Sr Manager, Continuous Manufacturing

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job Summary:

Leads the Manufacturing Sciences Teams and provides strategic direction and mentorship in the areas of manufacturing processes and technology, process improvement, quality performance and formulation development.

Lead and coordinate Operations for the Continuous Manufacturing Dept. Provide technical and managerial mentorship while implementing operational strategies. Collaborate with business unit leaders to support overall client and business unit goals.

Essential Functions

• Provides leadership to assigned staff through leading organizational change, empowerment, cultivates relationships; helps them achieve their personal career goals while also achieving organizational goals.
• Builds effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
• Ensures the rapid development of new dosage forms and processes according to customer requirements. Assures that processes are safe, reproducible, cost effective, environmentally sound and can be successfully validated and transferred to production operations, in order to meet agreed standards and require minimal continuing support.
• Defines resource needs (capital, expense, and headcount) so that current and future development needs are met. Recruits, hires, retains, trains, and motivates a scientifically proficient staff. Provides opportunities for staff career development.
• Ensure all production operations and equipment are controlled, validated, and in regulatory compliance and appropriate Standard Operating Procedures (SOPs) and batch record documents exist and are followed and reviewed regularly.
• Technical representation on new business quotes and senior-level client visitors and inter-site visitors. Leads development and coordination of realistic proposals and timelines, reviews technical packages. Leads meetings/teleconferences with clients.
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
• Works with Client Departments to introduce new technology and resolve complex OSD problems related to both existing portfolio and development work.
• Leads research of industry practices and processes and applies to innovative drug development internally and for client products. Presents recommendations internally and to clients. Publicizes research, scientific reports and white papers. Represents the organization on formal technical and scientific forums.
• Recommends and assists in implementing organizational and technical improvements designed to enhance the efficiency, reliability, and productivity of operations all conforming to applicable regulatory standards.
• Tracks quality performance trends and keeps Corrective Action Preventative Action (CAPA) actions on track.

Education:

• PHD in engineering or relevant physical science is preferred
• Bachelor’s of Science in Chemistry, Biochemistry, Biology, or related physical science required.

Experience:

• Minimum 5 years of Oral solid dose manufacturing experience
• Minimum 5 years of management experience
• Minimum 10 years of progressive scientific experience, including 9 years in a related life sciences field.
• Experience working directly with clients
• Previous Continuous Manufacturing Experience preferred
• Experience with Process Analytical Technology (PAT) preferred

Equivalency:

Equivalent combinations of education, training, and meaningful work experience may be considered.

Competencies:

Ability to drive functional, technical and operational excellence.

Ability to inspire and champion innovation, collaboration, transparency and team effectiveness.

Exceptional Good Manufacturing Practices knowledge.

Demonstrated decision making capabilities.

Strong leadership and conflict resolution skills.

Consistent track record to balance/maintain goals, responsibilities, and priorities of the organization.

Demonstrated success as agent of change.

Excellent interpersonal and communication skills, as well as the ability to empower and lead.

Working knowledge of Microsoft (MS) Office A