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Sr. Associate Scientist

Employer
Pfizer
Location
Durham, North Carolina
Salary
Competitive
Closing date
Jul 5, 2022

View more

Discipline
Physical Sciences, Chemistry
Position Type
Full Time
Job Type
Staff Scientist
Organization Type
Pharma
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Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

As a Senior Associate Scientist, you will will join the Analytical R&D (ARD) Microbiology Strategy and Testing (MST) organization to enable development of gene therapy products at our Durham, NC location.
  • Will be responsible for applying GMP microbiological methods to the assessment of product quality and detection of impurities, including management of samples and results in LIMS.
  • Perform and train others on Microbial methods for in-process testing of Drug Substance and Drug Product production.
  • The colleague is responsible for utilizing established microbiological methodologies to support GMP in-process, release, and stability testing of clinical supplies.
  • The individual demonstrate proficiency in aseptic lab techniques and facility gowning for EM, bioburden and LAL testing, and microbial identifications.
  • In addition, the qualified colleague is responsible for sample and inventory management activities, including tracking and shipping of samples, supplies and managing sample receipt and transfers in LIMS.
  • The colleague must work within corporate guidelines and must appropriately record, archive and report all data as this is a cGMP/GDP compliant laboratory.
  • The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team.
  • Must thrive in a fast-paced environment.


How You Will Achieve It

  • Prioritizes and organizes own work and assists others on the team to meet project task deadlines.
  • Contribute to achievement of immediate work group goals and collaborate with other team members across business functions.
  • Maintain a contemporary awareness of Global Business Practices, methods, specifications, Standard Operating Procedures, Pharmacopoeia trends, International Conference on Harmonization guidelines and regulatory expectations.
  • Work closely with analytical experts and project teams to provide timely support of quality data which can be used in support of regulatory documentation of new drug applications.
  • Ensures the maintenance, operational readiness and renewal of laboratory instruments, systems or apparatus, and in the maintenance and continuous improvement of safe and effective working practices.
  • Independently carry out all aspects of practical work necessary to provide right first time results.
  • Attend project team and brainstorming meetings and present data.
  • Maintain written records of all experimental work in accordance with Good Lab Practices/ (Current) Good Manufacturing Practices (GLP/GMP) and departmental Standard Operating Procedures.
  • Responsible for performing and troubleshooting microbial assays, while applying these methods to a broad range of early and late stage products in a Good Manufacturing Practices {also cGMP} environment.
  • Complete professional level Microbiology assignments independently in support of programs, and investigations with minimal supervision while demonstrating cGMP and scientific principles.


Qualifications

Must-Have

  • Bachelor's Degree
  • 3+ years of experience
  • Experience with laboratory data systems
  • Provides attention to detail and good at documentation of method validation/implementation experience
  • Ability to extract relevant information from scientific literature, accurately record observations, facts, data and conclusions during experimental work or Good Manufacturing Practices {also cGMP} investigations
  • Good knowledge of fundamental Microbial techniques and Quality Control and Assurance practices as it relates to Pharmaceutical Microbiology.
  • Interact effectively with peers and leaders as part of a multi-disciplinary team
  • Effective verbal and written communication skills
  • Ability to m ake decisions that require choosing between limited alternatives to resolve problems of moderate complexity. Works in less structured problem-solving situations within own work group. Increasingly some uncertainty of successful technical outcome for some of solutions attempted.


  • Nice-to-Have
  • Hands on experience or working knowledge of human pharmaceutical industry standards (FDA, ICH, USP) with respect to handling of analytical instruments and microbial assays.
  • Experience training team members on analytical and microbial assays.


PHYSICAL/MENTAL REQUIREMENTS
  • Light infrequent lifting (up to 25 lbs), frequent standing, sitting, walking, bending.
  • Ability to perform mathematical calculations and complex data analysis, ability to operate technical equipment with fine motor skills.
  • Visualize bacterial and fungal colonies on agar plates and cultures and discern color differences.
  • Ability to operate a microscope, ability to operate computer and learn/navigate electronic laboratory notebook software.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Adherence to aseptic technique and safe work practices in a laboratory setting - including aseptic gowning for extended periods of time.
  • Ability to work nights, weekends or holidays as needed (non-routine).
  • Ability to travel when needed for meetings ,training or cross-site support.
  • Adherence to aseptic gowning and laboratory hygiene standards and to work within a sterile environment.

Work Location Assignment: On Premise

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.

Research and Development
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