Current Openings

MSAT Protein Analytics lead (Analytical Development)

London, UK

About MeiraGTx

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

Purpose of Job

The purpose of the job is to lead the development and implementation of Protein analytical methods within the MSAT Analytical Development Group. This will involve managing the day-to-day activities of Scientists / Technicians and working to develop analytical methods for the manufacture of novel AAV gene therapies.

Major Activities

  • Managing the workload of Scientists / Technicians within the protein analytics subgroup of the Analytical Development Team.
  • Take a leading role in scheduling workload, organizing the laboratory, and tracking project timelines.
  • Lead technical investigations and liaise with other groups both within Analytical Development (i.e. Molecular Analytics) and outside of Analytical Development (i.e. Upstream Processing, Downstream Processing, Pre-Clinical and operations groups).
  • Present updates to other MSAT teams and senior management. This includes deputizing for he Analytical Development Lead when required.
  • Review study protocols, reports and SOPs and provide guidance to junior team members.
  • Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
  • Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken
  • Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state

Additional Activities

  • Identifying and testing opportunities to simplify our business processes and tools.
  • Ambassador for MeiraGTx at key Cell and Gene Therapy conferences.
  • Draft SOPs and Work instructions for the unit operations that are being developed.
  • Lead collaborations with third parties to evaluate new analytical equipment / methods.

Key Performance Indicators

  • Schedule project activities, workload / resources according to changes in business priorities.
  • Ensure timely completion and review of study protocols, study reports and SOPs as well as the timely completion of experiments according to study protocols.
  • Completion of development projects in accordance with deadlines.
  • Present data to key stakeholders in a timely manner to support go/no-go decision points.

 

 

 

Key Technical Competencies

  • Ability to manage multiple employees and projects.
  • Strong understanding of the activities required to develop protein analytical methods such as ELISA, HPLC, LC-MS, CE etc.
  • Understanding of ICH Q2B guidelines or industry equivalent.
  • Analytical skills, good problem-solving technique and statistical analysis skills using software such as Minitab / JMP or similar.
  • Ability to collaborate with team members as well as other departments as part of cross-functional teams.
  • Strong written and oral communication skills.

 

Key Job Competencies

  • Leadership – able to lead by example in terms of the standards expected of junior team members. Able to take a holistic approach to prioritization and scheduling that is inline with the goals of the wider organization.
  • Analytical mindset- synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs workflows and procedures.
  • Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
  • Planning/Organizing – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules their tasks; develops realistic action plans.
  • Professionalism – approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
  • Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
  • Communication (Oral and Written) – speaks and writes clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.

 

Candidate background

  • PhD, or MSc in a relevant Chemistry/Biochemistry/Analytical science field and at least 5 years industry experience within a technical department.
  • Previous experience in managing / leading projects and or leading a team of Scientists.
  • Experience of project management using tools such as Microsoft Project or Team Gantt to track deadlines and manage priorities.

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