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Team Leader Stability Testing

Employer
Pfizer
Location
Parsippany, New Jersey
Start date
Sep 28, 2022
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Job Details

ROLE SUMMARY

Responsible for supervising a group of chemistry analysts, and/or technicians in the stability testing laboratory to ensure accurate testing, evaluation and recording/reporting of stability data. Responsible for ensuring that testing is completed following all cGMP and internal company requirements for quality and timeliness. Acts as part of the Scientific and Laboratory Services (SLS) Parsippany Stability Laboratory Management Leadership Team. Responsible for mentoring and developing skills of their direct reports to ensure continuous growth. Responsible for completing and conducting performance evaluations of direct reports.

ROLE RESPONSIBILITIES

  • Ensure completion of stability testing within required regulatory timelines, while maintaining adherence to GMP, ALCOA, and all company practices.
  • Ensuring laboratory documentation submitted for contains strong scientific justification, adequate impact assessments and appropriate definition of root cause. These documents include, but are not limited to, laboratory investigation reports, deviation reports, analytical reports, change control documentation, etc.
  • Writes and approves SOPs, testing notes, URMs, and controlled forms.
  • Participates in regulatory inspections.
  • Acts as a subject matter expert for their direct reports as well as during interaction with other teams.
  • Leading and participating on limited duration teams to achieve specific objectives.
  • Managing assigned tasks/projects within agreed upon timeframes.
  • Ensuring all staff are trained for their assigned roles and responsibilities.
  • Engage and inspire their teams on performance expectations and coach the team to meet those expectations using Coaching Skills principles.
  • Focus on Safety and GMP compliance as operational priorities and as performance measures that should be included in metrics.
  • Know the processes and procedures, including the principles and practices of good data management (ALCOA), and must be able to guide, advise and coach their teams.
  • Be accountable for the Good Data Management and Data Integrity understanding and performance of their team.
  • Effectively monitor the actions of their team. Ensure an active daily presence in the GMP work area to observe the work activity and practices within their role responsibilities.
  • Be available to their direct reports for real time escalations of any concerns or support needs.
  • Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
  • Lead and support continuous improvement efforts, where applicable.
  • Be a role model to support a positive compliance culture.
  • Review the content of all Leader Lead Conversations and on an annual basis conduct two “Leader Lead Conversations” with their teams aimed at fostering a culture that supports compliance with procedures, including good data management.
  • Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.

BASIC QUALIFICATIONS

  • Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.
  • Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical API products, Current Good Manufacturing Practices {part of GxP}, validation principles, and applicable regulations
  • Good understanding of the principles and application of quality risk management.
  • Strong people management experience
  • Ability to manage multiple projects simultaneously typically involving cross functional teams.
  • Excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.

PREFERRED QUALIFICATIONS

  • Previous pharmaceutical stability experience is desired.
  • Education: Chemistry , Biology or Other Health Science (degreed candidates)
  • Previous experience supervising, coaching and mentoring others is desired.
  • 7+ years' experience working in the Pharmaceutical Industry or other GMP setting.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

First shift, 40 hrs per week.

Other Job Details:

  • Last Date to Apply:October 26, 2022

  • Eligible for Relocation Package: YES

  • Eligible for Employee Referral Bonus: YES

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Quality Assurance and Control

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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