Manager, Technical Services

August Bioservices, LLC; Nashville (TN); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

Join a forward-thinking company dedicated to transforming global health through innovative drug manufacturing. As the Manager of Technical Services, you will lead a dynamic team responsible for the technology transfer of sterile drug products and biologics, ensuring compliance and excellence in all processes. This role offers the opportunity to work on diverse client projects, write essential technical documents, and collaborate with various departments to drive successful outcomes. If you are passionate about making a difference in the pharmaceutical industry and thrive in a fast-paced environment, this position is perfect for you.

Qualifikationen

• 5+ years in pharmaceutical manufacturing with experience in aseptic processes.
• Strong leadership skills with a focus on technology transfer and project management.

Aufgaben

• Manage technology transfer of sterile drug products and biologics processes.
• Write and approve technical documents including protocols and reports.

Kenntnisse

Pharmaceutical Manufacturing

Aseptic Process Implementation

Team Leadership

Technical Document Writing

Problem Solving

Ausbildung

B.S in Pharmaceutical Sciences

M.S in Pharmaceutical Sciences

PhD in Pharmaceutical Sciences

Tools

Minitab

Microsoft Office

Quality System Software

Jobbeschreibung

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

The Manager, Technical Services is accountable for managing a team responsible for the technology transfer of sterile drug products and biologics processes into the August Bioservices facility and reports to the Senior Director of Technical Operations. The responsibilities include managing resources, planning activities and monitoring workload for the Technical Services team as they collaborate with Formulation Development, Process Engineers, Analytical Development, Production, Quality, and Regulatory to identify product and process criticalities and finding scientific data driven solutions to any Technology Transfer process.

In addition, the Manager, Technical Services is responsible for managing a team that is leading multiple client-based projects in a fast-paced environment. Apart from Technology Transfer activities, the position requires writing of technical documents to support, including protocols, reports, SOPs, Work Instructions, Batch records, and technical and risk assessments. This position will be responsible for participating in interdisciplinary leadership team meetings to represent status and risks for ongoing client projects.

Responsibilities:

1. Responsible for managing the team who reviews technology transfer documents such as product development reports, batch manufacturing and/or packaging records to provide the technical analysis for the overall process.
2. Responsible for review and approval of work by Technical Services team members as they identify gaps in capabilities needed to support new product/process introductions and recommend solutions to close these gaps.
3. Accountable for evaluations by Technical Services team of collected data during development and scale-up activities as they recommend opportunities and strategies for process optimization.
4. Accountable for performance of Technical Services team as they implement new processes as they relate to project execution timelines.
5. Accountable for selection of appropriate equipment, single-use systems and process strategies for compounding, and fill finish by the Technical Services team including sterile processing consumables.
6. Accountable for execution of Toxicological, Clinical, Scale-up, Exhibit/Registration, Process Validation batches as required in support of the Technical Services team leads.
7. Accountable for the identification and procurement requests for materials and consumables by Technical Services team leads.
8. Maintain a clean, organized and documentation compliant R&D laboratory and pilot-scale spaces including proper storage and labeling of materials specific to client.
9. Lead the evaluation and selection of new equipment in support of fill/finish production operations in collaboration with client and internal stakeholders as required.
10. Participate in multidisciplinary project teams through the complete product transfer in support of ongoing client projects on-time including “on the floor” batch execution.
11. Design phase specific studies based on DOE (Design of Experiments) and Quality-By-Design (QbD) as needed for manufacturing processes.
12. Support evaluation of new business opportunities for fit to existing capabilities and resources.
13. Write, review and approve documents including master batch records, protocols and reports, SOPs, Work Instructions, and other necessary technical documents.
14. Troubleshoot and resolve complex issues, diagnosing technical problems and identifying short and long-term solutions for ongoing projects.
15. Mentor and train Technical Services team in best practices for adherence to client project Core Team responsibilities including; customer facing messaging, preparation for technical discussions, driving review and closure of internal technical challenges to support project deliverable timelines.
16. Proficient in Quality system software such as Master control and related tasks such as MOC (change control), CAPA, Issue Reviews, Work Orders, collaboration, and approval of various documents.

Requirements:

1. B.S in Pharmaceutical Sciences (or equivalent). M.S in Pharmaceutical Sciences (or equivalent), or PhD in Pharmaceutical Sciences (or equivalent) preferred.
2. 5+ Years of Experience in the pharmaceutical manufacturing industry.
3. Experience in Pharmaceutical aseptic process implementation including new equipment, sterile filtration, Sterilize-in-Place principles, product dosing technologies and GMP fundamentals in production environments.
4. Experience in leading teams responsible for new process introductions or equivalent demonstrated leadership.
5. Knowledge of High-Pressure Homogenization, Rotary Evaporators, High Shear Homogenizers, Microfluidizers, Extrusion, Lyophilization, PFS, Vial filling operations, etc.
6. Knowledge of pharmaceutical processing technologies such as mixers, transfer pumps, temperature control devices.
7. Knowledge of appropriate process requirements for sterile operations including: compounding, sterile filtration, single-use systems and assemblies, aseptic formulation, steam in place, sterile filling for vials, pre-filled syringes and flexible IV bags.
8. Software: Minitab (or equivalent), Microsoft Office etc.

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering and Information Technology

Industries

Pharmaceutical Manufacturing