Associate Scientist, Analytical R&D, Microbiology

Company: Pfizer
Location: Chapel Hill
Posted on: June 9, 2021

Job Description:

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 an Associate Scientist, you will will join the Analytical R&D Microbiology Strategy and Testing organization to enable development of gene therapy products in Chapel Hill and Durham, NC. The qualified candidate will be responsible for applying GMP microbiological methods in the assessment of product quality and detection of impurities, including management of samples in LIMS. This candidate will also perform Environmental Monitoring (EM) of Drug Substance and Drug Product facilities. The qualified colleague is responsible for utilizing established microbiological methodologies to support GMP in-process, release, and stability testing of clinical supplies. The individual is responsible for becoming proficient in aseptic lab technique and facility gowning for EM, bioburden and LAL testing, and microbial identifications. In addition, the qualified colleague is responsible for sample management activities, including tracking and shipping of samples 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 compliant laboratory. The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team. The candidate must thrive in a fast-paced environment. Attention to detail, strong organizational skills, the ability to multitask and effective interpersonal, influencing skills and communication skills are required.

How You Will Achieve It

• Exercise and build basic team effectiveness skills {e.g., commitment, feedback, consensus management) within the work group.
• Prepare and review technical documents, including validation protocols and reports, analytical test procedures, investigation reports, and change controls.
• Direct interaction with project team members, including presentation of data.
• Complete all Good Laboratory Practice {part of GxP} and safety training in compliance with departmental requirements and follow appropriate safety practices in the workplace.
• Perform various experiments for microbial method development/qualification/validation and characterization for biological therapeutics.
• Perform and document drug substance or drug product related Microbiological activities.
• Conduct all work according to appropriate Standard Operating Procedures' following Good Manufacturing Practices/Good Laboratory Practices (GMP/GLP) requirements and ensure integrity of all data generated and documented.
• Independently analyze and provide conclusions regarding experimental data generated.
• Plan and prioritize related recovery and purification activities.
• Present problems and propose solutions in discussions with group members.

Qualifications

Must-Have

• Min years of experience: 2yrs
• Effective oral and written communication skills.
• Self-motivated and highly effective in a team-based environment.
• Bachelor's Degree in Microbiology, Biochemistry, Biology or related field.
• Experience with Quality Systems in a Good Manufacturing Practices {also cGMP} environment.
• Experience with laboratory data systems (LIMS).
• Knowledge of drug development process for progression of biological incumbents.
• Good documentation skills with high attention to detail, strong organizational skills, team oriented, effective interpersonal and communication skills.

Nice-to-Have

• Experience in quality control (QC) microbiological procedures.
• Hands on experience or working knowledge of human pharmaceutical industry standards (FDA, ICH, USP) with respect to handling of analytical instruments and microbial assays.

PHYSICAL/MENTAL REQUIREMENTS

• Position requires occasional light lifting and long periods of standing, sitting or walking.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Infrequent weekend and/or holiday work may be required.
• Adherence to aseptic technique and safe work practices in a laboratory setting - including aseptic gowning for extended periods of time.

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

Keywords: Pfizer, Chapel Hill , Associate Scientist, Analytical R&D, Microbiology, Other , Chapel Hill, North Carolina