Whitespace Associate, Mucinex R&D at Parsippany

Job Description

Reckitt Benckiser is a global success story in Health, Hygiene and Home products. Our success is led by successful brands like Lysol, Durex, Clearasil, Finish, Mucinex, Woolite, and Resolve that aim to achieve global market leadership. Our vision is a world where people are healthier and live better. Our purpose is to make a difference by giving people innovative solutions for healthier lives and happier homes.

As a key member of the Mucinex development team, this Associate will provide active support to support current commercial products and their global expansion. He/She will be relied upon to generate protocols, evaluate experimental data, and provide regulatory support. He/She will also be responsible for preparing CMC/CTD documents per established timelines, preparing reports to support regulatory submissions and supporting commercial product support activities with global RB manufacturing facilities.

Responsibilities will include the following;

• Write technical reports summarizing product development and stability of target formulations.
• Prepare documentation for CMC sections of NDAs/CTDs for new global regulatory submissions
• Plan, execute and document stability studies for key global markets
• Verify that current formulations are appropriate for declared shelf life in the prescribed product package for target markets.
• Communicate testing requirements for experimental batches to Analytical/SSG team
• Provide initial development cost estimates and timing to Project Manager and update as required
• Work with key manufacturing sites (Hull, UK or RB Nottingham, UK) to ensure seamless entry into approved markets
• Prepare regular project updates for presentation to RB management.

Job Requirements

• PhD in Pharmaceutics, chemical engineering or related technical discipline with 1-2 years of experience or BS/MS with 3+ years of experience
• Minimum of 2 years experience in an FDA regulated environment, preferably in pharmaceutical product development.
• Experience developing and commercializing controlled release products in a global environment is a plus.
• Proven track record of delivering key milestone of multiple projects simultaneously on expected budget
• Experience preparing technical reports used in CTD sections of global regulatory submission
• Fundamental understanding of key drug development activities and milestones
• Functional knowledge of common pharmaceutical ingredients and manufacturing equipment
• Understanding of risk-based experimentation including FMEA analyses
• Basic understanding of DOE principles and statistical data evaluation. Experience with Minitab a plus.
• Results oriented, entrepreneurial and self-motivated, with solid organisational capabilities.
• Good communication skills
• Self-starter capable of delivering independently on objectives with little oversight
• Strong analytical and problem solving skills
• Strong intellectual curiosity with an appetite for exploring new and previously uncharted territories and an openness to change and ability to think out of the box
• Ability to work under pressure and meet deadlines
• Hands-on scientist with drive and delivery focus
• Willingness to travel up to 30%

Expect responsibility. Expect challenges. Above all, expect rewards. And expect them all much sooner than you would anywhere else. Apply now and see just how much responsibility youll enjoy.
Country: USA, State: New Jersey, City: Parsippany, Company: Reckitt Benckiser.