Title: Sr. Product Development Sr. Scientist I

　　Location: Monmouth Junction, NJ

　　Job Type: Direct Hire

　　Hours: M-F 8AM-5PM

　　Overview:

　　The Product Development (PD) Senior Scientist I, under minimal guidance, designs, plans and conducts pre-formulation, formulation and process development activities as well as scale-up trials of complex projects using risk-based approach. The incumbent plans, coordinates and executes current Good Manufacturing Practices (cGMPs) pilot and pivotal/submission batches, including all required documentation. They prepare technical and product development reports and regulatory submission document and performs critical analysis.

　　Responsibilities:

　　Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws

　　Creates invention disclosures; Collaborates with internal and external counsel to perform patent landscape analysis, draft patent applications, and respond to office actions

　　Utilizes risk-based approaches and Quality by Design (QbD) principles in guiding pharmaceutical development and identifying critical quality attributes (CQA), critical material attributes (CMA), critical process parameters (CPP) and control strategies. Uses problem solving tools to trouble shoot, as needed

　　Designs and conducts physical and chemical characterization in liaison with analytical teams

　　Performs critical data analysis using statistical tools including stability analysis

　　Liaises, coordinates and manages PD activities with external labs, Clinical Research Organizations (CROs) and Clinical Development Manufacturing Organizations (CDMOs), including cGMP manufacturing activities; Collaborates closely with other functions within and outside R&D to ensure project timelines are met

　　Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports

　　Collaborates with Quality Assurance (QA) department on investigations, Corrective Action Preventive Action (CAPAs) and changes controls, as needed; Supports Technical Services and Operations departments to troubleshoot scale up and commercial processes

　　Participates in training of new employees and mentors lower level scientists

　　Requirements:

　　BS Degree in Pharmaceutical Science or related scientific field WITH Minimum 10 years experience in pharmaceutical formulation and product development

　　OR

　　MS Degree in Pharmaceutical Science or related scientific field WITH Minimum 8 years experience in pharmaceutical formulation and product development.

　　OR

　　PhD Degree in Pharmaceutical Science or related scientific field WITH minimum 3 years experience in pharmaceutical formulation and product development

　　In depth experience designing and conducting oral controlled release solids and liquids pharmaceutical formulation and process development studies with high scientific standard of multiple dosage forms

　　Working knowledge of QbD and risk-based approaches

　　Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational, Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines

　　Strong technical writing skills and experience (i.e., SOPs, investigations, protocols, reports, submission documents, etc.)

　　Proficiency with Microsoft Office

　　Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members

　　Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines

　　Planning, organization and time management skills including the ability to support and prioritize multiple projects

　　Benefits

　　Our client provides a comprehensive benefits package. Their benefits include competitive salaries, 401(k) plans with company match, medical, dental, and vision insurance, paid time off (vacation, sick leave, personal leave), paid parental leave, tuition reimbursement, life insurance, disability insurance, employee assistance program, on-site fitness center, free snacks and drinks, and casual dress code.

　　As this is a direct hire with our client System One benefits described below would not apply to this role. Benefits program listed above would be those applicable to this role.

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.