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The Outsourced Analytical Testing Manager is responsible for managing the analytical activities outsourced to contract testing laboratories (CTLs) via routine email, teleconferences and site visits as needed. The candidate must develop effective strategies for evaluating, selecting and managing contract testing organizations, review assay protocols for scientific and regulatory compliance, and review/analyze reports of executed testing in real time. The candidate must also communicate delays and risks to the QC Head and management on a regular basis. The candidate is also responsible to develop strategies for outsourced testing needs, considering timelines and schedules, risk mitigation and business priorities. Additionally, the candidate is required to review investigation and deviation reports from the testing laboratories and prepare in-house reports associated with these deviations/ investigations. The incumbent will work closely with the QC Head to develop metric parameters to evaluate and monitor performance of CTLs. The candidate may be required to perform audits of the CTLs. In addition, the Outsourced Analytical Testing Manager is required to communicate all of the above with the associated FB Project Managers and Clients routinely.

The Outsource manager is also responsible for the sample control group at Brammer Bio’s Alachua, FL site with respect to cGMP and development sample log-in under a LIMS system, control and distribution of samples for testing. The Manager will lead a team of professional QC personnel to support internal and external customers in matters of outsource testing and sample control. The Manager is expected to take the initiative to improve the quality of operations and to improve and maintain a quality culture with a goal of consistency

ESSENTIAL JOB FUNCTIONS:

The position is client facing and is called upon to represent outsource testing in client meetings, internal and external regulatory audits, and updates. To perform this job successfully, the individual must have sound knowledge and experience in the application of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations.

The Individual is responsible for managing the outsource testing and sample control teams. Provides leadership to assigned staff by performing the following: developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

• Technically review/analyze testing protocols and review data/ reports generated by CTLs for cGMP production lots including engineering and clinical lots and associated cell and viral banks. Submit documentation for QA review. Manage assay qualifications performed using developed protocols at testing laboratories. Communicate these activities to VVS Clients and Management as needed. Ensure that these activities meet project and production objectives on time
• Develop strategies for evaluating and selecting CTLs, managing outsourced testing needs, timelines, risk mitigation and business priorities. Work closely with staff responsible for shipping samples to CTLs. Communicate these activities to VVS Clients and Management as needed. Ensure that these activities meet project and production objectives on time.
• Develop, execute and ensure compliance to outsourced testing procedures. Review and approve deviations/ investigations from CTLs; prepare tandem in-house investigation/ deviation reports. Develop metric parameters to evaluate and monitor performance of CTLs.
• Audit CTLs for compliance. Set up Weekly teleconferences with CTLs. 5%
• Liaison with other departments as needed to ensure timely flow of samples and communicate any delays in testing, particularly project managers.
• Other duties as assigned.

Education and Qualifications:

• Minimum 7+ years GMP industry related experience with a Bachelor’s Degree in Life Sciences or Chemical/Biochemical engineering
  • An advanced degree in Biology, Microbiology or Cell/Molecular Biology, or related field with strong background in assay development, bioassay and analytical techniques may substitute for some years of experience
• Minimum of 3+ years of proven supervisory experience
• Analytical Testing and Validation experience required
• Strong interpersonal and communications skills; written and oral
• Solid understanding of applicable regulatory requirements

Knowledge, Skills, Abilities:

• Strong knowledge of FDA/EMA/ICH/JP regulatory requirements applicable to pharmaceutical Quality Systems.
• Hands on working knowledge of modern laboratory procedures with emphasis on bioanalytical techniques including experience in cell culture.
• QA or QC experience in gene therapy analytical testing and development is strongly recommended
• Ability to apply GMP regulations and other international guidelines to all aspects of the position.
• Coaches and mentors staff members including provision of cascaded annual goals, regular coaching and feedback, career mentoring, and in continuous improvements both individually and for the organization
• Extremely high attention to detail and concern for standards are required.
• Critical thinking with the ability to prioritize multiple projects simultaneously
• Must be skilled in the use of a personal computers and related software applications.
• Must have strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group.
• Must be proficient at public speaking, teaching, facilitating to peers, senior associates, and area management within their operational group.