Sr Associate Drug Product Manufacturing Lead United Kingdom
Job description
Why Patients Need You Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who appreciate the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them. What You Will Achieve As a Sr. Associate Drug Product Manufacturing (DPM) Lead within Drug Product Supply (DPS) in Sandwich, Kent, UK, the successful candidate will lead the manufacturing campaigns for Clinical Drug Product. The colleague will project manage complex development and clinical manufacturing activities, acting as the key interface in the cross-functional teams. Colleague will provide troubleshooting in ambiguous situations as well as technical solutions. Duties also include assist with compliance related activities, including GMP batch documentation, safety, training, and quality system. How You Will Achieve It Project Support: Represent Drug Product Manufacturing on multiple cross-functional Pharm Sci Small Molecule project teams. Global Supply Chain functional groups, including Supply Chain Leaders, Master Planner, Clinical Supplies Packaging, Import / Export / Distribution, Strategic Sourcing and Inventory Management as well as US based manufacturing groups as required. Partners lines including Drug Product Design, Quality Organization, Regulatory, API manufacturing, GMP Analytics, Global Operations, Pfizer Global Supply and external vendor sites as required. Apply process science/engineering skillset in the scale-up of solid oral dosage forms from lab to GMP manufacturing scale (immediate release tablets, modified release tablets, microspheres, capsules, etc.) Create/review GMP documentation, including batch records, product-specific cleaning assessments, and SOPs. Liaise with partner lines to: Rapidly translate lab scale formulations into robust GMP processes in partnership with formulation scientists. Manage material requests (procurement and movement) with Global Materials Management Ensure on-time test and release of clinical supplies with GMP analytical lab and Quality Operations. Overview of production activities and support resolution of any manufacturing issues that impact release to agreed timelines. Support the planning and scheduling of clinical, development, and PM/Cal activities in DPM. Technology and Capabilities: Provide operational floor support during manufacture to ensure engineering controls and target product attributes are met. Lead data review, capture lesson learned and document information that reflects both the positive and negative experiences of a project. Drive the timely resolution of quality deviations and assist in root cause analysis or CAPAs for manufacturing investigations. Develop comprehensive process understanding of current drug product technologies, procedures and job demands. Leadership: Provide excellent customer service through real-time project status updates and timely communications Assure adherence to compliance and data integrity requirements Support / manage continuous improvement initiatives and implementation of new technology commitment to project management excellence Qualifications Must-Have BS/MS in a relevant Scientific or Engineering discipline and working experience within the role Knowledge of industry practice for cGMP Excellent communication and organizational skills. Self-motivated and regularly delivering towards timelines. Nice-to-Have Master’s Degree Experience with solid dosage forms Experience with scheduling Experience with data visualization tools (e.g., Spotfire) Work Location Assignment: Flexible Purpose Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! Engineering #LI-PFE Pfizer
