Manager, MS&T - Drug Product (Relocation Assistance)
The Manager, Manufacturing Sciences & Technology – Drug Product will have primary responsibility for the Manufacturing Sciences & Technology (MS&T) department focused on formulation and fill finish operations at our Advanced Development and Manufacturing (ADM) facility located in Alachua, FL. The position will be responsible for managing the technology transfer of formulation and fill finish operations from process development or direct transfers from clients/sending units, MS&T technical production support, and cGMP readiness activities. The Manager, MS&T – Drug Product will provide leadership and guidance to a team of process engineers and ensure the alignment of the team to the site strategy. Other responsibilities and duties are listed below.
Essential Position Responsibilities:
- Provides oversight of all MS&T functions associated with formulation and fill finish technology transfer, drug product technical support, and cGMP readiness activities.
- Provides MS&T Team with oversight of deliverables, including technology transfer protocols, facility fit assessments, and cGMP documentation.
- Provides technical advisement for the transfer of formulation and fill finish (mixing, aseptic fill finish for vials, and labeling) operations.
- Knowledge of sterile vial filling and drug product manufacturing of monoclonal antibodies, recombinant proteins, viral vaccines, plasmids, and gene therapy products.
- Ensures process and quality control data are collected, archived, and presented effectively.
- Engages with MS&T leadership, business development, project management, process development, quality control, supply chain, and operations to ensure projects are planned and executed according to the Material Supply and Quality Agreements.
- Develops MS&T team members by providing coaching, mentoring, and professional development.
- Ensures adherence to MS&T department policy and procedures.
- May support other tasks as determined by management.
- Adheres to Ology Bio’s Standard of Behavior Agreement and Expectations.
- PhD in chemical engineering, pharmaceutical sciences or related field + 6 years industry experience, MS + 8 years industry experience, or BS + 10 years industry experience
- Strong leadership, relationship management, and organizational planning;
- Ability and willingness to learn and adapt skillsets for various areas of MS&T;
- Ability to perform well under aggressive timelines with maintenance of high-quality output while under pressure;
- Knowledge of cGMP compliance around sterile fill finish drug product manufacturing.
- Minimum of 8 years of experience in a fill finish role within the pharmaceutical industry;
- Technical expertise aseptic vial filling and labeling equipment;
- Experience with CGMP manufacturing;
- Knowledge of regulatory compliance in pharmaceutical development.
This job requires the employee to perform the following physical activities:
- Repetitive motion
This job requires the employee to work in the following conditions:
- Temperature changes
- Activities occur inside and outside
- Outside environment conditions
This job requires exposure to the following:
- Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
- Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
- Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
- Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 3, including for emergency response.
- Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
- Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
This job requires the employee to perform the following type of physical work:
- Medium work. Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects
This job requires routine or periodic use of respiratory protection:
- Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR).
- Tight-fitting respirators, such as half-masks or full facepieces which must seal to the face or neck.