Bachem Holding AG
Principal Scientist
Bachem Holding AG, Vista, California, us, 92085
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise, Bachem provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US, and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.
A brief overview
The Principal Scientist, Analytical Research and Development will fulfill a critical role in QC to support production operations for all production manufacturing, process development, and service order activities. The individual will work closely with process development, production manufacturing, QC material testing, QC IPC, and QC API testing to understand and align analytical strategies. This individual plays a key role in cross-departmental collaboration and fosters clear communication and accountability. This individual proactively provides solutions to resolve analytical challenges to support our internal and external customers in a timely manner. The individual will utilize their process experience and technical expertise to guide peers and (junior) scientists on analytical activities and help train the affected interface functions to become independent in tackling daily challenges.
What you will do
Independently plan, execute, and summarize analytical activities to support process R&D, production, CMC, and QC.
Maintain cross-functional channels of communication to stay focused on implementation of analytical strategy.
Work closely with QC teams studying product attributes to align the internal/external customer needs with the planned analytical activities.
Provide guidance and help peers and junior scientists troubleshoot abnormal results.
Independently conduct and document investigations related to analytical activities.
Monitor and evaluate the impact of new industry guidance and trends of advanced analytical technology on our analytical operations.
Be a technical liaison between the QC teams and other cross-functional teams.
Participate in the planning of QC strategy to support the projects, other production, and R&D activities.
Continuously improve working efficiency through streamlining the analytical process and introducing new technology.
Build or expand analytical capabilities as needed.
Develop and maintain an in-depth understanding of the scientific principles associated with analytical activities.
Routinely work with hazardous materials and manage hazardous waste in a satellite accumulation area.
Qualifications
B.S. in chemistry or related scientific field with 12 years’ industry experience or
M.S. in chemistry or related scientific field with 10 years’ industry experience or
Ph.D. in chemistry or related scientific field with 7 years’ industry experience.
Experience working in GMP manufacturing and laboratory testing.
Knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
Experience with HPLC (SEC, IC)/UPLC, GC, KF, Amino Acid Analysis, MS, MS/MS sequencing, and LC-MS.
Strong hands-on instrumentation experience using HPLC, GC, UV-VIS, LC-MS, spectrophotometer, FT-IR spectroscopy, Karl Fischer, wet chemistry, etc.
Experience in writing standard operating procedures (SOPs), test methods, technical protocols, and reports.
Experience in method development, validation, and method transfer.
Independently plan, execute, conclude analytical method development, validation, and method transfer.
Independently design method development plans and develop a variety of analytical methods.
Work closely with Production, QC RM, QC IPC, and QC API to provide analytical support.
Provide solutions to resolve analytical challenges to support our internal and external customers.
Independently evaluate compendial and customer's methods, implement these methods in-house, and transfer to the final users.
Ability to set priorities and to follow through on commitments.
Basic computer knowledge, including Microsoft Word, Excel, and PowerPoint.
Ability to effectively organize, multitask, and work in a fast-paced, timeline-driven work environment.
Detail-oriented with the ability to troubleshoot and resolve problems.
Ability to train and supervise the work of junior staff members.
Ability to coordinate work with other functions/departments to achieve project objectives.
Ability to provide expertise to management, technical project leaders, project/program leaders on method feasibility and risk assessment.
Excellent written and oral communication skills.
Experience with peptides (preferred).
Experience in both analytical development and quality control in the pharmaceutical/biopharmaceutical industry (preferred).
Base Salary Range:
$127,440 - $167,000
Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.
Total Rewards
We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.
Corporate Social Responsibility
Bachem takes responsibility for future generations by careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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A brief overview
The Principal Scientist, Analytical Research and Development will fulfill a critical role in QC to support production operations for all production manufacturing, process development, and service order activities. The individual will work closely with process development, production manufacturing, QC material testing, QC IPC, and QC API testing to understand and align analytical strategies. This individual plays a key role in cross-departmental collaboration and fosters clear communication and accountability. This individual proactively provides solutions to resolve analytical challenges to support our internal and external customers in a timely manner. The individual will utilize their process experience and technical expertise to guide peers and (junior) scientists on analytical activities and help train the affected interface functions to become independent in tackling daily challenges.
What you will do
Independently plan, execute, and summarize analytical activities to support process R&D, production, CMC, and QC.
Maintain cross-functional channels of communication to stay focused on implementation of analytical strategy.
Work closely with QC teams studying product attributes to align the internal/external customer needs with the planned analytical activities.
Provide guidance and help peers and junior scientists troubleshoot abnormal results.
Independently conduct and document investigations related to analytical activities.
Monitor and evaluate the impact of new industry guidance and trends of advanced analytical technology on our analytical operations.
Be a technical liaison between the QC teams and other cross-functional teams.
Participate in the planning of QC strategy to support the projects, other production, and R&D activities.
Continuously improve working efficiency through streamlining the analytical process and introducing new technology.
Build or expand analytical capabilities as needed.
Develop and maintain an in-depth understanding of the scientific principles associated with analytical activities.
Routinely work with hazardous materials and manage hazardous waste in a satellite accumulation area.
Qualifications
B.S. in chemistry or related scientific field with 12 years’ industry experience or
M.S. in chemistry or related scientific field with 10 years’ industry experience or
Ph.D. in chemistry or related scientific field with 7 years’ industry experience.
Experience working in GMP manufacturing and laboratory testing.
Knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
Experience with HPLC (SEC, IC)/UPLC, GC, KF, Amino Acid Analysis, MS, MS/MS sequencing, and LC-MS.
Strong hands-on instrumentation experience using HPLC, GC, UV-VIS, LC-MS, spectrophotometer, FT-IR spectroscopy, Karl Fischer, wet chemistry, etc.
Experience in writing standard operating procedures (SOPs), test methods, technical protocols, and reports.
Experience in method development, validation, and method transfer.
Independently plan, execute, conclude analytical method development, validation, and method transfer.
Independently design method development plans and develop a variety of analytical methods.
Work closely with Production, QC RM, QC IPC, and QC API to provide analytical support.
Provide solutions to resolve analytical challenges to support our internal and external customers.
Independently evaluate compendial and customer's methods, implement these methods in-house, and transfer to the final users.
Ability to set priorities and to follow through on commitments.
Basic computer knowledge, including Microsoft Word, Excel, and PowerPoint.
Ability to effectively organize, multitask, and work in a fast-paced, timeline-driven work environment.
Detail-oriented with the ability to troubleshoot and resolve problems.
Ability to train and supervise the work of junior staff members.
Ability to coordinate work with other functions/departments to achieve project objectives.
Ability to provide expertise to management, technical project leaders, project/program leaders on method feasibility and risk assessment.
Excellent written and oral communication skills.
Experience with peptides (preferred).
Experience in both analytical development and quality control in the pharmaceutical/biopharmaceutical industry (preferred).
Base Salary Range:
$127,440 - $167,000
Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.
Total Rewards
We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.
Corporate Social Responsibility
Bachem takes responsibility for future generations by careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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