R&D PDM Senior Associate

Reckitt • Wilson, NC

120d • $102,000 - $152,000

About The Position

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.

Requirements

• Bachelor's degree in relevant scientific discipline (e.g. Chemistry, Pharmaceutical Science, Chemical Engineering, Biology, Biochemistry).
• 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.

Nice To Haves

• 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)).
• Experience with laboratory start-up projects.
• Experience with stability programs; including designing and managing stability studies per ICH guidelines.
• Experience with data visualization tools (e.g., Power BI).
• Knowledge of Quality by Design (QbD) and Design of Experiment (DoE).

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 assessments.
• 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).

Benefits

• Medical, prescription, dental, vision, and life and disability insurance.
• Paid time off for vacation, sick and Company recognized holidays.
• 401(k) plan.
• 16-week paid parental leave or 26 weeks for the birthing parent.
• Adoption and fertility support.
• Tuition reimbursement.
• Employee Assistance Program to promote mental health.
• Discounts and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree