Robert Aichele Email & Phone Number

Durham, North Carolina, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

Wilmington, Massachusetts, Us

Supervise the Manufacturing Services Department focusing on Microbial Cell Banking. Develop qualification/validation protocols and methods for execution in order to generate material for presentation. Provide guidance to the Customer Service and Client Account Management departments handling customer relations. Ensure the Microbial Cell Banking laboratories maintain a state of compliance. Responsible for personnel management activities. Recommend short-range operating objectives, organizational structure, staffing requirements and succession plans. Assist in the standardization of pricing for assays manufacturing services by developing a pricing scale. Respond to RFPs and RFIs. Develop and write validation, qualification or large study project reports. Support on site and virtual client audits of the manufacturing facility. Oversee maintenance of group training manual and training records. Support the policy of equal employment opportunity through affirmative action in personnel actions. Participate in client and regulatory audit inspections as a subject matter expert. Follow all SOPs, STMs, and cGMP as they relate to specific tasks.

Wilmington, Massachusetts, Us

Supervised daily laboratory activities and scheduling to ensure optimal group performance. Performed and oversaw cell banking and vaccine manufacturing in a class 100 clean room environment while maintaining an aseptic environment. Trained technical personnel in general laboratory skills as well as reinforce cGMP standards and laboratory practices. Performed technical troubleshooting. Developed qualification/validation protocols. Worked directly with clients to prove necessary information regarding ongoing projects. Performed document revisions to ensure compendial guidance and compliance. Managed personnel activities including scheduling, personnel actions such as hiring and promotions, training and development, performance reviews and merit increases. Subject matter expert during regulatory and client audits. Followed all SOPs, STMs, and cGMP as they related to specific tasks. Served as a Subject Matter Expert during audits from the FDA, USDA, EMA, and all clients.

Wilmington, Massachusetts, Us

Assisted in supervising laboratory personnel. Provided guidance, assistance and training to lower level technicians. Assisted in determining daily work flow. Assisted in developing qualification procedures and client specific testing protocols and generated qualification reports and client specific reports corresponding to new procedures. Performed installation, operational and performance qualification procedures for equipment through change control procedures. Ensured testing was performed following well-defined regulatory guidelines. Performed thorough laboratory investigations.

Wilmington, Massachusetts, Us

Performed experiments, tests and procedures following well defined guidelines. Made detailed observations and accurately and precisely recorded data and summarize data. Reported results and analyzed data. Efficiently organized and planned daily activities. Maintained a safe working environment by adhering to company policies and procedures. Followed all SOPs, STMs and cGMPs as they related to specific tasks and performed all other tasks as assigned.

Wilmington, Massachusetts, Us

Performed laboratory tasks such as media preparation, aseptic processing and handling of client materials and microbial control stocks. Performed microbial testing in accordance with appropriate regulatory guidelines and generated testing reports. Managed daily laboratory schedule and inventory of laboratory components and supplies. Performed all other related duties as directed.

Wilmington, Massachusetts, Us

Performed laboratory tasks such as monitoring equipment, maintaining a stocked and clean laboratory environment, making media for internal and external laboratory use. Responsible for maintaining microbial cell lines for client manufacturing needs and internal testing. Performed all other related duties as directed.

University Park, Pa, Us

Within the Babitzke Laboratory:Investigated various stress response genes within E. coli to assess regulatory control relationship with global protein ‘csrA’.Contributed to the publication of "Circuitry linking the global Csr and σE-dependent cell envelope stress response systems"