Director/ Senior Director of Manufacturing OperationsLocation: Exton, PAFull-timeFrontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.CMC:Our broad portfolio of CMC services cover drug product development comprising formulation development, analytical, scale up, Phase I-III CTM manufacturing, registration batches, and commercial manufacturing. Our facilities house the latest formulation and analytical equipment for a broad range of dosage forms such as oral solids, sterile, nasal, Ophthalmics and topicals including API/product release, wide spectrum of analytical testing, ICH stability, and commercial testing.General DescriptionSenior Director/Director, Manufacturing Operations is a key leadership role in the CMC-CDMO Business Unit at Frontage Labs. This role will report to 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 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.
Salary and BenefitsFrontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.