The role will have a significant part in the approval of documentation and support for release of manufacturing systems and processes for cGMP use. This position is required to successfully complete projects in a timely manner supporting company goals and objectives. Decisions made by this position can significantly affect project timelines and the ability to manufacture drug substance/drug product meeting the Health Authority requirements.
Responsibilities:
1. Perform process validation activities related to drug substances and drug products, through defined clinical and commercial stages.
2. Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising supervised judgment within broadly defined procedures and practices to establish acceptance criteria, and to identify and implement solutions to meet Health Authority requirements.
3. Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
4. Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
5. Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures.
6. Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by the client, validation techniques/approaches and systems utilized.
7. Participate in multi-departmental meetings & project teams.
8. Identifies and assists with implementation of improvements to Process Validation systems (department level impact).
9. Generation of process validation master plans, core validation master plans and additional supporting documentation.
10. Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal laboratories.
11. Coordination of process validation activities involving cross-functional, multi-departmental teams including Manufacturing (contract), Manufacturing Sciences, Technical Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
Experience:
1. Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
2. 8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
3. 2+ years experience in a position utilizing formal project management a plus.
4. Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate.
5. Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations.
6. Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations.
7. Proficiency with technical writing expected.
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