Library Technical Services Director jobs in Ann Arbor, MI
Library Technical Services Director implements use of technology for library technical services operations. Develops policy and plan regarding materials acquisition budget, cataloging, serials and electronic licensing. Being a Library Technical Services Director requires a master's degree. Typically reports to a head of a unit/department. The Library Technical Services Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. To be a Library Technical Services Director typically requires 3+ years of managerial experience. (Copyright 2024 Salary.com)
Recently Added Library Technical Services Director jobs
Associate Director, Drug Product Technical Services
- ESPERION THERAPEUTICS INC
-
Ann Arbor, MI
FULL_TIME
-
Company Overview
Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.
Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.
Position Title: Associate Director, Drug Product Technical Services
The Associate Director, Drug Product Technical Services is responsible for leading drug product development, technology transfer and manufacturing technical support activities at contract manufacturing organizations (CMOs). A key component of the role is supporting ongoing commercial supply activities at the existing commercial sites as well as additional supply-chain expansion efforts. This role also leads investigations into manufacturing related deviations, implementation of CAPAs, change management, and process monitoring, as well as lifecycle management of Esperion’s lead drug products in commercial manufacturing. This is a remote, work from home position with approximately 25% travel. This position will report to the Executive Director, Drug Product Development.
Preferred Location: Remote – US
Essential Duties and Responsibilities*- Lead and support activities for commercial manufacturing of Nexletol and Nexlizet drug products at CMOs. This includes but not limited to review and approval of drug product batch records, provide on-site “person-in-plant” technical oversight, and supervision of other manufacturing activities at CMOs as required.
- This role will work collaboratively within Tech Ops and internal project teams including Drug Product, Supply Chain, Quality Control, Quality Management, CMC-Regulatory Affairs, Finance colleagues as required to necessary for timeline execution of project plans.
- As needed, work collaboratively with our Alliance Partners on product related quality or technical issues.
- Provide technical and process knowledge to lead process optimization, manufacturing/facilities investigations, the implementation of CAPAs, change management, and other quality related activities.
- Lead, co-ordinate and review activities related to OOS, deviations, change control, and CAPA’s.
- Manage documentation for process validation and commercial manufacturing under cGMP guidelines and author regulatory filings (NDA, MAA and related supplementary filings).
- Collect, analyze, and summarize data for continuous process verification (CPV) and develop remediation plans for identified gaps.
- Review and approve technical reports/regulatory documents (INDs, IMPDs, and NDA/MAAs) for global submissions.
- Be a key team member of commercial drug product Technology Transfers and interface with contract manufacturers to optimize commercial manufacturing processes.
- Interface with Quality Management, Regulatory-CMC Corporate Compliance, and consultants for ensuring compliance in the manufacture of drug product under current GMP standards.
- Create and review technical documents, reports, updates and presentations for cross-functional teams and management.
- Participate in planning sessions and cross-functional team meetings.
additional duties and responsibilities as assigned
Qualifications (Education & Experience)- Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry or closely related field from an accredited college or university, with minimum 8 years of experience in cGMP manufacturing environment in pharmaceutical industry either in a research and development, process development, manufacturing, or contract manufacturing role; (pharmaceutical industry); or equivalent education and experience
- Solid background in drug product and process development, technology transfer of manufacturing processes, troubleshooting and process improvements.
- Significant experience working with and managing drug product contract manufacturers including those in the US, Europe, and Asia is required.
- Experience working in a multi-cultural, multi-lingual environment is necessary with a demonstrated ability to contribute successfully to a multi-disciplinary team environment.
- Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals.
- Experience in statistical analysis, interpretation, and summarizing (control charts) of trending data preferred.
- Extensive knowledge of cGMP guidelines (US and EU).
- Attention to detail and familiarity with batch record review process and FDA quality standards.
- Hands on experience with quality systems in a regulated environment, including change control, CAPA and investigations. Working knowledge and experience with SOPs and ICH guidelines.
- Recent experience in preparation of CMC sections of US or EU regulatory filing is desirable.
- Strong project management experience with cross-functional team leadership and participation skills.
- Experience in Six Sigma with certification is a plus.
- Minimum five (5) years of experience managing CMO’s desired.
- Self-motivated, organized, and be reliable and responsive as needed to perform responsibilities.
- Demonstrated alignment with Esperion’s Vision, Mission, Values and Culture.
- Ability to deliver highly effective presentations which demonstrate technical expertise and are audience specific.
- Proficient with MS Office and laboratory systems. Knowledge of applicable business systems including: Trackwise, Veeva, etc.
- Excellent written and verbal English communication skills.
- Domestic and international travel required (up to 25 %).
- 1 Month Ago
Library Services Coordinator (Elementary)
- Howell Public Schools
-
Howell, MI
FULL_TIME
- Position: Library Services Coordinator - Elementary Location: Challenger Elementary School Reports To: Principal Status: Non-Exempt, Union Union Affiliation: HESPA Duration: Ten (10) months; Two weeks...
- 1 Month Ago
Library Assistant I
- JACKSON DISTRICT LIBRARY
-
Jackson, MI
FULL_TIME
- April 19, 2024 Library Assistant I Carnegie Circulation Part-time You belong at JDL! Our organization is dedicated to our diversity journey and believes we should strive to create an open and safe spa...
- 4 Days Ago
Library Assistant I Substitutes
- JACKSON DISTRICT LIBRARY
-
Jackson, MI
PART_TIME
- March 4, 2024 Library Assistant I Substitute On-call All JDL Branch Locations Come join the JDL team! Are you looking for a part-time job where you decide what your schedule will be week to week? We a...
- 1 Month Ago
Commissioning Field Engineer ll
- FST Technical Services
-
Ann Arbor, MI
FULL_TIME
- At FST Technical Services our commissioning division partners with clients for all phases of the project, design phase, construction phase and post acceptance phase. The Commissioning Process is one o...
- 19 Days Ago
Commissioning Engineering Manager
- FST Technical Services
-
Ann Arbor, MI
FULL_TIME
- FST Technical services commissioning (Cx) division formerly Horizon Engineering Associates, LLP is one of the leading Cx firms in the country. We partner with clients for quality assurance in the desi...
- 20 Days Ago
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0 Library Technical Services Director jobs found in Ann Arbor, MI area
Medical Assistant
- American Family Care
-
Ann Arbor, MI
- Company Overview American Family Care (AFC) is one of the largest primary and urgent care companies in the U.S. providin...
- 4/26/2024 12:00:00 AM
Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
- Department Of The Treasury
-
Ann Arbor, MI
- Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
- 4/26/2024 12:00:00 AM
Supervisory Internal Revenue Agent 12 month Roster
- Department Of The Treasury
-
Ann Arbor, MI
- Duties WHAT IS THE LBI - Large Business and InternationalDIVISION? A description of the business units can be found at: ...
- 4/25/2024 12:00:00 AM
WMS Analyst
- Longbow Advantage
-
Ann Arbor, MI
- Longbow Advantage is a trusted supply chain partner to various Fortune 500 companies across North America and Europe. Si...
- 4/25/2024 12:00:00 AM
Senior Project Manager of Training Grant Services
- University Of Michigan
-
Ann Arbor, MI
- How to Apply A cover letter is required for consideration for this position and should be attached as the first page of ...
- 4/24/2024 12:00:00 AM
Technical Architect
- Clarivate Analytic
-
Ann Arbor, MI
- As a Technical Architect, you will be responsible for the design, implementation and testing phases of the software deve...
- 4/24/2024 12:00:00 AM
Lead Medical Assistant
- American Family Care
-
Ann Arbor, MI
- Company Overview American Family Care (AFC) is one of the largest primary and urgent care companies in the U.S. providin...
- 4/22/2024 12:00:00 AM
Internal Revenue Agent / Senior Revenue Agent (Examiner)-12 Month Roster AMENDED
- Department Of The Treasury
-
Ann Arbor, MI
- Duties WHAT IS THE LARGE BUSINESS AND INTERNATIONAL DIVISION? A description of the business units can be found at: https...
- 4/22/2024 12:00:00 AM
About Ann Arbor, Michigan
Ann Arbor is a city in the U.S. state of Michigan and the county seat of Washtenaw County. The 2010 census recorded its population to be 113,934, making it the sixth largest city in Michigan.
Ann Arbor is home to the University of Michigan. The university significantly shapes Ann Arbor's economy as it employs about 30,000 workers, including about 12,000 in the medical center. The city's economy is also centered on high technology, with several companies drawn to the area by the university's research and development infrastructure.
Ann Arbor was founded in 1824, named for wives of the village'...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Library Technical Services Director jobs
$67,004 to $100,761
Ann Arbor, Michigan area prices
were up 1.3% from a year ago
were up 1.3% from a year ago
What does a Library Technical Services Director do?
Library Technical Services Director in Boulder, CO
Responsible to the Director of Library Services for cataloging all library materials and assisting with general library duties.
December 19, 2019
Library Technical Services Director in Long Beach, CA
Weber provides an overview of technical services and the impact electronic resources are having on this aspect of librarianship.
February 20, 2020
Library Technical Services Director in Savannah, GA
The Technical Services Manager will supervise the team of acquisitions and technical services librarians and clerks, and will work closely with the Research Manager who will be responsible for research and training. The Technical Services Manager will also be an integral part of the Library Management team and interact regularly with other members of the Library staff.
January 18, 2020