Stability Scientist

2 weeks ago

New Brunswick, United States Eclaro Full time

Job Description: 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 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



Required Knowledge/Skills/Qualifications:

Education: Required B.S. Chemistry, Biology, Microbiology or relevant discipline

Experience/Knowledge: 8 years of relevant work experience required, preferable 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 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 Quality

management 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.

- 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, promoting 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 in order to accommodate priority

requests.

- Advanced knowledge of Microsoft office applications , LIMS, Quality

Management system (e.g. TrackWise or Veeva), Statistics software (e.g.

SlimSTAT, JMP).

Additional Job Requirements:

None

  • Stability Scientist

    2 weeks ago

    New Brunswick, United States Axelon Services Corporation Full time

    Pay Rate :$70--$81 Job Description: 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 Scientist

    2 weeks ago

    New Brunswick, United States LanceSoft, Inc. Full time

    Title: Stability ScientistLocation: New Brunswick, NJ 08903Duration: 12 MonthsJob Description: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...

  • Stability Scientist

    2 weeks ago

    New Brunswick, United States LanceSoft, Inc. Full time

    Title: Stability ScientistLocation: New Brunswick, NJ 08903Duration: 12 MonthsJob Description: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...

  • Stability Scientist

    5 days ago

    New Brunswick, United States LanceSoft, Inc. Full time

    Title: Stability ScientistLocation: New Brunswick, NJ 08903Duration: 12 MonthsJob Description: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...

  • Stability Scientist

    1 week ago

    New Brunswick, United States Aequor Full time

    Position: Stability Scientist 58195-1Location: New Brunswick NJ 08903Duration: 12 months (possibility of extension for the right candidate depending on performance)Pay rate: $79.48/ hour on W2 Must Haves:8+ years of experience in Stability Program Management for small molecules (oral and sterile products)Strong understanding of stability ICH guidelines and...

  • Stability Scientist

    1 week ago

    New Brunswick, United States Aequor Full time

    Position: Stability Scientist 58195-1Location: New Brunswick NJ 08903Duration: 12 months (possibility of extension for the right candidate depending on performance)Pay rate: $79.48/ hour on W2 Must Haves:8+ years of experience in Stability Program Management for small molecules (oral and sterile products)Strong understanding of stability ICH guidelines and...

  • Stability Scientist

    1 week ago

    New Brunswick, United States Eclaro Full time

    Job Description: 100% onsitePrinciple Objective of Position:The Principal Scientist Stability is responsible for stability product strategy and oversight of product stabilityprograms for commercial small molecules Drug Substances and Drug Products Oral and Sterile. Activities includethose associated with product stability strategy, stability program...

  • Stability Scientist

    3 weeks ago

    New Brunswick, United States Sunrise System Inc Full time

    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...

  • Stability Scientist

    2 weeks ago

    New Brunswick, United States TSR Consulting Services, Inc. Full time

    TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.Our client, a leading pharmaceutical company is hiring a Stability Scientist on a contract basis. Please only local candidates to New Brunswick NJ. 8 years of relevant work experience required in a Pharmaceutical environment.Work Location: New Brunswick NJPay:...

  • Stability Scientist

    2 weeks ago

    New Brunswick, United States TSR Consulting Services, Inc. Full time

    TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.Our client, a leading pharmaceutical company is hiring a Stability Scientist on a contract basis. Please only local candidates to New Brunswick NJ. 8 years of relevant work experience required in a Pharmaceutical environment.Work Location: New Brunswick NJPay:...

  • Deep Learning Scientist

    2 weeks ago

    New York, United States Stealth Full time

    We are a distinguished firm known for our leading-edge research and development in the financial sector. With an emphasis on innovation and a collaborative culture, we strive to attract and nurture top-tier talent. Our workplace is crafted to encourage creativity and peak performance. At the heart of our operations is a commitment to a culture defined by...

  • Deep Learning Scientist

    3 weeks ago

    New York, United States Stealth Full time

    We are a distinguished firm known for our leading-edge research and development in the financial sector. With an emphasis on innovation and a collaborative culture, we strive to attract and nurture top-tier talent. Our workplace is crafted to encourage creativity and peak performance. At the heart of our operations is a commitment to a culture defined by...

  • Deep Learning Scientist

    2 weeks ago

    New York, United States Stealth Full time

    We are a distinguished firm known for our leading-edge research and development in the financial sector. With an emphasis on innovation and a collaborative culture, we strive to attract and nurture top-tier talent. Our workplace is crafted to encourage creativity and peak performance. At the heart of our operations is a commitment to a culture defined by...

  • Deep Learning Scientist

    5 days ago

    New York, United States Maven Search Full time

    Company Overview: We are a distinguished firm known for our leading-edge research and development in the financial sector. With an emphasis on innovation and a collaborative culture, we strive to attract and nurture top-tier talent. Our workplace is crafted to encourage creativity and peak performance. At the heart of our operations is a commitment to a...

  • Deep Learning Scientist

    3 weeks ago

    New York, United States Maven Search Full time

    Company Overview: We are a distinguished firm known for our leading-edge research and development in the financial sector. With an emphasis on innovation and a collaborative culture, we strive to attract and nurture top-tier talent. Our workplace is crafted to encourage creativity and peak performance. At the heart of our operations is a commitment to a...

  • Scientist II, QC Microbiology

    2 weeks ago

    Lakewood, New Jersey, United States Renaissance Lakewood LLC Full time

    Overview: The Scientist II, Microbiology will test and report cGMP test results for the Quality Control Microbiology Laboratory.  This role also provides training and support for less experienced members of the laboratory. Shift: 3rd shift, Sunday-Thursday 11:00 pm - 7:30 am Responsibilities: • Follows current GMP requirements and complies with company...

  • Senior Scientist I, Analytical Development and Clinical Supply

    4 days ago

    New Haven, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do: The Analytical Development Senior Scientist position is a technical position responsible for supporting Analytical and Process Development with early and late phase LC methods including process residuals and physiochemical chromatography (size exclusion, ion-exchange, reversed phase, hydrophobic interaction, etc.) in support of DS...

  • Associate Director/Group Lead

    2 weeks ago

    New York, New York, United States Proclinical Full time

    Associate Director/Group Lead - Permanent - OnsiteProclinical Staffing is seeking an Associate Director/Group Lead to join a cutting-edge biotech company. This is a permanent role located in San Francisco Bay Area.Primary ResponsibilitiesThe role of group lead within the formulation group is to support preclinical studies for discovery projects as well as...

  • CRNA - Anesthesia - $242K-288K per year

    3 weeks ago

    New York, United States Memorial Sloan Kettering Cancer Center Full time

    Memorial Sloan Kettering Cancer Center is seeking a CRNA Anesthesia for a job in New York, New York. Job Description & Requirements Specialty: AnesthesiaDiscipline: CRNADuration: Ongoing10 hours per weekShift: 13 hours, flexibleEmployment Type: StaffOur dedicated team of CRNAs is looking to hire a strong performer to deliver comprehensive care to our...

  • CRNA - Anesthesia - $242K-288K per

    3 weeks ago

    New York, New York, United States Memorial Sloan Kettering Cancer Center Full time

    Memorial Sloan Kettering Cancer Center is seeking a CRNA Anesthesia for a job in New York, New York. Job Description & RequirementsSpecialty: AnesthesiaDiscipline: CRNADuration: Ongoing10 hours per weekShift: 13 hours, flexibleEmployment Type: StaffOur dedicated team of CRNAs is looking to hire a strong performer to deliver comprehensive care to our...