We are looking for:
The position we are seeking to fill is for a Senior Manger, Downstream Development.
You will be responsible for leading a team of Senior Scientists, Scientists, Scientific Associates and Support Operators to deliver a range of activities associated with the development, technical transfer, validation and GMP manufacture of bulk drug substances with a focus on Gene Therapies.
At Pharmaron we offer:
- Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
- Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
- A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!
Requirements:
Degree (or equivalent) in a relevant life sciences or engineering discipline.- Significant experience in leading the design, optimisation and operation of processes for biologic manufacture within the biotechnology industry.
- A track record of leading direct reports with strong managerial skills with emphasis on coaching and development.
- Experienced people manager, with track record in effectively resourcing, scheduling and delivering development programmes .
- Experience in the production and scale-up of therapeutics from mammalian, microbial or gene therapy expression systems.
- Understanding of CMC development for the manufacturing process stages of the drug substance.
- Project management skills.
- Leading troubleshooting investigations, root cause analysis and knowledge of GMP and Quality Management Systems.
- Strong organisational skills with a track record of successfully managing laboratory operations.
- Demonstrated competency in building effective teams, motivating staff, setting goals, measuring performance and staff development.
- Evidence of continued learning within their own discipline, as well as the desire to acquire higher level knowledge and skill across the business.
- Ability to solve complex problems.
- Focus on continuous improvement with the ability to evaluate systems to improve system functionality and efficiency.
- Excellent interpersonal skills, with ability to influence outcomes.
- Strong decision making.
- Flexible attitude to work - ability to adapt to changing demands and lead people through these changing demands.
Key roles and responsibilities:
- Leading the Process Sciences team to design and optimise the manufacturing process using mammalian, microbial or Gene Therapy technologies, in line with client and business needs.
- Ensure the scientific studies and other technical activities are conducted and reported in line with regulatory guidance, executed to the right quality, time, budget and in compliance with HSE and Quality requirements.
- Setting objectives and giving performance feedback regularly throughout the year. Devising the training and development plan for the team.
- Ensuring all project work is delivered on time, to budget and to the required levels of technical quality, and that the team generates high quality outputs from experimental programmes, including presentation of results and technical reports.
- Ensuring all work is undertaken to the required quality systems, where applicable to cGMP standards and always in compliance with the requirements of the Health and Safety Policy.
- Reviewing and approving experimental programmes and documentation including but not limited to protocols, proformas, lab books and manufacturing instructions.
- Building an effective team through continued development and through recruitment, retention and reward of scientific staff to ensure that Process Sciences is well equipped with scientific and technical competences to demonstrate excellence in the development of client projects.
- Making proposals and implementing actions as part of the 5S, Gemba Walks, Operational Excellence and CAPEX programmes to drive technical and scientific excellence for improving quality, timelines and efficiencies within the team.
- Support site audits and inspections as required by the business whilst performing all activities in accordance with regulatory, quality and EHS requirements.
- Provide periodic cover outside of normal working hours for essential operations when required by the business.
- Expand expertise in areas relating to GMP manufacture, upstream process development, downstream process development or cell line development.
- Liase with client as required for the technical leadership role and be a Pharmaron ambassador to promote the company, the site and our technical capabilities.
- Respect the confidentiality of information obtained in the course of duties performed and refrain from disclosing such information without written consent from Management, except where disclosure is required by law or by the order of a Court.
We are based in the vibrant city of Liverpool with a world class R&D and manufacturing facility that offers a complete end to end development service. Our 80,000 sq. ft facility houses an established Biologics Department that consists of Analytical and Process Sciences. Our Liverpool site has a remarkable 20 Year Track Record in Biologics Development, which now offer A Fully Integrated
Gene Therapy Drug Substance Solution in our state of the art cGMP facility purpose designed for viral vectors with onsite plasmid DNA and renowned analytical capabilities for release and characterisation
The Pharmaron Liverpool Team has consistently delivered biologics programs across all development phases and due to constant growth we are now recruiting a Senior Manager, Downstream Development.
We offer a competitive salary and a progressive and comprehensive suite of employee benefits- We offer state of the art working environment in our modern Liverpool site
- We offer the opportunity for growth and development and will support funding for relevant training and development programmes
We do more than manufacture batches, we develop medicines!
Why Should You Apply?
- This is an opportunity for you as a Senior Manager, Downstream Development professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
- Build and shape your career in an environment that sets and commits to the highest standards.
- To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.
Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 19,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.