Product Development Manager
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
We’re looking for someone hands-on and technically strong to lead Cycle’s products in the commercial phase. You’ll bring analytical and technical know-how, take ownership of driving projects, and make sure our commercial products are robust, reliable, and ready to support our patients. This is an exciting opportunity where you’ll team up with colleagues across functions, contributing directly to key projects. You’ll have a real impact on the business and leverage your transferable skills to make a difference to our growth plan.
Our Company
At Cycle, we believe thatEvery 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 expertise to support the robustness of commercial products, specifically the manufacturing processes.
- Build and develop strong working relationships with new and existing third-party vendors.
- Support with the commercial manufacture of our products.
- Lead the trending of product performance from a technical point of view, conducting gap analysis, reviewing stability data and manufacturing process efficiency.
- Identify & lead additional development projects as required to ensure robustness of commercial supply, by investigating issues and risks, designing suitable scope of work and managing execution of projects with Cycle’s CMOs.
- Maintain knowledge of relevant regulatory guidance (US-FDA focused).
- Execute assigned tasks relating to development projects, following SOPs/guidelines and provide suggestions for improvement on processes.
- Participate in projects, discussions and team meetings to improve knowledge and contribute ideas.
Departmental responsibilities:
- Contribute to the discussion around budget spend identifying any savings, operational planning that implements the department strategy, budget timelines to ensure wider department are aware of assigned actions.
- Act as a role model for management attributes, demonstrating focus, flexibility and creativity, and creating an environment in which people are encouraged and able to model these behaviours.
- Attend team meetings and engage with internal and external stakeholders providing support and subject leadership as required.
- Develop and improve procedures and processes used by the department, identifying problem areas, proposing and implementing robust solutions to improve efficiency and consistency.
- Provides cover for the Product Development Team during absences.
Skills and experience that will help you thrive in this role:
- Degree or equivalent experience within the Pharmaceutical or Life Science industry.
- Experience with drug product formulation development (pharma or academic environment) from early to late phase in at least one of the following:
- oral solid dose form,
- solutions and suspensions
- Application of ICH guidelines.
- Confident presenter with strong communication skills, essential for this client-facing role.
- Strong project management skills with exceptional attention to detail, even in high-pressure situations.
- Strong negotiation skills, and confidence in challenging co-workers or third parties, whilst ensuring relationships are maintained.
- Enthusiasm and personal initiative to solve problems, a self-starter with ability to work unsupervised.
- Results oriented and takes ownership and accountability to deliver objectives on time and to budget.
- High level of prioritisation and organisation to manage assigned work effectively.
Desirable skills that would support in this role but not essential:
- Analytical method development and validation.
- Risk assessment / Quality by Design.
- Technical transfer of product manufacturing to commercial scale.
- Vendor management of third party CMOs / CROs or experience working at a third party CMO or CRO.
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.
