Position Summary The Global Biologic Stability (GBS) team manages the stability programs for commercial biologics Drug Substances and Drug Products. The global stability program supports all internal and external manufacturing sites. The Stability Senior Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for end-to-end oversight of product stability programs. Activities include (but not limited to) those associated with developing product stability strategy; stability data analysis/trending; and preparation, review and approval of stability protocols, reports and regulatory filings.
Key Responsibilities • Accountable for end-to-end program management for biologics marketed product stability program, including: • Stability product strategy: determines/communicates stability requirements (e.g. Health Authority annual commitments, product/process change qualification batches, etc.) and assists with identifying production batches that meet these defined requirements for inclusion in the stability program. • Perform change control impact assessments and document the assessments in change controls. Review and endorse change controls as required. • Author change controls for changes to stability program/operations. • Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP), batch-specific enrollment documentation, and LIMS stability studies. • Perform stability data analysis/trending in support of data out-of-trend (OOT) analyses, regulatory submissions, Annual Product Quality Reviews (APQR), internal reports, etc. • Authors stability sections of regulatory submissions (CTD dossiers for post-approval filings, annual reports, product renewals, health authority queries), APQR, and internal reports. • Serve as stability subject-matter expert (SME) on project teams related to pre-market and post-approval changes. • Develop and maintain expertise on the overall stability performance of biologic products, including maintaining a working knowledge of the attributes that impact product performance/stability profile. • Serves as GBS representative for OOT/OOS investigations and other stability-related investigations/deviations. Complete stability impact assessments as needed. • Expected to work with limited oversight from direct manager; but expected to identify and promptly escalate to management any critical issues related to stability program (e.g. potential impact to regulatory commitments, lab capacity, stability storage capacity). • Expected to critically evaluate situations and make decisions that require choosing between multiple options, or develop new options, to resolve moderately complex problems. • Acts as an advisor/mentor to stability staff. • Good organization skills and keen attention to detail.
Qualifications & Experience • (MS) or BS degree required with relevant cGMP experience in biopharma • Strong working 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 • Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system. • Ability to work collaboratively in a team matrix environment is required. • Significant experience with evaluating and interpreting stability data using statistical software. • Working knowledge of biologics drug substance manufacturing and drug product filling operations and good understanding of analytical and microbiological methods. • Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking. • Experience in Operational Excellence, with proven record of accomplishment in continuous improvement. Prior experience with commercial stability trouble-shooting • Experience with front room FDA/health authority inspectional experience. • Works independently, review data and demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects, and deliver according to overall strategy. • Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices. • Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, etc.
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.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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: $60.00/daily.
