Senior Specialist, Manufacturing Gmp Support

Who is BlueRock?
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.
The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.
What Are We Doing?
Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.
We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.
We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.
The Manufacturing GMP Support Sr Specialist provides investigation and other quality system continuous improvement to the GMP teams at BlueRock by performing complex root cause analysis, working with stakeholders to identify corrective and preventative actions, ensure the Manufacturing team is audit ready, facilitate reviews, and investigate product complaints and adverse events (within CMC). The Mfg GMP Support Sr Spec will report to the Director, GMP Support.
Responsibilities:

• Ensuring safe and compliant cGMP operations and maintains permanent inspection readiness; Actively supports regulatory inspections.
• Provides consistent direction and ensures timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone through close collaboration with Manufacturing and Quality teams.
• Collaborates with other leaders across the organization and assists in the continuous improvement and life cycle management of implemented GMP policies and quality management systems with phase appropriate risk-based approach.
• Develops a comprehensive understanding of the manufacturing processes.
• Following lean manufacturing practices, track deviations, events and provide reports or presentations to management on investigation findings, trending and status as requested.
• Follow up to determine if corrective actions adequately addressed root cause of NC event.
• Independently prepares quality system and regulatory documentation required to implement corrective actions and changes to various GMP processes, SOPs and other documents and in accordance with phase appropriate cGMP standards and written procedures.
• Coaching and mentoring of colleagues on Investigation Program fundamentals and best practices, human performance HP improvement.
• Use Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste.
• Independently monitoring and proactively progressing multiple projects concurrently; identifying, addressing, and/or raising potential obstacles in a timely manner.
• Recognize and act on potential compliance issues and opportunities for process changes/improvement.
• Staying current with industry trends and standards and participating in best practice forums consistent with function responsibilities.
• This position performs related tasks associated with the deviation and change management processes (deviations, investigations, change controls, corrective and preventative actions, and document workflows) to ensure the written investigation report contains the technical merit and completeness according to phase appropriate regulatory expectations.
• Foster a culture of continuous improvement through employee training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.
• 30-40% travel to multiple sites (Cambridge and Toronto)
• Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
• This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory deviations. This position will lead root cause analysis sessions with site SME’s and determine the associated corrective action to prevent the deviation from recurring. This person will be a key player in the GMP team and a champion for quality priority principles and compliance within the Manufacturing organization.

Requirements:

• Significant experience with deviation or investigation management processes, reports and systems.
• Have experience navigating a controlled quality system.
• Ability to author and review standard operating procedures, on-the-job-trainings, and other controlled documents.
• Have an attention to detail.
• Have strong technical writing and interpersonal communication skills.
• Excellent verbal/written communication skills and ability to influence at all levels
• Instills Trust
• Excel in a risk-based, phase appropriate quality focused organization. Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills.
• Decision Quality
• Drives Results
• Ability to think strategically, and to translate strategy into action
• Action Oriented
• Can learn and apply computerized systems for the performance of daily tasks.
• Eight years total experience with a minimum of 3+ years of experience in a cGMP regulated clinical or commercial manufacturing cell therapy/biotech environment, preferred and additional 3+ years of technical writing experience, with deviations, CAPAs and other technical reports in the cell+gene therapy/biotech industry.
• Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment using: 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, Human Error Reduction.
• Communicates Effectively
• Collaborates
• Competencies
• Ability to prioritize and provide clear direction to team members in a highly dynamic environment
• Balances Stakeholders
• Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report.
• Organizational Savvy
• Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
• Bachelor’s Degree in Sciences, Engineering, Pharmaceutical Technology or equivalent scientific degree

BlueRock Therapeutics Company Culture Highlights
Winner of Comparably's Award for Best Company for Diversity 2022
Winner of Comparably's Award for Best Company for Women 2022
Winner of Comparably's Award for Best CEO 2022
BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.
Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.
Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics
Equal Opportunity Workplace:At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.