What are the responsibilities and job description for the QC Chemist II position at LTS Lohmann Therapy?
About LTS:
LTS Lohmann is a premier, global Contract Development and Manufacturing Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes.
We Care.
We Create.
We Deliver.
No agencies please!
Job Summary
We are seeking a highly motivated and experienced QC Chemist II to join our dynamic team. In this pivotal role, you will be responsible for quality control activities related to new product development, ensuring adherence to cGMP and pharmacopeial standards. You will actively participate in project meetings, develop and transfer analytical methods, and play a key role in the release of raw materials. This position offers a unique opportunity to contribute to innovative drug delivery solutions and advance your career in a leading CDMO.
- This is a full time, onsite role located in West Caldwell, NJ
*** We do not offer relocation assistance for this role: Candidates with existing plans to move to the area, may be considered. ***
What You Will Do:
- Represent Quality Control in project development meetings.
- Perform routine analysis of raw materials, in-process samples, finished products, and stability samples.
- Lead the preparation and execution of method validations and transfers to LTS.
- Conduct special projects related to analytical procedures and instrument problem-solving.
- Ensure strict adherence to SOPs, cGMPs, and safety protocols.
- Prepare comprehensive reports of project results according to cGMP standards.
- Identify areas for improvement and propose effective solutions.
- Provide training to new employees in laboratory techniques.
- Author and revise SOPs and control specifications.
- Participate in lab investigations, CAPAs, and change controls.
- Support internal and external customers to meet Quality Unit expectations.
- Maintain and calibrate laboratory instruments.
- Work with contract labs to ensure timely verifications/validations and releases.
- Generate control specifications and release raw materials.
- Implement and evaluate analytical technology and methodology transfers.
- Abide by all cGMP, FDA, and DEA regulatory standards.
Qualifications:
- Bachelor’s degree in Chemistry or Biochemistry.
- Minimum of 5-6 years of experience in a laboratory or research environment.
- Proficiency in Microsoft Word, Excel, PowerPoint, and SAP.
- Proven experience in technical writing and documentation, including method writing.
- Experience with Chromatography Data Systems (CDS) such as Chromeleon or Empower.
- Strong project management skills.
- Excellent team player with strong problem-solving abilities.
- In-depth knowledge of cGMPs and pharmacopeial procedures, including USP testing and requirements.
If this sounds like you, we want to hear from you!
LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
