Manufacturing Manager

Job Locations US-IL-LAKE FOREST
ID
2022-1144
Category
Engineering
Type
Regular Full-Time

Overview

Responsible for providing technical support for Assertio’s products.  Interacts with Contract Manufacturing organizations and internal Assertio teams to resolve technical manufacturing and packaging issues for commercial and clinical manufacturing activities. Will serve as the technical expert on the products under his/her responsibility and will provide feedback, guidance and solutions to questions associated with products under his/her responsibility. Will contribute to the overall strategy and planning to support site registration, process Validation, Product launch and post-approval manufacturing activities. 

 

Responsibilities

Essential Functions

  • Manufacturing and packaging technical support for Assertio’s commercial products interfacing Commercial, Quality Assurance, Quality Control, Clinical, Regulatory. Oversees the development and manufacturing of drug products and/or transfer of development activities with CMO. 
  • Oversees preparation and reviews documentation, including batch records, protocols and reports. Helps generate schedules and coordination of manufacturing activities.
  • Writes /reviews development and validation technical reports 
  • Oversees clinical trial material manufacturing and packaging activities.
  • Work with Quality Systems to ensure implementation and maintenance of quality standards, meeting compliance/regulatory requirements.
  • Support manufacturing investigations and regulatory submissions.

Qualifications

Education/Experience

  • BS or equivalent in Chemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field. An advanced degree in sciences would be a plus.
  • A minimum of 7 years of pharmaceutical or biotech industry experience, with experience in development or manufacturing of pharmaceutical products.

Physical Requirements

  • Ability to operate a motor vehicle
  • Ability to travel via airplane
  • Ability to sit for long periods of time
  • Ability to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal.
  • Reaching: Extending hand(s) and arm(s) in any direction.
  • Standing: Remaining upright on the feet.
  • Pushing: Using upper extremities to press against something with steady force in order to thrust
  • Lifting: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position of up to 20 lbs. on occasion

 Mental Requirements

  • Ability to prepare and analyze data and figures
  • Ability to understand, remember and apply oral and written instructions
  • Ability to organize and prioritize own works schedule
  • Ability to apply common sense in performing job
  • Ability to understand and follow instructions

Accommodations for Applicants with Disabilities

Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email hr@assertiotx.com or call 224-441-6867 for assistance.

 

For more information about your EEO rights as an applicant under the law, please click here.

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