Quality Control Scientist
The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides
In order to continue our organic growth, we are constantly looking for talent.
The QC Scientist performs laboratory day-today operations, guides and interacts with QC and department personnel to accomplish goals and objectives as directed by supervisor. Other duties include performing raw material testing, final product testing, QC documentation and related GMP activities.
- Maintain and perform daily operations of the QC on a daily basis in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects
- Write and work with other QC Staff and other Department in the creation and approval of control documents such as specifications, SOPs, STMs, etc.
- Maintain and perform regular verification of the QC equipment for GMP compliance regularly in coordination with QC Director / Supervisor
- Implement and maintain GMP procedures such as following SOP’s, Standard Testing Procedures (STP’s), written procedure and maintaining proper documentation as necessary for Quality Control
- Test, review, and release raw material used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy
- Receive, test and release final product peptide manufactured at Bachem
- Test and release in-process control samples used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy
- Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work
- Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy
- Write standard operating procedures, standard test procedures and other related GMP documentation
- Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
- Perform QC analysis to include: HPLC, UPLC, Water, Mass Spec, UV, GC, melting point, Optical Rotation, TLC and misc. wet chemistry lab work and other related analytical equipment used for control quality of the GMP facility. This work may include calibration and validation of these methods
- Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing and QC release
- Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor
- Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility
- Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals
- Support validation, and stability as necessary to include but not limited to analytical work, documentation and quality GMP procedure
- Bachelor’s Degree in Chemistry or related field
- Minimum of 5 years’ experience in the GMP industry
- Use of analytical techniques/ instruments, such as, HPLC, GC, etc. and computer skills
- Excellent written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
- Detail oriented with the ability to troubleshoot and resolve problems
- Ability to work independently and manage one’s time
- Communicate effectively and ability to function well in a team environment
- Ability to review Certificate of Analysis for Reagents for the creation of specification documents
- Organization skills to support the department in the creation and approval of controlled documents in a timely manner
- Flexibility of working hours based on business needs, may include some nights and occasional weekends
- Experience with Peptides
- Technical writing experience
- Master’s degree in Chemistry or related field
- Experience with Equipment Maintenance Programs
Candidates for positions as US employees of Bachem Americas, Inc. (“Company”) must be in the process of or fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of employment, except for U.S. employees who request and qualify under applicable law for disability and religious accommodation from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S employee will be required to provide proof of vaccination status, or request and receive a disability or religious accommodation for which the applicant is entitled under applicable law, before their first day of employment or any later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regard to an individual’s disability, religion or on any other basis prohibited by law.