Incline Therapeutics employees share a commitment to innovation, exchange of ideas, and teamwork in a dynamic, rewarding environment. Our common drive to build a leading hospital-focused specialty pharmaceutical company makes Incline an exciting and challenging place to work. We are committed to maintaining a diverse workforce, quality work environment, and excellent benefits. We seek smart, talented, and driven individuals to join our team.
Senior Manager Quality Assurance
Position Summary: This position requires knowledge and experience in drug and medical device Quality Control (QS) and analytical testing requirements for clinical trial and commercial products (drug device combination products). This position is responsible for participating in the management of the Incline Quality Control to assure GMP of analytical and microbiological testing activities at Incline and at the Incline suppliers. In-depth knowledge of United States Quality Regulations (21 CFR 210/211-drugs and 21 CFR820-devices) and comparable outside US (OUS) quality system and compliance requirements is required.
Participate in the ongoing operations of Quality Control Activities associated with lot release, stability and investigational studies of Drug/Device Product, including the following activities:
• Manage contract QC testing of suppliers for GMP compliance ( US, Europe and Japanese requirements) and technical review which includes:
• Raw materials and components
• In-process testing
• Lot release testing and certificate of analysis
• Stabiltiy testing
• Investigational studies
• New test method validation
• Method transfers
• Review supplier deviations and Out of Specification test result events associated with testing and manage Incline discrepancy systems for QC data.
• Manage Change Control requests for new or revised specifications with vendors. Track status of the CCR and compile CCR files for QC documentation.
• Conduct and manage trend analysis of QC data.
• Participate in Change Control Requests (CCR) for assessment of impact to QC testing.
• Review and approve method transfer, validation and analytical equipment protocols and reports.
• Participate in the Supplier (contract testing laboratotries) Qualification and oversight program, and perform supplier audits
• Coordinate with Document Control for document reviews and participate as an approver for documents such as Incline SOPs, Incline deviations, CCRs, CAPAs that are associated with QC testing.
• Participate in the review, proof reading, and audit of CMC submission sections in support of Regulatory Affairs.
Reporting Relationship: This position reports to the Senior Director, Quality
The Person: An enthusiastic individual with attention to detail. This individual must be able to work effectively in an entrepreneurial, developmental environment, and with contract manufacturing organizations, contract testing laboratories and suppliers. This individual must be able to function effectively as a hands-on team member internally. They must be able to work very effectively, communicate well and establish strong relationships with multi-functional areas internally and with outside contractors.
Education BA or BS required,
Typical Experience 5+ years experience in pharmaceutical Quality Control organizations
Fields of Expertise Management/communications with Contract Testing Laboratories, familiar with method transfer/qualification and validation requriements, analytical instrument qualification, calibration and maintenance, testing requriements for raw materials, components, pharmaceutical products and stability, OOS and deviation investigations, generation of QC documentation such as SOPs, computer skills with MS WORD, EXCEL, Power Point and Visio. Good interpersonal communication and written skills.
Equipment Used Personal computers, technical instrumentation/equipment, statistical tools.
Incline is seeking a project management professional with a strong background in managing cross-functional pharmaceutical development projects. The Project Manager will be expected to work in a fast pace environment tracking all project activities and actively managing a detailed project task list. The individual will be expected to organize project information (scope, cost, resources, and time) and cross-functional interactions in order to enable prioritization, resource allocation, and decision making in a timely manner. The Project Manager will be expected to provide regular updates and make presentations to the senior leadership team. The individual must be comfortable working in a team environment and deal with the dynamic nature of product development.
• College degree or equivalent in a science or related subject
• Strong written and oral communication skills
• 5-7 years project management experience with cross-functional responsibilities including major regulatory filings for late stage pharmaceutical products
• Must have provided project management support for at least 1 NDA
• Experience with medical device project management is highly desirable
• Expertise in MS Project, Visio, and MS Office
Senior Manufacturing Engineer, Medical Products
This position will provide manufacturing engineering in support of development and commercial manufacturing of IT-101 and future Incline products. Primary responsibility for this position will be to provide process engineering support for Incline’s EMS’ operation . Given the company’s culture of cross functional problem solving, the candidate will work closely with R&D, Quality Engineering, Production and Planning. Successful experience with new product development, NPI and ramp-up is critical. This position will be based in either Huntsville AL or Redwood City CA. Frequent travel to the other location and supplier locations will be required. This position will:
• Support manufacturing in all engineering issues including documentation, test, component evaluation, process validations, failure analysis, performance monitoring, issue resolution; and processing engineering change orders.
• Establish a process capability monitoring program including project management of development programs for testers and data management systems.
• Assist in achieving cost-of-goods reduction objectives.
• Coordinate product support with Production, R&D engineering, Quality, Planning and Purchasing.
• Work with R&D engineers and suppliers to concurrently evaluate products for manufacturability, and provide DfX analysis for both commercial and new product introductions.
• Implement process improvements, qualifications and validations, technical support, root cause analysis, and monitoring production metrics
The ideal candidate will have a minimum of a B.S. in Mechanical, Electrical or Manufacturing Engineering, and 5-8 years of experience working on electronic device manufacturing for medical product companies, or other highly regulated industries.
Required experience and skills:
• Electronics manufacturing experience including working knowledge of Surface Mount Technology (SMT).
• Experience with electromechanical assemblies and process techniques such as welding, soldering, adhesive bonding, electrical testing, injection molding and decorating.
• Experience with medical product scale-up including automation development and NPI.
• Strong knowledge of ISO Quality System Regulations
Experience with Statistical Process Control, Design of Experiments, Just in Time, and Lean manufacturing techniques. Additional desired experience and skills include:
• Experience with medical product scale-up including automation development.
• Strong knowledge of FDA Quality System Regulations
• Experience with Statistical Process Control, Design of Experiments, Just in Time, and Lean manufacturing techniques.
• Involvement with failure analysis programs.