Senior Associate, R&D PDM (Formulation and Technology Transfer) --- DIRECT HIRE/PERMANENT!

Senior Associate, R&D PDM (Formulation and Technology Transfer)

Manpower Engineering is exclusively partnering with a global nutritional/food manufacturer and industry leader in Wilson, NC on a highly visible and direct hire/permanent Senior Associate, R&D PDM (Formulation and Technology Transfer) that's available due to continued growth and has strong advancement potential.

Position: Senior Associate, R&D PDM (Formulation and Technology Transfer) This position will have direct reports as the team continues to grow.

Location: Wilson, NC (Newer start-up site roughly 30-40 employees and expected to grow to 300-400 in a few years.)

Salary Range: $117,000 to $155,000 (may be able to go higher depending on qualifications/experience)

Bonus: 15% of salary (+max multiplier 2x) Potential to earn $45,000+ in bonus.

Full Benefits Package (including but not limited to): Health, Dental, and Vision Insurance, 401k match, paid vacation time and holidays, etc.

Relocation Assistance Yes.

Job Description

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.

Responsibilities/Accountabilities:

• 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 program 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).

Deliverables/Indicators of Success:

• 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.

Qualifications:

• Education:

  • 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).

• Skills & Experience:

  • Required:
  • 4-5+ years of related formulation and technology transfer experience in a regulated industry (e.g. pharmaceuticals, personal care products, healthcare, food, beverage, consumer goods, etc.).
  • 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.
  • Preferred:
  • 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).

• Personal Attributes:

  • Strong communication and leadership skills; with the ability to delegate whilst remaining accountable.
  • Strong project and time management skills are essential.
  • Stakeholder collaboration and the ability to manage expectations are also key.
  • Comfortable with ambiguity and be a 'self-starter' with the ability to quickly learn and adapt to keep up with the fast pace of the role.
  • Technically diligent and able to grasp new science and visualize a business benefit.