Job#:

Job Description:

Job SummaryThe Clinical Manufacturing Operations Director supervises and manages a manufacturing production team consisting of microbiome process associates and assistants, a quality assurance professional, and bioengineers responsible for performing technical laboratory procedures to support biomanufacturing of live biotherapeutics (LBPs) for early phase FDA–approved clinical trials. The ideal candidate will work with scientists, industry partners, and clinicians involved in highly innovative, translational, early–stage clinical investigations focusing on microbiome reconstitution/augmentation with lyophilized commensal bacterial strains in a range of clinical scenarios. The director will have accountability and responsibility to lead the end–to–end manufacturing process, consisting of key unit operations such as master cell banking, fermentation, harvest, lyophilization, and milling of LBPs. A key component of the role will be FDA documentation for GMP manufacturing, including authoring, reviewing, and approving batch production record and general suite/operational activity SOPs and supervising analytical biological assays to assess the stability and integrity of LBPs. In addition, the ideal candidate will be responsible for the optimization of lyophilization procedures for anaerobic bacterial strains, procedures for manufacturing LBP capsules, and documentation of product quality, purity and stability, as well as documentation of cGMP activities while consistently maintaining workplace safety by providing supervision and training for cGMP staff.

Responsibilities

• Responsible for supervising and managing a team of professional staff who perform technical laboratory procedures to assure compliance in drug manufacturing processes.

• Provides technical guidance to staff, colleagues, and clients.

• Works directly with leaders, faculty, and clinical staff to prioritize facilities and equipment requirements for LBP manufacturing.

• Develops goals and executes operating procedures, practices, and guidelines for all clinical manufacturing activities.

• Executes a comprehensive GMP facility master plan to optimize resources.

• Maintains all Engineering Standards for GMP facilities and manufacturing operations. Ensures appropriate Business Continuity Planning, Emergency Coordination and Risk Management procedures are in place.

• Enforces policies and Standard Operating Procedures (SOPs) for equipment and facility calibration and maintenance.

• Ensures proper biological and safety protocols are followed to maintain compliance with equipment, facility, and asset management infrastructure. Reviews facility technical documentation in support of regulatory submissions.

• Oversees the investigations of facility, equipment, and process deviations for the development of corrective actions to prevent re–occurrences and change management for any changes to qualified systems and process equipment in order to maintain equipment, facility and systems in a validated state.

• Acts as a liaison with regulatory agencies (e.g., FDA) and community officials.

• Manages maintenance records for equipment, facility, and systems is to keep operations optimized.

• Hires and establishes performance expectations for staff members. Coaches staff on proper training, performance, and professional development.

• Actively promotes safety rules and awareness by demonstrating good safety practices at all times including appropriate use of protective equipment.

• Reports and takes initiative to correct safety and environmental hazards.

• Manages the administration of the database(s) and subscribers, including the teams installation and maintenance of hardware and software.

• Manages user support. Ensures that the team provides prompt and effective answers and issue resolutions to incoming questions.

• Perform other related work as needed.

Minimum Qualifications

Education:

Work Experience:

Certifications:

Preferred Qualifications

Education:

• Advanced degree in Pharmaceutical Sciences, Microbiology, Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline.

Experience:

• Previous role in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.

• Hands on experience with GMP manufacturing and/or bioprocess development related to live biotherapeutic processes.

• Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics.

• Prior experience in Microbiology including familiarity with Bacterial Culturing, Culture Media Preparation and Selection, Bacterial Viability and Stability Determination and ability to interpret data resulting from a range of Bacterial Functional Assays.

• Prior experience in developing lyophilized LBPs or biologic formulations.

Preferred Competencies

• Demonstration of a high degree of flexibility, adaptability, and a willingness to learn and being both the 'coach and player' on the field.

• Excellent organizational and communication skills, with a mindset of driving performance and innovation in a lean and highly effective team setting.

• Strong analytical and problem–solving skills.

• Strong team building, mentoring, leadership, or management experience.

Working Conditions

• Onsite, regular attendance.

• GMP facility, laboratory environment.

• Must have physical ability to move compressed gas cylinders.

• Occasional weekend/evening hours necessary to complete time–sensitive projects.

Application Documents

• Resume (required)

• Cover Letter (required)

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Apex Systems is a world–class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.