Overview
R&D PDM Senior Associate (Wilson, NC, US, 27893)
We are Reckitt
​Research & Development​
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
We are seeking a high-calibre individual with the necessary skill set to lead a team of scientists working on a cross-functional platform of projects spanning in-market R&D activities, regulatory technical support, troubleshooting and margin improvement programmes.
This challenging role comprises of leading a team of scientists – both from a managerial and technical excellence standpoint – to deliver a new R&D laboratory and champion the technology transfer of multiple Over-the-Counter (OTC) and Vitamins, Minerals, and Supplements (VMS) products.
Your responsibilities
- Acting as Subject Matter Expert (SME) for the end-to-end technology transfer of multiple OTC and VMS products, in partnership with Technical/Supply
- Ensuring Critical Process Parameters (CPP’s) and Critical Quality Attributes (CQA’s) are considered during early-stage technology transfer (TT1/2), providing input on supply equipment ordering, facility start-up and process transfer risk assessmentsÂ
- Leading and managing a team of scientists to execute R&D laboratory start-up, maintenance and analytical method transfer activities, working in close partnership with R&D counterpart, QC and QA
- Establishing and overseeing the Wilson stability program to support technology transfer and commercialization of multiple OTC and VMS products, in partnership with QC/Supply
- Responsible for all R&D technical activities in the compliance programme under your remit, working closely with the technical project manager to ensure tasks are completed by you and your team on time to meet the transfer schedule
- Accountable for the delivery and execution of project work of your team
- Accountable for the KPIs / delivery of project milestones of your team
- Responsible for the development of your direct line reports
- Collaborate with cross-functional teams including Technical, Manufacturing, Quality, Regulatory, Procurement to ensure seamless product technology transfers into the Wilson site
- Foster a culture of safety, quality, and continuous improvement with the team
- Ensure all activities comply with relevant regulatory standards (e.g. FDA, cGMP)
- Can be counted on to consistently deliver performance targets
- An engaged and high performing individual, with the ability to motivate and develop their team
- Healthy, working relationship between cross-functional business partners
The experience we're looking for
- Bachelor's degree in relevant scientific discipline (e.g. Chemistry, Pharmaceutical Science, Chemical Engineering, Biology, Biochemistry)
- Post graduate qualifications in further scientific disciplines would also be beneficial (i.e. PhD, or MSc, post-graduate diplomas (e.g. Pharmaceutical Quality by Design)
The skills for success
Required:
- Five+ years of related formulation and technology transfer experience in a regulated or technical industry (e.g. pharmaceuticals, manufacturing, healthcare)
- Experience leading or supporting technology transfer from R&D to manufacturing or site-to-site transfer projects
- Experience working with oral solid dosage (OSD) and liquid products (preferably OTC and/or VMS products)
- Strong knowledge of analytical testing equipment, techniques and method transfer requirements (proven experience strongly preferred)
- Proven experience in managing scientific teams and cross-functional projects
- Proficient in risk management processes and tools (e.g, FMEA)
- Proven ability to identify, assess and mitigate technical and regulatory risks
- Excellent project management, communication and leadership skills
- Ability to problem solve under pressure
- Strong technical writing skills
- Must be familiar with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), as well as FDA and ICH guidelines
- Proficient in Microsoft Project, Word, Excel and PowerPoint
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Preferred:
- Experience with laboratory start-up projects
- Experience with stability programs; including designing and managing stability studies per ICH guidelines  Â
- Experience with data visualization tools (e.g., Power BI)
- Knowledge of Quality by Design (QbD) and Design of Experiment (DoE)
What we offer
Salary ranges
Pay transparency
Equality
IMPORTANT: Before applying for this role, please make sure you have the right to work in the country where the role is based. Unless it clearly stipulates within in the job advert above that the hiring company is looking to or able to sponsor applicants it is deemed that the hiring employer will only consider applications from those able to comply with and work in the country where the role is based.