Position: Principal Scientist Stability Location: New Brunswick Duration: 12 Months 100% onsite
Principle Objective of Position: The Principal Scientist Stability is responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile. Activities include those associated with product stability strategy, stability program requirements, authoring/approving stability protocols, and preparation, review, and approval of stability reports and regulatory filings.
Major Duties and Responsibilities: The Principal Scientist stability is accountable for the stability program on assigned brand (s) and acts as Stability Product Lead. • Participates on transfer team for new products to internal and external sites (as required), reviews registrations stability studies, and conducts gap analysis against Global Manufacturing & Supply requirements. Develops stability data where gaps exist. • Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products’ performance/stability profile • Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change • Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations • Provide the technical requirements in a Master Stability Protocol, review and approve study-specific protocols and /or batch enrollment forms • Responsible for the handling of the annual commercial stability program for assigned products in coordination with sample management groups. • Authors stability sections of CTD dossiers for post-approval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability-related responses to health authority inquiries. • Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and deviations from standards. • Leads work activities involving Change Controls and CAPAs. • Identify information regarding the stability program that may impact lab capacity, product studies, or regulatory commitments directly, escalate promptly to management, and act as required. • Responsible for stability procedures and ensures consistency with site department and groups procedures. • Participate and/or lead OpEx initiatives to streamline and standardize the management of stability programs • Support health authorities' inspections internal and external. • Represents the department in cross-functional projects • Ensure training requirements are met. • Acts as an advisor and mentor to stability staff
Required Knowledge/Skills/Qualifications: Education: Required B.S. in Chemistry, Biology, Microbiology, or a relevant discipline Experience/Knowledge: 8 years of relevant work experience required, preferably in a Pharmaceutical environment.
Skills/Competencies: Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives, and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility. - Expert Knowledge of US/EU/ROW Requirements, Corporate Directives, and industry best practices. - Knowledge of Drug Substance and Drug Product manufacturing and a good understanding of analytical and/or Microbiology methods. - Very good skills to drive the development of technical or scientific initiatives for solving complex problems/issues; recommending and driving science-based decisions/ implementation of solutions. - Experience with authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality management principles - Good Knowledge of evaluation and interpretation of stability data using statistics software. Review data and demonstrate the ability to recognize anomalous trends or results - Experience overseeing external service providers involved in stability studies. - Significant experience in health authorities' inspections of stability programs. - Excellent written and verbal communication skills - Exhibit strong leadership and decision-making skills. - Advanced ability to work independently and collaboratively in a team matrix environment, contribute to a team-based environment and promote a high commitment to business goals and objectives. - Advanced ability to prioritize objectives from multiple projects and ability to adapt to quick changes in schedules to accommodate priority requests. - Advanced knowledge of Microsoft Office applications, LIMS, Quality Management systems (e.g. TrackWise or Veeva), and Statistics software (e.g. SlimSTAT, JMP).
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $72.00/hr.
