**Principal Scientist, Injectables**


Direct Hire


Location: Pine Brook, NJ


The Principal Scientist is responsible for the development of complex injectable dosage forms including formulation development, process development, technical transfer, and commercial product support. The complex injectable products include long acting/peptides/drug-device combination injectables.


**RESPONSIBILITIES**


+ Design and execute R&D batches through Quality by Design (QbD) approach

+ Conducts scientific literature search.

+ Identify key process parameters and their impact on product quality

+ Lead the development plan to address scale up and tech transfer issues

+ Develop and execute scale up/tech transfer and submission batches.

+ Reviews data, performs root cause analysis for trouble shooting and seek path forward under advisement

+ Document preparation and review such as batch records, protocols, sampling plans, engineering reports and qualification reports

+ Prepare and/ or review product development reports, process development report and other relevant documents as required for ANDA filing

+ Be Proactive, have good organizational and time management skills

+ Support and drive the project to targeted timelines with the manufacturing site for a timely and successful product filing

+ Complete all required in-house and external training to keep current on regulatory and industry changes

+ Must be able to work in a cross-functional environment interacting with departments such as tech services, analytical, regulatory, biopharmaceutics, quality, and project management.


**QUALIFICATIONS**


+ Ph.D. with 5 years or MS 8 years of formulation and process development experience in generic industry, especially in injectable dosage forms.

+ Working experience in the development of complex injectables such as peptides, sensitive APIs and long acting injectables.

+ Experience in drug device combination products is a plus.

+ Strong oral and written communications skills

+ Proficient in computer use (Word, Excel, PowerPoint) with ability to learn new computer applications

+ Ability to follow standard operating procedures to perform work function.

+ Strong technical aptitude, sound judgment and operates with a sense of urgency in a fast-paced environment

+ Up to date information and knowledge of FDAs requirements for ANDAs cGLP, cGMP related to pharmaceutical product development, manufacturing, and documentation

+ Experience and understanding of Design of Experiments (DOE), Quality by Design (QBD), scale-up and process technologies

+ Experience in working with CRO/CMO is a plus

+ Must be able to travel. Travel up to 30% domestic and could have some International.


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
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