Product Development Manager

Product Development Manager, Commercial (Cambridge, UK) The Opportunity Cycle Pharmaceuticals is looking for an enthusiastic and talented team player to join its growing Product Development Department as a Product Development Manager, Commercial. The role will be responsible for providing technical and analytical knowledge of Cycle’s commercial products as well as leading projects at commercial phase. You will take ownership and be accountable for driving projects to ensure robustness in Cycle’s commercial products. This exciting opportunity will provide a platform to work across different therapeutic areas including metabolic, immunology and neurology, and investigating a range of different technologies and dosage forms. You will build your internal network and contribute to cross-functional project teams. Having the opportunity to participate in a range of company projects, you will leverage your transferable skills to make a real difference to our growth plan and patients we support. Job Interactions & Interface: This role interacts internally with key areas such as Product Managers, Project Management Operations (PMO), Regulatory Affairs, Quality, Supply Chain. 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 Manager, Commercial 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: Provide Formulation and Analytical technical expertise to support commercial products and work alongside Product Management, Quality and Regulatory Affairs teams as required. Builds and develops strong working relationships with new and existing third-party vendors. Support commercial manufacture of products. Lead trending of product performance from a technical point of view, conducting gap analysis, reviewing stability data and manufacturing process efficiency. 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 (in particular US-FDA focused). Execute assigned tasks relating to development projects, following SOPs/guidelines and make suggestions for improvement on processes. Prepare and review technical documentation following SOPs/guidelines/internal processes. Participate in projects, discussions and team meetings to improve knowledge and contribute ideas. Departmental responsibilities: Contributes to the discussion and creation of the annual budget, identifying spend and savings for the year ahead. Contribute to the discussions around the operational planning that implements the department strategy. Lead the representation of the department on cross-functional project teams – input into discussions on budget and timelines, and ensure wider department are aware of assigned actions. Acts as a role model for management attributes, demonstrating focus, flexibility and creativity, and create an environment in which people are encouraged and able to model these behaviours. Provide suitable training and development of relevant stakeholders to ensure their continued professional development. 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 in order to improve efficiency and consistency. Provides cover for the Product Development Team during absences. 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: Essential: Degree or equivalent in a science field (higher degree preferred). 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. Excellent written and oral communication. Consistently works in a proactive manner, whether working autonomously or as part of a team. Excellent project management skills with a high level of attention to detail, including when under pressure. Ability to create and maintain strong working relationships across the organisation and with external partners. 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. Strong analytical and problem-solving skills, and the ability to think outside the box. Quality focused. 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: · At least 5 years’ experience in at least one of the following: o Analytical method development and validation. o Risk assessment/Quality by Design. o Technical transfer of product manufacturing to commercial scale. o Vendor management of third party CMOs/CROs or experience working at a third party CMO or CRO. o 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.