Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need. We are a leader in understanding the role of the transforming growth factor-beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. We have leveraged this understanding and developed a discovery approach to generate large and small molecules to address diseases of these tissues. Targeting TGF-ß signaling pathways has been clinically proven to elicit robust changes in blood cells, muscle, and bone, which we believe provides a precedent and strong rationale for our strategy.
Job Summary: The Manager of Quality Control is primarily responsible for receipt, collation, initial analysis, documentation and storage of contract testing lab data, as well as analytical sample supply chain logistics. In addition, the ideal candidate will be able to contribute to a wide range other QC related deliverables (Examples: specification setting, COA generation, method qualification / validation activities). This role requires extensive interaction with external testing labs, Analytical Development, Quality Control, Quality Assurance, Quality Operations, Program and CMC project management and Regulatory Affairs.
Primary Responsibilities:
Implement, maintain, and continually assess the quality control function and the quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements, including but not limited to, the following tasks:
- Review stability study design, track on-time delivery of stability data, collate stability data, assist in the trending and reporting of stability data.
- Coordinate and oversee test sample shipments around the globe.
- Plan and coordinate quality control activities, in collaboration with analytical R&D, as appropriate.
- Assist in the generation of release and stability specifications for raw materials, drug substances and drug products.
- Manage method Qualification/Validation activities for drug substances, intermediates, and finished drug products.
- Perform clinical material evaluation and COA generation.
- Manage method transfer activities to contract manufacturing organizations/testing laboratories.
- Write/review/approve, methods, protocols, validation reports etc.
- Write/review/approve deviations and investigations at contract manufacturing organizations/testing laboratories.
- Maintain a document control system for QC procedures, work instructions and forms.
- Ownership of test record review and COA creation.
- Contribute to Annual Product Reviews.
- Contribute to the preparation and review of analytical sections of CMC for regulatory submissions and annual reports.
- Participate in the internal quality auditing of the QC function (including applicable vendors or subcontractors), customer quality audit response, and other QC related quality management system activities.
- Contribute to continuous improvement plans for growing and maturing the quality control function and the quality management system, including the following tasks:
- Supporting periodic internal quality control system reviews and audits
- Developing, implementing and enforcing best practices, processes, guidelines, systems, and technology to support and enhance the quality control function and the quality management system.
- Maintain current knowledge base of regulations, corporate policies and standards to ensure that the quality control function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices.
- Support strategic planning by timely communication of Quality deliverables, constraints, risks and options, and collaborating with Technical Development, Program management, Clinical, Commercial, Supply Chain, and internal and external Manufacturing teams.
- Identify risks and assumptions in plans, anticipate problems and plan for contingencies. Remove obstacles to move work forward and/or to get efforts back on track.
Qualifications:
- Bachelor's Degree is required (Chemistry, Biological sciences, Engineering or related degree); advanced degree is a plus.
- Minimum of 5 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.
- Ideally a minimum of 3 years of experience working in Analytical Development/Quality Control function, preferably at the Associate or Manager level.
- Experience with large molecule drug development desired.
- Proven track record of effective communication.
- Demonstrated skills in project management and working with vendors and contractors.
- Familiarity with FDA, ISO, EMA, GMP and ICH requirements ideally for large molecules.
- Excellent interpersonal skills, organizational skills, written and oral communication skills.
- Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables.
- Energetic, flexible, collaborative and proactive; a colleague who can positively and productively impact initiatives.
Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
What We Do
Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from rare hematologic and musculoskeletal disorders with high unmet medical need
