Senior Manager

3 days ago


Bloomington, Indiana, United States Glenmark Pharmaceuticals USA Full time
Job Summary

We are seeking a highly experienced Senior Manager to lead our Stability Program, ensuring compliance with internal procedures, industry regulations, and regulatory guidance documents. The ideal candidate will have a strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).

Key Responsibilities
  • Develop and implement the stability program, including sample management and stability oversight.
  • Ensure compliance with FDA, ICH, WHO, and other international agencies.
  • Manage and facilitate completion of all stability-related tasks, including sample request, receipt, labeling, lay down procedure, calculation, and execution of stability pulls.
  • Coordinate with QC management for scheduling of stability sample analysis.
  • Ensure data is managed and evaluated, including creation, review, and trending, to meet company, industry, and regulatory requirements.
  • Review and approve change controls, deviation, investigation, out-of-trend or out-of-specification reports.
  • Manage stability chambers, including daily monitoring and excursion evaluation.
  • Write and maintain SOPs in support of the stability program.
Requirements
  • Master's Degree in Pharmacy, Pharmaceutics, or Biotechnology.
  • Five (5) years of experience in a Pharmaceutical Quality Control Laboratory environment, including experience with conducting stability studies.
  • A minimum of 4 years of laboratory managerial experience, including involvement with regulatory audits.
  • Strong understanding of GMP, GLP, GDP, cUSP, and ICH Q1A (R2).
  • Experience with electronic systems such as Trackwise, SAP, and/or other relevant QMS systems.
  • Experience with Lab Equipment such as UPLC, HPLC, and GC and Software such as Empower or Lab Solutions.
  • Experience with statistical applications for stability data evaluation and shelf-life determination.
  • Strong documentation skills, including writing SOPs, technical papers, and investigations.
  • Knowledge and experience in all aspects of quality system management, lean manufacturing skills, and managerial experience in Oral solid dosage and parenteral pharmaceutical manufacturing process.
  • Experience supervising and guiding internal resources during stability testing and troubleshooting.
Preferred Qualifications
  • Experience with Microsoft Word, Microsoft Excel, and PowerPoint.
  • Strong knowledge of Pharmaceutical Development Process with multiple dosage forms: Oral Solids, Liquids, Injectables, Lotions, liquids, foams, Creams, Ointments, and Sprays.
  • Strong organizational and communicative skills.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your resume and cover letter for consideration.


  • Resident Care Manager

    4 weeks ago


    Bloomington, Indiana, United States Cedarhurst Senior Living Full time

    Job SummaryCedarhurst Senior Living is seeking a highly skilled and compassionate Resident Care Manager to join our team. As a key member of our care services team, you will be responsible for ensuring the highest level of care and support for our residents.Key ResponsibilitiesDevelop and Facilitate Resident-Directed Programming: Create and implement...


  • Bloomington, Indiana, United States Mortenson Full time

    Job Summary:Mortenson is seeking an experienced Senior Quality Manager to lead and manage the quality system on one or more significant projects. The ideal candidate will have a strong background in quality management, with experience in leading quality initiatives, managing quality events, and resolving issues. The Senior Quality Manager will be responsible...

  • Resident Care Manager

    3 weeks ago


    Bloomington, Indiana, United States Cedarhurst Senior Living Full time

    About the RoleCedarhurst Senior Living is seeking a dedicated and compassionate Resident Care Manager to join our team. As a key member of our care services team, you will play a vital role in ensuring the highest level of care and support for our residents.Key ResponsibilitiesDevelop and implement resident-directed programming to meet the assessed needs,...


  • Bloomington, Indiana, United States Catalent Inc Full time

    About the RoleCatalent Inc, a global leader in the development and manufacturing of new treatments for patients worldwide, is seeking a highly skilled and experienced Senior Accounting Manager to join our team. As a key member of our accounting team, you will play a critical role in ensuring the accuracy and timeliness of financial reporting, while fostering...


  • Bloomington, Indiana, United States Insurance Office of America Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Account Manager to join our team at Insurance Office of America. As a Senior Account Manager, you will be responsible for managing a portfolio of insurance accounts, building strong relationships with clients, and driving business growth through strategic account management.Key...


  • Bloomington, Indiana, United States Midwest Financial Staffing & Executive Search Group Full time

    Senior Accounting Manager Job DescriptionWe are seeking a highly skilled Senior Accounting Manager to join our team at Midwest Financial Staffing & Executive Search Group. As a key member of our finance team, you will be responsible for ensuring the accuracy and integrity of our financial reporting processes.Key Responsibilities:Manage multiple revenue...


  • Bloomington, Indiana, United States Catalent Inc Full time

    Senior Manager, Accounting Job DescriptionCatalent Inc is seeking a highly skilled Senior Manager, Accounting to join our team. As a key member of our accounting team, you will be responsible for managing the daily operations of our accounting department, ensuring timely and accurate financial reporting, and fostering a positive environment for employee...


  • Bloomington, Indiana, United States Indiana University Foundation Full time

    Job Title: Senior Marketing ManagerAt the Indiana University Foundation, we are seeking a dynamic and visionary Senior Marketing Manager to lead our newly established account services team. In this pivotal role, you will be instrumental in crafting integrated marketing strategies that drive business outcomes.As a key member of our team, you will approach...


  • Bloomington, Indiana, United States Blue Cross and Blue Shield of Louisiana Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Provider Data Management Leader to join our team at Blue Cross and Blue Shield of Louisiana. This role will be responsible for leading the Credentialing and Provider Data Management functions, ensuring that our provider credentialing practices are efficient and precise in accordance with...


  • Bloomington, Indiana, United States Catalent Inc Full time

    Job SummaryCatalent Inc is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Senior Manager, Accounting to join our team in Bloomington. As a key member of our accounting team, you will be responsible for managing the daily operations of our accounting team, ensuring timely and...


  • Bloomington, Indiana, United States Graphic Packaging International Full time

    Job Title: Plant ControllerCompany: Graphic Packaging InternationalJOB FUNCTIONS:The Plant Controller plays a pivotal role in overseeing the financial operations of the facility and is an integral part of the plant leadership team. This position is tasked with ensuring precise and prompt financial and management reporting; establishing and upholding a robust...


  • Bloomington, Indiana, United States Graphic Packaging International Full time

    Job Title: Plant ControllerCompany: Graphic Packaging InternationalROLE OVERVIEW:The Plant Controller plays a pivotal role in overseeing the financial operations of the facility, actively engaging with the operational leadership team. This position is essential for ensuring precise and prompt financial reporting, establishing a robust internal control...


  • Bloomington, Indiana, United States Graphic Packaging International Full time

    Job Title: Plant ControllerCompany: Graphic PackagingJOB FUNCTIONS:The Plant Controller plays a crucial role in overseeing the financial operations of the facility and is an integral part of the leadership team. This position ensures the accuracy and timeliness of financial and management reporting, establishes and maintains a robust internal control...

  • Senior Auditor

    3 days ago


    Bloomington, Indiana, United States Sponsel CPA Group Full time

    Audit Senior AccountantSponsel CPA Group is seeking a highly skilled and experienced Audit Senior Accountant to join our team.Job Duties:Lead the planning, fieldwork, and completion of compilations, reviews, and audits with minimal supervision.Prepare and review financial statements and management letters with a high level of accuracy and attention to...


  • Bloomington, Indiana, United States Nexus Dynamics Full time

    Senior Physician OpportunityWe are seeking a highly skilled Senior Physician to join our team at Nexus Dynamics. As a Senior Physician, you will be responsible for providing exceptional patient care and leading our internal medicine department.About the Role:Provide high-quality patient care and treatment plansLead and manage a team of physicians and medical...


  • Bloomington, Indiana, United States Sponsel CPA Group Full time

    Job Title: Tax SeniorWe are seeking a highly skilled Tax Senior to join our team at Sponsel CPA Group. As a Tax Senior, you will play a key role in preparing tax projections, estimated federal and state income tax payments, and year-end accrual calculations.Key Responsibilities:Maintain a high level of technical knowledge in taxation.Prepare tax returns,...


  • Bloomington, Indiana, United States Catalent Inc Full time

    About the RoleCatalent is seeking a highly skilled Senior Manager, Form/Fill to join our team in Bloomington. As a key member of our operations team, you will be responsible for leading a group of staff and ensuring the performance and results of our Form Fill team.Key ResponsibilitiesLead a team of thirty-five or more staff, including 2 or more direct...

  • Dishroom Attendant

    2 weeks ago


    Bloomington, Indiana, United States Five Star Senior Living Full time

    Join Our Team as a Dishwasher at Five Star Senior LivingWe are seeking a reliable and detail-oriented individual to join our team as a Dishwasher at Five Star Senior Living. As a key member of our kitchen staff, you will play a crucial role in maintaining the cleanliness and organization of our dishroom and kitchen areas.Responsibilities:Wash and inspect all...

  • Dishroom Attendant

    2 weeks ago


    Bloomington, Indiana, United States Five Star Senior Living Full time

    Join Our Team as a Dishwasher at Five Star Senior LivingWe are seeking a reliable and detail-oriented individual to join our team as a Dishwasher at Five Star Senior Living. As a key member of our kitchen staff, you will play a crucial role in maintaining the cleanliness and sanitation of our dishroom and kitchen areas.Responsibilities:Wash and inspect all...


  • Bloomington, Indiana, United States American Senior Benefits Full time

    Unlock Your Potential in Insurance SalesAre you passionate about helping people and building a successful career in insurance sales? American Senior Benefits is seeking a dynamic and driven individual to join our team as an Insurance Sales Representative in Bloomington, Indiana.About UsWe are a hybrid sales organization that offers unparalleled access to...