Job Overview
Compensation
Hourly
Range $13.25 - $17.00
Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k)
Paid vacation
Paid Personal Days
paid sick days
Annual performance bonus
Job Description
Bachem Americas is a leading specialty pharmaceutical company renowned for its expertise in the development and manufacture of peptides and complex organic compounds. As part of a global organization, Bachem is committed to providing high-quality products and services to the biotech, pharmaceutical, and other related industries. The company embraces innovation, operational excellence, and environmental responsibility, striving to make a positive impact through sustainable practices and social responsibility initiatives. Bachem was awarded the Gold Medal status by EcoVadis for its outstanding ecological performance and commitment to environmental awareness. The organization values diversity and fosters an inclusive workplace culture where all employees are treated with respect and given equal opportunities based on merit and qualifications.
The Commercial Manufacturing Team Member at Bachem Americas plays a crucial role within a multidisciplinary team comprised of members from Manufacturing, Quality Assurance (QA), and Quality Control (QC). This unique role operates within a matrix reporting structure, whereby team members maintain their functional reporting lines but are collectively accountable to the Commercial Manufacturing Team (CMT) Leader for the execution of projects and delivery of outputs. The team may be responsible for managing one or several products depending on their complexity. As new products transition from development to commercial stages, the CMT acts as the custodian overseeing the validation activities and filings, while driving process innovations to optimize product output and performance.
The role of the CMT Member is multifaceted and centers on advancing operational excellence and identifying continuous process improvement opportunities across manufacturing and quality functions. This position requires a deep understanding of the Plan-to-Produce process, with responsibilities spanning production planning, cycle time adherence, data monitoring, and collaboration with cross-functional stakeholders. The CMT Member contributes to ensuring that manufacturing and release processes adhere to the stringent Right First Time methodology, thereby securing the timely and compliant delivery of products to downstream customers.
In addition to operational responsibilities, the member actively participates in strategic planning and proposal development, including capital expenditures aimed at enhancing production capacity and efficiency. Regular communication with internal teams and customers is vital, facilitating transparency related to schedules, performance indicators, and deviation management. The role demands strong project management skills, expertise in regulatory compliance including GMP standards, and proficiency with industry-specific software such as SAP and LIMS.
Bachem offers a competitive base salary range of $70,658 to $97,155, determined by education, experience, and skillset. The total rewards package includes an annual performance bonus, comprehensive medical, dental, and vision coverage, 401(k) plan with employer match, and paid time off including vacation, personal, and sick days. Bachem’s commitment to social responsibility, sustainability, and employee development makes it an attractive employer for professionals in the pharmaceutical and biotech manufacturing sectors. This role is ideal for candidates who thrive in collaborative, fast-paced environments and are passionate about driving excellence in commercial manufacturing operations.
The Commercial Manufacturing Team Member at Bachem Americas plays a crucial role within a multidisciplinary team comprised of members from Manufacturing, Quality Assurance (QA), and Quality Control (QC). This unique role operates within a matrix reporting structure, whereby team members maintain their functional reporting lines but are collectively accountable to the Commercial Manufacturing Team (CMT) Leader for the execution of projects and delivery of outputs. The team may be responsible for managing one or several products depending on their complexity. As new products transition from development to commercial stages, the CMT acts as the custodian overseeing the validation activities and filings, while driving process innovations to optimize product output and performance.
The role of the CMT Member is multifaceted and centers on advancing operational excellence and identifying continuous process improvement opportunities across manufacturing and quality functions. This position requires a deep understanding of the Plan-to-Produce process, with responsibilities spanning production planning, cycle time adherence, data monitoring, and collaboration with cross-functional stakeholders. The CMT Member contributes to ensuring that manufacturing and release processes adhere to the stringent Right First Time methodology, thereby securing the timely and compliant delivery of products to downstream customers.
In addition to operational responsibilities, the member actively participates in strategic planning and proposal development, including capital expenditures aimed at enhancing production capacity and efficiency. Regular communication with internal teams and customers is vital, facilitating transparency related to schedules, performance indicators, and deviation management. The role demands strong project management skills, expertise in regulatory compliance including GMP standards, and proficiency with industry-specific software such as SAP and LIMS.
Bachem offers a competitive base salary range of $70,658 to $97,155, determined by education, experience, and skillset. The total rewards package includes an annual performance bonus, comprehensive medical, dental, and vision coverage, 401(k) plan with employer match, and paid time off including vacation, personal, and sick days. Bachem’s commitment to social responsibility, sustainability, and employee development makes it an attractive employer for professionals in the pharmaceutical and biotech manufacturing sectors. This role is ideal for candidates who thrive in collaborative, fast-paced environments and are passionate about driving excellence in commercial manufacturing operations.
Job Requirements
- Bachelor's degree in chemistry, chemical engineering, pharmaceutical sciences, or related field
- 4-6 years of experience in production, quality control, or quality assurance within pharmaceutical or chemical manufacturing
- 1-3 years experience in biotech, pharma, or CMO industry
- Knowledge of CMC development of APIs and KSAs
- Experience with Lean Six Sigma or equivalent operational excellence initiatives
- Experience working cross-functionally and managing daily priorities
- Proficiency with data analysis software such as Minitab
- Strong understanding of GMP and regulatory compliance
- Proficiency in SAP, LIMS, and quality systems
- Familiarity with project planning tools
- Excellent communication skills
- Strong project management capabilities
- Knowledge of peptide manufacturing preferred
- Effective interpersonal skills
- Strong organizational and attention to detail
- Ability to work in fast-paced environment
- Proactive communication style
- Strong problem-solving skills
- Excellent computer skills with MS Office, MS Project, Minitab, PowerBI, Master Control, SharePoint, ShareFile, ERP (SAP), and conferencing tools
- Ability to work independently
- Familiarity with drug substance characterization analysis
- Portfolio Management Professional (PMP) certification preferred
Job Qualifications
- Bachelor's degree in chemistry, chemical engineering, pharmaceutical sciences, or related field
- 4-6 years proven experience in production, quality control, or quality assurance within pharmaceutical or chemical manufacturing
- 1-3 years experience in biotech, pharma, or CMO industry with good knowledge of CMC development of APIs and KSAs
- Experience leading or contributing to operational excellence initiatives
- Green Belt certification in Lean Six Sigma or equivalent preferred
- Experience working in cross-functional teams and coordinating daily priorities
- Proficiency with data analysis software such as Minitab for data trending and KPI reporting
- Strong understanding of GMP and regulatory compliance and CMO business
- Proficiency in SAP, LIMS, and quality systems
- Familiarity with project planning tools and methodologies
- Excellent communication and cross-functional coordination skills
- Excellent project management skills including customer interactions, presentation, root cause analysis, and statistical data trending
- Knowledge of peptide manufacturing preferred
- Chemistry, Manufacturing, and Controls (CMC) knowledge including key guidelines such as ICHQ3C, Q3A, Q3R, Q7A, Q1, 21 CFR 514.8
- Effective interpersonal and facilitation skills working well in a team environment
- Strong organization, attention to detail, and ability to work in fast-paced environment
- Proactive and solution-focused communication including managing potential issues with management
- Strong problem-solving skills with ability to troubleshoot and implement solutions
- Excellent computer skills with MS Office, MS Project, Minitab, PowerBI, Master Control, Document-sharing systems (SharePoint, ShareFile), ERP (SAP), and online/video conferencing tools
- Ability to work independently and manage time effectively
- Familiarity with drug substance characterization analysis methods (HPLC, UPLC, LC-MS, MS, GC-MS, AAA, CHN)
- Portfolio Management Professional (PMP) certification preferred
Job Duties
- Assist CMT to ensure ongoing planning, production, analysis and review is performed within cycle time and committed service processing time in QC and QA
- Learn material and information flows within commercial setting to ensure robust and efficient product cycles
- Maintain and update end-to-end process mapping to adhere to Plan-to-Produce process while reducing cycle and service processing times
- Coordinate with Team Leader and schedulers to optimize production schedule ensuring product demand aligns with planned deliveries and commitments
- Participate in huddles to optimize equipment usage to improve operational equipment effectiveness and ensure SAP out-of-process and invoicing dates are communicated clearly
- Monitor key process data to maintain controlled manufacturing state and drive process improvements including revalidation and change implementation
- Communicate deviations and delays to relevant supervisors and assist in cross-functional investigations for resolution to maintain operational continuity
- Prepare for and attend customer interactions including meetings, workshops, and visits to coordinate key deliverables ensuring customer satisfaction
- Maintain production dashboard reflecting key performance indicators for manufacturing performance
- Develop proposals for capital expenditures as needed to meet production objectives and work with CMT Leader to develop strategic long-term operational initiatives
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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