Product Development Associate or Senior Associate
Cycle Company: Cycle Pharmaceuticals Ltd
Position Summary: This is a full-time position within the Regulatory Affairs & Product Development department, working in our Cambridge office on a hybrid basis (minimum 3 days in the office).
Overview of the role
Are you ready to make a real impact in a fast-growing, patient-focused company?
We're looking for a driven professional to lead and contribute to development projects from early feasibility all the way through to successful commercial launch. This is a key role within our Regulatory Affairs & Product Development team where you’ll combine your technical expertise and analytical thinking with strong project leadership to ensure projects are delivered on time, on budget, and to the highest standards through effective vendor management.
You'll collaborate with cross-functional teams, connect with external CDMOs, and play a critical part in advancing our product pipeline. We're open to Associate or Senior Associate level of experience so, if you're looking to grow and progress your career, apply your transferable skills in meaningful ways, and make a real difference to our growth plan and our patient’s then we want to hear from you.
Our Company
At Cycle, we believe that Every Single Patient Matters. This is at the heart of why we work and were looking for people to join our team who 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.
At Cycle we focus on providing treatments and services for patients with neurological, rare metabolic, and rare immunological conditions, most of which are genetic conditions. Some of our patients are diagnosed with a rare disease at birth, others are affected later in life, and some can spend years trying to get diagnosed.
No matter what stage our patients or their caregivers are at, we strive to provide them with the support they require. If you want to know more about what we do then, why not check out our website below and look at some of our patient stories:
Patient Stories - Cycle Pharma
What you will be doing
* Provide Formulation and Analytical technical input to development projects to support the Quality and Regulatory Affairs teams as required.
* Build and develop strong working relationships with new and existing third-party vendors.
* Drive 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.
* Provide cover for the Technical Team during absences.
* Collaborate on 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 and making suggestions for improvement on processes.
* Research and analyse new technologies, excipients & dosage forms, preparing talking points and questions for discussion with your manager / colleagues.
* Participate in projects, discussions and team meetings to improve knowledge and contribute new ideas.
Skills and experience that will help you thrive in this role
* Degree or equivalent experience within the Pharmaceutical or Life Science field
* Experience with 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
* Ability to work in a proactive and autonomous manner, as well as being part of a team.
* Ability to create and maintain strong working relationships across the organisation and with external partners.
* Enthusiasm and personal initiative to solve problems, a self-starter with ability to work unsupervised.
* Strong analytical, organisational and problem-solving skills.
* Quality focused and high attention to detail.
Desirable skills that would support in this role but by no means essential
* 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 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.