Our client, a renowned leader in the field of biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines. As a guiding force in the biotech industry, they set the bar for innovation and advancement. We are excited to announce a fantastic opportunity to join the team as a Senior Manufacturing Associate! We are seeking a dynamic individual who is eager to contribute their expertise and drive their mission forward.
New Product Introductions (NPI) program management and non-capitol project management. The individual will be responsible for leading projects of diverse subjects and complexity and have proven strong communication and collaborative capabilities, both within and outside of the immediate team. The Sr Associate, Manufacturing will successfully inform, influence, and assign accountability to members of cross-functional teams that include Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
Job Responsibilities:
- Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur with a Right the First-Time approach.
- Strong project management skills, with prior project experience preferred.
- Timely closure of change control records in relation to procedural guidance and/or disposition timelines
- Identifying improvement opportunities within the organization and take pro-active steps to build consensus to implement those opportunities
- Succinctly communicate verbally and in writing to staff and leadership
- Presenting records and business processes to a variety of audiences, including auditors and inspectors
- Participating/leading Continuous Improvement Transformation activities
- Champion safety and compliance at all times
Qualifications:
- Masters Degree
- Experience with PAS X Werum software for electronic batch records
- Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection
- Experience leading change controls in Trackwise
- Degree in life sciences or engineering
- Strong scientific, technical interactions with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory
