Sr. API Microbiologist
Provides technical support and process data monitoring and analyses for the fermentation processes. Interprets, evaluates and trends process-generated data assessing potential GMP impact relative to master record ranges and recommends appropriate corrective action where necessary. Recognizes atypical trends and informs supervision of relevant problems and independently develops and implements solutions. Serves as a key contributor to process deviation reporting, investigation, and determination of root causes. Leads efforts to improve process performance and to meet changing quality and regulatory compliance. Develops and validates sterilization of fermentation vessels and support systems. Participates with Kalamazoo Process Technology to transfer new technology and products to the fermentation plant. On a rotational basis, provides routine microbiological assessment of the process, possibly including weekends and holidays. Independently writes SOPs, master and batch records, technical reports, and project plans. Provides leadership and expertise to support technical direction, strategy, and objectives of the fermentation plant.
Knowledge of basic discipline. General knowledge of other related disciplines. Apply basic leadership principles. Focus is on leading/overseeing defined processes, which may require detailed knowledge.
Problem Solving and Innovation:
Provide solutions to a wide range of problems, some complex. Able to gather, analyze and interpret information and identify cause and effect relationships.
Discretion, Latitude, Level of Independence:
Works under general direction. Participates in determining objectives of assignments. Independently determines and develops approach to solutions.
Impact and Organizational Contribution:
Contributes to the completion of specific programs and projects.
Primary contacts are internal. May assist in training less experienced team members. May lead site teams. Work collaboratively with others to gain agreement on a course of action.
Time Span of Work:
Projects and tasks covering one month to three month deliverables or milestones; progress of work measured weekly to monthly.
BS in Microbiology, Bacteriology, Biology, or related science and 5 years of related experience or MS and 3 years related experience.
Effective written and oral communication
May require periods of extended standing or extended periods at a computer. Stair and ladder climbing for production observation. Capable of manual manipulations with fine dexterity.
Office environment with frequent time in the manufacturing and lab settings. Laboratory settings have potential for BL-1 level microorganisms, corrosive and hazardous chemicals. Use of hearing and eye protection required.
Excellent sterile technique
Six Sigma (green belt or better)/applied statistics
• Physical Demands: Frequent time in both manufacturing and office environments. The manufacturing environment includes equipment with moving parts.
Requires lifting, sitting, standing, walking, stair climbing and roof access. Must be available to support 24/7 - 365 operation.
• Work Environment: Office environment, with frequent time in the manufacturing areas. Possible exposure to high noise environments, solvents, and pharmaceutical ingredients. Use of hearing and eye protection is required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Role supports a 24 hour production environment. Primary responsibilities occur M-F during normal working hours. Some off hour and holiday coverage may be required.
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.
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Last Date to Apply for Job: 05/09/2018
Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Website : http://www.pfizer.com
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