SENIOR SCIENTIST - GMP STABILITY COORDINATOR

Company: PPD
Location: New Brunswick
Posted on: May 16, 2022

Job Description:

JOB DESCRIPTIONPPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD - Laboratories FSP. PPD - Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.Position Summary:
This position is in the Stability group in the Analytical Strategy & Operations (ASO) department and is located at the Client facility in New Brunswick, New Jersey. In this role, you will apply knowledge of stability guidelines to author stability protocols, reports and regulatory submission stability sections in support of small and large molecule products. In addition, this position will also support stability sample management in the Stability Operations group, including labeling, organizing samples, and weighing drug substance powders in a hood. Refer to the Other Requirements section. Note, there is no analytical work required for this position.DUTIES & RESPONSIBILITIES:
Essential Duties and Responsibilities include, but are not limited to, the following:

• Authors stability protocols in accordance with global stability guidelines to support clinical use and registration of small and large-molecule drug substances and products.
• Analyzes and trends stability data. Can identify issues, summarizes and presents results from stability studies and authors technical memos and reports.
• Authors the stability section in investigational global filings.
• Manages protocol and stability data reports in LIMS.Other Requirements
  
  • Must be able to work with samples and weighing of drug substance powders.
  • The candidate will assist in organizing and labeling stability samples and delivering samples to New Brunswick labs or packing and shipping samples to external labs.
  • The candidate will interact with stability scientists, written protocols, and laboratory information management system (LIMS). Must have good organizational and time management skills and attention to detail is essential.
    
    • LI-SW1
      Job QualificationEducation and Experience:
      • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
      • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years).
      • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:
        • The candidate must be able to deliver when working under assigned timelines.
        • Understanding of cGMP and EHS requirements is essential. Ability to comply with all applicable SOPs, internal requirements and external regulations is a must.
        • Expertise in MS Office applications, in particular MS Word and Excel, is required. Familiarity with electronic documentation systems (e.g. Qumas, Infinity, LIMS) for routing protocols/reports, for review and approval is a plus.
        • Familiarity with laboratory test methods desired.
        • Must demonstrate good communication skills, particularly in documentation of data and writing reports and methods.
        • Skill in communicating/escalating critical issues to appropriate team leaders and functional area management is necessary.
        • At least one year of cGMP experience in a Regulated Lab is required.
        • The candidate must be able to deliver when working under assigned timelines.
        • Understanding of cGMP and EHS requirements is essential. Ability to comply with all applicable SOPs, internal requirements and external regulations is a must.
        • Expertise in MS Office applications, in particular MS Word and Excel, is required. Familiarity with electronic documentation systems (e.g. Qumas, Infinity, LIMS) for routing protocols/reports, for review and approval is a plus.
        • Familiarity with laboratory test methods desired.
        • Proven ability in technical writing skills
        • Time management and project management skills
        • Ability to work in a collaborative work environment with a teamWorking Environment:
          PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
          
          Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
          
          Able to work upright and stationary and/or standing for typical working hours.
          
          Able to lift and move objects up to 50 pounds
          
          Able to work in non-traditional work environments.
          
          Able to use and learn standard office equipment and technology with proficiency.
          
          May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
          
          Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
          Diversity StatementPPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.COVID-19 Vaccination Update for U.S. Colleagues
          • All U.S. colleagues are required to report vaccination status. New hires will be asked to report vaccination status within the first two weeks of employment.
            
            • All U.S. new hires who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), remote site monitors-local (RSM-L) all CRA and RSM-L line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.

Keywords: PPD, New Brunswick , SENIOR SCIENTIST - GMP STABILITY COORDINATOR, Other , New Brunswick, New Jersey