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Director Laboratory Operations, Burlington Site

Massachusetts, United StatesOperations

Job description

ProtaGene is a world leading analytical CRO partner for the global biopharmaceutical, gene, and cell therapy industries. From early development support through product CMC characterization, clinical testing, and post-market release lifecycle management and monitoring, we provide some of the most advanced, integrated, and quality system driven analytical capabilities available. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services with BioAnalytix in 2019, and subsequent merger in 2021 with GeneWerk’s unique capabilities in vector safety, integration site analysis, and gene editing bioinformatics. Our organization operates in four sites in Europe and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.


About the Role: We are seeking an experienced Laboratory Operations professional to manage and grow the laboratory systems and processes at our ProtaGene US Site located in Burlington, MA. This is a unique opportunity to join a dynamic team and play a key role in supporting next-stage growth in a fast-paced, high growth CRO environment serving leading biopharma companies in biologics development and cell & gene therapy markets. This candidate will manage and develop the analytical testing laboratory and lab staff for growth, focusing on scaling up the organization, driving performance, and developing technical and leadership capabilities in support to a robust succession planning.
The position requires a broad knowledge of laboratory and supporting facility systems, operating within quality environments, and must have a level of proficiency with the implementation and management of analytical and bioanalytical method laboratories integrating control systems for the development of biologics.


Proficiency with laboratories operating in compliance with GCP, GLP, and/or GMPs is required. Success is achieved through effective collaboration with internal and external partners in analytical sciences, quality, technical operations, executive support functions, to develop and execute the overall strategies.


Additionally, this position is responsible to author and or review relevant final report/technical sections and contribute to regulatory communications, briefing documents for scientific advisory meetings as well as responses to health authority information requests from USA and EU, as needed.


This individual will report to the VP Site Head and will work closely with managers and departmental heads across the site. They will play a key role in expanding and shaping ProtaGene’s operational systems, success and culture.


This is a full-time, onsite position. Title and salary commensurate with experience.


Responsibilities 

  • Provide leadership and guidance to the various Site laboratory teams developing, validating, and standardizing complex LC-MS, PCR, and other high end technology and analytical methods supporting Preclinical, Product CMC, BioAnalytical, Clinical Sample support testing.
  • Responsible for leading the laboratory teams according to internal policies, instructions, operating within GCP and GLP compliance as needed, specifically focusing on operational throughput and success, safety, quality, and laboratory performance.
  • Responsible for providing oversight and performance consistency to the laboratory teams while continuously reducing variability and elimination of adverse and critical events through the monitoring of all KPIs, trend analysis and process mapping.
  • Lead and develop next-stage LIMS strategy, design, and development to expand and improve lab systems and processes to optimize workflows.
  • Responsible for laboratory performance and site compliance, ensuring that all instrumentation and equipment is properly validated, calibrated and maintained and procedures are maintained and followed within their qualified or validated states.
  • Manage the overall financial performance of the labs (including lab ops budgeting), and identify and implement appropriate strategies for improving quality of services.
  • Ensure readiness as needed for client and regulatory audits and inspections. Lead the audits and inspections through the laboratory areas.
  • Author and revise standard operating procedures and batch records.
  • Review technical reports. Conduct deviation investigations and write process deviation reports.
  • Develop material/staffing forecasts and detailed project schedules to meet commercial and clinical demand in cooperation with cross functional teammates (MST, PD, Planning, Procurement).
  • Lead continuous improvement projects through capacity optimization and cost reduction programs.
  • Measure and appraise manager/supervisor/operator performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations.
  • Serve as area expert in cross functional meetings. Champion company policies to area staff.
  • Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation.
  • Communicate safety and maintenance problems, status of operations, and employee related issues in a timely manner to management.
  • Evaluate new technologies and innovations to improve operational efficiency or expand facility capabilities.
  • Sustain employee engagement by creating a culture of excellence and an environment in which individuals and teams can excel and continuously improve.


Job requirements

  • MS in biology, chemistry, or related discipline, or equivalent degree plus combined work experience.
  • Minimum of 8-12 years’ experience working with biologics in a pharmaceutical development or leading contract research setting, with a minimum of 6-10 years of personnel/staff management experience in regulated environment.
  • Must have previous experience in a high-paced CDMO/Laboratory work environment.
  • Advanced knowledge of biopharmaceutical analytical methods and assays, with proven experience in the development and implementation of analytical lab systems, methods, LIMS and SOP’s.
  • Established track record of success, sound technical qualifications and knowledge in analytical method transfers, method validation.
  • Knowledge of Data Integrity Guidance and Data Management Systems utilized in a Quality Operation.
  • Must be apt for critical decision making. Must be able to effectively (clearly and accurately) communicate decisions to clients, staff and upper management.
  • Prior experience recruiting, coaching and developing talent.
  • Must be able to mentor/coach staff as well as lead staff with honesty and integrity. Highly motivated to lead by example and exceed expectations in all aspects of the role.
  • Must have a thorough theoretical understanding and technical proficiency of operations within an area. Must be able to apply technical and operational experience to solve complex problems.
  • Must be able to write effectively as demonstrated through authorship of project results reporting, standard operating procedures, and non-conformance event investigations.
  • Must exhibit a team first attitude.
  • Must be able to comfortably and confidently discuss, present to and lead tours for clients and regulatory inspectors.
  • Must possess excellent communication, interpersonal, and written skills.
  • Must meet the physical requirements of the job.
  • Must be a creative thinker with a flexible mindset .
Burlington, Massachusetts, United States
Operations

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Burlington, Massachusetts, United States
Operations