- Lead the execution of all clinical drug product (DP) batches; directly accountable for right first time quality.
- Perform all activities supporting the production of sterile Drug Product, including but not limited to: operation of the filling line, formulation of buffers and dilution, preparation of components and supplies, documentation (batch records, logbooks, etc.), visual inspection, and batch record review.
- Arrange for proper BOM development and ensure availability of Ready to Use components.
- Provide front line supervision of formulation development staff and shared plant manufacturing resources during GMP production.
- Provide training on SOP’s, aseptic technique, and activity-based competency assessments; own and maintain Drug Product training curriculums.
- Author and maintain SOP’s required to support production of sterile drug product.
- Coordinate calibration and preventive maintenance activities.
- Supports deviation investigations and implementation of CAPA’s.
- Supports and executes ongoing validation activities and change controls.
- Supports the development of batch records, test protocols, sampling plans.
- Supports operation of a non-GMP development, including reference standards, tox fills, and other early product development studies.
- Maintain environment for drug product equipment—automated and semi-manual.
- Represent drug product capabilities to potential Clients.
- Support Distributed Quality and Safety Culture for drug product and viral banking offering.
- Coordinate and supervise resource allocation/sharing with upstream, downstream, and solution prep managers.
- Maintain the Drug Product capabilities in “audit ready” state at all times.
- Supports technical troubleshooting of the filling line and resolution of atypical events during clinical manufactures.
- Supports internal & external audits.
- Supports ongoing continuous improvement / risk assessment activities required to operate and maintain the GMP Drug Product facility.
- Supports upstream/downstream/cell banking manufacturing operations as-needed.
- Perform all other duties and projects as assigned and required.
Required Skills & Abilities:
- Strong history of working in Drug Product operations for vialed product.
- Strong leadership qualities and demonstrated success in management of change.
- Ability to coordinate, facilitate and organize resources.
- Ability to develop strategic relationships; strong verbal and written communication skills; good presentation skills.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to work effectively under extreme pressure to meet deadlines.
- Well organized with ability to handle multiple activities simultaneously.
- Detail oriented and accurate.
- Excellent computer skills and proficient in MS Office (Word, Excel, Outlook, PowerPoint).
- Good interpersonal skills with an understanding of diverse backgrounds and an emphasis on communication: training, team building, negotiation skills, interdepartmental interactions, leadership and supervision (motivation, directing) and management (planning, budgeting, etc.)
- Ability to hire, train, and develop employees to grow within the organization.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, some bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- May be required to lift up to 40 pounds on occasion.
- Attendance is required.
- Master’s degree preferably in business, engineering, science, or a related field with a minimum of 6 years’ experience preferably in Biotechnology or Pharmaceutical Operations with at least 4 years’ experience in a managerial position; OR
- Bachelor’s degree preferably in business, engineering, science or a related field with a minimum of 8 years’ experience preferably in Biotechnology or Pharmaceutical Operations with at least 4 years’ experience in a managerial position.
- cGMP experience
- Expertise with highly automated/isolated systems
- Experience filling live virus
- Experience with highly automated/isolated systems
- Experience supporting competent authority inspections