Downstream Processing (DSP) Team Lead

Proclinical are recruiting for a Downstream Processing (DSP) Team Lead to join a biotech organisation. This position is on a permanent basis and is located in London, UK. This individual will be responsible for the execution of safe, compliant and reliable manufacturing for clinical and commercial gene therapies in our Downstream manufacturing facility.

Responsibilities:

• Line manage a team of Senior Bioprocessing Scientists and their manufacturing operatives, providing training, support, motivation, development and performance management to ensure manufacturing goals are achieved
• Recruitment, onboarding and training of highly skilled manufacturing operatives
• Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
• Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken
• Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a right-first-time state
• Ensure on-time availability of GMP product manufactured according to the agreed manufacturing plan (medium term) and schedule (short term)
• Work collaboratively across departments to deliver UK manufacturing performance targets and to solve problems and remove barriers constraining performance and improvement.
• In partnership with Quality, embed and maintain a robust and positive quality culture
• Embed a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment
• Manage manufacturing workforce planning, establishing and developing a team plan and developing the team capability to enable routine, reliable GMP commercial supply operation.
• Effectively communicate business and operation goals, progress and updates within the manufacturing team.
• Lead continuous improvement initiatives that address recurring deviations, process yield opportunities, and other initiatives that improve the quality, safety, and eliminate waste and ensure high levels of supply reliability
• 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
• Prevention of injuries and incidents across the manufacturing facilities
• Timely closure of GMP commitments (regulatory, deviations, CAPA, change Control)
• Adherence to manufacturing and supply schedule
• Delivery of product development, clinical and launch manufacturing milestones
• Positive regulatory inspection outcomes
• High employee engagement and talent retention

Key Skills and Requirements:

• Management and oversight of advanced biochemical drug substance manufacturing to cGMP requirements
• Management of operational health and safety in a dynamic and changing environment
• Leadership, coaching and development of operational and technical teams with high potential individuals in organizations undergoing significant growth and change.
• Strong organisation skills, planning and managing risk effectively to ensure manufacturing and project commitments are achieved on time and in full
• Strong analytical mindset, synthesizes complex information, uses intuition and experience to compliment data
• Creation and embedding performance systems, establishing workflows and procedures built on simplicity, reliability and effectiveness
• Experienced with structured problem solving, identifies and resolves problems effectively and urgently; gathers and analyses information skillfully; develops alternative solutions; works very well in cross functional teams for problem solving
• Fosters a continuous improvement mindset and capability within and across teams
• Lead a team of up to 3 supervisors and up to 20 indirect reports
• Financial authority for revenue spend against agreed purchase orders
• Accountable for GxP compliance within Downstream processing areas
• Accountable for safety of Downstream processing team and areas
• University degree in Science or Engineering
• Experience in scale-up and development of cGMP products from late stage development to commercial manufacture and regulatory approval
• Strong background in manufacturing operations and quality systems and understanding of process development lifecycle.
• Experience in conducting regulatory inspections and audit readiness activities

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at +44 203 0590923.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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