Director/ Senior Director of Manufacturing Operations
Full-time
Exton, PA
Frontage Laboratories:
Frontage Laboratories Inc. (Frontage) is a global contract research and development organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several global locations and is headquartered in Exton, PA. Frontage's core competencies include a full spectrum of pre-clinical and clinical development including chemistry and manufacturing controls (CMC), safety and toxicology, and bioanalytical services.
General Description
Senior Director/Director, Manufacturing Operations is a key leadership role in the CMC-CDMO Business Unit at Frontage Labs. This role will report to the Executive Vice President, Global CMC and CDMO Services and is responsible for all aspects of manufacturing and packaging operations starting with working with R&D scientists, scale up, and Clinical Trial Material (CTM) manufacturing. This person will lead a team of 6-10 technicians and operators for technology transfer of sterile and non-sterile dosage forms, scheduling, and management of manufacturing projects. This role is also responsible for project management, sourcing, warehousing, maintenance of GMP, equipment, and process development. The candidate is expected to have strong technical, communication, and leadership skills to lead internal efforts and interface with Business Development, clients, and regulatory authorities.
Responsibilities
- Responsible for manufacturing and supply of clinical trial materials (CTM) for various dosage forms such as sterile injectables, oral solids (tablets, capsules), topicals, Ophthalmics, and nasal products for Phase I-III clinical studies.
- Plan and recommend expansion into contract manufacturing.
- Identify new equipment needs, prepare justification, work with Facilities and Procurement to prepare Capex documents.
- Supervise staff and plan manufacturing schedules.
- Responsible for warehousing, calibration, preventative maintenance (PM) and troubleshooting of all equipment.
- Serve as the Subject Matter Expert (SME) and use knowledge of scientific techniques to troubleshoot processing or product quality issues with a sense of urgency.
- Process and analyze manufacturing results, data, and provide appropriate status updates to management.
- Collaborate with product development and Corporate Quality teams to define project tasks, coordinate timelines, and ensure compliance.
- Establish and maintain positive relationships with external partners and internal stakeholders for the benefit of the company and the completion of project deliverables.
- Lead deviation investigations and support on-time closure of deviations and CAPAs for areas of focus.
- Ensure overall audit/inspection readiness and lead regulatory agency inspections.
- Provide feedback and updates to departmental leadership on product/process KPIs.
- Develop and lead Project Management in manufacturing for alignment and prioritization to deliver CTM in accordance with clinical study timelines.
- Manage production and quality control records and the review and approval of Change Controls, CAPAs, and other GMP-related documents.
- Lead clinical trial material packaging and labeling operation.
- Ensure efficiency, accuracy, timeliness, and cost savings are incorporated into the functional area.
Qualifications
- Minimum BS degree in pharmaceutical, life sciences, or related scientific discipline; MBA preferred.
- 10+ years of experience in pharmaceutical manufacturing in a cGMP environment.
- Experience in sterile manufacturing is a must.
- Prior experience of working at a CDMO highly desirable.
- 5+ years of people management experience.
- Strong knowledge of cGMP regulations and working knowledge of US and EU sterile standards.
- Strong organizational and time management skills.
- Ability to work well in a team environment, eager, adaptable.
- Excellent oral and written communication skills as well as strong focus and attention to details.
- Ability to perform frequent physical tasks with strength and mobility.
- Demonstrated scientific creativity and technical proficiency.
- Independent and self-starting.
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