HireDiversity

Fort Washington, PA, US

PRINCIPAL SCIENTIST, MICROBIOLOGY-6205130123

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Principal Scientist, Microbiology within the R&D organization located in Fort Washington, PA.

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB, ROLAIDS® antacid products, and SUDAFED® nasal decongestants.

The Principal Scientist, Microbiology position provides technical direction within R&D for New Product Development/Supported Marketed Products (NPD/SMP) Teams on microbiology requirements and related activities [e.g. Antimicrobial Efficacy Test [AET], test method suitability, scale-up] and also helps resolve any microbiological issues from early stage development through process validation and marketplace. This role will create, access, and review new raw materials, Developmental and Finished product microbial-related specifications for products through development. This role also partners with the R&D sample Life Cycle Process Teams for activities related to microbiology including Clinical Supply Release and related Research and Stability studies, which includes setting the requirements for validation protocols and reports, procedures, test methods, method suitability studies, hold time studies, stability plans and protocols.

A key role will be to provide input into the SOPs /tier documents currently being developed, and then to ensure appropriate implementation. Technical input includes preservative selection and AET strategy for cross-functional teams and other technical groups to ensure product robustness and compliance to internal policies/procedures, and external regulations. The individual in this role will act as SME [Subject Matter Expert] on these teams. This person will participate in the Consumer World Wide Community of microbiological practice and participating in Johnson & Johnson network microbiological initiatives and meetings.

The position will include, as required, participation on the Functional Action Teams and assist with the new Quality Standards and SOPs as related to R&D Microbiology. This role may also participate in microbiological assessment of contract sites & suppliers.

J2W:LI

Qualifications


A minimum of a Bachelor's degree in Biology, Biochemistry, Medical Technology, Microbiology, or related discipline with at least 10 years of R&D experience in a drug, device or biologics manufacturing environment OR a Master's degree with at least 7 years experience or a PhD with at least 4 years of the aforementioned experience is required. Knowledge of cGMPs is required. Knowledge of Industrial Microbiology, Formulation, Preservatives, and Compendia particularly USP chapters 61,62,1227,1111, and 51 are required. Experience with regulatory inspections, regulatory submissions and auditing are all preferred. The ability to schedule/prioritize work with minimal supervision is critical to the success of this position.

The selected candidate must have excellent oral and written communication skills. Efficiency with MS Office, Excel and PowerPoint is necessary.

This position is located in Fort Washington, PA. This position will require up to 10% domestic travel.

All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)