Lab Manager III, Analytical Testing

About Us PTC Therapeutics is a science-driven, global biopharmaceutical company founded in 1998 initially focused on the discovery and development of orally-administered, proprietary small molecule drugs that target post-transcriptional control processes. As we have grown, our technology platforms have expanded from this foundational scientific expertise in RNA mechanisms to include multiple approaches including gene therapy. While PTC’s discovery programs are directed at targets in multiple therapeutic areas, PTC is focusing particularly on the development and commercialization of treatments for orphan and ultra-orphan disorders. Our internally discovered pipeline addresses multiple therapeutic areas, including neuromuscular disorders, oncology, metabolic and infectious diseases. Our mission is to provide access to best-in-class treatments for rare disease patients who have little to no treatment options. At PTC, you are not joining a company, you are joining a cause. For more information on the company, please visit our website www.ptcbio.com. **At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position. Please Beware of False Job Advertisements PTC Therapeutics is aware of employment hiring scams that make false use of our company, leader and employee names to defraud job seekers. PTC does not make job offers without interviews and we never ask candidates for money. If you have encountered a job posting or been approached with a job offer from an email address that does not use ptcbio.com, or that you feel may be fraudulent, we strongly encourage you NOT to respond. Job Description Summary: Job Description: The Lab Manager III, Analytical Testing highest priority will be the development and management of processes and systems to build laboratory infrastructure and promote efficiency, compliance and scientific excellence within the Analytical Services Group (ASG). He/She will lead the ASG training and proficiency initiative and provide strategic and technical assistance to the testing Directors (ASG, Molecular, Quality Control, Analytical Chemistry, Bioassay) to identify and implement long term strategies for continuous improvements. The incumbent will assist in coordinating testing workflow between the Testing and Process Development groups to ensure accurate and timely test performance and reporting of CMC results. The Lab Manager III, Analytical Testing will support laboratory personnel’s efforts in achieving Chemistry, Manufacturing and Controls (CMC) program goals and provide leadership to small teams of Testing personnel. Lab Manager III, Analytical Testing will promote adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) and Policies as appropriate. Primary duties/responsibilities: Development of Laboratory Infrastructure Creates and manages lab related process improvements and documentation. Establishes a book of laboratory work instructions and guidelines for ASG. Collaborates with testing personnel during Sapio LIMS software system build. Assists with Sapio implementation of sample and results management, reagent inventory and equipment management. Establishes, organizes, and administers laboratory specific training and orientation. Develops and administers a pipette training program for current and onboarding employees. Establishes a competency program with focus on continuous improvement. Laboratory Operation and Procedures Ensures adherence to highest quality and efficiency standards in laboratory operations. Practices continuous improvement through evaluation and revision of standard operating procedures and policies. Leads testing Crosstalk meetings and conducts regularly scheduled ASG operations meetings with testing groups and/or Directors to resolve lab operations issues and ensure teams are aligned on goals, expectations and progress of ongoing projects. Recognizes and takes action to correct technical, procedural, and instrument concerns in a manner that ensures continual workflow. May assist with ASG scheduling to accommodate STAT and escalated client samples. Collaborates cross-functionally with other departments. Upholds and ensures compliance with Company laboratory policies, including but not limited to, Quality, Safety, Standard Operating Procedures, and Ethics. Training, Competency, and On-Boarding Work with ASG supervising staff to facilitate quick and smooth onboarding of new employees. May request and manage learning hub and Veeva trainings and instrument access for new hires and existing ASG Staff. Maintains ASG training matrix and may identify training opportunities. Administers annual ASG competency program and performs in-lab competency observations Sample Management and Results Tracking Act as an Administrator for ASG Sapio implementation and ongoing Sapio testing build out. Facilitates accurate and timely reporting of results. Laboratory Equipment Performs required reviews of usage, maintenance, and instrument error logs. Assists lab staff with pipette calibration schedule and Artel pipette calibration systems. Functions as primary point of contact for non-GMP laboratory equipment for maintenance and repair. Utilizing Sapio LIMS system, monitors instrument maintenance and calibration dates. Quality Assurance Ensure that laboratories are in a constant state of audit/inspection readiness. Participates in technical assay review of results as needed due to high testing volume. Additional Responsibilities May serve as problem solving lead in special situations as assigned, including technical assay issues. May prepare and revise technical documents for method improvements, method transfer and/or method validation within ASG and in collaboration with other departments. May review executed ASG testing documents to ensure compliance with Standard Operating Procedures (SOP). Performs other tasks and assignments as needed and specified by management. Minimum level of education and years of relevant work experience. Bachelor’s in molecular biology (preferred) or biological sciences and a minimum of 7 years of relevant experience or a Master’s and 5 years in a pharmaceutical, biotechnology, or related environment and at least 2 years of supervisory experience in a GMP laboratory. Special knowledge or skills needed and/or licenses or certificates required. GMP experience in a high throughput molecular testing laboratory is required. Hands-on knowledge and experience with current analytical instrumentation and automation. Ability to work independently and collaboratively in a fast-paced, science driven, matrixed, team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to troubleshoot problems with analytical instrumentation and analytical assays. Excellent planning, organizational and time management skills including the ability to effectively prioritize and multitask, make critical decisions and drive multiple projects to completion. Excellent verbal and written communication skills including the ability to communicate with employees at all levels of the organization. Proficiency with Microsoft Office (particularly Excel) *Special knowledge or skills and/or licenses or certificates preferred. Experience with ELISA, Analytical Chemistry and Potency Assays, in addition to Molecular Biology experience, is a plus. **At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position. EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. Click here to return to the careers page