Sr Manager, Continuous Manufacturing

Manufacturing Sciences Team Leader

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 Applications (Word, Excel, PowerPoint, Share point)

Proficiency with the English language.

Demonstrated commitment to our fundamental principles of Integrity, Respect & Excellence.

Physical Requirements : Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Relocation assistance is NOT provided.

Must be legally authorized to work in the United States without sponsorship, now or in the future.

Must be able to pass a comprehensive background check, which includes a drug screening.

Disclaimer : This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.