Cmc Drug Product Lead

3 weeks ago


Nottingham, United Kingdom Catalent Full time

Catalent are currently recruiting for a CMC Drug Product Lead to join the Nottingham site. The CMC Drug product lead will be the accountable individual for delivery of client projects. They will set the technical and scientific strategy for the project in consultation with the client and also work in partnership with Business Development, Commercial Services and the corporate Science and Technology function to define the technical scope of the potential project.

The job:

- To set the technical strategy to ensure client and product requirements are met and ensure the science throughout the project is meeting those expectations. The development of this technical strategy may start through involvement in the business development phase prior to the contract being agreed.
- Provides leadership and clear direction to the technical leads regarding the scientific strategy of the project - at the outset, during and in reporting and delivery of the project. Partners the project manager to ensure overall project delivery.
- Technical approval and sign-off on client documents (including but not limited to technical specifications, project risk assessments, development reports, powerpoints) and data provided to the client. Where any of the above are delegated to the project team, the responsibility and accountability remain with the Study Director.
- Escalates high impact technical, quality, resourcing and client relationship issues that will significantly impact the outcome of the project to the appropriate senior management level.
- Anticipates technical blockers and acts to address
- Will lead technical capability projects to improve on or bring in new technologies into the site. This may be in collaboration with the corporate S&T function, other sites in Catalent, external companies or academic groups
- Coaching, mentoring and development of junior staff (direct and indirect reports)
- Education to degree level or higher in pharmaceutical sciences, chemistry, physical sciences or engineering or Equivalent experience.
- Extensive experience in pharmaceutical product design, development and manufacture
- In depth understanding of formulation development and process development of simple and complex oral dosage forms, and the supporting analytical methodologies and characterisation techniques.
- Effective project management skills - ability to develop work plans with tasks, timeframes, milestones resources and dependencies.
- Excellent GMP knowledge and working practices.
- Experience leading projects.

Internal job title; Technical Manager/Study Director.

**Catalent offers rewarding opportunities to further your career** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.



  • Nottingham, Nottingham, United Kingdom Quotient Sciences Limited Full time

    OverviewQuotient Sciences Limited is a leading drug development and manufacturing accelerator. We provide integrated programs and tailored services across the entire development pathway, helping biotech and pharma customers save time and money in getting drugs to patients.As a growing and successful business, we employ over 1,100 talented individuals...

  • Drug Discovery Expert

    2 months ago


    Nottingham, Nottingham, United Kingdom Sygnature Discovery Limited Full time

    About the CompanySygnature Discovery Limited is a world-leading integrated drug discovery Contract Research Organisation based in the UK and Canada. We partner with global pharma, biotech, and NFP organisations, providing expertise in bioscience, chemistry, and pharmacology.Job DescriptionWe are seeking a Drug Discovery Expert to join our team at Sygnature...


  • Nottingham, Nottingham, United Kingdom Quotient Sciences Limited Full time

    OverviewQuotient Sciences Limited is a leading provider of integrated drug development and manufacturing solutions. Our company is dedicated to helping pharmaceutical and biotechnology clients accelerate the discovery, development, and delivery of innovative medicines.


  • Nottingham, United Kingdom Metric Bio Full time

    Metric Bio are partnered with a highly reputable European Drug Discovery CRO on the search for a Vice President of Business Development (UK based), to lead commercial efforts within Europe.As a Vice President of Business Development, you would be expected to individually contribute revenue from both Biotech & Large Pharma. This role also possesses scope for...


  • Nottingham, United Kingdom CK GROUP Full time

    CK Group have an amazing opportunity for an ambitious Group Leader/ Director with senior industry experience within bioprocessing and formulation development of viral vaccines, to join a newly established team within a growing biotechnology company attheir recently renovated campus in Nottingham, on a permanent basis, with flexibility of hybrid working **The...

  • Production Team Lead

    2 weeks ago


    Nottingham, Nottingham, United Kingdom Disability Solutions Full time

    Job DescriptionWe are seeking a highly skilled Production Team Lead - Engineering to join our engineering team at Catalent. This role offers an exciting opportunity to work in a dynamic and fast-paced environment, where you will be responsible for leading a team of engineers, overseeing maintenance of site utilities, infrastructure, and equipment, and...


  • Nottingham, United Kingdom Scienta Full time

    The Organisation Join a leading global CDMO specializing in innovative drug development and manufacturing solutions across small molecules, biologics, and advanced modalities such as ADCs and oligonucleotides. With a proven track record of delivering high-quality, end-to-end services to thousands of global clients, this organization is at the forefront of...

  • Production Supervisor

    4 weeks ago


    Nottingham, Nottingham, United Kingdom Quotient Sciences Limited Full time

    Quotient Sciences Limited is a leading drug development and manufacturing accelerator, providing integrated programs and tailored services across the entire development pathway.About the RoleWe are seeking an experienced Production Supervisor to join our team in Ruddington, Nottingham. This role involves coordinating activities associated with the Goods-In...

  • Production Lead

    4 weeks ago


    Nottingham, Nottingham, United Kingdom Pioneer Selection Careers Full time

    Pioneer Selection Careers is currently looking for a Production Lead to join their team in Nottingham.The successful candidate will be responsible for overseeing the production process, ensuring maximum efficiency and productivity. With a salary of £60,000+, this role offers a fantastic opportunity for experienced professionals to take on new challenges.We...


  • Nottingham, United Kingdom Lead Talent Full time

    **Lead Talent is excited to be exclusively partnering with a very special organisation based on the outskirts of Nottingham who supply high-quality, handcrafted furniture to premium retailers across the UK. In-line with year-on-year growth, this dynamic, innovative and collaborative organisation is seeking an Order Processing Administrator to join their...


  • Nottingham, Nottingham, United Kingdom SRG Full time

    Job Description:We are seeking a skilled Product Innovation Lead to join our team at SRG. The successful candidate will be responsible for leading product innovation within the suncare market, formulating new products, and collaborating with internal and external stakeholders.About the Role:As a Product Innovation Lead, you will lead technical projects,...

  • Operational Lead

    4 weeks ago


    Nottingham, Nottingham, United Kingdom Prince Personnel Limited Full time £41,000

    About the Opportunity:We are seeking an experienced production operations supervisor to join our team in Telford. The successful candidate will be responsible for leading a team of production operatives and ensuring the smooth operation of our manufacturing facility. This is a permanent position with a competitive salary and opportunities for professional...


  • Nottingham, Nottingham, United Kingdom Central England Coop Full time

    Job DescriptionWe are seeking a highly skilled and motivated Lead Production Coordinator to join our team at Central England Coop. As Lead Production Coordinator, you will be responsible for coordinating the activities of our production team, ensuring that we meet our targets and deliver high-quality products to our customers.You will work closely with our...


  • Nottingham, Nottingham, United Kingdom Quotient Sciences Full time

    Quotient Sciences is a leading drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. We help biotech and pharma customers save precious time and money in getting drugs to patients.Job DescriptionAs a Clinical Research Physician at Quotient Sciences, you will be responsible...


  • Nottingham, Nottingham, United Kingdom ZipRecruiter Full time

    About the Role:We are looking for an experienced Lead Project Manager to join our team and lead biotech initiatives. As a senior project manager, you will be responsible for overseeing drug development projects in the pharma industry.Your Key Responsibilities:Develop and manage project Gantt charts, including budget and resource planningWork in partnership...


  • Nottingham, Nottingham, United Kingdom Overwolf Full time

    Job DescriptionWe are seeking a highly skilled Product Development Lead to join our team at Overwolf. In this role, you will be responsible for developing and implementing innovative solutions to enhance the monetization strategies of our publishers.The ideal candidate will have a strong technical background in ad tech stacks and tools, including SSP, DSP,...


  • Nottingham, Nottingham, United Kingdom oilandgas Full time

    Your Role:This position reports to the Lead Global Product Manager, overseeing all aspects of offering lifecycle management for the Europe, Middle East, and Asia-Pacific regions. Key responsibilities include developing business plans that drive sustainable growth, identifying portfolio gaps, and initiating product launches.


  • Nottingham, Nottingham, United Kingdom SRG Full time

    About the Role:The Product Development Lead will play a critical role in developing and launching new SPF and suncare products that meet regulatory requirements and exceed customer expectations. As a key member of our team, you will be responsible for leading technical projects, collaborating with stakeholders, and driving business growth through...


  • Nottingham, Nottingham, United Kingdom I Holland Ltd Full time

    About the CompanyI Holland Ltd is a leading precision engineering company dedicated to delivering exceptional products and services to our customers. We pride ourselves on our commitment to quality, innovation, and customer satisfaction.About the RoleWe are seeking an experienced Assembly Production Lead to join our team and drive precision engineering...


  • Nottingham, Nottingham, United Kingdom Central England Coop Full time

    Key ResponsibilitiesAs Head of Manufacturing Excellence, you will be responsible for:Leading and managing production teams to achieve operational excellenceImplementing improvements to increase efficiency and productivityMaintaining high standards of Health & Safety and regulatory complianceA competitive salary of £65,000 - 75,000 per annum reflects your...