Production Team Leader (BAS/Drug Substance)

1. Ipsen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care.
2. The Production Team Leader (Drug Substance) is responsible for directing manufacturing activities within their respective area, in this instance BAS or Bulk Active Substance.
3. We provide competitive salaries and enhanced benefits package which includes annual bonus, generous pension scheme, wellness allowance and so much more.

Ipsen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make a difference. We attract and develop bold, agile and entrepreneurial individuals who take full ownership of their decisions, leaders drawn by a purpose to make a direct impact through their work in people’s lives, all of which is underpinned by our Ipsen Way of Being.

The Production Team Leader (Drug Substance) is responsible for directing manufacturing activities within their respective area, in this instance BAS or Bulk Active Substance.

Fostering a culture of engagement and continuous improvement and through the use of effective scheduling of resources and equipment, the BAS Team Leader is tasked with executing against agreed Production plans and delivering products that meet Quality, Cost and Supply requirements.

What will you be doing…

• Ensure that the day-to-day activities involved in the preparation, manufacturing and dispensing of Drug Substance are completed in accordance with the production schedule. Resource is fully utilised.
• Working closely with Engineering & utilising good planning techniques, ensure all PPM’s, calibration and validation activities are executed to schedule.
• To ensure all relevant c-GMP documentation is compliant, accurate, easy to understand and followed, with KPI’s in place to track RFT performance and improvement plans.
• All production activities are appropriately recorded and that all deviations or incidents are reported, investigated, and resolved in a timely fashion, to prevent reoccurrence and facilitate batch dispositioning.
• Identify improvement and efficiency opportunities and contribute to or lead (as appropriate) continuous improvement activities and projects to improve the performance of all production activities and the Production Teams, in alignment with the sites business objectives and imperatives.
• Lead and manage the Production Team, ensuring performance appraisals are carried out for all team members and that both good and poor performance are appropriately managed.
• To coach, mentor and enable team members in problem solving activities and to develop their continuous improvement skills and support them in the delivery of appropriate improvement projects.
• Identify individual training needs to drive personal development and a cross functional team.
• Ensure that the team as a whole and individuals have the necessary skills, knowledge, and experience to deliver the production schedule on time and in full and actively contribute to improving processes.
• Provide dedicated technical expertise to support the Manufacturing function in Managing Unplanned events, deliver Integrated projects and Efficiency projects to provide opportunities to Fuel the Future.
• Batch documentation is reviewed within 48 hours and is right first time.
• Actively manage the documentation to ensure SOP’s, INS’s, MMI’s and FOR’s are current, reflective of processes, operations and meet cGMP and EHS guidelines.

What are we looking for…

• A strong understanding of cGMP and EHS standards
• Extensive experience within a Pharmaceutical or other highly regulated environment
• Toxin/API manufacturing and preparation standards and processes, including sterilisation via autoclave technology, use of microbiological safety cabinets, fermentation, and purification.
• Knowledge of validation and engineering activities
• Experience of Internal/External audits.
• Supervisor/ management of a multi-skilled team.
• Proactive, positive, dedicated, and flexible approach.
• Strong organisational and leadership skills.
• Excellent problem-solving skills and ability to make informed decisions.
• Ability to communicate at all levels.
• Ability to manage competing priorities.

Why Ipsen…

• We are a business that is experiencing exponential growth and transformation, therefore presenting a wide range of opportunities and challenges
• Major £multi-million investment in a New Drug Product Facility to increase the scale and capability of our Wrexham site, ultimately enhancing the products we develop for our customers
• A fantastic culture and working environment with many long-serving employees
• Huge commitment to Diversity & Inclusion - almost 50% of our top 160 leaders are women
• A genuine focus on the environment and sustainability – our Wrexham site is powered by 100% renewable electricity
• Competitive salaries and enhanced benefits package which includes annual bonus, generous pension scheme, wellness allowance and so much more.
• Awarded ‘Best Workplaces’ and ‘Best Workplaces for Wellbeing’ status in the Large Organisations category, as well as ‘Best Workplaces for Women’ in 2023.
• The pride of working for a company that directly impacts and changes lives for the better