Sr. Manager MS&T

Job Description

Sr. Manager, MS&T

The purpose of this position is to lead a group of scientific personnel who are responsible for the products through their lifecycle, including the processes used to manufacture those products. The Sr. Manager, MS&T is responsible for managing the team involved with the technical aspects of product development as well as commercial manufacturing. The size and scope of the development projects will vary from small to large, will be complex, and usually consist of high-profile development activities. The commercial manufacturing activities will be managed day to day by the Operations Team; however, MS&T will be engaged in continuous improvement as well as troubleshooting. The product profile for which the Sr. Manager, MS&T will be knowledgeable includes, but is not limited to, nasal (Unit dose, Bi-Dose, Multi-dose) and injectable. These products include suspensions, solutions, and emulsions. The Sr. Manager will be responsible for the drafting and review of documentation, compilation, and assessment of process data, and providing technical input for deviation investigations, change controls, and CAPAs. The Sr. Manager will be client facing and shall work collaboratively with clients and internal cross-functional stakeholders to move projects forward.

As a member of the Site’s Management team, participate in the successful execution of site strategy and policies. The Sr. Manager, MS&T works under the direction of the Director of MS&T.

Responsibilities:

• Lead the technical team in the support of both development projects and commercial production to ensure the products are manufactured to meet the specifications including quality considerations.
• Ensure the appropriate technical resources are available and trained to support commercial operations and to execute development projects.
• Develop employees to manage all technical aspects of their assigned products, both for development and commercial manufacturing.
• Manage all technical standards and templates, including but not limited to tech transfer reports, process development reports, batch records, technical project deliverables and applicable validation reports in collaboration with the validation department.
• Support and direct the technical team to address issues, deviations, CAPAs, and risks associated with production and project execution and ensure they are communicated appropriately within the organization and to our healthcare partners.
• Develop and/or implement pharmaceutical packaging, both primary and secondary level in partnership with Engineering.
• Maintain a level of scientific knowledge in assigned area, to include cGMP, sterile manufacturing techniques; perform scientific literature searches and evaluations as required and understand and comply with accepted laboratory and safety procedures.
• Works cross functionally with Process Engineering, Operations, Quality Assurance, R&D, EH&S, Supply Chain, Project Management, Facilities, and other departments to effectively maintain processes in the facility.
• Evaluates existing processes and identifies process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.
• Ensure compliance with regulatory requirements including GMP, OSHA, FDA, EPA, etc. and be the SME supporting inspections from the associated regulator.
• Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state, and local regulations.
• Perform other duties and responsibilities as assigned.

Qualifications:

• Master’s Degree (MS) with at least 5 years related experience and/or training; Bachelor’s Degree (BS) in a Natural Science or Engineering with at least 10 years related experience and/or training.
• Experience with design of experiments (DOE) and related multivariate experimentation approaches is desired.
• Must understand concepts of QbD and pharmaceutical technology transfer.