Endo
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary
The Director of Operations at the Rochester MI facility leads the establishment, implementation, maintenance and execution of: cleaning, sanitization, and/or sterilization of production equipment and facilities; raw material sampling, dispensing and product formulation; aseptic/sterile primary packaging of liquid, suspension, or lyophilized product in plastic bottles, vials or syringes; inspection, secondary labeling and packaging of the finished product. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff members to achieve overall organizational objectives and sustain site’s positive performance record associated with Quality Management System (QMS), cGMP and EHS compliance.
Job Description
Scope of Authority:
Span of Control: oversight of five budgetary departments representing seven operational working units. Operating Budget ~$15M; Spend/signing authority at $25K Key Accountabilities:
Directs production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging. Oversees execution of commercial production to meet patient, quality, business, and financial objectives. Maintains proper staffing and training levels to meet requirements. Provides management reporting through development and use of department metrics aligned with Site Objectives and Scorecard. Sets priorities to meet internal cycle times and delivery schedules. Assure adequate maintenance of department machinery and supplies. Establishes and drives expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives. Responsibilities:
Operations (20%): Directs production, oversees execution of commercial production, maintains proper staffing and training levels, provides management reporting. Compliance (20%): Develops and maintains a safe manufacturing environment, promotes a quality and compliance focused culture, assures cGMP compliance with regulatory agencies. Supervisory Responsibilities (20%): Interviews, hires, and ensures training of employees, plans, assigns, and directs work, appraises performance, rewards and redirects employee’s activities. Leadership (40%): Establishes expectations, drives accountability & influences effective team building and team work, creates an atmosphere of team effort, open communication and inspirational shop floor management. Qualifications
Education & Experience:
Direct parenteral manufacturing/quality experience preferred. Bachelors/Master's degree from an accredited college or university with a major in Science, Packaging Engineering or Business Six-ten years of progressively responsible work-related experience designing, customizing, managing and evaluating manufacturing operations. Minimum of 10 years supervisory/leadership experience with specific involvement with Operations, Quality and/or Compliance Management. Knowledge:
Microsoft Office Suite, Quality Management Systems(QMS: Trackwise, LMS, LIMS), Enterprise Resource Planning (ERP) Systems, Calibration Maintenance Management Systems (CMMS) CFR 210, 211, 610, Part 11, and Parenteral Manufacturing Guidance (FDA/EU Annexes) Skills & Abilities:
Managing People, Leadership, Interpersonal Skills, Oral Communication, Written Communication, Teamwork, Strategic Thinking, Ethics, Organizational Support, Motivation, Planning/Organizing, Professionalism, Adaptability, Dependability, Initiative, Skilled and Determined. Physical Requirements:
Stand, walk, sit, lift, talk and hear in office, laboratory and manufacturing work areas Frequent walkthroughs of shop floor operations EEO Statement: We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered.
#J-18808-Ljbffr
Scope of Authority:
Span of Control: oversight of five budgetary departments representing seven operational working units. Operating Budget ~$15M; Spend/signing authority at $25K Key Accountabilities:
Directs production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging. Oversees execution of commercial production to meet patient, quality, business, and financial objectives. Maintains proper staffing and training levels to meet requirements. Provides management reporting through development and use of department metrics aligned with Site Objectives and Scorecard. Sets priorities to meet internal cycle times and delivery schedules. Assure adequate maintenance of department machinery and supplies. Establishes and drives expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives. Responsibilities:
Operations (20%): Directs production, oversees execution of commercial production, maintains proper staffing and training levels, provides management reporting. Compliance (20%): Develops and maintains a safe manufacturing environment, promotes a quality and compliance focused culture, assures cGMP compliance with regulatory agencies. Supervisory Responsibilities (20%): Interviews, hires, and ensures training of employees, plans, assigns, and directs work, appraises performance, rewards and redirects employee’s activities. Leadership (40%): Establishes expectations, drives accountability & influences effective team building and team work, creates an atmosphere of team effort, open communication and inspirational shop floor management. Qualifications
Education & Experience:
Direct parenteral manufacturing/quality experience preferred. Bachelors/Master's degree from an accredited college or university with a major in Science, Packaging Engineering or Business Six-ten years of progressively responsible work-related experience designing, customizing, managing and evaluating manufacturing operations. Minimum of 10 years supervisory/leadership experience with specific involvement with Operations, Quality and/or Compliance Management. Knowledge:
Microsoft Office Suite, Quality Management Systems(QMS: Trackwise, LMS, LIMS), Enterprise Resource Planning (ERP) Systems, Calibration Maintenance Management Systems (CMMS) CFR 210, 211, 610, Part 11, and Parenteral Manufacturing Guidance (FDA/EU Annexes) Skills & Abilities:
Managing People, Leadership, Interpersonal Skills, Oral Communication, Written Communication, Teamwork, Strategic Thinking, Ethics, Organizational Support, Motivation, Planning/Organizing, Professionalism, Adaptability, Dependability, Initiative, Skilled and Determined. Physical Requirements:
Stand, walk, sit, lift, talk and hear in office, laboratory and manufacturing work areas Frequent walkthroughs of shop floor operations EEO Statement: We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered.
#J-18808-Ljbffr