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Product Development Associate

4 months ago

Cambridge Cambridgeshire, United Kingdom Cycle Pharmaceuticals Full time

Cycle Pharmaceuticals is looking for an enthusiastic and talented team player to join its growing Product Development Department as a Product Development Associate.

The role will be responsible for providing technical and analytical input as well as leading development projects from feasibility assessment through to commercial launch. It also encompasses being accountable for driving development projects to Cycle’s goals, timelines, and costs through efficient vendor management. You will be working across different therapeutic areas including metabolic, immunology and neurology.

This role interacts internally with key areas such as Project Management Operations (PMO), Regulatory Affairs, Quality, Supply Chain etc. Externally this position interacts with Contract Manufacturing Organisations (CMOs) as well as a range of suppliers and third-party vendors.

The Cambridge team is relatively small but highly dynamic, and the work environment is representative of an expanding company, hence requiring an adaptive and pragmatic mindset. Coaching and mentoring to support continuous learning and professional development will be provided and tailored to individual needs.

Our Company

At Cycle, we believe that Every Single Patient Matters, this is at the heart of why we work, and we’d love for you to share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.

We are a pioneering pharmaceutical company, reimagining how drugs and services can benefit patients with rare disease to make their lives easier and improve their quality of life. Cycle, as a company, works closely with patient groups and healthcare professionals to understand the unmet needs of patients and their carers. By collaborating with academic communities and using the latest cutting-edge pharmaceutical technologies, we translate innovations into medicinal products that patients and caregivers actually desire. We deliver the required medicine with the minimum impact on daily routines and, just as importantly, provide individualized support services to patients, families, carers and the healthcare professionals community.

Cycle has three core areas of pharmaceutical development and work across rare metabolic, immunological and neurological genetic conditions: improving drugs – optimizing an existing drug; repurposing drugs – creating a new indication for an existing drug; and generics – reinstating generic drugs, previously available in the market. These three areas of focus are underpinned by formulation technology – using new drug delivery technologies to improve the efficacy and effectiveness of drugs, allowing us to give patients greater freedom and choice.

Job Title: Product Development Associate

Cycle Company: Cycle Pharmaceuticals Ltd

Position Summary: This is a full-time position within the Product Development department, working in our Cambridge office.

What you will be doing

Technical responsibilities:

• Provides Formulation and Analytical technical input to development projects and supporting the Quality and Regulatory Affairs teams as required.

• Builds and develops strong working relationships with new and existing third-party vendors.

• Drives development projects with support from line manager, to ensure they are delivered according to Cycle’s timelines, costs and milestones whilst maintaining efficient vendor management.

• Provides cover for the Technical Team during absences.

• Supports development planning, scope design and issue resolution for formulation development.

• Maintain knowledge of relevant guidance (in particular US-FDA focused).

• Execute assigned tasks relating to development projects, following SOPs / guidelines. Make suggestions for improvement on processes.

• Research and analyse new technologies, excipients & dosage forms, preparing talking points and questions for discussion with your manager / colleagues.

• Prepare and review technical documentation following SOPs / guidelines / internal processes.

• Provide support for department processes and as part of project teams.

• Participate in projects, discussions and team meetings to improve knowledge and contribute ideas.

Departmental responsibilities:

• Represent the department on cross-functional project teams, delivering on assigned tasks as required, working to budget and within assigned timelines.

• Attend team meetings and engage with internal and external stakeholders as directed to provide support and guidance on areas of knowledge.

What will enable you to thrive

The following skills and experience will be important in helping set you up to succeed and thrive in

this role:

• Degree or equivalent in a science field (higher degree preferred)

• Drug product formulation development (pharma or academic environment) in at least one of the following:

  • oral solid dose form,
  • solutions and suspensions.

• Application of ICH guidelines

The following skills and experience would be an advantage to this role:

• At least 2 years’ experience in at least one of the following:

  • Analytical method development and validation
  • Risk assessment / Quality by Design.
  • Vendor management of third party CMOs / CROs or experience working at a third party CMO or CRO.
  • API development

What makes this role special

• Seek to have a profound impact on patients and their families.

• Work across a range of different disease states.

• Mentoring, coaching and training that will give you the opportunity for personal and professional development.

• Help shape the culture and future of an emerging pharmaceutical company with a grand vision.

• Work with a growing team of experienced professionals.

• Learn from a strong leadership team with a proven history of success.

What can we offer to you

In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:

• Competitive salary based on experience

• A collaborative high performing work environment

• Performance based bonus

• Opportunity to join a fast growing and ambitious business

• Company pension scheme

• 100% employer paid membership for Private Health Insurance

• Life and Critical Illness Insurance

• Corporate Gym membership

• Regular team building events and an agile working environment

Applications

Cycle Pharmaceuticals embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements