioritise a heavy workload and work both reactively and pro-actively.
  • Capable of reacting swiftly to changing business demands
  • Organised, ability to work efficiently and effectively using own initiative,
  • Questioning attitude with creative problem-solving abilities
  • Keeps up to date with professional knowledge, expertise and best practice
  • Willingness to travel up to approximately 20% of time

Education
  • A minimum BSc or equivalent, in bioprocessing, medical technology, chemical engineering, or biological sciences

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.

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