Description

　　Core Hours: Monday - Friday, 8am-5pmPurpose and ScopeThe Microbiology Development and Technical Scientist I is primarilyresponsible for performing development activities for the MicrobiologyLaboratory. Provides technical expertise for microbiological testing as wellas for sterility and packaging issues and ensures department compliance withnew microbiology and regulatory requirements. Performs microbiologicalactivities in support of new product development.Essential Duties & ResponsibilitiesServe as Microbiological investigator providing technical expertise for rawmaterials, component, finished product, water bioburden, environmentalmonitoring, and endotoxin testing.Provide position/risk assessment papers, as required.Represent the Microbiology department and provide expertise when responding togovernmental authorities and marketing partners during inspections.Continually assess development systems and procedures in the laboratory toassure they comply with business directives, cGMPs, applicable cGLPs andcurrent industry practices.Investigate antimicrobial properties of new drugs and new products.Provide expertise for sterilization, sterility, and packaging issues.Assist with interpretations of bacterial and fungal identifications and keeppersonnel technologically informed of new microbiology and regulatorydevelopments.Develop methods for development projects and new products.Maintain up-to-date knowledge with FDA regulations and applicablepharmacopeias in areas where product might be marketed.Audit contract service suppliers.Perform other duties as assigned.Knowledge, Skills & AbilitiesKnowledge of pharmaceutical, food and cosmetic, and clinical microbiologyin order to interpret the impact and relative importance of microorganismswhen they are isolated from raw materials, component, finished product,water bioburden, and environmental monitoring samples.Demonstrated technical leadership when working on complex problems within atechnical scope in which analysis of situations or data requires an in-depthevaluation of various factors.Skill in problem solving.Ability to manage multiple projects concurrently and under tight timeconstraints.Ability to clearly communicate (verbal & written) and work well withemployees at all levels.Ability to be organized and self-directed.Ability to function as a team member and independently.Ability to use specialized computer software such as spreadsheets and graphingsoftware.Mechanical/electrical ability to effect minor instrument repairs is preferred.Advanced skills in math-related processes, with an emphasis on statistics.Ability to fluently and clearly write lab notebooks, reports, andregulatory submissions.Core ValuesThe Microbiology Development and Technical Scientist I is expected to operatewithin the framework of Tolmar's Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart ofour company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients,and take action with great speed and efficiency no matter the task.Education & ExperienceBachelor's degree in Microbiology or closely related field with 7 or moreyears of Pharmaceutical laboratory work experience required.Master's in Microbiology or closely related field preferred, with 5 ormore years of Pharmaceutical laboratory work experience required.PhD in Microbiology or closely related field preferred, with 3 or more yearsof Pharmaceutical laboratory work experience required.Experience with aseptic processing, and sterility testing preferred.Working ConditionsLaboratory setting and office. Will be exposed to biohazard materials andpharmaceuticals.May require occasional holiday, weekend and/or evening work.Compensation and BenefitsAnnual pay range $110,000 - $120,000Bonus eligibleBenefits information:Tolmar compensation programs are focused on equitable, fair pay practicesincluding market-based base pay and a strong benefits package. The finalcompensation offered may vary from the posted range based on the selectedcandidates qualifications and experience.Tolmar is an Equal Opportunity Employer. We do not discriminate on the basisage 40 and over, color, disability, gender identity, geneticinformation, military or veteran status, national origin, race,religion, sex, sexual orientation or any other applicable status protectedby state or local law. It is our intention that all qualified applicants begiven equal opportunity and that selection decisions are based on job-relatedf

　　The contractor will not discharge or in any other manner discriminate againstemployees or applicants because they have inquired about, discussed, ordisclosed their own pay or the pay of another employee or applicant.However, employees who have access to the compensation information of otheremployees or applicants as a part of their essential job functions cannotdisclose the pay of other employees or applicants to individuals who do nototherwise have access to compensation information, unless the disclosure is(a) in response to a formal complaint or charge, (b) in furtheranceof an investigation, proceeding, hearing, or action, including an