Manufacturing Specialist - The Steely Group

The Manufacturing Specialist 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.

Responsibilities include, but are not limited to: 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.

Responsibilities:

• Succinctly communicate verbally while leading meetings and in writing to staff and leadership
• Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur with a Right-First-Time approach.
• Strong project management skills, with prior project experience a must
• Lead meetings with cross functional teams to align on change scopes and impact assessments when new products are introduced to the Building 20 Manufacturing Facility
• Timely closure of change control records in relation to procedural guidance and/or disposition timelines
• Represent Building 20 Manufacturing as the receiving site for incoming Technology Transfers/New Product Introductions into Building 20
• Identifying improvement opportunities within the organization and take pro-active steps to build consensus to implement those opportunities
• 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

Requirements / Qualifications:

• Masters Degree
• Bachelor's Degree in life sciences or engineering
• Experience using TrackWise software
• Prior experience leading cross-functional teams to align on CAPAs and closing deviations
• Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP Formulation, DP Filling, Inspection
• Strong scientific, technical interactions with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory
• Demonstrated technical writing skills
• Demonstrated ability to work in a team