Job Title
Senior Manager, Technical Operations
Requisition
JR000014216 Senior Manager, Technical Operations (Open)
Location
College Park, Dublin - IRL006
Additional Locations
Dublin, IRL
Job Description
The Senior Manager, Technical Operations will provide oversight of the Technical Operations team supporting drug substance and drug product intermediate manufacturing operations in College Park, Dublin (CPMF). This role will serve as front-line support for resolution of manufacturing and quality issues at CPMF. This person will also be responsible for leading the onsite development lab and driving program initiatives to meet business objectives. The Senior Manager will maintain flexibility to also lead key strategic projects for Mallinckrodt’s marketed products beyond CPMF as needed. The individual in this role will be responsible for developing and maintaining a robust training curriculum for College Park Manufacturing operators. The Senior Manager will also be a key member of the CPMF Plant Leadership Team and the broader Global Technical Operations Council.

Essential Functions

• Partner with both Operations and Quality to support our Commercial products.
• Implement actions identified to support CPMF strategic initiatives.
• Work with our internal and external partners to implement process improvements.
• Manage a late-stage process development lab and associated laboratory projects.
• Lead the development and implementation of lab scale models of commercial processes.
• Collaborate with site leadership to leverage manufacturing personnel for technical operations initiatives and to support employee professional development.
• Establish and maintain a CPV program for CPMF and other MNK Brands products as applicable.
• Serves as Person in Plant for manufacturing campaigns as required.
• Leads Tech Transfer projects between CMOs and internal stakeholders.
• Authors or provides technical review of project documents, validation protocols, batch records, etc.
• Supports technical investigations both internally and at external partners
• Responsible for authoring and reviewing CMC documentation for regulatory submissions
• Works to identify process / yield improvement opportunities for drug substances and drug product intermediates.
• Leads project meetings and technical forums
• Technical lead for new material introductions and raw material/component replacement projects

Education:

• PhD in Chemistry, Biology, Engineering or related science.
• MS in Chemistry, Biology, Engineering or related science.
• BA or BS in Chemistry, Biology, Engineering or related science

Experience:

• PhD in Chemistry, Biology, Pharmaceutical Science, Physics, or related science with a minimum of 5 years of pharmaceutical or related work experience in the field.
• MS in Chemistry, Biology, Pharmaceutical Science, Physics, or related science typically with a minimum 8 years of pharmaceutical or related work experience in the field.
• BA or BS in Chemistry, Biology, Pharmaceutical Science, Physics, or related science typically with a minimum of 10 years of pharmaceutical or related work experience in the field.
• At least 3 years in a supervisory/lead role preferred

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• Manages, develops, and evaluates personnel to ensure the efficient operation of the function.
• Monitors documentation maintenance within the group.
• Ensures safety and training compliance of research personnel.
• Maintains an awareness of literature appropriate to projects.
• Maintains an awareness of global regulatory guidelines and applies those to product development strategy.
  Minimum Requirements
  Education / Experience / Skills:

Education:

• PhD in Chemistry, Biology, Engineering or related science.
• MS in Chemistry, Biology, Engineering or related science.
• BA or BS in Chemistry, Biology, Engineering or related science.

Experience:

• PhD in Chemistry, Biology, Pharmaceutical Science, Physics, or related science with a minimum of 5 years of pharmaceutical or related work experience in the field.
• MS in Chemistry, Biology, Pharmaceutical Science, Physics, or related science typically with a minimum 8 years of pharmaceutical or related work experience in the field.
• BA or BS in Chemistry, Biology, Pharmaceutical Science, Physics, or related science typically with a minimum of 10 years of pharmaceutical or related work experience in the field.
• At least 3 years in a supervisory/lead role preferred.

Competencies:
Required Skills/Competencies: Needs to possess excellent oral and written communication skills. Advanced knowledge of laboratory procedures is necessary. Individual must demonstrate advanced problem-solving skills and technical competency. Must demonstrate the ability to work effectively in a team environment.
Preferred Skills/Qualifications: Cross-functional knowledge of process chemistry and biomanufacturing is desired. Incorporation of laboratory automation technologies to enhance departmental efficiency is expected. Chemical Design for Six Sigma knowledge is a plus.
Organizational Relationship/Scope:
Position directly reports to the Executive Director, Global Technical Operations and Development

Working closely with the key stakeholders, including:

• Quality
• Internal/External Manufacturing Operations
• Regulatory

Working Conditions:
This position involves normal office conditions with routine exposure to research laboratory operations. Occasional travel may be required for engagement with external laboratories and collaborators.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

LI-KD1

Essential Functions

• Partner with both Operations and Quality to support our Commercial products.
• Implement actions identified to support CPMF strategic initiatives.
• Work with our internal and external partners to implement process improvements.
• Manage a late-stage process development lab and associated laboratory projects.
• Lead the development and implementation of lab scale models of commercial processes.
• Collaborate with site leadership to leverage manufacturing personnel for technical operations initiatives and to support employee professional development.
• Establish and maintain a CPV program for CPMF and other MNK Brands products as applicable.
• Serves as Person in Plant for manufacturing campaigns as required.
• Leads Tech Transfer projects between CMOs and internal stakeholders.
• Authors or provides technical review of project documents, validation protocols, batch records, etc.
• Supports technical investigations both internally and at external partners
• Responsible for authoring and reviewing CMC documentation for regulatory submissions
• Works to identify process / yield improvement opportunities for drug substances and drug product intermediates.
• Leads project meetings and technical forums
• Technical lead for new material introductions and raw material/component replacement project