Stability Scientist
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring a Stability Principal Scientist

Job Title: Stability Principal Scientist
Position type: Full-time Contract
Duration: 12 Months
Location: New Brunswick, NJ
Pay range: $75 -$ 79.47 Per Hour

As a Stability Principal Scientist you will:
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.

Required Knowledge/Skills/Qualifications:

• Education: Required B.S. Chemistry, Biology, Microbiology, or relevant discipline
• Experience/Knowledge: 8+ years of experience in Stability Program Management for small molecules (oral and sterile product)
• Strong understanding of stability ICH guidelines and cGMP regulation
• Very good experience on New Product Introduction
• Very good understanding on Regulatory CMC , US/EU/ROW submission requirement for stability
• Hand on experience on handling QC Deviation OOS / OOT, authorship , interpret results.

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 registrational.
• 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 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/or deviations from standards.
• Leads work activities involving Change Controls and CAPA's .
• Identify information regarding 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 client groups procedures.
• Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs
• Support health authorities' inspection internal and external.
• Represents department in cross functional projects.
• Ensure training requirements are met.
• Acts as an advisor and mentor to stability staff

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 good understanding of analytical and/or Microbiology methods.
• Very good skills to drive development of technical or scientific initiatives for solving complex problems/issues; recommending and drive science-based decisions/ implementation of solutions.
• Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Qualitymanagement principles
• Good Knowledge of evaluation and interpretation of stability data using statistics software. Review data and demonstrated ability to recognize anomalous trends or results
• Experience to oversee external service providers involved in stability studies.
• Significant experience on health authorities inspections on stability programs.
• Advanced knowledge of Microsoft office applications , LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP).

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
Sara Almas
Team Recruitment
Sara.Almas@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay range: $75 -$ 79.47 Per Hour

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:
One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
ClearlyRated® Client Diamond Award Winner (2020)
One of the Largest Certified MBE Companies in the NMSDC Network (2022)
Advanced Tier Services partner with AWS and Gold with MS
Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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